Study on the legal aspects of supplementary protection certificates in the EU . Annex I, National reports EU.
Date: 2018-05-31
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
Subjects: European patent, free movement of goods, legislation, market approval, marketing standard, medicinal product, pharmaceutical legislation, plant health product, public health

Study on the Legal Aspects of 
Supplementary Protection 
Certificates in the EU 

Annex I: National Reports EU 

Written by 
Max Planck Institute for Innovation and Competition 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study on the Legal Aspects of SPCs – Annex I

EUROPEAN COMMISSION 

Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs 
Directorate F — Innovation and Advanced Manufacturing 

Unit GROW-F.5 — Intellectual property and Fight against Counterfeiting 

Contact: Alfonso CALLES SANCHEZ 

E-mail:  alfonso.calles-sanchez@ec.europa.eu 

European Commission 
B-1049 Brussels 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study on the Legal Aspects of SPCs – Annex I

Study on the Legal Aspects of 
Supplementary Protection 
Certificates in the EU 

Annex I: National Reports EU 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study on the Legal Aspects of SPCs – Annex I 

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Study on the Legal Aspects of SPCs – Annex I

INDEX 

INTRODUCTION .................................................................................. 1 

DENMARK ......................................................................................... 2 

Dr. Dorte Krehan Seir Petersen, Kim Fogtmann, María Victoria Rivas Llanos 

2 

FRANCE ......................................................................................... 12 

Mathilde Junagade Anais Collin 

12 

GERMANY ....................................................................................... 24 

Dr. Oliver Werner 

24 

HUNGARY ....................................................................................... 44 

Dr. Laszlo Vass, Ildikó Prohászka, María Victoria Rivas Llanos 

44 

LITHUANIA ...................................................................................... 54 

Dovilė Tebelškytė 

54 

POLAND ......................................................................................... 59 

Wioleta Świerczyńska 

59 

PORTUGAL ...................................................................................... 67 

Inês Cristóvão da Silva 

67 

ROMANIA ....................................................................................... 76 

Mirela Georgescu, María Victoria Rivas Llanos 

76 

  SPAIN ........................................................................................... 85 

Gabriel González Limas, María Victoria Rivas Llanos 

85 

  SWEDEN ........................................................................................ 96 

Mr. Joakim Sånglöf, Mr. Andreas Gustafsson, Mrs. Carolina Palmcrantz,  
Mrs. Terese Sandström 

96 

  THE NETHERLANDS ........................................................................... 105 

Dr. M.W. Martijn de Lange, Peter R. Slowinski 

105 

  UNITED KINGDOM ............................................................................ 110 

Fiona Warner, Michael Warren, Jason Bellia, Philip Mountjoy, Lawrence Cullen 

I 

 
 
 
 
 
 
 
 
 
 
 
     
 
Study on the Legal Aspects of SPCs – Annex I

INTRODUCTION 

The national reports have been drafted with the support of the corresponding national 
intellectual  property  offices.  The  purpose  of  the  reports  was  to  collect  information 
about the national rules implementing the SPC Regulations, the national practices and 
procedures.  Particular  attention  has  been  dedicated  to  the  questions  whether  the 
country  concerned  has  adopted  implementing  rules,  whether  the  national  office 
competent  for  the  grant  of  SPCs  has  published  guidelines  for  examination  of  SPC 
applications,  the  scope  of  the  SPC  application’s  examination,  the  product  definition, 
the  calculation  of  the  SPC  duration,  whether  the  SPC  application  is  published  and  to 
other aspects not addressed by the SPC Regulations. 

This  Annex  supplements  Chapter  20  of  the  Study,  where  the  information  collected  is 
summed  up  and  some  proposals  or  hypotheses  for  further  harmonisation  of  the 
applicable law have been discussed.  

The  report  includes  countries  whose  NPOs  conduct  full  examination  of  patents  and 
countries that do not provide full examination, countries that cover  large market and 
countries with a middle size market, countries that were founding members of the EU 
and countries that have more recent EU membership. 

In addition, the content of these reports has been supplemented by information which 
the  MPI  extracted  from  a  questionnaire  for  NPOs  elaborated  by  the  MPI  and  by  the 
information  received  in  a  workshop  organised  by  the  MPI  in  collaboration  with  the 
German Patent and Trade Mark Office in March 2017.  

1 

 
 
 
 
 
Study on the Legal Aspects of SPCs – Annex I

DENMARK 

Dr. Dorte Krehan Seir Petersen* Kim Fogtmann** María Victoria Rivas Llanos*** 

INTRODUCTION: THE SOURCES OF LAW 

Denmark  is  an  EPC  Contracting  State,  as  well  as  Member  of  the  Strasbourg 
Convention,  the  PCT,  the  PLT  and  the  TRIPS  Agreement.  Denmark  also  takes  part  in 
the enhanced cooperation in the area of the creation of unitary patent protection1 and 
ratified the UPCA in 2014. 

Patents  are  regulated  under  Patent  Act  No.  221  of  26  February  2017,2  which  Articles 
91 and 103 are dedicated to SPCs.  

The scope of protection of national patents3 and the rights conferred by such patents4 
are  regulated  by  provisions  with  similar  wording  to  that  of  Article  69  EPC  and  Article 
28 TRIPS Agreement respectively. 

The  requirements  for  patentability  are  the  same  as  those  of  the  EPC.5  The  same  is 
true  regarding  the  requirement  of  sufficiency  of  disclosure6  and  the  possibility  of 
amending the patent application.7 

Denmark  has  made  use  of  the  option  provided  by  Article  19  of  Regulation 
469/2009/EC and Article 18 of Regulation 1901/2006/EC to include in the national law 
special  procedural  provisions  on  SPCs  through  Order  No.  25  of  18  January  2013  on 

*   Dr. Dorte Krehan Seir Petersen - senior examiner, Danish Patent and Trademark Office. 
**   Kim Fogtmann - Legal advisor, Danish Patent and Trademark Office. 
***   María  Victoria  Rivas  Llanos  -  doctoral  student  and  junior  research  fellow,  Max  Planck  Institute  for 

Innovation and Competition. 

4  

2  
3  

1   See Regulation (EU) 1257/2012 of the European Parliament and of the Council of 17 December 2012 
implementing enhanced cooperation in the area of the creation of unitary patent protection [2012] OJ 
L361/1. 
The Ministry of Business and Growth, the Patent and Trademark Office, File No 16/00060. 
Patent Act No 191, Section 39: ‘The extent of the protection conferred by a patent shall be determined 
by the claims. For the interpretation of the claims the description may serve as a guideline’. 
Patent Act No 221, Section 3: 
(1) The exclusive right conferred by a patent shall imply that no one except the proprietor of the patent 
may without permission exploit the invention  
(i)  by  making,  offering,  putting  on  the  market  or  using  a  product  which  is  the  subject-matter  of  the 
patent, or by importing or stocking the product for such purposes, or  
(ii) by using a process which is  the subject-matter of the patent or by offering the process for use in 
this  country,  if  the  person  offering  the  process  knows, or  it  is  obvious  in  the  circumstances,  that  the 
process may not be used without the consent of the proprietor of the patent, or  
(iii) by offering, putting on the market or using a product obtained by a process which is the subject-
matter of the patent or by importing or stocking the product for such purposes.  
(2)  The  exclusive  right  shall  also  imply  that  no  one  except  the  proprietor  of  the  patent  may  without 
permission  exploit  the  invention  by  supplying  or  offering  to  supply  any  person  who  is  not  entitled  to 
exploit  the  invention  with  means  for  working  it  in  this  country,  if  these  means  relate  to  an  essential 
element  of  the  invention  and  the  person  supplying  or  offering  to  supply  the  means  knows,  or  it  is 
obvious in the circumstances, that they are suitable and intended for such use. This provision shall not 
apply when the means are staple commercial products, except when the person supplying or offering 
to supply the means induces the person supplied to commit the acts referred to in subsection 1. 
Patent Act No 221, Sections 1 to 2. 
Patent Act No 221, Section 8(2): ‘…The description shall be sufficiently clear to enable a person skilled 
in the art to carry out the invention…’ 
Patent Act No 221, Section 13: ‘An application for a patent may not be amended in such a way that the 
patent is applied for in respect of subject-matter which was not disclosed in the application as filed’. 

5  
6  

7  

2 

 
 
 
 
                                                 
  
  
  
  
  
Denmark 

Patents and Supplementary Protection Certificates8. Chapters 16 and 17 of this Order 
are dedicated to SPCs. 

INSTITUTIONAL ASPECTS 

The  patents  and  SPCs  granting  authority  in  Denmark  is  the  Danish  Patent  and 
Trademark Office (hereinafter DKPTO), which is part of the Danish Ministry of Business 
and Growth (previously called Ministry of Economic and Business Affairs).9 

The  DKPTO  is  headed  by  a  Director  and  the  Board  of  Appeal  for  Patents  and 
Trademarks.10 The latter is in charge of the examination of appeals from the decisions 
of the DKPTO pursuant to the Patent Act and  pursuant to the Designs Act, the Trade 
Marks Act, etc. The Board of Appeal consists of no more than 18 members, appointed 
for  a  term  of  five  years.  Two  of  the  members,  one  of  whom  is  the  chairman,  must 
possess  the  general  qualifications  for  appointment  to  the  office  of  high  court  judge, 
whereas  the  other  members  combined  must  possess  the  best  possible  expert 
knowledge  on  patents.  They  must  be  graduates  from  the  Technical  University  of 
Denmark (Danmarks Tekniske Universitet) or another institute of higher education or 
have  acquired  the  necessary  expert  knowledge  in  another  way.11  Considering  the 
circumstances  of  each  particular  case,  the  chairman  decides  which  and  how  many  of 
the members of the Board are to participate in the examination of the case.12 

The examiners of the DKPTO have a technical background and undertake substantive 
examination  of  patent  applications.  At  the  DKPTO,  the  technical  examiners  work  in 
close collaboration with the legal department.13 

In Denmark, applicants have the possibility of applying for a national patent before the 
DKPTO  pursuant  to  national  law  or  for  a  European  patent  before  the  EPO  under  the 
EPC rules. In addition, the DKPTO can act as receiving and designated office for patent 
applications internationally filed under the PCT procedure.14 

FILING OF THE APPLICATION AND PUBLICATION 

An  application  for  an  SPC  and/or  the  extension  of  its  duration  (with  regard  to 
medicinal products for paediatric use) must be filed by the owner of the basic patent15 
before  the  DKPTO16  in  Danish  or  English17  and  upon  fee  payment.18  The  application 

8 The Patent and Trademark Office, Order No. 25 of 18 January 2013, http://www.dkpto.org/media/183780/ 

the%20patent%20and%20trademark%20office%20order%202013%20no%20%2025.pdf. 

9   See:  Order  No126  of  19  February  2009  on  Reference  of  Certain  Rights  to  the  Patent  and  Trademark 

Office. 

10   Patent Act No 221, Section 7(1). 
11  
12  
13   MPI's  Questionnaire  for  National  Patent  Offices  of  the  EU  Member  States,  answer  to  questions  No  52 

ibid, Section 7(2). 
ibid, Section 7(3). 

and 54 by the DKPTO. 

14   Patent Act No 221, Section 28. 
15   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 3 by 

the DKPTO. 

16   Order No 25 of 18 January 2013 on Patents and Supplementary Protection Certificates, Section 70(1). 
17  
18  

Ibid, Section 71. 
Ibid, Section 70(4). 

3 

 
 
 
 
 
                                                 
Study on the Legal Aspects of SPCs – Annex I

must  contain  all  the  prescribed  information  under  Article  8  of  the  SPC  Regulations,19 
including the following information: 

The name and address of the applicant;20 
The name and address of the representative, if representation is required; 

i. 
ii. 
iii.  The number of the basic patent and the title of the invention; 
iv.  The  number  and  date  of  the  first  authorisation  to  place  the  product  on  the 
market  in  the  EEA  -when  the  marketing  authorisation  for  the  territory  of 
Denmark was not the first  one in the EEA-; and the number  and date of the 
first marketing authorisation to place the product on the market in Denmark, 
accompanied by a copy of both authorisations. 

The  application  must  be  filed  within  the  timeframe  indicated  in  Article  7  of  the  SPC 
Regulations.  Such  timeframe  is  calculated  according  to  national  provisions  regulating 
the calculation of time limits in the patent grant procedure. 

The  number  and  the  filing  date  of  the  SPC  application,  as  well  as  the  identity  of  the 
product, are published together with the information referred to in Article 9(2) of the 
SPC Regulations21 namely: 

The name and address of the applicant; 
The number of the basic patent and the title of the invention; 

i. 
ii. 
iii.  The  number  and  date  of  the  first  authorisation  to  place  the  product  on  the 
market  in  the  EEA  -when  the  marketing  authorisation  for  the  territory  of 
Denmark was not the first  one in the EEA-; and the number  and date of the 
first marketing authorisation to place the product on the market in Denmark. 

In addition, the SPC application must include information regarding the identity of the 
product covered by the marketing authorisation.22  

The  subject  matter  of  the  SPC  is  defined  as  the  production  definition.  The  DKPTO 
checks whether there is compliance between the indication of MA and the basic patent. 

Practice regarding the definition of the product is that the applicant has to define the 
product on the application form. All product definitions are examined case-by-case and 
Danish NPO has not any rules or guidelines on the product definition. However, Danish 
NPO do not accept the  wording of the claim as a product definition nor  “as protected 
by the basic patent” in the wording of the product definition is accepted. 

It  is  admissible  to  have  product  definition  “compound  y  in  all  acceptable  salts  and 
derivatives”, however, the wording of the claim must reflect the wording all acceptable 
salts  and  derivatives  i.e.  a  product  definition  “compound  Y  and  pharmaceutically 
acceptable salts and derivatives thereof” is acceptable as long as “acceptable salts and 
derivatives thereof” is reflected in the claims. 

Ibid, Section 70(2). 

19  
20   Order No 25 of 18 January 2013, Section 70(2): 

If a certificate is applied for by several persons jointly, and they are not represented by an agent, the 
application  shall,  moreover,  state  whether  any  of  the  applicants  shall  be  authorised  to  receive 
communications from the Patent and Trademark Office on behalf of all the applicants. If no recipient is 
stated, the applicant stated first shall receive communications from the Patent and Trademark Office on 
behalf of all the applicants… 

21   Order No 25 of 18 January 2013, Section 70(5). 
22   Order No 25 of 18 January 2013, Section 70(3). 

4 

 
 
                                                 
  
Denmark 

There  is  no  specific  practise  if  it  is  process  patent,  however,  where  the  method  of 
production  defines  the  nature  of  the  product  the  method  may  be  included  in  the 
product definition. 

In  the  case  of  a  biological  product,  DKPTO  would  admit  a  definition  that  include  in 
some  form  possible  future  biosimlars if  the  basic  patent is  bio-product  and  biosimilar 
thereof.  

In the case of second medical use is not accepted in the SPC product definition. 

The SPC application is published once the formal examination is completed. 

FORMAL EXAMINATION 

If the applicant has not complied with the requirements prescribed under Article 8 of 
the SPC Regulations at the date of filing of the application, the DKPTO will notify him 
accordingly and invite him to correct the application within a specified time limit. If the 
applicant fails to correct the application within the given time limit, the application will 
be shelved. However, the examination and other processing of the application will be 
resumed if the applicant takes steps to correct the application within four months after 
the  expiry  of  the  specified  time  limit  and  pays  the  prescribed  resumption  fee.23  If, 
after  having  received  the  applicant's  reply,  the  DKPTO  still  has  objections  to  the 
acceptance  of  the  application,  and  if  the  applicant  has  had  an  opportunity  to  file 
observations on the objections, the application will be refused, unless the DKPTO feels 
called  upon  once  more  to  invite  the  applicant  to  file  observations  or  correct  the 
application.24  25  The  applicant  must  demonstrate  through  these  observations  that  all 
the necessary information and facts that the DKPTO requires are provided in order for 
the DKPTO to start the substantive examination of the application. 

SUBSTANTIVE EXAMINATION26 

The DKPTO will examine the requirements under Article 3(a), (b) and (c) of Regulation 
469/2009/EC or Article 3(1)(a), (b) and (c) of Regulation 1610/96/EC. However, it will 
not  verify  whether  the  condition  of  Article  3(d)  of  Regulation  469/2009/EC  or  Article 
3(1)(d) of Regulation 1610/96/EC (i.e. that the authorisation to place the product on 
the market in Denmark is the first authorisation granted for that product in the EEA) is 
complied with. Therefore, the DKPTO may grant the SPC in absence of this condition. 
The  examination  is  performed  by  an  examiner  and  double-checked  by  a  second 
examiner. 

Danish  guidelines  are  compliant  with  both  the  Medeva  and  Neurim  case,  however, 
there has not yet been final national practice regarding Eli Lilly. 

23   Similar to the right to further processing under Article 121 EPC.  
24   Order No 25 of 18 January 2013 on Patents and Supplementary Protection Certificates, Section 74, in 

conjunction with Section 15(2) and (3) and Section 16 of Patent Act No 191 of 1 March 2016. 

25   An application may be refused if no further arguments are provided or if the DKPTO believes that no 

further arguments can be provided. 

26   Order No 25 of 18 January 2013, Article 73(1) and (2). 

5 

 
 
 
 
 
                                                 
Study on the Legal Aspects of SPCs – Annex I

  Examination of Medeva-requirement (specified in the claim27)  

The  Danish  Patent  Office  understands  Medeva  in  the  sense  that  the  fact  that  the 
product falls under the scope of protection of the basic patent is a necessary, but not 
sufficient  condition  to  consider  the  product  as  being  protected  by  the  basic  patent 
within the meaning of Art. 3(a). However, if the product is not specified in the claim of 
the  patent,  but  the  patent  can  be  limited  in  such  a  way  that  the  product  of  the  SPC 
can  be  considered  to  be  specified  in  the  wording  of  the  claims,  the  DKPTO  would 
consider Art. 3(a) satisfied by the application for the certificate. 

A product is considered to be specified in the wording of the claims when the product 
is  described  by  a  chemical  name,  a  structural  formula  i.e.  specifically  mentioned  or 
covered  by  a  Markush  formula.  A  product  can  in  some  cases  be  considered  to  be 
specified in the wording of the claims of the basic patent if the product is described by 
a functional term. 

  Implementation of Neurim (Art. 3(d) Reg. 469/2009)28 

DKPTO  has  taken  the  decision  in  Neurim  into  account  when  examining  SPC 
applications  for  second-medical  use.  It  is  possible  to  obtain  a  second  medical  use 
certificate  whether  one  goes  from  a  veterinary  product  to  a  human  product  (or  vice 
versa) or from a human product to another human product. Furthermore, it is possible 
to  obtain  a  second  medical  use  certificate  based  on  an  updated  marketing 
authorization  if  the  update  contains  a  new  therapeutic  application.  In  this  case,  it  is 
the  date  of  variation  which  is  the  date  of  the  marketing  authorization.  The  first 
marketing  authorization  in  the  EU  is  the  marketing  authorization  mentioning  the 
therapeutic application which the SPC is applied for. 

However,  all  applications  are  examined  case-by-case  on  the  basis  of  the  following 
criteria: 

scope of the basic patent; 
the marketing authorization; 

 
 
  new therapeutic indication. 

Regarding  MA,  more  than  one  MA  within  the  concept  of  “global  MA”  can  be  used  for 
the  purpose  of  SPC  and  thus  one  is  able  to  receive  a  new  SPC  on  a  variation  with 
regards to a new therapeutic indication. 

THIRD PARTY OBSERVATIONS 

Section  7  of  the  Public  Administration  Files  Act  No.  606  of  12  June  201329  enables 
“anyone” to apply for insight to a given administrative procedure. 

The  DKPTO  always  take  third-party  observations  into  account  when  examining  an 
application.30  When  DKPTO’s  decision  is  final,  the  third-party  is  informed  about  the 

27   The MPI Questionnaire, answer to question 19. 
28   The MPI Questionnaire, answer to question 37. 
29   Public  Administration  Files  Act  No.  606  of  12  June  2013,  https://www.retsinformation.dk/forms/ 

r0710.aspx?id=152299 . 

6 

 
 
 
                                                 
Denmark 

decision. If the observation was not regarded, the third-party will also receive a short 
explanation  of  why.  Further,  the  third-party  will  be  informed  about  the  possibility  of 
requesting administrative re-examination of the SPC. 

GRANTING  OR  REJECTION  OF  THE  SPC.  APPEAL  AND 
REVOCATION PROCEDURES 

The grant of the SPC is published in the Danish Official Patent Gazette, including the 
information required pursuant to Article 11(1) of the SPC Regulations,31 in addition to 
the  number  and  date  of  filing  of  the  SPC  application,  as  well  as  the  SPC  registration 
number.  The  same applies to the publication of the grant  of an  extension of the SPC 
duration  with  regard  to  medicinal  products  for  paediatric  use  (hereinafter  paediatric 
extension).32  There  is  no  certain  time  for  such  publication  set  by  law  and  the  Danish 
Official Patent Gazette is updated weekly. 

The  DKPTO  keeps  a  register  of  applications  for  SPCs  and  paediatric  extensions, 
containing  the  information  required  for  publication  under  Article  9(2)  of  the  SPC 
Regulations.  If  the  applicant  or  the  holder  is  represented  by  an  agent,  the  name  or 
firm  name  and  postal  address  of  the  agent  will  also  be  included  in  the  register.33  In 
addition, the SPC Register will include the information contained in the Patent Register 
regarding the basic patent.34 35 

The  refusal  of  an  application  for  an  SPC  or  a  paediatric  extension  will  also  be 
published, indicating the number and the filing date of the application, as well as the 
information referred to in Article 9(2) of the SPC Regulations including the identity of 
the product.36 

The  SPC  applicant  can  appeal  the  decision  of  the  DKPTO  before  the  Danish  Board  of 
Appeal  for  Patents  and  Trademarks37  not  later  than  two  months  from  the  notification 
of the decision and upon fee payment.38 

30   See  Order  No  25  of  18  January  2013  on  Patents  and  Supplementary  Protection  Certificates,  Section 

73(1). 

31   The name and address of the SPC holder, the number of the basic patent, the title of the invention, the 
number  and  date  of  the  first  authorisation  to  place  the  product  on  the  market  in  the  EEA  -when  the 
marketing authorisation for the territory of Denmark was not the first one in the EEA-, the number and 
date  of  the  first  marketing  authorisation  to  place  the  product  on  the  market  in  Denmark  and  the 
duration of the SPC. 

32   Order No 25 of 18 January 2013 on Patents and Supplementary Protection Certificates, Section 75(1). 
33  
34  
35  

ibid, Section 76(1). 
ibid, Section 76(2) in conjunction with Section 42. 
i.e. the date of the grant of the patent; the number of the application and the registration number of 
the patent; the classes of the patent; the name or firm name and postal address of the proprietor of 
the  patent;  if  the  proprietor  of  the  patent  is  represented  by  an  agent,  the  name  or  firm  name  and 
postal address of the agent; the name and postal address of the inventor; the title of the patent; the 
application's filing date, information as to where the application serving as a basis for claiming priority 
was filed and the date of filing and number of that application; the number of the parent application; 
the date on which the files of the application were made available to the public; if the patent comprises 
the deposit of a sample of biological material, information to that effect; and the cited documents. 

36   Order No 25 of 18 January 2013, Section 75(3) in conjunction with Section 70(5). 
37   Patent Act No 221, Sections 7(1) and 24(1). 
38   Patent Act No 221, Section 25(1). 

7 

 
 
 
 
                                                                                                                                                    
Study on the Legal Aspects of SPCs – Annex I

A request for re-examination of the SPC can be file by any person before the DKPTO, 
pursuant  to  the  invalidity  grounds  indicated  in  Article  15(1)  of  the  SPC  Regulations 
and upon fee payment.39 The request for re-examination must include: 

i. 

The  name  or  firm  name  and  postal  address  of  the  person  requesting  the  re-
examination;  
The SPC registration number and the name or firm name of the SPC holder;  

ii. 
iii.  The grounds within Article 15(1) of the SPC Regulations on which the request 
is  based  and  a  complete  account  of  all  the  facts,  evidence  and  arguments 
presented in support of those grounds;  

iv.  The  name  or  firm  name  and  postal  address  of  the  agent,  if  the  person 

v. 

requesting the re-examination is represented by an agent; 
In the case that licensees of the SPC holder are entered in the SPC Register, 
the request for re-examination must also include documentation to prove that 
such licensees have been notified that re-examination has been requested.40 

If  the  request  is  based  on  the  grounds  stated  in  Article  15(1)(a)  or  (b)  of  the  SPC 
Regulations,  the  DKPTO  will  notify  the  SPC  holder  of  the  request  for  re-examination 
and will give him the opportunity to file observations within a time limit of six months. 

The  DKPTO  will  then  undertake  the  re-examination  of  the  SPC  on  the  basis  of  the 
materials  and  the  grounds  produced  in  connection  with  the  request.  The  decision  of 
the  DKPTO,  which  may  be  to  revoke  the  SPC  or  to  maintain  it  unamended,  will  be 
notified to the parties.41 

There is no standard hearing procedure before Danish NPO. 

EFFECT  ON  THE  SPC  GRANTING  PROCEDURE  OF  PENDING 

REVOCATION  OR  OPPOSITION  PROCEDURES  AGAINST  THE 
PATENT42 

If the SPC re-examination request is based on the grounds stated in Article 15(1)(c) of 
the  SPC  Regulations,  a  re-examination  of  the  basic  patent  must  be  requested  at  the 
same time. In such a case, the re-examination of the SPC will be suspended until the 
re-examination of the basic patent has finished.43  

If the SPC re-examination request is filed during the period prescribed for the filing of 
oppositions  against  the  basic  patent  or  if  there  is  a  pending  opposition  against  the 
basic  patent,  the  DKPTO  will  suspend  the  re-examination  of  the  SPC  until  the 
opposition period has expired or a decision on the opposition request has been made. 

The re-examination of the SPC will also be suspended until the DKPTO has come to a 
decision  regarding  the  basic  patent,  when  a  previous  request  for  re-examination  or 
termination of the basic patent is still pending. 

39   Order No. 25 of 18 January 2013, Section 78(3). 
40  
41  
42  
43  

ibid, Section 78(1). 
ibid, Section 79. 
ibid, Section 78(2), in conjunction with Section 80. 
In case there is a pending re-examination of the basic patent during the SPC examination procedure, 
the  DKPTO  may  suspend  the  examination  of  the  SPC.  However,  the  DKPTO  does  not  suspend  the 
examination  automatically  and  the  applicant  can  submit  arguments  in  order  for  the  examination  to 
proceed. 

8 

 
 
 
                                                 
Denmark 

The  SPC  will  be  revoked  pursuant  to  Article  15(1)(c)  of  the  SPC  Regulations  if  the 
basic  patent is  revoked/declared  invalid  or if  the  basic  patent is  amended  to  such  an 
extent that the product for  which the SPC  was granted is no longer protected by the 
basic patent. 

CALCULATION  OF  THE  PATENT  AND  SPC  DURATION. 
CALCULATION OF TERMS. RELIEF BEFORE THE DKPTO 

Calculation of the patent and SPC duration 

According  to  Section  40  of  the  Danish  Patent  Act,  ‘[a]  granted  patent  may  be 
maintained  until  20  years  have  elapsed  from  the  date  of  filing  of  the  patent 
application...’ 

For  the  calculation  of  the  SPC  term,  the  DKPTO  takes  into  account  the  date  of 
signature  of  the  first  authorisation  to  place  the  product  on  market  in  the  EEA,  when 
such authorisation was granted by the Danish health authorities. However, if the first 
marketing authorisation was granted by the EMA, the relevant date for the calculation 
of  the  SPC  term  is  the  date  of  the  notification  to  the  applicant  of  the  grant  of  the 
marketing authorisation. 

Calculation of terms 

According to Section 40 of the Danish Consolidate Patents Act No. 221 of 26 February 
2017, a granted patent may be maintained until 20 years have elapsed from the date 
of filing of the patent application. On this basis, the patent term is calculated from and 
including the date of filing. The patent term expires 20 years later on the day having 
the same number as the date of filing. In practice this means that the DKPTO applies a 
“20  years  +  1  day”-rule,  in  compliance  with  Rule  131  of  the  EPC.  However,  the  SPC 
duration is not calculated with a “+ 1 day” rule. 

Relief before the DKPTO for missed deadlines44 

If  the  non-observance  of  a  time  limit  vis-à-vis  the  DKPTO  prescribed  in  the  SPC 
Regulations causes a loss of rights to an SPC applicant or proprietor who has taken all 
due care reasonably required, the DKPTO will re-establish his rights, upon request.  

The request must be filed with the DKPTO within two months from the removal of the 
obstacle causing non-observance of the time limit, but at the latest, one year after the 
expiry of the time limit. The omitted act must be completed and the prescribed fee for 
re-establishment of rights must be paid within the same time limits. 

Re-establishment  of  rights  may  also  be  granted  when  an  SPC  has  lapsed  under  the 
provisions of Article 14(c) or (d) of the SPC Regulations.  

The  request  for  re-establishment  of  rights  will  be  published  in  the  Danish  Official 
Patent Gazette. 

44   Order No 25 of 18 January 2013, Section 85 in conjunction with Patent Act No 191, Section 72. 

9 

 
 
 
 
 
 
 
                                                 
Study on the Legal Aspects of SPCs – Annex I

  REPRESENTATION BEFORE THE DKPTO 

The  DKPTO  may45  invite  the  applicant  to  appoint  an  agent  residing  in  the  EEA  to 
represent  him  in  all  matters  relating  to  the  application.46  If  an  agent  is  appointed,  a 
letter concerning the power of attorney must be filed,47 unless the appointed agent is: 

1)  a lawyer or  
2)  a patent attorney/advisor who  

a) 

is  employed  in  a  company  who  for  the  last  3  years  have  served  as  an 
agent for IP-applications,  

b)  declares that he or she is on the EPO professional advisor list, 
c)  declares that he or she has worked with IP rights and served as an agent 
for  applications  for  at  least  3  years  directly  up  to  the  to  the  current 
application, or  
is able to refer to a previous given power of attorney. 

d) 

  POST-GRANT AMENDMENT OF THE SPC DURATION  

According to Section 82(1) of Order No 25 of 18 January 2013, any person can file a 
request for re-examination of the SPC duration before the DKPTO, upon fee payment. 
Section  78  of  the  same  Order,  which  refers  to  the  filing  of  a  request  for  re-
examination of the SPC, will apply in the case  of a request for  re-examination of the 
SPC  duration,  provided  that  a  reference  is  made  to  the  grounds  of  Article  13  of  the 
SPC Regulations. 

If the  request  for  re-examination of the SPC duration is filed by another person than 
the  SPC  holder,  the  DKPTO  will  notify  the  SPC  holder  accordingly,  giving  him  the 
opportunity to file observations within a time limit of two months.48 

for  re-examination  meets  the 
The  DKPTO  will  decide  whether  the  request 
requirements  of  Section  82  in  conjunction  with  Section  78  of  Order  No  25  of  18 
January  2013.  If  the  request  meets  such  requirements,  the  DKPTO  will  change  the 
SPC duration, otherwise the request will be refused.49 

Both the filing of the request and the DKPTO's decision will be published and entered 
in  the  SPC  Register.  The  publication  of  the  DKPTO's  decision  will  state  the  name  or 
firm  name  of  the  SPC  holder,  the  number  and  filing  date  of  the  SPC  application,  the 
SPC registration number, the number of the basic patent, the title of the invention and 
the duration of the SPC. The publication of the filing of the request for re-examination 
will,  in  addition  to  the  aforementioned,  state  the  name  or  firm  name  of  the  person 
who requested the re-examination.50  

45   The DKPTO can only encourage the applicant to appoint an agent, but the applicant is free to choose 
whether or not to appoint one. In order to represent the applicant as an agent, the agent must reside 
in the EEA and be of legal age. 
46   Patent Act No 221, Section 12. 
47   Order No 25 of 18 January 2013, Section 102. 
48   Order No 25 of 18 January 2013, Section 82(3). 
49  
50  

ibid, Section 82(4). 
ibid, Section 84. 

10 

 
 
                                                 
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The above-mentioned under this section applies mutatis mutandis to the amendment 
of the duration of a paediatric extension.51 

  PAYMENT OF FEES 

The  maintenance  of  the  SPC  is  subject  to  a  renewal  fee,  to  be  paid  for  each  year 
commenced after the expiry of the term of the basic patent. The renewal fee falls due 
on the last day of the month in which the fee year begins and may not be paid earlier 
than  three  months  before  the  due  date.  If  the  applicant  fails  to  pay  the  renewal  fee 
within the prescribed time limit, he has the possibility to pay it with surcharge within 
six months after its original due date.52 

  ENFORCEMENT OF THE SPC 

A  published  SPC  application  grants  provisional  protection  to  the  applicant,  which 
entitles  him  to  claim  damages  for  infringement  during  the  transition  period.  The 
applicant  must  make  the  files  of  the  application  available  to  the  public  (in  Danish  or 
English) before he can assert his right.53 The national Maritime and Commercial Court 
is to decide whether or not the applicant should receive damages. 

Once  the  SPC  has  been  granted,  any  person  who  intentionally  or  grossly  negligently 
infringes the exclusive right conferred by an SPC will be punished with a fine. In such 
a case the proceeding will be instituted by the injured party. 

If  the  infringement  has  been  committed  intentionally  and  under  aggravating 
circumstances,  the  penalty  may  increase  to  imprisonment  of  up  to  one  year  and  six 
months,  unless  a  heavier  penalty  is  provided  for  by  Section  299b54  of  the  Penal 
Code.55  Aggravating  circumstances  will  be  considered  to  exist  in  particular  if  a 
significant and obviously unlawful profit is intended by the infringement. In this case, 
proceedings  will  be  instituted  only  at  the  request  of  the  injured  party  unless  the 
institution of proceedings is required in the interests of the public.56 

ibid, Section 83. 
ibid, Section 77. 

51  
52  
53   Patent Act No 221, Section 60. 
54  
55  
56   Patent Act No 191, Section 91(3) in conjunction with Section 57. 

Imprisonment for up to six years, in case of patent infringement of a particularly serious nature. 
Justitsmin, j nr 2016-730-0967. 

11 

 
 
 
 
 
                                                 
Study on the Legal Aspects of SPCs – Annex I

FRANCE 

Mathilde Junagade Anais Collin 

INTRODUCTION: THE SOURCES OF LAW 

France is an active member of all the relevant intellectual property agreements at the 
European and international level in the field of patents. It was a Contracting State of 
the  EPC  and  founding  member  of  the  European  Patent  Organisation  since  1973,  a 
party  of  the  PCT  and  the  PLT,  as  well  as  a  member  of  the  TRIPS  Agreement. 
Furthermore,  France  was  a  Contracting  State  of  the  Strasbourg  Convention  and 
ratified this Agreement on 27 February 1980. Finally, France is a Contracting State of 
the UPCA and takes part in the enhanced cooperation for the creation of unitary patent 
protection.57  

Patent  protection  in  France  can  be  obtained  therefore  by  filing  a  European  patent 
application  with  the  EPO  or  by  filing  a  national  patent  application  with  the  National 
Patent Office, the INPI. Provisions dealing with national patents are laid down in Book 
6, Title I, of the Intellectual Property Code58 (hereinafter IPC). European and national 
patents  are  subject  to  provisions  and  conditions  that  are  largely  uniform,  since 
national patent law was aligned with the substantive provisions of the EPC. 

The  scope  of  protection  of  national  patents59  and  the  rights  conferred  by  such 
patents60 are regulated by provisions with wording similar to that of Article 69 EPC and 
Article 28 TRIPS Agreement respectively. The scope of protection of European patents 
is governed in national proceedings directly by Article 69 EPC; the rights conferred by 
the  European  patents  are  subject  to  the  same  provisions  that  apply  to  national 
patents.61 

The  requirements  for  patentability  that  apply  to  national  patent  applications  (articles 
L.611-10 to L.611-19 IPC) are similar to those of Articles 52 to 57 EPC. The wording of 
the provision governing the requirement for a sufficient disclosure is also aligned with 

   Mathilde Junagade - INPI – Direction Juridique et Financière. 
   Anais Collin - INPI – Direction de la Propriété industrielle.  
57   See Regulation (EU) 1257/2012 of the European Parliament and of the Council of 17 December 2012 
implementing enhanced cooperation in the area of the creation of unitary patent protection  [2012] OJ 
L361/1. 

60  

58   The IPC was created by the Law n° 92-957 of July, 1st, 1992, published in the OJ dated 3 July 1992 
59  

IPC,  Article  L613-2:  ‘L'étendue  de  la  protection  conférée  par  le  brevet  est  déterminée  par  les 
revendications.  Toutefois,  la  description  et  les  dessins  servent  à  interpréter  les  revendications.  Si 
l'objet  du  brevet  porte  sur  un  procédé,  la  protection  conférée  par  le  brevet  s'étend  aux  produits 
obtenus directement par ce procédé’. 
IPC, Article L613-3: 
Sont interdites, à défaut de consentement du propriétaire du brevet :  
a)  La  fabrication,  l'offre,  la  mise  dans  le  commerce,  l'utilisation,  l'importation,  l'exportation,  le 
transbordement, ou la détention aux fins précitées du produit objet du brevet; 
b)  L'utilisation  d'un  procédé  objet  du  brevet  ou,  lorsque  le  tiers  sait  ou  lorsque  les  circonstances 
rendent  évident  que  l'utilisation  du  procédé  est  interdite  sans  le  consentement  du  propriétaire  du 
brevet, l'offre de son utilisation sur le territoire français;  
c) L'offre, la mise dans le commerce, l'utilisation, l'importation, l'exportation, le transbordement ou la 
détention aux fins précitées du produit obtenu directement par le procédé objet du brevet. 

61   EPC, Article 64(1). 

12 

 
 
 
 
                                                 
  
  
  
  
France 

the  corresponding  provision  of  the  EPC.  The  same  holds  true  for  the  revocation 
grounds of the national patents. They are all consistent with Article 138 EPC62.  

In France, a system of national SPCs was introduced by the law n° 90-510 of 25 June 
199063.  It  was  then  replaced  by  the  system  of  European  SPCs  when  Regulation 
EEC/1768/92 came into force. 

The  IPC  contains  provisions  in  its  Book  6  “Protection  of  Inventions  and  Technical 
Knowledge”  designating,  amongst  provisions  applicable  to  patents,  those  which  are 
applicable  also  to  SPCs.  Those  provisions  (Articles  L611-2  and  R617-2)  were  first 
introduced  for  application  to  former  national  SPCs,  and  now  apply  to  European  SPCs 
under Regulations EEC/1768/92, EC/469/2009 and EC/1610/96. The IPC also contains 
a provision concerning procedural aspects of SPCs’ fee payment (Article R617-1), and 
the following provisions concerning the examination’s timeframe: 

Article R617-2-1 IPC:  

The  Institute  shall  decide  on  the  application  for  a  supplementary  protection  certificate  within 
twelve months of  the date  of  filing  said  application.  If  the  Institute  notifies  the  applicant  of  any 
deficiencies,  this  time  limit  shall  be  interrupted  until  the  deficiencies  are  remedied  pursuant  to 
Reg. (EC) No. 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning 
the creation of a supplementary protection certificate for plant protection products and Reg. (EC) 
No.  469/2009  of  the  European  Parliament  and  of  the  Council  of  6  May  2009  concerning  the 
supplementary protection certificate for medicinal products.  
The  provisions  of  the  first  paragraph  of  this  Article  shall  be  applicable  to  applications  for  an 
extension  filed  pursuant  to  the  provisions  of  Article  36  of  Reg.  (EC)  No.  1901/2006  of  12 
December 2006 on medicinal products for paediatric use and amending Reg. (EC) No. 1768/92, 
Dir. 2001/20/EC, Dir. 2001/83/EC and Reg. (EC) No. 726/2004.  

Article R617-2-2 IPC:  

In  the  absence  of  an  express  decision  within  the  time  limit  referred  to  in  Article  R617-2-1,  the 
application shall be deemed to be refused. 

INSTITUTIONAL ASPECTS 

The  National  Institute  of  Industrial  Property  (INPI)  is  a  self-financing  agency  created 
in  1951,  ruled  by  the  IPC.  It  is  placed  under  the  supervision  of  the  ministry 

62   Article L613-25 : Le brevet est déclaré nul par décision de justice :  

a) Si son objet n'est pas brevetable aux termes des articles L. 611-10, L. 611-11 et L. 611-13 à L. 611-
19;  
b) S'il n'expose pas l'invention de façon suffisamment claire et complète pour qu'un homme du métier 
puisse l'exécuter ;  
c)  Si  son  objet  s'étend  au-delà  du  contenu  de  la  demande  telle  qu'elle  a  été  déposée  ou,  lorsque  le 
brevet a été délivré sur la base d'une demande divisionnaire, si son objet s'étend au-delà du contenu 
de la demande initiale telle qu'elle a été déposée ;  
d) Si, après limitation, l'étendue de la protection conférée par le brevet a été accrue.  
Si les motifs de nullité n'affectent le brevet qu'en partie, la nullité est prononcée sous la forme d'une 
limitation correspondante des revendications.  
Dans le cadre d'une action en nullité du brevet, son titulaire est habilité à limiter le brevet en modifiant 
les revendications ; le brevet ainsi limité constitue l'objet de l'action en nullité engagée.  
La  partie  qui,  lors  d'une  même  instance,  procède  à  plusieurs  limitations  de  son  brevet,  de  manière 
dilatoire  ou  abusive,  peut  être  condamnée  à  une  amende  civile  d'un  montant  maximum  de  3  000 
euros, sans préjudice de dommages et intérêts qui seraient réclamés. 

63   Published in OJ n° 147, June 27, 1990 

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Study on the Legal Aspects of SPCs – Annex I

responsible  for  industry,  except  for  what  concerns  the  examination  and  issuance  of 
titles. 

The  INPI  employs  around  780  persons  and  has  several  national local representations 
(23 sites) and international representations (11 sites).  

The  INPI  is  in  charge  of  granting  industrial  property  rights  (including  patents, 
trademarks,  designs,  supplementary  protection  certificates  and  geographical 
indications on manufactured goods), centralising and delivering information in the field 
of  industrial  property.  It  implements  laws  and  regulations  on  industrial  property  and 
takes  initiative  for  their  adaptation  to  the  needs  of  innovators  and  enterprises.  It 
participates  in  the  drafting  of  international  agreements  and  the  representation  of 
France in the relevant international organisations. 

Under  the  national  patent  procedure  the  INPI,  a  first  administrative  and  preliminary 
technical examination is performed the main purposes of which are to withdraw patent 
applications  related  to  matter  excluded  from  patentability  and  to  ask  technical 
clarification  before  performing  the  interiorities  search.  After  this  first  examination, 
INPI  directs  80%  patent  applications  to  the  EPO  for  the  preliminary  search  report 
(PSR)  and  written  opinion  and  performs  internally  20%  of  the  preliminary  search 
report  (PSR)  and  written  opinion.  Then,  a  second  technical  examination  takes  place: 
the applicant’s observations or amendments in response to the PSR are examined by a 
technical patent examiner (qualified with a technical master degree)  who draws up a 
definitive search report and grants the patent. The INPI has authority to grant patents 
if the novelty criterion is fulfilled. If the patent examiner considers that the inventive 
step  is  not  certain,  he  mentions  it  on  the  definitive  search  report.  The  INPI  cannot 
reject an application with the argument that the subject matter is not inventive, but it 
can  do  that  with  the  argument  that  the  subject  matter  is  not  novel  or  industrial 
applicable or is not a technical invention. 

The  INPI  is  also  the  national  competent  authority  to  grant  SPCs  according  to  Article 
9(1) of the SPC Regulations.  

FILING  OF  THE  APPLICATION.  PUBLICATION  OF  THE 
APPLICATION 

In France, an SPC application can be filed at the INPI by the owner of the basic patent 
himself  or  by  an  authorised  representative.64  If  the  patent  is  owned  by  several 
entities, a common representative is entitled to file the SPC application.  

The  request  form  must  be  filled  out  according  to  the  formal  requirements  stipulated 
under Article 8 of the SPC Regulations, including mandatorily the name of the product 
for  which  the  grant  of  the  SPC  is  sought,  which  must  comply  with  the  definition  of 
Article 1(b) of Regulation EC/469/2009 (“the active ingredient or combination of active 
ingredients of a medicinal product”) and in Article 1 of Regulation EC/1610/96 ( “the 
active  substance  or  combination  of  active  substances  of  a  plant  protection  product”). 
This product is either designated by its INN (International Non-proprietary Name), as 
mentioned in the summary of product characteristics of the marketing authorization or 

64  

IPC, Article R. 612-2. 

14 

 
 
 
                                                 
France 

by  a  functional  name  where  the  product  does  not  have  an  INN.  References  to  an 
adjuvant or excipient are not permitted in the product identification.65 The request can 
also  contain  information  proving  that  the  product  is  protected  by  the  basic  patent 
indicated by its proprietor for the purpose of obtaining the SPC. 

The  protection  conferred  by  a  certificate  shall extend  only  to  the  product  covered  by 
the marketing authorisation and for any use of the product as a medicinal product or 
plant protection product that has been authorised before the expiry of the certificate. 

According to the French practice, a wording such as “product X in any form protected 
by  the  basic  patent”  in  the  definition  of  the  product  is  accepted.  Furthermore,  a 
wording such as “product X and its salts and esters” in the definition of the product is 
accepted,  provided  that  designated  forms  are  also  protected  by  the  basic  patent. 
Nevertheless,  a  wording  such  as  “product  X  and  its  mutants  and  variants”  in  the 
definition  of  the  product  is  not  accepted  because  the  mutants  and  variants  are  not 
considered to be the same active ingredient as the product. Moreover, a wording such 
as  “product  X  and  biosimilar  within  the  meaning  of  the  article  10(4)  of  the  Directive 
2001/83/EC, as protected by the basic patent” is not accepted either. 

The  application  must  be  filed  within  the  timeframe  indicated  in  Article  7  of  both  SPC 
Regulations: “within 6 months of the date on which the patent is granted or within 6 
months of the date on which the authorisation referred to in Article 3(b) to place the 
product on the market as a medicinal product was granted”. Where the patent owner 
files the SPC application after the expiry of the 6 month time period, he can ask a re-
establishment of right with a legitimate reason.  

Finally, the application should also include a proof of payment of the application fee.  

If the application includes a  request for paediatric extension, required documentation 
pursuant to Article 8(1) (d) of Regulation EC/469/2009 must also be included. 

The  SPC  applications  are  published  at  the  Bulletin  Officiel  de  la  propriété  industrielle 
(BOPI) within four weeks of their filing. The SPC extensions are published within four 
weeks of their grant. They are also made available on the patent database on the INPI 
website. 

FORMAL EXAMINATION  

Upon reception of the application, the INPI examines that the application fee has been 
paid, that the patent is in force at the date of filing of the SPC application and that the 
application  contains  the  necessary  information  for  its  publication  according  to  Article 
9(2) of the SPC Regulations. 

In the event of a formal irregularity being observed or in case of a missing document, 
for  example  the  marketing  authorisation,  this  formal  irregularity  is  notified  to  the 
applicant  at  the  same  time  as  the  substantive  irregularities.  Irregularities  may  be 
rectified within two months (extendable once  by the same time period), failing which 
the application is rejected.  

65   CA Paris, September 11th, 2013, Lantheus v/ INPI. 

15 

 
 
 
 
                                                 
Study on the Legal Aspects of SPCs – Annex I

The French Office is required by law to grant or reject the SPC within one year of the 
request.  However,  the  notification  of  an  irregularity  interrupts  this  time  period  until 
regularisation, at which point the time period is re-initialised. 

SUBSTANTIVE EXAMINATION 

The French Office examines ex officio all the substantive requirements for issuing the 
SPCs. The examination is carried out by three technical examiners with post-graduate 
qualifications in biology or chemistry. Legal aspects are handled by a legal expert, who 
also  defends  the  decisions  of  the  Office  on  SPCs  in  case  of  judicial  appeal  before  the 
Court of Appeal.  

The practice of the INPI is reflected in its  guidelines for examination of SPC, updated 
in 2017, which are made available on the INPI website, both in French and in English. 

The  active  ingredient  for  which  the  SPC  application  is  filed  shall  be  the  substance 
identified  as  active  substance  in  the  MA,  “qualitative  and  quantitative  composition” 
rubric  of  the  summary  of  the  product  characteristics.  A  SPC  cannot  be  granted  for  a 
combination  of  two  substances,  where  only  one  of  them  is  identified  as  active 
substance in the MA.  

The  INPI considers a new  salt  as a new product if it’s covered by the MA and by the 
basic patent, and if the MA is the first MA for this salt.  

In accordance with CJEU ‘Farmitalia’ case law a definition such as “compound Y in all 
acceptable  salt  and  esters”  is  accepted,  provided  that  said  “salts  and  esters”  are 
protected by the basic patent. 

A product definition such as ‘compound y in all acceptable salts and derivatives”, is not 
admitted because “derivatives” may cover several different products. 

As  regards,  more  specifically,  the  examination  under  Article  3(a)  of  Regulation 
EC/469/2009, the Office checks whether the product is specified in the wording of the 
claims in accordance with the Medeva66 case law. In the event that the claims relate to 
a product defined under a functional formula implicitly covering the one requested for 
the  SPC,  the  INPI  ensures  that  these  claims,  interpreted  in  light  of  the  description, 
necessarily and specifically target the product, conformant to Eli Lilly67 case law. This 
may  be  the  case  if  the  product  is  identified  in  an  example  or  as  a  preferred 
embodiment in the description, for  example under its chemical name or its structural 
form.  

If  there  is  no  mention  and  individual  disclosure  of  the  product  in  the  patent 
specification  so  that  the  patent  cannot  be  limited  to  such  a  product  without  violating 
the French provisions corresponding to art. 123 (2) EPC, it isn’t still possible to get a 
SPC.  

As for Markush formulae, the product is considered to meet the requirement of Article 
3(a)  of  the  SPC  Regulations  if  it  appears  to  be  covered  by  the  Markush  formulae 

66   Case C-322/10 Medeva [2011] ECR I-12051. 
67   Case C-493/12 Eli Lilly and Company [2013].  

16 

 
 
 
                                                 
France 

identified in the claims, even if the product is not precisely identified in the wording of 
the claims or in the description. 

In  the  case  of  SPCs  filed  for  combinations  of  products  such  as  "A  +  B",  the  SPC  is 
refused  if  the  applicant  has  already  obtained  an  SPC  on  A  in  the  same  basic  patent 
(regardless of whether the patent is subject to a limitation in the interval between the 
issuance of the first SPC and the second one’s application or it is rejected) unless A + 
B constitutes a "totally separate innovation" compared to A. The INPI does not, in this 
case, undertake an analysis of what constitutes the "inventive step of the patent", but 
only engages in an interpretation of the claims in the light of the description. 

The fact that both A + B and A are claimed independently in the basic patent can itself 
be considered to indicate that they are separate innovations. 

Conversely, the fact that the patent claims only A and that the possible association of 
A with an ingredient such as B is merely evoked in the description does not allow for 
the conclusion that A + B constitutes the subject-matter of the invention68. 

Concerning the examination of Article 3(b) and (d) of the SPC Regulations, the French 
Office,  in  connection  with  the  national  health  authorities  (the  ANSM  or  the  ANSES), 
ensures  that  the  marketing  authorisation  specified  in  the  application  is  the  first 
marketing authorisation for the product as a medicinal product, without regard to the 
medical use identified in the marketing authorisation and whether this MA was in force 
at the date of filing of the SPC application.  

In  exceptional  cases,  where  the  marketing  authorisation  is  not  the  first  for  the 
product,  but  the  applicant  relies  on  the  Neurim69  case  law  of  the  CJEU,  the  French 
Office examines the medical use of the marketing authorisation and the patent, based 
on a strict interpretation of the notion of “new medical use”. The criteria of the Neurim 
case  law  is  considered  satisfied  if,  on  one  hand,  the  patent  is  -strictly  speaking-  a 
patent  for  a  “new  medical  use”  and,  on  the  other  hand,  if  the  new  medical  use 
identified in the marketing authorisation concerns the treatment of a different disease 
–  falling in  the  scope  of  the  protection  of  the  basic  patent.70  A  new  dosage  or  a  new 
form  of  the  medicinal  product  or  the  treatment  of  a  new  population  group  is  not 
considered  as  “new  medical  uses”.  The  French  office  applies  Neurim  even  if  both  MA 
are for a human use but the second MA, provided the 2d MA is for a new medical use. 

Finally, the INPI verifies that the product has not already been subject to an SPC, as 
required by Article 3(c) of the SPC Regulations. In this regard, it is irrelevant whether 
the previous SPC was issued for the product obtained by another process,71 or having 
a different degree of concentration, or different purity. Similarly, it is irrelevant that a 
first  SPC  has  been  issued  for  the  racemate  and  that  the  second  is  required  for  an 
enantiomer.72  Where  two  applications  from  the  same  applicant  for  the  same  product 
are pending before the INPI, the applicant shall be asked to choose one and the other 
one shall then be rejected by the Office. 

68   CA Paris: June 8th, 2012, Boerhinger v. INPI and May 30th, 2014 Syngenta v. INPI. 
69   Case C-130/11 Neurim Pharmaceuticals [2012]. 
70   CA Paris, February 15th, 2013, Merck & Co v/ INPI. 
71   CA Paris, April 12th, 2016, The Government of the USA v/ INPI. Cass.com, September 29th.2009, AETS 

v/ INPI. 

72   CA Paris, June 9th, 2010, Syngenta Participations v/ INPI. 

17 

 
 
 
                                                 
Study on the Legal Aspects of SPCs – Annex I

THIRD PARTY OBSERVATIONS 

French  Law  does  not  allow  third  party  observations.  Where  such  observations  are 
addressed to the Office, the Office transmits them to the applicant for information but 
does not take them into account in its examination. 

EFFECT  ON  THE  SPC  GRANTING  PROCEDURE  OF  PENDING 

REVOCATION  OR  OPPOSITION  PROCEDURES  AGAINST  THE 
PATENT 

The  time  frame  of  one  year  imposed  by  aforesaid  article  R.617-2  IPC  on  the  French 
Office  to  grant  or  reject  the  SPC  is  regardless  of  any  revocation  or  opposition 
procedure  that  may  be  pending  against  the  basic  patent.  However,  the  Office  may 
accept  to  delay  the  procedure  within  the  constraints  of  this  legal  limit.  According  to 
Article R617-2-1 IPC and Article R617-2-2 IPC if the time frame is not respected, the 
SPC application is deemed to be rejected. 

GRANTING OR REJECTION OF THE SPC. APPEAL PROCEDURE 

Where the SPC application (or the paediatric extension) is regular, the INPI grants the 
SPC  (or  the  paediatric  extension)  and  notifies  the  SPC  owner  the  decision  by 
specifying the date and number of the Official Bulletin of Industrial Property in which 
the decision is to be published, according to Article 11(1) of the SPC Regulations. This 
grant  is  registered  in  the  Patents  National  Register  and  all  documents  relating  to  the 
examination are made available on the INPI’s website.  

Where  the  SPC  application  (or  the  paediatric  extension)  is  irregular,  the  INPI  rejects 
the  SPC  application  (or  the  paediatric  extension)  and  notifies  the  applicant  the 
rejection.  This  rejection  decision  is  published  in  the  Official  Bulletin  of  Industrial 
Property, according to Article 11(2) of the SPC Regulations, registered in the National 
Patents Register, and all documents relating to the examination are made available on 
the INPI’s website. 

The right to request an oral hearing is not formally written in law. However, this may 
be granted at the request of the applicant if the Office considers it appropriate. 

The  possibility  of  appealing  the  INPI’s  decision  on  the  grant  or  rejection  of  the  SPC, 
within  the  meaning  of  Article  of  18  Regulation  EC/469/2009  and  Article  17  of 
Regulation EC/1610/96 is provided by Article L.411-4 of the IPC. The  appeal shall be 
filed  within  one  month  (three  months  for  non-French  resident  appellants)  from  the 
notification  or  publication  of  the  decision,  before  the  Paris  Court  of  Appeal,  which  is 
the  sole  national  Court  competent  in  the  field  of  patents.  The  INPI  submits 
observations to the Court during the appeal procedure in order to defend its decision. 

18 

 
 
 
 
 
France 

CALCULATION  OF  THE  PATENT  AND  SPC  DURATION. 
CALCULATION OF TERMS. RELIEF BEFORE THE INPI 

Calculation of the patent and SPC duration 

Calculation of the patent duration:  

According to Article L611-2 IPC, inventions shall be protected by patents, granted for 
a term of 20 years from the day the application is filed. 

The  patent  expires  on  the  day  prior  to  the  anniversary  date  of  its  application;  for 
example, a patent filed on 21/02/1997 expires on 20/02/2017 at midnight. 

As regards calculation of SPC duration, according to Article 13 of the SPC Regulations, 
the  certificate  takes  effect  at  the  end  of  the  lawful  term  of  the  basic  patent  for  a 
period  equal  to  the  elapsed  period  between  the  date  on  which  the  application  for  a 
basic patent was lodged and the date of the first authorisation to place the product on 
the  market  in  the  Community,  reduced  by  a  period  of  five  years.  The  maximum 
duration of the certificate may not exceed five years. 

In  accordance  with  CJEU  Seattle  Genetics73  case  law,  where  the  first  marketing 
authorisation  in  the  EU  as  referred  to  in  Article  13  of  the  SPC  Regulations  is  a 
European  marketing  authorisation,  its  “date”  is  considered  to  be  the  date  of  its 
notification; whereas the “date” of a French marketing authorisation is the date of the 
decision. 

According to CJEU Merck74 case law, in order to allow a possible paediatric extension, 
the INPI does not reject SPCs with negative duration, provided this negative duration 
is no longer than six months.75 

Calculation of terms 

The current method for calculation of SPC term applied by the INPI is as follows: 

The term of the SPC is fixed corresponding to the less favourable of the two following 
calculations: 

  Date of issue of the marketing authorisation (notification or granting according 

to Seattle’s case) + 15 years. 

  Date of the legal term of the patent (the day before the anniversary date of the 

patent) + 5 years. 
E.g.:  an  SPC  is  attached  to  a  patent  filed  on  November  29th,  1994,  which 
reaches  the  end  of  its  legal  term  on  November  28th,  2014.  The  marketing 
authorisation corresponding to the SPC is granted on August 11th, 2004. 

  Expiry of 5 years from the legal term of the patent: November 28th 2019. 
  Expiry  of  15  years  from  the  date  of  issue  of  the  marketing  authorization: 

August 11th 2019. 

73   Case C-471/14 Seattle Genetics Inc. [2015]. 
74   Case C-555/13 Merck Canada Inc. [2014]. 
75   CA Paris, July 5th, 2013, Hoffmann-Laroche v/ INPI. 

19 

 
 
 
 
 
 
 
                                                 
Study on the Legal Aspects of SPCs – Annex I

The SPC term is fixed on August 11th 2019. 

Relief before the INPI for missed deadlines 

Article  L.612-16  IPC  allows  an  applicant  who  has  not  complied  with  a  time  limit  as 
regards the INPI to submit a request for reinstatement of his rights if he is able to give 
a legitimate reason and if the direct consequence of the hindrance has been refusal of 
his patent application or of a request or the loss of any other right or means of appeal. 

The  appeal  must  be  submitted  to  the  Office  within  two  months  of  the  hindrance 
ceasing  to  exist.  The  act  that  has  not  been  carried  out  must  be  accomplished  within 
that  period.  The  appeal  shall  only  be  admissible  within  a  period  of  one  year  from 
expiry of the time limit not complied with. 

This provision applies to SPC. 

Article  R612-52  IPC  also  provides  for  the  right  of  a  patent  -or  SPC-  applicant  to 
request further processing with respect to the application in cases where he has failed 
to comply with a time limit fixed by the Office:  

If a patent application is refused or is liable to be refused due to failure to comply with 
a time limit afforded by the National Institute of  Industrial Property, the refusal shall 
not  be  pronounced  or  shall  not  have  effect  if  the  applicant  submits  a  request  to 
continue  the  procedure.  The  request  shall  be  submitted  in  writing  within  a  period  of 
two  months  as  from  notification  of  the  refusal  decision.  The  act  that  has  not  been 
carried  out  shall  be  carried  out  within  that  time  limit.  A  request  shall  be  admissible 
only if accompanied by payment of the required fee. 

  REPRESENTATION BEFORE THE INPI 

Pursuant to Article R. 612-2 of IPC, the election of a representative is only mandatory 
if the applicant is not an EU or EEA resident. A representative, where elected, must be 
a qualified patent attorney or a barrister.  

  POST-GRANT  AMENDMENT  OF  THE  SPC  DURATION.  POST-

GRANT LIMITATION OR REVOCATION OF THE PATENT 

  Post-grant amendment of the SPC duration 

With regard to appeals concerning the duration of the certificate, the INPI implements 
Article  17(2)  of  Regulation  EC/1610/96,  which  allows  the  applicant  to  correct  the 
duration  of  the  certificate  if,  as  a  result  of  an  error  on  his  part,  the  date  of  the  first 
marketing authorisation in the Community as contained in the SPC application appears 
to be incorrect. However, as for any appeal against a decision of the INPI, this appeal 
may be exercised: 

  before  the  Paris  Court  of  Appeal,  within  one  month  of  the  notification  of  the 

decision to issue the SPC 

20 

 
 
 
France 

  before  the  INPI  itself,  provided  that  such  appeal  has  been  exercised  within  a 
period  which  allows  the  Office  to  amend  its  decision  at  the latest  four  months 
after its issue. 

Where  the  duration  of  the  certificate  is  incorrect  because  of  the  INPI  itself,  in 
particular in the light of the Seattle Genetics case law of the CJEU, it is also possible: 

 

 

for the SPC  owner, to lodge an  appeal before  the Paris Court  of Appeal within 
one month of notification of the SPC grant decision 
for  the  Office,  to  amend  this  expiry  date,  ex  officio  or  on  request;  such 
amendment  to  be  made  within  four  months  from  the  issuance  of  the  grant 
decision, in accordance with the provisions applicable to French administrative 
decisions and in particular Articles L.242-1, L.242-3 and L.242-4 of the code of 
relations between the general public and the civil service. 

In the event that these periods of appeal have expired, the owner nevertheless retains 
the possibility of having the date of notification of the marketing authorization entered 
in the National Patent Register for the purpose of informing third parties. However, the 
duration of the SPC may not be corrected if the periods of appeal are expired. 

  Post-grant limitation or revocation of the patent  

According to Article L.613-24 IPC, at any point after the grant of the patent and until 
five years after its expiration, the patent  owner may either  file a  request to  limit the 
patent  -through  the  amendment  of  the  patent  claims-  or  file  a  declaration  of 
renunciation. 

The INPI grants the limitation of the patent as long as the modified patent claims are 
clear  and  concise  and  the  limitation  does  not  extend  the  protection  conferred  by  the 
patent  and  does  not  extend  the  content  of  the  application  as  filed,  otherwise  the 
patent is partly void pursuant to Article L613-25. 

It  shall  reject  the  request  for  limitation  or  renunciation  if  there  are  existing  licences 
inscribed in the Patents Register and the owners  of those  rights have  not given their 
consent to such limitation or revocation.  

The amendment of the claims has retroactive effect on the protection conferred by the 
patent,  which  determines  the  protection  conferred  by  the  SPC  to  the  extent  that  the 
limitation of the basic patent affects the product protected by the SPC. 

Pursuant to Article 15 of Regulation EC/469/2009, revocation of the basic patent after 
the grant of the SPC and, in certain circumstances, its limitation, constitute a ground 
for  invalidation  of  the  SPC.  However,  since  the  INPI  is  not  a  competent  body  under 
French  law  to  invalidate  a  patent,  any  request  for  invalidation  of  the  SPC  on  this 
ground  may  only  be  referred  to  the  Paris  Court  of  First  Instance,  in  accordance  with 
Article 15 in fine of the Regulation. 

21 

 
 
 
Study on the Legal Aspects of SPCs – Annex I

  SPECIFIC ISSUES CONCERNING EXTENSION PURSUANT TO ART. 

36 OF REG. 1901/2006/EC 

The  INPI  is  also  responsible  for  the  issuance  of  SPC  paediatric  extensions  under 
Regulation  EC/1901/2006.  The  following  documents  must  be  attached  to  the 
application for the extension:  

a copy of the statement indicating compliance of the marketing authorisation with an 
agreed  completed  pediatric  investigation  plan  as  referred  to  in  article  36(1)  of  the 
Regulation EC/1901/2006; and the proof of marketing authorisation in all the Member 
States. 

The  applicant  can  file  the  application  for  an  extension  of  the  SPC  term  together  with 
the  SPC  application  or  separately,  no  later  than  two  years  before  the  expiry  of  the 
SPC.  

For  the  INPI  to  grant  such  extension,  the  application  must  meet  the  requirements  of 
Article 8(1)(d) of Regulation EC/469/2009 in conjunction with Article 36 of Regulation 
EC/1901/2006.  If  the  INPI  detects  an  irregularity  or  deficiency  in  the  documentation 
submitted by the applicant, the applicant is notified accordingly. Irregularities may be 
rectified within two months (extendable once  by the same time period), failing which 
the prorogation application is rejected. 

The  extension  of  the  SPC  term  is  subject  to  revocation  under  circumstances  as 
foreseen in Article 16(1) of Regulation EC/469/2009 (i.e. when it was granted contrary 
to the provisions of Article 36 of Regulation EC/1901/2006). However, since the INPI 
is  not  a  competent  body  under  French  law  for  the  revocation  of  the  corresponding 
basic  patent,  any  request  for  revocation  of  the  extension  of  the  duration  on  this 
ground may only be referred to the Paris Court of First Instance, in compliance with an 
Article 16(2) of Regulation EC/469/2009.  

In  the  French  practice  it is  possible  to  get  the  extension  even  if  the  pediatric  studies 
were conducted by a third party. 

22 

 
 
 
 
France 

  PAYMENT OF FEES 

According  to  article  R.617-1  IPC,  the  filing  fee  for  a  supplementary  protection 
certificate  shall  not  cover  the  first  annual  fee.  The  payment  of  annual  fees  shall 
become due  on the last day of the  month of the anniversary date  of  the filing of the 
application for the basic patent. Overall payment of all annual fees may be accepted if 
made within the year preceding the entry into effect of the certificate. 

Filing of SPC 

Filing of extension 

Annuities 

Table 3.1: 

520€ 

470€  

940€ 

  ENFORCEMENT OF THE SPC 

According  to  Article  L611-2  IPC,  in  conjunction  with  Articles  4  and  5  of  the  SPC 
Regulations, the SPC holder or the holder of an exclusive license can enforce his rights 
against third parties in the same terms as in relation to the basic patent, but limited to 
the product covered by the marketing authorisation. 

According  to  article  L613-5  IPC,  the  rights  afforded  by  the  patent  or  SPC  do  not 
extend to: 

 

 

the studies and tests required for the granting of a marketing authorisation for 
a medicinal product, as well as for the acts necessary for their realisation and 
for obtaining the authorisation;  
the  acts  necessary  for  obtaining  the  advertising  visa  referred  to  in  Article  L. 
5122-9 of the Public Health Code; 

A published SPC application entitles the holder to introduce infringement proceedings 
under Article L615-4 IPC. The court hearing an action for infringement on the basis of 
a patent or SPC application stays proceedings until the patent is granted. 

23 

 
 
 
  
 
 
Study on the Legal Aspects of SPCs – Annex I

GERMANY 

Dr. Oliver Werner* 

INTRODUCTION: THE SOURCES OF LAW 

Germany  has  signed  and  ratified  most  European  and international  agreements  in  the 
patent  field,  including  the  Paris  and  Strasbourg  Conventions,  the  EPC,  the  PCT  and 
TRIPS. A notable exception is the PLT, which was signed in 2001 but not yet ratified, 
even though some PLT provisions have been incorporated into the German Patent Act 
in the meantime. Germany is also party to the enhanced cooperation for the creation 
of  unitary  patent  protection  and  a  Contracting  Member  State  of  the  Agreement  on  a 
Unified  Patent  Court  (UPCA),  the  ratification  process  for  the  latter  currently  being 
finalized. 

Patent  protection  in  Germany  can  therefore  be  obtained  by  filing  a  national  patent 
application  at  the  German  Patent  and  Trade  Mark  Office  (Deutsches  Patent-  und 
Markenamt;  DPMA),  or  by  filing  a  European  patent  application  at  the  EPO  with 
subsequent  validation  in  Germany.  Filing  in  both  cases  is  also  possible  via  the  PCT 
route (national or regional phase entry respectively). 

English 

The provisions governing national patents and patent applications are laid down in the 
German  Patent  Act  as  published  on  16  December  1980  (Patentgesetz  PatG;  BGBl. 
1981  I  page  1;  last  amended  17  July  2017,  BGBl.  2017  I  page  2541;  unofficial 
http://www.gesetze-im-internet.de/englisch_ 
consolidated 
patg/englisch_patg.html).  Provisions  dealing  with  international  applications  and 
European  patents  are  set  out  in  the  Act  on  International  Patent  Treaties  of  21  June 
1976  (Gesetz  über  internationale  Patentübereinkommen  IntPatÜbkG;  BGBl.  1976  II 
page 649; last amended 17 July 2017, BGBl. 2017 I page 2541; unofficial consolidated 
German version at http://www.gesetze-im-internet.de/intpat_bkg/  
BJNR206499976.html).  

version 

at 

Both  Acts  are  largely  harmonized  with  the  EPC,  in  particular  the  provisions  having 
regard  to  patentability  (Articles  52  to  57  EPC  vs.  Sections  1  to  5  PatG),  scope  of 
protection  (Article  69  EPC  vs.  Section  14  PatG),  and  revocation  (Article  138  EPC  vs. 
Section 22 PatG and Section 6 IntPatÜbkG) are consistent. 

While  Regulations  (EC)  no.  469/2009  and  (EC)  no.  1610/96  are  directly  applicable, 
German law on SPCs is governed by Sections 16a and 49a of the Patent Act.  

By means of Article 1 no. 1 of the Act Amending the Patent Act and other Acts (Gesetz 
zur  Änderung  des  Patentgesetzes  und  anderer  Gesetze)  of  23  March  1993,  Sections 
16a  and  49a  were  included  in  the  Patent  Act  with  effect  from  1  April  1993  (Section 
16a last amended 19 October 2013; Section 49a last amended 31 July 2009).  

Sections 16a and 49a read as follows: 

*   Dr. Oliver Werner - German Patent and Trade Mark Office (DPMA). 

24 

 
 
 
 
 
 
                                                 
Germany 

Section 16a 
(1)  An  application  for  supplementary  protection  for  the  patent  can  be  filed  pursuant  to  the 
provisions  set  out  in  the  Regulations  of  the  European  Communities  concerning  the  creation  of 
supplementary  protection  certificates,  reference  to  which  shall  be  made  in  the  Federal  Law 
Gazette,  which  supplementary  protection  shall  follow  immediately  upon  expiry  of  the  patent  in 
accordance with section 16. Annual renewal fees shall be paid for supplementary protection. 
(2) Unless otherwise provided by the law of the European Communities, the provisions of this Act 
regarding the applicant’s entitlement (sections 6 to 8), regarding the effect of the patent and the 
exceptions  thereto  (sections  9  to  12),  regarding  an  order  for  use  and  the  compulsory  licence 
(sections 13 and 24), regarding the extent of protection (section 14), regarding licences and their 
registration  (sections  15  and  30),  regarding  the  lapse  of  the  patent  (section  20),  regarding 
revocation  (section  22),  regarding  the  willingness  to  grant  a  licence  (section  23),  regarding 
representatives  in  Germany  (section  25),  regarding  the  Federal  Patent  Court  and  proceedings 
before  the  Federal  Patent  Court  (sections  65  to  99),  regarding  proceedings  before  the  Federal 
Court  of  Justice  (sections  100  to  122a),  regarding  the  re-establishment  of  rights  (section  123), 
regarding  the  obligation  to  tell  the  truth  (section  124),  regarding  electronic  documents  (section 
125a), regarding the official language, notifications and judicial assistance (sections 126 to 128), 
regarding  legal  infringements  (sections  139  to  141a,  142a  and  142b),  regarding  the  joinder  of 
actions  and  arrogation  of  patent  (sections  145  and  146)  shall  apply  mutatis  mutandis  to 
supplementary protection. 
(3)  Licences  and  declarations  made  pursuant  to  section  23  which  take  effect  for  a  patent  shall 
also apply mutatis mutandis to supplementary protection. 

Section 49a 
(1) If the person registered as the proprietor of the patent applies for supplementary protection, 
the Patent Division shall examine whether the application complies with the relevant Regulation of 
the European Communities as well as with subsection (5) and section 16a. 
(2) If the application meets these requirements, the Patent Division shall issue the supplementary 
protection certificate for the duration of its term. Otherwise, it shall invite the applicant to correct 
any deficiencies within a time limit of at least two months to be set by the Patent Division. If the 
deficiencies are not corrected, the Patent Division shall take a decision to refuse the application. 
(3)  If  a  Regulation  of  the  European  Communities  provides  for  the  extension  of  the  term  of  a 
supplementary protection certificate, subsections (1) and (2) shall apply mutatis mutandis. 
(4)  The  Patent  Division  shall  take  a  decision  on  the  requests  provided  for  in  Regulations  of  the 
European Communities to 
1. correct the term of a supplementary protection certificate if the date included in the application 
for  the  certificate  in  respect of  the  first  authorisation  for  placing  the  invention  on  the  market  is 
incorrect; 
2. revoke the extension of the term of a supplementary protection certificate. 
(5) Section 34 (6) shall apply. Sections 46 and 47 shall apply to the procedure before the Patent 
Division. 

Supplementary  provisions  can  be  found  in  Sections  30(1),  81(1),  first  and  third 
sentences,  142(1)  of  the  Patent  Act,  Sections  19  to  21  of  the  Patent  Ordinance 
the  Patent  Costs  Act 
(Patentverordnung),  Sections  3(2),  5(2),  7(1)  of 
(Patentkostengesetz),  Section  2  of  the  DPMA  Ordinance  (DPMA-Verordnung)  and,  for 
European  patents,  in  Article  II  Section  6a  of  the  Act  on  International  Patent  Treaties 
(Gesetz über internationale Patentübereinkommen). 

In order to ensure consistent and expeditious examination of SPC applications by the 
patent  divisions  of  the  DPMA  and  to  inform  applicants  on  the  application  procedure 
and  examination  practice,  the  DPMA  has  issued  "Examination  Guidelines  for  SPCs" 
(current version as of 23 January 2015; German and English version available at the 
DPMA  website  https://www.dpma.de/docs/service/formulare/patent/p2799.pdf; 
; 
https://www.dpma.de/docs/service/formulare_eng/patent_eng/p2799_1.pdf 
).  The 
following  statements  in  essence  summarize  the  Guidelines,  which  in  most  cases 
contain more detailed information on the respective issues. 

25 

 
 
 
 
Study on the Legal Aspects of SPCs – Annex I

INSTITUTIONAL ASPECTS: THE GRANTING AUTHORITY 

The  German  Patent  and  Trade  Mark  Office  (DPMA)  is  the  central  federal  authority  in 
the field of industrial property protection in Germany.  It  operates  within the portfolio 
of  the  Federal  Ministry  of  Justice  and  Consumer  Protection  (BMJV).  The  office  was 
originally founded in 1877 and currently employs about 2,500 staff in its headquarters 
in Munich and its Jena and Berlin branch offices. It is the statutory duty of the DPMA 
to  grant  and  administer  industrial  property  rights  and  to  provide  information  to  the 
public  on  industrial  property  rights  effective  in  Germany.  The  DPMA  is  also  an  active 
partner in European and international industrial property systems. 

The DPMA is the examining and granting authority for SPCs and paediatric extensions 
pursuant to Article 9(1) of Regulation (EC) no. 469/2009 (Section 49a Patent Act and 
Article II Section 6a of the Act on International Patent Treaties). 

According to Section 49a(1) and (2) Patent Act, the relevant body within the DPMA is 
the  Patent  Division.  The  Patent  Division  is  a  panel  consisting  of  at  least  three 
technically  qualified  members  (chair,  rapporteur,  assessor)  and  optionally  a  legally 
qualified member (Section 27 Patent Act) which takes decisions inter alia on the grant 
of  SPCs  and  paediatric  extensions,  the  correction  of  term  of  an  SPC,  and  the 
revocation  of  a  paediatric  extension.  The  composition  of  the  Patent  Division  is 
governed by the IPC heading indicated in the basic patent on which the application for 
the certificate is based. The rapporteur usually is the patent examiner in charge of the 
respective  IPC  heading.  Currently  about  30  examiners  (with  varying  frequency)  are 
carrying  out  SPC  examinations  as  members  of  patent  divisions.  About  10  additional 
persons act as chairs (mostly heads of Patent Departments and group leaders). 

FILING OF THE APPLICATION 

Applications  for  certificates  must  be  filed  in  writing  at  the  DPMA  (cf.  Art.  9 
Regulations,  Section  19  in  conjunction  with  Section  4(2)  nos.  1,  4  and  5  Patent 
Ordinance).  They  cannot  be  validly  filed  at  a  patent  information  centre  because 
Sections 16a and 49a of the Patent Act do not contain a reference to Section 34(2) of 
the Patent Act. The form "Antrag auf Erteilung eines ergänzenden Schutzzertifikats für 
Arzneimittel/Arzneimittel einschließl. Verlängerung der Laufzeit / Pflanzenschutzmittel" 
(form  P  2008;  https://www.dpma.de/docs/service/formulare/patent/p2008.pdf)  must 
be used for the application.  

The DPMA will send an acknowledgement of receipt to the applicant indicating the file 
number and the date of receipt and will also enclose a copy of the request; the date of 
receipt is printed on the copy or is shown on the data bar printed onto the bottom of 
the fax document by the DPMA.  

The necessary content of an application for a certificate, which is described in detail in 
the following sections, is based on Articles 6, 7, and 8 of the Regulations. 

26 

 
 
 
 
 
 
Germany 

FORMAL EXAMINATION 

In the procedure for the grant of a certificate it has to be initially examined whether all 
formal requirements of the request for the grant of a certificate are met.  

Unless otherwise specified, staff of the upper grades of the civil service are responsible 
for the examination of the application as to (obvious) formal deficiencies, pursuant to 
in 
the  Administration  Ordinance 
conjunction with (1) no.1 Administration Ordinance).  

(Wahrnehmungsverordnung) 

(Section  1(3) 

These  staff  can  send  a  letter  to  the  applicants  inviting  them  to  rectify  the  formal 
deficiency.  In  the  case  of  extensive  and  complex  deficiencies,  the  result  of  the 
preliminary formal examination will be forwarded to the patent division.  

Within the scope of a substantive examination, the patent division must also examine 
compliance with formal requirements and object to existing deficiencies, if any.  

The individual formal requirements of an application for a certificate are: 

a)  Name and address  of the applicant and  – if a representative is appointed  – of 

the representative (Art. 8(1)(a)(i), (ii) of the Regulations) 

b)  Number and title of the basic patent in force at the date of the application (Art. 

8(1)(a)(iii) of the Regulations) 

c)  Number and date of the authorisation(s) (Art. 8(1)(a)(iv) of the Regulations) 
d)  Copies of authorizations (Art. 8(1)(b) and (c) of the Regulations) 
e)  Title of the product for which protection is sought 
f)  Information  explaining  the  protection  provided  by  the  basic  patent  for  the 

product 

g)  Payment  of  application  fee  (Art.  8(2)  Regulation  (EC)  no.  1610/96  and  Art. 
8(4)  Regulation  (EC)  no.  469/2009  in  conjunction  with  Section  2(1)  Patent 
Costs Act) 

h)  Observance of time limits for lodging an application (Art. 7 of the Regulations) 
i)  Entitlement to file an application (Art. 6 of the Regulations) 

Ad b) 

Staff  of  the  upper  grades  of  the  civil  service  will  check  whether  the  basic  patent, 
indicated in the request, was in force in Germany at the time when the application for 
the certificate was filed. 

Ad c) and d) 

The  application  must  also  contain  the  number  and  the  date  of  the  first  valid 
authorisation  (national  or  central)  to  place  the  product  on  the  market  in  Germany 
(hereinafter  referred  to  as  "authorisation";  form  P  2008:  field  8).  Pursuant  to 
applicable  case  law,  the  date  of  notification  of  the  decision  shall  be  considered  the 
relevant date for all types of authorizations (CJEU C-471/14 Seattle Genetics).  

If an authorisation for placing the product on the market was already granted in an EU 
or  EEA  member  state  before  the  first  authorisation  in  Germany,  the  number  and  the 
date of the first authorisation in the EU or the EEA must be given (form P 2008: field 
9). Furthermore, information regarding the identity of the authorised product and the 

27 

 
 
 
 
Study on the Legal Aspects of SPCs – Annex I

legal provision which governed the authorisation procedure must be  stated (compare 
form P 2008: annexes 2 and 3 in field 12).  

A  copy  of  the  authorisation  to  place  the  product  on  the  market  in  Germany  must  be 
filed (form P 2008: annex 1 in field 12). For an authorisation for the identical product 
in  a  member  state  of  the  EU  or  EEA  that  was  granted  earlier  than  the  German 
authorisation, only a copy of the notice publishing the authorisation in the appropriate 
official publication must be filed under Article 8(1)(c) of the Regulations (form P 2008: 
annex 4 in field 12). 

Ad e) and f) 

In the request form the applicant must indicate the product for which the grant of the 
SPC is sought (form P 2008: field 7).  

The  title  of  the  product  should  be  directed  to  the  name  of  the  active  ingredient  or 
combination  of  active  ingredients  resulting  from  the  valid  authorisation  to  place  the 
product  on  the  market.  Combinations  of  active  ingredients  should  be  phrased  as 
"component 
active 
2". 
ingredients/substances  shall  be  indicated  for  medicinal  products  as  well  as  for  plant 
protection products.  

The  German 

component 

1  with 

names 

of 

The  name  of  the  active  ingredient  or  names  of  the  active  ingredients  in  the  German 
authorisation to place the medicinal product on the market is/are usually indicated in 
the  section  "arzneilich  wirksame  Bestandteile"  or  "qualitative  und  quantitative 
Zusammensetzung"  according  to  the  annex  to  the  marketing  authorisation  and  in  a 
European authorisation at section "qualitative and quantitative composition" in annex I 
(Summary of product characteristics). If the name of the active substance of the plant 
protection product cannot be derived from the text of the authorisation, the text of the 
Register  of  Plant  Protection  Products  (Pflanzenschutzmittelverzeichnis,  published  by 
the Federal Office of Consumer Protection and Food Safety) can be used alternatively.  

Notably, an SPC can be granted for a product that covers the active ingredient as such 
as well as its various derived (chemical) forms (e.g. salts and esters) where only one 
of  its  possible  forms  is  covered  by  the  marketing  authorisation  provided  that  these 
forms  are  also  protected  by  the  basic  patent  (cf.  CJEU  C-392/97  Farmitalia  and 
Federal Court of Justice, NJW 2000, p. 1723 et seqq. – Idarubicin II). 

Since the product has to be protected by a basic patent that is in force at the time of 
filing  the  application  for  a  certificate  pursuant  to  Article  3(a)  of  Regulation  (EC)  no. 
469/2009 or Article3(1)(a) of Regulation (EC) no. 1610/96, a seamless documentation 
explaining the correlation between the authorised product and the text passage in the 
patent specification must be furnished as annex to the request for the grant of an SPC 
(annex  6  in  field  12)  showing  the  protection  afforded  by  the  patent  for  this  product 
(cf.  Section  19(2)  Patent  Ordinance).  Typically,  it  is  useful  and  necessary  to  furnish 
copies of documents, namely  

 

 

from chemical or pharmaceutical standard publications showing the relationship 
between  the  chemical  or  the  biological  structure  and  the  international  non-
proprietary name (INN) or the "common name",  
from  official  publications  or  documents  clearly  identifying  the  product  covered 
by  the  authorisation  (for  plant  protection  products,  for  example,  an  excerpt 

28 

 
 
Germany 

from the Register of Plant Protection Products published by the Federal Office of 
Consumer Protection and Food Safety),  

  a copy of the relevant passages of the granted basic patent.  

Ad g) 

Where  the  application  fee  is  not  paid  upon  filing  the  application,  the  DPMA  will  set  a 
time  limit  for  payment  of  the  fee.  This  time  limit  shall  be  at  least  two  months  (Art. 
10(3) Regulations in conjunction with Section 49a(2), second sentence, Patent Act). If 
the  time  limit  expires  without  response,  the  DPMA  will  reject  the  application  (Art. 
10(4) Regulations). 

Ad h) 

Article  7  of  the  Regulations  prescribes  periods  for  lodging  an  application  for  a 
certificate.  

In this respect, two cases must be distinguished:  

a)  Where the basic patent is granted before the authorisation to place the product 
on  the  market,  the  period  for  lodging  an  application  for  a  certificate  is  six 
months from the date of the authorisation in Germany.  

b)  Where  the  authorisation  to  place  the  product  on  the  market  in  Germany  is 
granted before the grant of the patent, the period for lodging an application for 
a certificate is six months from the date of the grant of the patent.  

Pursuant to applicable case law (CJEU C-471/14 Seattle Genetics and CJEU C-127/00 
Hässle),  with  regard  to  case  (a),  the  date  of  notification  of  the  authorisation  is 
considered the date from which the period starts.  

According to the office’s current practice with regard to case (b), the publication date 
of  the  grant  in  the  German  Patent  Gazette  or  the  European  Patent  Bulletin  is 
considered the date from which the period starts. Usually, this date is printed on the 
first page of the patent specification following the INID code (45).  

Compliance  with  these  time  limits  is  monitored  through  staff  of  the  upper  grades  of 
the civil service. 

Ad i) 

Pursuant to Article 6 of the Regulations, only the holder/s of the basic patent or their 
successor/s  in  title  can  file  an  application  for  a  certificate,  because  only  this/these 
person/s has/have the right to the supplementary protection certificate.  

Staff  of  the  upper  grades  of  the  civil  service  also  examine  whether  this  formal 
requirement  for  an  application  for  a  certificate  is  met  and  in  case  of  failure  to  meet 
this requirement, a deficiency letter is sent to the applicant. 

In  case  of  filing  an  application  for  an  SPC  extension,  similar  requirements  are 
examined. Additional ones regard in particular: 

a)  Reference  to  a  pending  SPC  application  or  granted  certificate  (Art.  8(2)  and 

8(3) of Regulation (EC) no. 469/2009) 

29 

 
 
 
Study on the Legal Aspects of SPCs – Annex I

b)  Copy of the compliance statement (Article 8(1)(d)(i) of the Regulation (EC) no. 

469/2009) 

c)  Proof  of  marketing  authorisation  in  all  member  states  (Article  8(1)(d)(ii)  of 

Regulation (EC) no. 469/2009) 

d)  No  Orphan  Market  Exclusivity  or  extended  Regulatory  Data  Protection  (Article 

36(3) and (4) of Regulation (EC) No 1901/2006) 

Ad j) 

Where  an  application  for  a  certificate  is  pending,  an  application  for  an  extended 
duration shall include a reference to the pending application for a certificate (Art. 8(2) 
Regulation (EC) no. 469/2009).  

Where  a  certificate  has  already  been  granted,  the  application  for  an  extension  of  the 
duration  of  a  certificate  shall  contain  a  copy  of  the  decision  of  the  certificate  already 
granted (Art. 8(3) Regulation (EC) no. 469/2009). 

Ad k) and l) 

Pursuant  to  Article  8(1)(d)(i)  of  Regulation  (EC)  no.  469/2009,  the  request  for  an 
extension of the duration shall include a copy  of the statement indicating compliance 
with an agreed  completed paediatric investigation plan as  referred to in Article 36(1) 
of  Regulation  (EC)  No  1901/2006.  The  statement  indicating  compliance  cannot  be 
replaced  by  an  opinion  of  the  Paediatric  Committee  pursuant  to  Article  23(2)  of 
Regulation (EC) No 1901/2006. 

Pursuant to Article 8(1)(d)(ii) of Regulation (EC) no. 469/2009, proof shall be filed of 
possession  of  authorisations  to  place  the  product  on  the  market  in  all  other  member 
states, as referred to in Article 36(3) of Regulation (EC) No 1901/2006. 

If  documents  k)  or  l)  are  (partially)  missing  at  the  time  of  filing,  the  applicant  is 
invited to file the documents within a fixed period set by the office. This period may be 
extended  upon  request  until  the  time  limit  given  in  Art.7  (4)  of  Regulation  (EC)  no. 
469/2009.  If  documents  have  not  been  issued  by  the  respective  authorities  at  the 
time of filing, the applicant has to prove that he has made  every effort to obtain the 
documents  and  that  he  could  have  expected  to  receive  the  documents,  if  the 
procedure  would  have  been  completed  by  the  respective  authorities  within  the 
prescribed time limits. The documents have to be filed at latest at a time point, which 
allows a final decision before the expiry of the SPC. 

No  extension  of  the  duration  can  be  granted  with  documents  missing  at  the  time  of 
grant. 

Ad m) 

The  medicinal  product  shall  not  be  designated  as  an  orphan  medicinal  product 
pursuant to Regulation (EC) no. 141/2000 (cf. Art. 36(4), second sentence, Regulation 
(EC) No 1901/2006) and the applicant must not have applied for, nor obtained, a one-
year extension of Regulatory Data Protection for the medicinal product concerned (cf. 
Art. 36(5) Regulation (EC) No 1901/2006).  

30 

 
 
Germany 

If a corresponding self-declaration by the applicant is ticked on the  form, this will be 
accepted by the DPMA. 

SUBSTANTIVE EXAMINATION  

Applications  for  a  certificate  should,  if  possible,  be  handled  in  such  a  way  that  an 
intermediate office action or the decision on grant will be provided within eight months 
after  receipt  of  the  request  for  grant  of  a  certificate.  The  decision  on  the  request  for 
grant  of  a  supplementary  protection  certificate  shall  be  taken,  if  possible,  before  the 
expiry of the basic patent to avoid a delay in the certificate becoming effective. 

Substantive examination at the DPMA includes an assessment of compliance  with the 
requirements of Articles 3(a), 3(b), 3(c), and (to a limited extent) 3(d). 

Article 3(a) 

Pursuant  to  Article  3(a)  of  Regulation  (EC)  no.  469/2009  or  Article  3(1)(a)  of 
Regulation  (EC)  no.  1610/96,  the  product  for  which  an  application  for  the  grant  of  a 
certificate is filed, must be protected by a basic patent in force at the date of filing the 
application  for  a  certificate.  That  means  that  the  basic  patent  must  not  have  lapsed, 
withdrawn  or  declared  invalid  at  the  time  of  filing  the  application  for  the  certificate. 
Even where the marketing authorisation has been granted only after  the lapse of the 
basic  patent,  an  application  for  a  certificate  cannot  be  filed.  Usually,  the  staff  of  the 
upper grades of the civil service in charge of the matter will check whether the basic 
patent  indicated  in  the  application  for  the  certificate  was  in  force  in  Germany,  at  the 
time of filing the application for the certificate.  

The  patent  division  must  perform  an  additional  examination  of  the  legal  status  or 
procedural  status  of  the  basic  patent  concerned  by  inspecting  the  respective  patent 
registers (DPMAregister; European patent register).  

At  the  time  of  the  grant  of  the  certificate,  it  should  be  considered  and  verified,  with 
regard  to  the  grounds  of  invalidity  stated  in  Article  15(1)(b)  of  the  Regulations  that 
the  basic  patent  has  not  lapsed  before  its  lawful  term  expires.  In  that  case,  the 
application must be rejected.  

However, if, after the regular expiry of the term of the patent, the basic patent is no 
longer in force at the date of the grant of the certificate, it is nevertheless possible to 
grant a certificate.  

If  the  outcome  of  pending  opposition,  limitation  or  revocation  proceedings,  if  any,  in 
respect of the basic patent is known when the certificate is granted this shall also be 
taken  into  consideration.  This  may  retroactively  affect  the  scope  of  protection  of  the 
basic  patent  to  such  extent  that  the  scope  of  protection  no  longer  covers  the 
authorised  product.  In  that  case,  the  application  for  the  certificate  shall  be  rejected 
due  to  non-compliance  with  the  requirement  of  Article  3(a)  of  Regulation  (EC)  no. 
469/2009 or Article 3(1)(a) of Regulation (EC) no. 1610/96, as the case may be. The 
same  applies  in  case  of  the  revocation  of  the  basic  patent.  A  certificate  may  be 
granted  in  spite  of  opposition,  limitation  and  revocation  proceedings  if  these 
proceedings have not yet been completed.  

31 

 
 
 
 
 
Study on the Legal Aspects of SPCs – Annex I

Where  the  product  is  protected  by  several  patents  (for  example,  product  patent  or 
process patent) the applicant himself may decide which patent to choose as the basic 
patent.  

The basic patent,  on which protection is based, may be a process patent, use patent 
or product patent (substance patent or product patent).  

For  the  examination  of  the  requirement  of  Article  3(a)  of  Regulation  (EC)  no. 
469/2009 or Article 3(1)(a) of Regulation (EC) no. 1610/96, the extent of protection in 
accordance  with  Section  14  of  the  Patent  Act  shall  be  taken  into  consideration  for 
German basic patents and the extent of protection in accordance with Article 69 of the 
European  Patent  Convention  (EPC)  in  conjunction  with  the  Protocol  on  the 
Interpretation  of  Article  69  of  the  EPC  shall  be  taken  into  consideration  for  European 
patents taking effect in the territory of the Federal Republic of Germany.  

In its decisions in the cases Medeva (CJEU C-322/10 Medeva) and Georgetown (CJEU 
C-484 Georgetown) the CJEU has clarified that a supplementary protection certificate 
in  accordance  with  Article  3(a)  of  Regulation  (EC)  no.  469/2009  can  be  granted  only 
for  those  active  ingredients  which  are  specified  in  the  wording  of  the  claims  of  the 
basic patent.  

In  order  to  fulfil  this  requirement  it  is  not  necessary  for  the  active  ingredient  to  be 
identified  in  the  claims  of  the  patent  by  a  structural  formula  (CJEU  C-493/12  Eli 
Lily/Human Genome Sciences). On condition that it is possible to reach the conclusion 
on  the  basis  of  the  claims,  interpreted  inter  alia  in  the  light  of  the  description  of  the 
invention,  that  the  claims  relate,  implicitly  but  necessarily  and  specifically,  to  the 
active  ingredient  in  question,  it  suffices  where  the  active  ingredient  is  covered  by  a 
functional or general structural formula in the claims.  

It should be recalled that, in accordance with the case law cited at paragraph 34 of the 
mentioned  judgment,  an  active  ingredient  which  is  not  identified  in  the  claims  of  a 
basic patent by means of a structural, or indeed a functional definition cannot, in any 
event, be considered to be protected within the meaning of Article 3(a) of Regulation 
(EC)  no  469/2009  (CJEU  C-493/12  Eli  Lily/Human  Genome  Sciences;  also  Federal 
Patent Court 3 Ni 28/11 Ranibizumab, para. I.3.4.). 

Due  to  the  lack  of  clarity  of  the  CJEU  case  law  no  further  guidelines  for  the 
examination  of  the  Article  3a  requirement  have  been  issued  by  the  DPMA  to  date. 
Decisions  are  taken  on  a  case  by  case  basis  by  the  respective  patent  divisions, 
applying national and CJEU case law. 

Article 3(b) 

Pursuant  to  Article  3(b)  of  Regulation  (EC)  no.  469/2009  or  Article  3(1)(b)  of 
Regulation (EC) no. 1610/96, as appropriate, an authorisation to place the product on 
the market, valid in Germany at the time of filing the application for a certificate, must 
have been granted for the product on which the application for the certificate is based.  

The  application  for  a  supplementary  protection  certificate  can  validly  be  made  only 
after  a  valid  marketing  authorisation  has  been  issued  (CJEU  C-210/12  Sumitomo 
Chemical/DPMA).  This  requirement  has  to  be  fulfilled  at  the  filing  date  of  the 
application and cannot be corrected after filing. 

32 

 
 
 
Germany 

During  examination  of  the  furnished  authorisations  it  must  be  confirmed  that  these 
authorisations were granted according to the European Directives mentioned in Article 
3(b)  of  Regulation  (EC)  no.  469/2009  or  Article  3(1)(b)  of  Regulation  (EC)  no. 
1610/96 (Directive 65/65/EEC for medicinal products, meanwhile replaced by Directive 
2001/83/EC;  Directive  81/851/EEC  for  veterinary  medicinal  products,  meanwhile 
replaced by Directive 2001/82/EC; Directive 91/414/EEC for plant protection products, 
meanwhile replaced by Regulation (EC) no. 1107/2009).  

Provisional  authorisations  to  place  plant  protection  products  on  the  market,  which 
were  granted  pursuant  to  Article  8(1)  of  the  Directive  91/414/EEC  (implemented  in 
Section 15c Plant Protection Act [Pflanzenschutzgesetz]), are recognised as valid first 
marketing  authorisations  (cf.  CJEU  C-229/09  Lovells/Bayer).  However,  this  is  not 
applicable  to  emergency  authorisations  to  place  a  product  on  the  market  granted 
under  Article  8(4)  of  the  Directive  91/414/EEC  (implemented  in  Section  11(2)  Plant 
Protection Act; cf. CJEU C-210/12 Sumitomo Chemical/DPMA). 

Pursuant  to  Article  13(3)  of  Regulation  (EC)  no.  1610/96,  for  the  purposes  of 
calculating  the  duration  of  the  certificate,  provisional  marketing  authorisations  are 
taken  into  account  as  first  authorisations  to  place  a  product  on  the  market  in  the 
Community  only  if  they  are  directly  followed  by  a  definitive  authorisation  concerning 
the  same  product.  Where  no  definite  marketing  authorisation  has  been  furnished, 
making it impossible to assess whether authorisations seamlessly followed each other, 
the  provisional  authorisation  shall  nevertheless  be  taken  into  account  for  calculating 
the duration of the certificate in order to take into account the CJEU case law (CJEU C-
229/09 Lovells/Bayer).  

The  central  marketing  authorisations,  available  for  medicinal  products,  granted 
pursuant  to  Regulation  (EEC)  no.  2309/93  or  Regulation  (EC)  no.  726/2004,  and 
hence  also  valid  in  Germany  must  be  considered  as  first  marketing  authorisations 
pursuant to Article 3(b) of Regulation (EC) no. 469/2009. 

Article 3(b) of Regulation (EC) no. 469/2009 or Article 3(1)(b) of Regulation (EC) no. 
1610/96, as appropriate, stipulates as condition for obtaining a certificate that a valid 
authorisation to place the product on the market in Germany has been granted at the 
date  of  the  filing  the  application.  According  to  the  office’s  current  practice,  this 
condition is interpreted to mean that the authorisation actually is in force at the date 
of  filing  the  application  for  the  certificate  and,  in  particular,  has  not  lost  validity  by 
revocation, withdrawal or expiry of the term of the authorisation.  

With regard to the reason for the lapse  of a certificate, mentioned in Article 14(d) of 
the  Regulations,  it  must  be  ensured  that  the  furnished  authorisation  to  place  the 
product on the market in Germany has not been revoked or withdrawn at the date of 
the grant of the certificate. Otherwise, the application must be rejected. However, the 
application  will  not  be  rejected  for  the  reason  that  the  duration  of  the  authorisation 
expires after the date of filing the application. 

Article 3(c) 

Pursuant to Article 3(2), first sentence, of Regulation (EC) no. 1610/96 and recital 17 
as well as Article 3(c) of Regulation (EC) no. 469/2009 or Article 3(1)(c) of Regulation 
(EC)  no.  1610/96,  a  certificate  for  the  identical  product  must  not  have  already  been 

33 

 
 
 
 
Study on the Legal Aspects of SPCs – Annex I

granted  in  Germany  to  the  same  applicant.  If  the  same  applicant  applies  for  several 
certificates  for  the  same  product,  he  can  only  receive  one  certificate  even  though  he 
possesses  and  indicates  various  patents  as  basic  patents  (Art.  3(2),  first  sentence, 
Regulation (EC) no. 1610/96 and recital 17).  

However, where two or more applications concerning the same product and emanating 
from two or more holders of different basic patents are pending, one certificate for this 
product  may  be  issued  to  each  of  these  holders  (Art.  3(2),  second  sentence, 
Regulation  (EC)  no.  1610/96)  even  though  a  certificate  for  that  product  has  already 
been granted (see CJEU C- 482/07 AHP Manufacturing).  

It  is  possible,  on  the  basis  of  a  patent  which  protects  several  different  products,  to 
obtain  several  supplementary  protection  certificates  in  relation  to  each  of  those 
different  products,  provided  that  each  of  those  products  is  protected  as  such  by  that 
basic patent (CJEU C-484/12 Georgetown University/Octrooicentrum Nederland; CJEU 
C-443/12 Actavis/Sanofi).  

For  example,  on  the  basis  of  this  patent  and  the  marketing  authorisation  for  a 
medicinal  product  which  is  a  combination  of  active  ingredients,  the  holder  of  a  basic 
patent  may  be  granted  a  supplementary  protection  certificate  for  this  combination  of 
active ingredients as well as for one of those active ingredients which, individually, is 
also  protected  as  such  by 
that  patent  (CJEU  C-484/12  Georgetown 
University/Octrooicentrum Nederland).  

the 

In contrast, where, on the basis of a patent protecting an innovative active ingredient 
and  a  marketing  authorisation  for  a  medicinal  product  containing  that  ingredient  as 
the  single  active  ingredient,  the  holder  of  that  patent  has  already  obtained  a 
supplementary  protection  certificate  for  an  innovative  active  ingredient,  this  holder 
may not be granted a second supplementary protection certificate on the basis of that 
same  patent  but  a  subsequent  marketing  authorisation  for  a  different  medicinal 
product containing that active ingredient in combination with another active ingredient 
which  is  not  protected  as  such  by  the  patent  (see  CJEU  C-443/12  Actavis/Sanofi; 
Federal Patent Court 3 Ni 5/13 Telmisartan).  

For  identification,  the  definitions  of  the  product  stated  in  Article  1  of  the  Regulations 
must be taken into account.  

A search for certificates that have already been granted must be conducted at least in 
the  special  internal  DPMA  database  of  supplementary  protection  certificates  for 
medicinal  and  plant  protection  products  (Fachdatenbank  für  Arzneimittel-  und 
Pflanzenschutzmittelzertifikate  [SPC]).  Alternatively,  a  search  may  be  carried  out  in 
INPADOC and INPAFAM databases of STN.  

According to the  office’s current practice, the  date stated in the decision on grant by 
the patent division is deemed the day of the grant of the certificate. 

Article 3(d) 

Pursuant  to  Article  3(d)  of  Regulation  (EC)  no.  469/2009  or  Article  3(1)(d)  of 
Regulation  (EC)  no.  1610/96,  a  certificate  shall  be  granted  only  if  the  furnished 
authorisation to place the product on the market in Germany is the first authorisation 
for this product in Germany.  

34 

 
 
 
Germany 

The  DPMA  does  not  have  the  verification  and  search  options  required  for  a 
comprehensive  verification  of  this  condition.  Since  it  is  not  possible  in  Germany  to 
waive  the  verification  of  this  condition,  as  laid  down  in  Article  10(5)  of  the 
Regulations, verification has at least to be carried out as far as it is feasible. In view of 
the  applicant’s  obligation  to  tell  the  truth  it  is  generally  assumed  that  the  respective 
statements of the applicant are accurate.  

However, if any evidence or information is found that challenges the statements of the 
applicant,  it  has  to  be  considered  and  clarified  during  the  course  of  the  procedure. 
Information  on  an  earlier  first  marketing  authorisation  of  the  product  is  available  in 
the  relevant  authorisation  lists  (for  example,  Rote  Liste®,  website  of  the  European 
Medicines  Agency  [EMA],  website  of  the  Federal  Institute  for  Drugs  and  Medical 
Devices,  website  of  Paul-Ehrlich-Institut,  website  of  the  Federal  Office  of  Consumer 
Protection and Food Safety, Register of Plant Protection Products). 

According  to  current  case  law,  products  containing  identical  active  substances  and 
which  only  differ  with  regard  to  the  additional  adjuvants  or  the  content  of  active 
substances  should  be  regarded  as  identical  products  within  the  meaning  of  the 
Regulations. Therefore the respective authorisations for these products shall be taken 
into account as first marketing authorisations.  

According  to  the  former  office’s  practice,  it  was  irrelevant  for  which  use  of  a  product 
the  first  marketing  authorisation  was  granted  (for  example,  medicinal  product  for 
human use or as a veterinary medicinal product; second medical uses; CJEU C-31/03 
Dostinex).  However  the  CJEU  (CJEU  C-130/11  Neurim)  stated  that  "the  mere 
existence  of  an  earlier  marketing  authorisation  obtained  for  a  veterinary  medicinal 
product  does  not  preclude  the  grant  of  a  supplementary  protection  certificate  for  a 
different application of the same product for which a marketing authorisation has been 
granted,  provided  that  the  application  is  within  the  limits  of  the  protection  conferred 
by  the  basic  patent  relied  upon  for  the  purposes  of  the  application  for  the 
supplementary protection certificate“.  

Pursuant to the Neurim judgment, Article 13(1) of Regulation (EC) no. 469/2009 must 
be  construed  as  meaning  that  it  relates  to  the  authorisation  of  a  product  which  falls 
within  the  scope  of  protection  of  the  basic  patent  to  which  the  application  for  the 
supplementary protection certificates refers. 

For practical purposes, a "different application" according to Neurim is interpreted as a 
"new  medical  use"  by  the  DPMA  patent  departments,  which  may  be  equal  to  a  new 
group of patients that can be treated. In this regard it is possible that the DPMA may 
accept  a  new  therapeutic  indication  in  a  type  II  variation  as  a  new  marketing 
authorisation  for  the  purposes  of  Articles  3(b)  and  3(d),  if  the  new  marketing 
authorisation  required  a  full  application  in  accordance  with  Article  8(3)  of  Directive 
2001/83/EC. 

PUBLICATION OF THE APPLICATION  

Information  regarding  the  supplementary  protection  certificates  required  under  the 
provisions  of  the  Regulations  (Art.  9  and  11  Regulations  and  Art.  17  Regulation  (EC) 
no.  469/2009  or  Art.  16  Regulation  (EC)  no.  1610/96)  or  due  to  Section  16a  of  the 

35 

 
 
 
 
Study on the Legal Aspects of SPCs – Annex I

Patent Act in conjunction with the provisions mentioned therein, shall be published in 
part  7  of  the  Patent  Gazette  (Patentblatt;  application,  application  for  an  extension, 
withdrawal, grant, rejection, revocation, rectification, invalidity and lapse). Since there 
is  no  separate  register  for  supplementary  protection  certificates,  they  are  also 
recorded  in  the  Patent  Register  (Section  30(1)  Patent  Act).  These  entries  have  the 
same  extent  as  the  entries  for  patents  or  patent  applications.  Thus,  publication  is 
ensured (Section 32(5) Patent Act).  

The product protected by the basic patent is published in the Patent Gazette using the 
INID  code  (95)  when  the  application  is  published  or  the  certificate  is  granted.  The 
designation  of  the  product  need  not  be  identical  to  the  product  identified  by  the 
authorisation.  

After  the  conclusion  of  the  formal  examination,  the  applications  or  the  requests  are 
published in the Patent Gazette. A certificate document similar to the first publication 
of a patent application (Offenlegungsschrift) or to a patent grant is not issued. 

via 

online 

the  DPMAregister  website 

Bibliographic and status information is available in an electronic version of the Patent 
Gazette 
(https://register.dpma.de/ 
DPMAregister/uebersicht  ).  Part  7  of  the  Patent  Gazette  is  dedicated  to  SPC 
information 
). 
Online  file  inspection  of  documents  is  available  via  the  DPMAregister  website 
(https://register.dpma.de/DPMAregister/uebersicht ). After searching for a specific file 
via 
interface  https://register.dpma.de/DPMAregister/pat/einsteiger? 
lang=en ) press the button "file inspection" at the bottom of the results page. 

(https://register.dpma.de/DPMAregister/blattdownload/pat?lang=en 

the  search 

THIRD PARTY OBSERVATIONS 

Section 16a does not explicitly refer to Section 43(3) German Patent Act, which deals 
with  third  party  observations.  But  since  the  DPMA  follows  the  principle  of  ex  officio 
examination,  third  party  observations  have  to  be  taken  into  account  on  a  regular 
basis.  

In the course of examination the applicant is provided with a copy of any observations 
that are filed by a third party and he is invited to comment on the observations. The 
patent  division  may  use  these  observations,  when  asking  the  applicant  to  correct 
deficiencies of the application, but is not obliged to discuss it, when granting an SPC or 
SPC extension.  

By filing observations, the third party does not become a party to the proceedings.  

GRANT / REFUSAL PROCEDURE 

 Intermediate communication  

If  the  application  for  a  certificate  does  not  meet  the  requirements  of  the  Regulations 
and  Section  16a  of  the  Patent  Act,  the  patent  division  shall  invite  the  applicant, 
pursuant  to  Section  49a(2),  second  sentence,  of  the  Patent  Act,  to  correct  any 
deficiencies within a time limit of at least two months to be set by it. The period may 

36 

 
 
 
 
 
Germany 

be extended upon a request by the applicant stating the reasons. For reasons of legal 
certainty,  this  must  be  done  in  writing.  Hence,  an  intermediate  communication  must 
be issued. 

The number of intermediate communications is determined by the obligation to clarify 
the  facts,  to  grant  the  right  to  be  heard  and  the  special  circumstances  of  each 
individual case.  

The  intermediate  communications  must  be  drafted  in  a  neutral  and  clear  style.  The 
formal  and  substantive  deficiencies  must  be  noted  so  concretely  that the  applicant is 
not left unclear as to what kind of deficiency has been noted.  

The  intermediate  communications  serve  to  prepare  the  grant  of  a  certificate  or  the 
rejection of the application for a certificate pursuant to Section 49a of the Patent Act. 
In case that the rejection of the application for a certificate is intended, this possibility 
will be pointed out in the intermediate reply.  

The intermediate communication can also be issued by the reporting examiner alone. 
In this case, this must be noted in the records. 

 Hearing  

Pursuant  to  Section  49a(5),  second  sentence,  of  the  Patent  Act,  Section  46  of  the 
Patent Act (further examination, hearing, minutes) shall apply mutatis mutandis to the 
examination  procedure  for  certificates  before  the  patent  division.  The  patent  division 
may summon and hear the parties at any time, may examine witnesses, experts and 
parties and may undertake further examination as necessary to examine the matter.  

Generally,  a  hearing  can  be  expedient  for  conducting  the  procedure  speedily. 
However,  deficiencies  regarding  the  application  requirements  and  conditions  for  the 
grant of a certificate may as a rule be noted and rectified in the procedure  conducted 
in writing.  

The  hearing  is  chaired  by  the  head  of  the  patent  division;  the  hearing  is  not  public. 
Third parties may only attend the hearing with the consent of the applicant.  

The  applicant  shall  be  heard  upon  request  (Section  46(1),  second  sentence,  of  the 
Patent Act shall apply mutatis mutandis). The request must be submitted in writing. If 
the request is not submitted in the requisite form, the request will be refused (Section 
46 (1), fourth sentence, of the Patent Act shall apply mutatis mutandis). The decision 
to refuse the request is not independently contestable.  

Minutes  shall  be  drawn  up  of  the  hearings  (and  taking  of  evidence,  if  any)  by  a 
member of the patent division or a recording clerk. The minutes contain the essentials 
of  the  proceedings  and  the  relevant  statements  made  by  the  parties.  Sections  160a, 
162  and  163  of  the  Code  of  Civil  Procedure  shall  apply  mutatis  mutandis  (Section 
49a(5),  second  sentence,  Patent  Act  in  conjunction  with  Section  46(2),  second 
sentence, Patent Act). The following, inter alia, shall be included in the minutes: place, 
date, persons attending, course of the hearing, new circumstances and aspects as far 
as necessary to understand the course of the hearing or are conducive to the grant of 
the  right  to  be  heard  and  the  relevant  statements  made  by  the  parties.  The  latter 
comprises  everything  substantively  altering  the  subject  matter  of  the  application  (for 

37 

 
 
 
 
Study on the Legal Aspects of SPCs – Annex I

example,  the  product)  or  affecting  the  procedure,  for  example,  all  requests, 
amendments to requests and withdrawals of requests. 

The  provisions  of  the  guidelines  of  the  opposition  proceedings  shall  apply  mutatis 
mutandis to the minutes.  

As a rule, the decision of the patent division on the application should be taken at the 
end  of  the  hearing.  The  decision  as  well  as  the  operative  part  of  the  decision  taken 
shall be included in the minutes of the hearing.  

When  delivering  the  decision,  it  is  sufficient  to  announce  the  operative  part  of  the 
decision  and  to  refer  to  the  written  statement  of  grounds  (Section  49a(5),  second 
sentence, Patent Act in conjunction with Section 47(1), second sentence, Patent Act). 
If  the  chair  considers  it  appropriate,  he  may  also  give  an  oral  statement  on  the 
essential contents of the grounds. Any inconsistencies between the written statement 
of  grounds  and  the  orally  communicated  grounds  are  non-prejudicial,  but  should  be 
avoided, if possible.  

The  written  statement  of  grounds  shall  be  executed  without  delay  and  the  complete 
decision shall be served in an execution copy.  

The  DPMA  is  bound  by  the  decision  delivered.  Written  pleadings  received  after  the 
decision was delivered must not be taken into consideration – except later, in the case 
that an appeal is allowed.  

Decision to grant the certificate  

If  the  application  for  the  certificate  complies  with  the  Regulations  as  well  as  Section 
16a  of  the  Patent  Act,  the  patent  division  shall  decide  to  grant  the  certificate  for  the 
duration  of  its  term  and,  if  appropriate,  its  extension  pursuant  to  Section  49a  of  the 
Patent Act.  

In analogy to opposition proceedings, the decision shall be taken in a session or in lieu 
of  a  session  by  way  of  a  written  procedure.  If  a  session  is  held,  the  form  P  2543 
"Sitzungsprotokoll" (minutes of session) shall be completed.  

The  decision  need  not  be  reasoned  if  the  single  request  or  the  main  request  of  the 
applicant  is  granted.  However,  a  decision  shall  be  reasoned  if  it  falls  short  of  the 
request  of  the  applicant,  for  example,  if  only  a  subsidiary  request  is  allowed.  A 
statement  of  grounds  is  required,  in  particular,  where  the  certificate  is  granted 
according  to  the  request,  but  an  extension  of  the  duration  applied  for,  if  any,  is  not 
granted.  

The decision must be executed in writing and served on the applicant (Section 49a(5), 
second sentence, Patent Act in conjunction with Section 47 Patent Act).  

ingredient/substance  or  combination  of  active 

The decision to grant a supplementary protection certificate shall contain: the product 
(active 
ingredients/substances) 
identified by the marketing authorisation pursuant to the Regulations, the name of the 
holder of the certificate, the file number of the basic patent, number and date of the 
above-mentioned  marketing  authorisation  as  well  as  the  first  authorisation  to  place 

38 

 
 
 
Germany 

the product on the market in the Community as well as the duration of the certificate 
and the period of extension of the duration, if any. 

Furthermore,  a  declaration  instructing  the  applicant  on  the  possibility  to  appeal  shall 
be  attached  (Section  49a(5),  second  sentence,  in  conjunction  with  Section  47(2) 
Patent Act).  

The grant is published in the Patent Gazette.  

Decision to reject the application  

The  patent  division  shall  reject  the  application  for  a  certificate  pursuant  to  Section 
49a(2), third sentence, of the Patent Act, if the application does not comply with the 
Regulations  as  well  as  Section  16a  of  the  Patent  Act.  The  applicant  shall  be  given 
sufficient opportunity to be heard.  

In analogy to opposition proceedings, the decision shall be taken in a session or in lieu 
of a session by way of a written procedure. If a session is held, the form P 2543 shall 
be completed.  

The decision to reject the certificate shall be reasoned, executed in writing and served 
on  the  applicant  ex  officio,  pursuant  to  Section  49a(5),  second  sentence,  in 
conjunction with Section 47(1) of the Patent Act. In accordance with Section 47(2) of 
the  Patent  Act,  the  written  execution  copy  shall  be  accompanied  by  a  declaration 
instructing the applicant about the possibility to appeal.  

In case that decisions must be taken on several requests (main request and subsidiary 
requests) in an application for a certificate, one decision on all requests shall be taken 
in analogy to the patent examination procedure and the  opposition proceedings. This 
decision shall contain the rejection of the main request and the subsidiary requests as 
well as, if appropriate, the grant pursuant to a subsidiary request. 

4.9A.  CALCULATION OF THE PATENT AND SPC DURATION 

Pursuant  to  Section  16  of  the  Patent  Act  the  patent  term  is  20  years  beginning  with 
the  day  following  the  application  and  ending  on  the  same  day  as  the  application 
(Sections 186 and 188 German Civil Code). So e.g. a patent filed on 15 October 2015 
ends on 15 October 2035. This calculation is in line with Rule 131 EPC. 

The  start  date  of  an  SPC  in  the  example  above  would  be  16  October  2035,  the 
maximum expiry date (five years) 15 October 2040, with paediatric extension 15 April 
2041. 

Pursuant to Article 13 of the Regulations, the certificate takes effect at the end of the 
lawful term of the basic patent for a period equal to the period which elapsed between 
the  date  on  which  the  application  for  a  basic  patent  was  lodged  and  the  date  of  the 
first authorisation to place the product on the market in the Community, reduced by a 
period  of  five  years.  The  maximum  duration  of  the  certificate  may  not  exceed  five 
years.  

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Study on the Legal Aspects of SPCs – Annex I

For calculating the duration, the period between the filing date of the basic patent and 
the date of issuance of the grant of the first marketing authorisation in the Community 
is  calculated  first.  This  period  is  reduced  by  a  period  of  five  years  resulting  in  the 
residual  period  pursuant  to  Article  13(1)  of  the  Regulations.  Then  the  duration  that 
may  be  granted  for  the  certificate  can  be  calculated,  bearing  in  mind  that  the 
maximum duration is five years (Art. 13(2) Regulations). For the calculation, the years 
will  always  be  determined  first,  then  the  months  and  at  last  the  days.  Years  and 
months are to be understood as whole units regardless of the actual number of days. 
In contrast, the calculation at day level must be based on the actual number of days 
of the respective month. The beginning of the duration of the certificate is always the 
first day after the end of the lawful term of the basic patent.  

In  its  Merck  judgment  the  CJEU  clarified  that  the  grant  of  a  certificate  cannot  be 
rejected  by  reason  only  of  the  fact  that  the  duration  determined  in  accordance  with 
the calculation rules laid down in Article 13(1) of Regulation (EC) no. 469/2009 is not 
positive (CJEU C-125/10 Merck). The reason for this is a possible paediatric extension 
pursuant to Article 13(3) of Regulation (EC) no. 469/2009. The period of the paediatric 
extension starts to run from the date determined by deducting from the patent expiry 
date  the  difference  between  five  years  and  the  duration  of  the  period  which  elapsed 
between lodging the patent application and obtaining the first marketing authorisation 
(CJEU C-125/10 Merck).  

All  authorisations  granted  in  the  member  states  of  the  EU  or  in  a  state  party  to  the 
Agreement  on  the  European  Economic  Area,  Norway,  Iceland  or  Liechtenstein,  are 
regarded as a first authorisation to place the product on the market in the Community. 
This also applies to Swiss authorisations due to their recognition in Liechtenstein. The 
transitional provisions of Articles 19 to 22 of Regulation (EC) no. 469/2009 or Articles 
19  and  20  of  Regulation  (EC)  no.  1610/96,  as  appropriate,  apply  to  the  first 
authorisations  to  place  a  product  on  the  market  in  the  Community  in  the  new  EU 
member states before their accession to the EU.  

Provisional  authorisations  to  place  a  product  on  the  market  as  a  plant  protection 
product,  granted  under  Article  8(1)  of  the  Directive  91/414/EEC  (implemented  in 
Section  15c  Plant  Protection  Act),  are  recognised  as  valid  first  authorisations  within 
the  meaning  of  Article  3(1)(b)  of  Regulation  (EC)  no.  1610/96  (CJEU  C-229/09 
Lovells/Bayer).  To  take  account  of  this  judgment,  a  certificate  must  be  granted  even 
where a definite authorisation has not yet been issued. In that case, the calculation of 
the duration must be based on the provisional marketing authorisation.  

If  a  request  for  the  extension  of  the  period  has  been  received  together  with  the 
request  for  the  grant  of  a  certificate  for  a  medicinal  product,  the  former  has  to  be 
considered for calculating the duration. The periods laid down in Article 13(1) and (2) 
of  Regulation  (EC)  no.  469/2009  will  be  extended  by  six  months  in  the  case  where 
Article  36  of  the  Regulation  (EC)  No  1901/2006  applies.  The  months  are  treated  as 
whole units. If, for  example, the certificate ends on 31 August it will be  extended by 
six months to 28/29 February of the following year. However, the period laid down in 
Article 13(1) of Regulation (EC) no. 469/2009 may be extended only once.  

The beginning and the end of the term must be indicated in the decision to grant the 
certificate pursuant to Section 49a(2), first sentence, of the Patent Act. 

40 

 
 
Germany 

4.9B.  CALCULATION  OF  TERMS;  RELIEF  BEFORE  THE  DPMA  FOR 

MISSED DEADLINES 

Terms  are  calculated  at  the  DPMA  according  to  Section  222(1)  of  the  German  Civil 
Procedure  Code  with  Section  187  et  seqq.  of  the  German  Civil  Code,  which 
corresponds  to  Rule  131  EPC.  The  sole  difference  lies  in  Section  193  German  Civil 
Code,  which  states  that  if  a  declaration  of  intent  is  to  be  made  or  an  act  of 
performance  to  be  done  on  a  particular  day  or  within  a  period,  and  if  the  particular 
day  or  the  last  day  of  the  period  falls  on  a  Sunday,  a  general  holiday  officially 
recognised at the place of the declaration or performance, or on a Saturday, the next 
day takes the place of this day. 

In  case  of  a  paediatric  extension,  the  latest  date  for  filing  the  application  for  an 
extension of the duration is two years before expiry of the certificate. The period has 
to  be  calculated  backwards.  It  ends  at  the  beginning  (0:00)  of  the  day  of  the  year 
before  the  previous  year  whose  date  is  equivalent  to  the  day  when  the  certificate 
expires.  

Example:  

If  the  duration  of  the  certificate  ends  on  14  September  2025,  the  application  for  an 
extension must have been lodged by 0:00 on 14 September 2023. 

The re-establishment of rights for a failure to comply with a time limit, which cause a 
legal disadvantage (e.g. in respect of the six-month period for filing the application or 
in respect of the period for payment of the annual fee) is possible pursuant to Sections 
16a(2) and 123 of the Patent Act under the conditions mentioned in these provisions.  

Although  Section  16a(2)  of  the  Patent  Act  lacks  a  corresponding  reference,  further 
processing is possible in case of a failure to comply with a time limit fixed by the office 
due to legal similarity by applying Section 123a of the Patent Act mutatis mutandis. 

It  is  noted  that  all  substantive  requirements,  as  specified  in  Article  3  of  the 
Regulations, must be satisfied at the time of filing and no re-establishment of rights or 
further processing is possible in these cases. 

For missing documents in an application for a paediatric extension according to Article 
8(1)(d) of Regulation (EC) no. 469/2009 see section 4, letters k, l above. 

  APPEAL PROCEDURE 

Pursuant to Section 73(1) of the Patent Act in conjunction with Section 16a(2) of the 
Patent Act, the decisions of the patent divisions may be appealed.  

Appeals are possible against decisions by the DPMA regarding 

a)  a rejection of an SPC application, 
b)  a rejection of an application for the extension of the duration, (both Art.10 Reg. 

(EC) no. 469/2009), 

41 

 
 
 
Study on the Legal Aspects of SPCs – Annex I

c)  a decision on the revocation of an extension of the duration (Art.16 Reg.  (EC) 

no. 469/2009), or 

d)  a decision on the correction of the duration of an SPC (Art. 17(2) Reg. (EC) no. 

1610/96). 

The applicant for a certificate or the holder of the certificate shall be entitled to appeal.  

The appeal shall be filed in writing with the DPMA within one month of service of the 
decision  (Section 73(2),  first  sentence,  Patent  Act  in  conjunction  with Section  16a(2) 
Patent  Act).  An  appeal  fee  pursuant  to  the  Patent  Costs  Act  is  due  upon  filing  the 
appeal.  If  the  appeal  fee  is  not  paid  within  the  time  limit  for  filing  an  appeal,  the 
appeal is deemed not to have been filed (Sections 2, 3, 6 Patent Costs Act).  

The  patent  division  shall  examine  whether  an  appeal  received  is  admissible  (filing  in 
the due form and within the prescribed time limit) and well-founded. If it regards the 
appeal  as  well-founded,  it  shall  rectify  the  decision  (Section  73(3)  Patent  Act  in 
conjunction with Section 16a(2) Patent Act).  

A decision can be rectified only if the grounds for the rejection outlined by the patent 
division do no longer exist, e.g. because the reasons provided in support of the appeal 
convinced  the  patent  division  of  the  other  opinion  or  because  the  requested 
amendments  have  been  made.  If  the  decision  is  rectified,  the  patent  division  may 
order that the appeal fee be reimbursed (Section 73(3), second sentence, Patent Act).  

Reimbursement of the appeal fee shall be ordered if, due to particular circumstances, 
it would not be equitable to retain the fee. This is the case, if an obvious error of the 
DPMA prompted the appellant to file an appeal.  

If the decision is not rectified, the appeal shall be remitted to the Federal Patent Court 
within  one  month  and  without  comment  as  to  its  merits  (Section  73(3),  third 
sentence,  Patent  Act),  even  if  the  submission  of  further  documents  has  been 
announced. 

Invalidity  actions  against  granted  SPCs  can  also  be  brought  to  the  Federal  Patent 
Court.  Appeals  against  decisions  by  the  Federal  Patent  Court  are  possible  with  the 
Federal Supreme Court (Bundesgerichtshof, BGH). 

  ARTICLE 17(2) 

Pursuant to Article 17(2) and recital 17 of Regulation (EC) no. 1610/96 the decisions 
to  grant  the  certificate  are  open  to  an  appeal  aimed  at  rectifying  the  duration  of  the 
certificate  (of  the  certificate  for  a  medicinal  product  extended  by  six  months,  if 
appropriate) if the date, which is indicated in the application for a certificate pursuant 
to  Article  8  of  the  Regulations,  of  the  first  authorisation  to  place  the  product  on  the 
market in the Community is incorrect.  

Section  49a(4)  no.  1  of  the  Patent  Act  prescribes  that,  for  Germany,  the  decision  on 
the  request  to  correct  the  duration  of  a  supplementary  protection  certificate  shall  be 
taken  by  the  patent  division.  The  request  may  be  filed  any  time  before  the  expiry  of 
the  SPC  and  by  any  person.  The  proceedings  may  be  conducted  in  an  adversarial 
manner. 

42 

 
 
Germany 

  ENFORCEMENT OF THE SPC 

The  protection  provided  by  an  SPC  may  be  enforced  by  action  for  infringement  as  if 
the  SPC  were  a  patent.  Consequently  infringement  proceedings  must  be  started  at  a 
Regional  Court  (Landgericht),  with  subsequent  appeals  possible  to  a  Higher  Regional 
Court (Oberlandesgericht) and the Federal Supreme Court (Bundesgerichtshof). 

Typical  venues  for  infringement  proceedings  are  e.g.  the  Düsseldorf,  Munich  and 
Mannheim Regional Courts. 

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Study on the Legal Aspects of SPCs – Annex I

HUNGARY 

Dr. Laszlo Vass* Ildikó Prohászka** María Victoria Rivas Llanos*** 

INTRODUCTION: THE SOURCES OF LAW 

Hungary  is  an  EPC  Contracting  State,  as  well  as  a  Member  of  the  TRIPS  Agreement, 
the  PCT  and  the  PLT.  Hungary  takes  part  in  the  enhanced  cooperation  in  the  area  of 
the  creation  of  unitary  patent  protection76  and  has  signed  but  not  yet  ratified  the 
UPCA. 

Although  Hungary  is  not  a  Member  of  the  Strasbourg  Convention,  the  domestic 
provisions  are  consistent  with  the  substantive  provisions  of  the  latter  Convention, 
since they have been harmonised with the EPC. 

Patents are regulated under Act No XXXIII of 1995 on the Protection of Inventions by 
Patents.77 SPCs are referred to in Article 22/A of Act No XXXIII, which establishes the 
mandate  of  drafting  specific  legislation  for  the  implementation  of  Article  19  of 
Regulation  469/2009/EC  and  Article  18  of  Regulation  1610/96/EC.  This  mandate  has 
been  accomplished  through  Government  Decree  No  26  of  2004  (II.  26.)  on  the  rules 
necessary for the implementation of the European Community Regulations concerning 
the supplementary protection for certain products.78 

The  scope  of  protection  of  national  patents79  and  the  rights  conferred  by  such 
patents80  81 are regulated by provisions with similar wording to that of Article 69 EPC 
and Article 28 TRIPS Agreement respectively. 

*   Dr. Laszlo Vass - legal advisor, Hungarian Intellectual Property Office. 
**  
***   María  Victoria  Rivas  Llanos  -  doctoral  student  and  junior  research  fellow,  Max  Planck  Institute  for 

Ildikó Prohászka - patent examiner, Hungarian Intellectual Property Office. 

Innovation and Competition. 

76   See Regulation (EU) 1257/2012 of the European Parliament and of the Council of 17 December 2012 
implementing enhanced cooperation in the area of the creation of unitary patent protection [2012] OJ 
L361/1. 

77   Consolidated text (01.01.2017) available at: 

< https://www.sztnh.gov.hu/sites/default/files/patent_act_xxxiii_1995_en_20170617_ footnotes.pdf>. 

78   Consolidated text (08.05.2014) available at: 

<https://www.sztnh.gov.hu/English/jogforras/26_2004_Kr_SPC_EN.pdf>. 

79   Act No XXXIII, Article 24(1): ‘The scope of protection conferred by a patent shall be determined by the 

claims. The claims shall be interpreted on the basis of the description and the drawings’. 

80   Act No XXXIII, Article 19: 

(1) Patent protection shall afford the holder of the patent (patentee) the exclusive right to exploit the 
invention.  
(2)  On  the  basis  of  the  exclusive  right  of  exploitation,  the  patentee  shall  be  entitled  to  prevent  any 
person not having his consent  
(a) from making, using, putting on the market or offering for sale a product which is the subject matter 
of the invention, or stocking or importing the product for such purposes;  
(b)  from  using  a  process  which  is  the  subject  matter  of  the  invention  or,  where  such  other  person 
knows, or it is obvious from the circumstances, that the process cannot be used without the consent of 
the patentee, from offering the process for use;  
(c)  from  making,  using,  putting  on  the  market,  offering  for  sale  or  stocking  or  importing  for  such 
purposes a product obtained directly by a process which is the subject matter of the invention. 

81   Please  note  that  the  so-called  Bolar  exemption  and  the  private  use  exemption  are  foreseen  by  this 
provision.  The  preparation  for  individual  cases,  in  a  pharmacy,  of  a  medicine  in  accordance  with  a 
medical prescription, or acts concerning the medicine so prepared also constitute an exception to the 
rights conferred under Article 19 of Act No XXXIII. 

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The requirements for patentability are essentially the same as those of the EPC.82 The 
same is true regarding the requirement of sufficiency of disclosure83 and the possibility 
of amendment of the patent application.84  

INSTITUTIONAL ASPECTS 

The Hungarian Intellectual Property Office (hereinafter HIPO) is the government office 
for the protection of intellectual property and has competence in patent matters85 and 
also proceeds in matters relating to SPCs provided for in Government Decree No 26 of 
2004.86 The HIPO covers its operational costs from its own incomes and is entitled to 
manage them independently and use them to cover its operational costs.  

The  incomes  of  the  Office  consist  of  the  fees  for  administrative  services,  the 
maintenance and renewal fees, the fees and shares for administrative activities carried 
out by the Office on the basis of the international treaties administered by the WIPO, 
and shares from fees paid for the European Union or other regional industrial property 
protection  with  a  unitary  effect  extending  to  the  territory  of  Hungary;  taking  into 
account the tasks performed by the Office, the income from services provided by the 
Office, as well as other sources of income.87  

Applicants  have  the  possibility  of  applying  for  a  national  patent  before  the  HIPO 
pursuant  to  Act  No  XXXIII  or  for  a  European  patent  before  the  EPO  under  the  EPC 
rules.  In  addition,  the  HIPO  can  act  as  receiving  office  for  patent  applications  filed 
under the PCT procedure.88 

The  examiners  of  the  HIPO  have  a  technical  background89  and  perform  substantive 
examination of patent applications at the request of the applicant, which must be filed 
either  simultaneously  with  the  filing  of  the  patent  application  or,  at  the  latest,  within 
six months after the date of the official information on the performance of the novelty 
search.90 An examination fee prescribed by specific legislation must be paid within two 
months from the filing of the request for substantive examination.91 

82   Act No XXXIII, Articles 1 to 6. 
83  

ibid, Article 60(1): ‘A patent application shall disclose the invention in a manner sufficiently clear and 
detailed  for  it  to  be  carried  out  by  a  person  skilled  in  the  art  on  the  basis  of  the  description  and  the 
drawings…’ 
ibid, Article 72: 
(1) A patent application may not be amended in such a way that, by introducing new subject matter, it 
contains subject matter which extends beyond the content of the application at the date of filing.  
(2)  The  applicant  shall  be  entitled  to  amend  the  description,  claims  and  drawings  as  laid  down  in 
paragraph (1) until the day on which the decision on the grant of the patent is delivered. 
In accordance with the provisions of the Act on the General Rules of Public Administration Procedures 
and the Act on the General Rules of Electronic Administration and Trust Services. See Act No XXXIII, 
Article 45(1). 

84  

85  

86   Act No XXXIII, Article 44, in conjunction with Decree No 26/2004, Article 2. 
87   Act No XXXIII, Articles 115/D and 115/E. 
88  
89   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 54 by 

ibid, Article 45(6). 

the HIPO. 

90   Act No XXXIII, Articles 74 and 75. 
91  

ibid, Article 75(3). 

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FILING AND EXAMINATION OF THE SPC APPLICATION92 

An  SPC  application  must  be  filed  by  the  patent  holder93  before  the  HIPO  and  in 
Hungarian  language,94  within  six  months  of  the  date  of  grant  of  the  marketing 
authorisation95 referred to in Article 3(b) of Regulation 469/2009/EC or Article 3(1)(b) 
of Regulation 1610/96/EC, according to the requirements prescribed in Article 8 of the 
SPC Regulations. In particular, the application must contain: 

An indication that an SPC is sought, together with the name of the product;96 
Information identifying the applicant;  

i. 
ii. 
iii.  The registration number of the basic patent and the title of the invention;  
iv.  The  number  and  date  of  the  first  authorisation  to  place  the  product  on  the 
market,  as  referred  to  in  Article  3(b)  of  Regulation  469/2009/EC  and  Article 
3(1)(b)  of  Regulation  1610/96/EC  and,  if  this  authorisation  is  not  the  first 
authorisation  for  placing  the  product  on  the  market  in  the  EEA,  the  number 
and date of that authorisation.  

The  SPC  filing  date  will  be  the  date  on  which  the  application is  filed before  the  HIPO 
containing all the aforementioned documentation.97 

A filing fee, determined by special legislation,98 must be paid within two months of the 
SPC filing date. If the filing fee is not paid at the date of filing of the application, the 
HIPO will invite the applicant to rectify this irregularity within the given time limit. In 
the  event  of  failure  to  rectify  the  irregularity,  the  application  will  be  considered 
withdrawn. 

Following the filing of an SPC application,99 the HIPO examines whether the application 
meets the conditions laid down for according a filing date under Article 3(2) of Decree 
No 26/2004. Where the filing date cannot be accorded, the applicant will be invited to 
rectify  the  irregularities  within  30  days  of  the  notification  of  the  irregularities  to  the 
applicant. If the irregularities are rectified within the time limit, the date of receipt of 
the  rectification  of  irregularities  will  be  accorded  as  the  filing  date.  Otherwise,  the 
application will be considered withdrawn. 

92   Decree No 26/2004, Articles 3 and 4. 
93   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 3 by 

the HIPO. 

94   Act No XXXIII, Article 52(1), in conjunction with 22/A(3) of the same Act and Article 5(3) of Decree No 

95  

26/2004. 
If a European patent granted by EPO is designated as the basic patent of an SPC application, the SPC 
application may be lodged at the HIPO from the date of the national validation of the European patent 
in Hungary. 

96   The  product  must  be  identified  as  an  active  substance  in  the  annex  to  the  marketing  authorisation 
under  qualitative  and  quantitative  composition.  The  combinations  of  active  ingredients  should  be 
phrased as “combination of component 1 and component 2”. The name of the product given by the SPC 
applicant is an essential topic at the HIPO procedure because of the Article 3(9) of Decree No 26/2004, 
according to which the application may not be modified to the effect that the certificate extends to a 
product, to an authorisation to place a product on the market, or to a basic patent different from the 
ones  designated  at  the  date  of  filing  of  the  application.  Therefore  only  minor  modifications  of  the 
product name can be carried out during the examination procedure, for example the modification of a 
combination product to a mono product is not allowable. 

97   Decree No 26/2004, Article 3(2) 
98   Decree  No.  19/2005.  (IV.12.)  GKM  on  the  Fees  for  Administrative  Services  in  Industrial  Property 
Procedures before the Hungarian Patent Office, Article 6(1): ‘The fee for an application for the grant of 
a supplementary protection certificate and the fee for a request for the extension of the duration of a 
supplementary protection certificate is HUF 214 000 alike’. 

99   The  HIPO  starts  the  examination  of  an  SPC  application  on  the  filing  date  of  the  application.  There  is 
neither  a  time  limit  under  national  procedural  law  within  which  to  complete  the  examination,  nor  a 
formalised procedure for the acceleration of the examination of the SPC applications. 

46 

 
 
 
                                                 
Hungary 

If the application meets the conditions for according a filing date, the HIPO will publish 
in  the  Gazette  of  Patents  and  Trademarks100  the  information  on  the  SPC  application 
required  under  Article  9(2)  of  the  SPC  Regulations.  A  notification  on  the  SPC 
application is also recorded, referring to its basic patent, in the Patent Register. 

The  HIPO  will  then  examine  whether  the  SPC  application  meets  the  substantive 
requirements of the SPC Regulations and the conditions lay down in Act No XXXIII and 
in  Decree  No  26/2004.  Three  patent  examiners  with  a  technical  background  are  in 
charge of carrying out the examination of SPC applications. 

During  the  substantive  examination  all  of  the  requirements  of  Article  3  of  Regulation 
469/2009/EC  and  Article  3(1)  of  Regulation  1610/96/EC  are  verified,  including 
confirming  with  the  medicine  regulatory  authorities  (e.g.  through  online  databases), 
whether  information  provided  by  the  applicant  on  the  first  marketing  authorisation is 
correct. However, the HIPO only partially verifies whether the marketing authorisation 
provided by the applicant is indeed the first one. The HIPO checks the data available in 
International Patent Documentation database (INPADOC) and on the websites of some 
national patent offices to ascertain which marketing authorisations were submitted as 
being the first in other Member States, but does not carry out further verification.  

If the application meets the substantive requirements of the SPC Regulations and the 
conditions laid down in Act No XXXIII and in Decree No 26/2004, the HIPO will grant 
an  SPC  for  the  subject  of  the  application  and  a  notification  of  the  grant  will  be 
published in the Gazette of  Patents and Trademarks,  in accordance with Article 11 of 
the SPC Regulations. The grant of the SPC will also be recorded in the Patent Register, 
referring to its basic patent, and in the SPC Register. 

If  the  application  does  not  meet  the  above-mentioned  substantive  requirements,  the 
applicant will be invited to rectify it or to submit his comments within a given time.101 
The  application  will  be  rejected  if  it  still  does  not  meet  the  prescribed  requirements 
after rectification of the irregularities or the submission of comments. If the applicant 
fails  to  comply  with  the  HIPO's  invitation  within  the  given  time  limit,  the  application 
will  be  considered  withdrawn.  The  rejection  or  withdrawal  of  the  SPC  application  will 
be published in the Gazette of Patents and Trademarks, in accordance with Article 11 
of the SPC Regulations. 

FILING  AND  EXAMINATION  OF  A  REQUEST  FOR  PAEDIATRIC 
EXTENSION102 

A  request  for  extension  of  the  SPC  duration  with  regard  to  medicinal  products 
addressed  to  the  infant  population  (hereinafter  paediatric  extension)  must  be  filed 
before  the  HIPO  in  accordance  with  the  requirements  of  Article  8(1)(d)  of  Regulation 
469/2009/EC  in  conjunction  with  Article  36  of  Regulation  1901/2006/EC.  A  filing  fee, 
determined by special legislation, must be paid within two months of the date of filing 
of the request for a paediatric extension. 

100   Act No XXXIII, Article 56. 
101   The  application  may  not  be  modified  to  the  effect  that  the  certificate  extends  to  a  product,  to  an 
authorisation to place a product on the market, or to a basic patent different from the ones designated 
at the filing of the application. 

102   Decree No 26/2004, Articles 4/A and 4/B. 

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Study on the Legal Aspects of SPCs – Annex I

The request for a paediatric extension will be published in the Gazette of Patents and 
Trademarks, in accordance with Article 9(2) and (3) of Regulation 469/2009/EC. 

The HIPO will then examine whether the request satisfies the requirements laid down 
in  Regulation  469/2009/EC  in  conjunction  with  Regulation  1901/2006/EC,  Act  No 
XXXIII and Decree No 26/2004. If the request complies with these requirements, the 
HIPO  will  extend  the  SPC  term  as  prescribed  in  Article  13(3)  of  Regulation 
469/2009/EC. 

Should the request not comply with the above-mentioned requirements, the HIPO will 
invite the applicant to rectify the irregularities or submit comments within a given time 
limit. The request will be rejected if it still does not meet the prescribed requirements 
after the applicant has been given the opportunity to rectify the application or submit 
his comments. If the applicant does not reply to the HIPO’s invitation within the time 
limit, the request will be considered withdrawn. 

The request for a paediatric extension can be filed simultaneously with the application 
for  an  SPC  or  in  the  course  of  the  procedure  for  the  grant  of  the  SPC,  in  which  case 
the  HIPO  will  decide  on  the  request  for  a  paediatric  extension  in  its  final  decision  on 
the grant of the SPC. 

If  there  is  a  pending  procedure  on  the  lapse  or  invalidity  of  the  SPC  when  the 
application  for  a  paediatric  extension  is  filed,  the  procedure  on  the  paediatric 
extension  will  be  suspended  until  the  decision  on  the  lapse  or  invalidity  of  the  SPC 
becomes  final.  Should  the  HIPO  declare  the  SPC  to  be  lapsed  or  invalid,  the  request 
for  a  paediatric  extension  will  be  considered  withdrawn;  otherwise  the  procedure  on 
the paediatric extension will continue. 

The HIPO will publish its decision on the grant or rejection of the paediatric extension 
in  the  Gazette  of  Patents  and  Trademarks,  in  accordance  with  Article  11  of  the  SPC 
Regulations. In addition, the extension of the SPC duration will be recorded in the SPC 
Register. 

The HIPO will revoke the paediatric extension  ex officio103 should the basic patent be 
revoked after the grant of the paediatric extension. 

THIRD PARTY OBSERVATIONS 

During  the  SPC  granting  procedure,  any  third  party  may  file  an  observation  with  the 
HIPO  to  the  effect  that  the  application  does  not  comply  with  the  requirements  laid 
down  in  the  SPC  Regulations,  in  Act  No  XXXIII  or  in  Decree  No  26/2004.  Such 
observation  will  be  taken  into  consideration  when  the  requirement  objected  to  in  the 
observation  is  examined.  The  HIPO  will  notify  to  the  third  party  the  outcome  his 
observation.104 

103   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 70 by 

the HIPO. 

104   Act  No XXXIII,  Article  71,  in conjunction  with  22/A(3)  of  the  same  Act  and  Article  5(3)  of Decree  No 

26/2004.  

48 

 
 
 
                                                 
Hungary 

EFFECT  ON  THE  SPC  GRANTING  PROCEDURE  OF  PENDING 

REVOCATION  OR  OPPOSITION  PROCEDURES  AGAINST  THE 
PATENT 

A pending revocation procedure against the basic patent does not have an impact on 
the  SPC  granting  procedure  before  the  HIPO.105  The  same  applies  when  there  is  a 
pending  opposition  procedure  against  a  European  basic  patent.  However,  there  is  no 
opposition procedure in the Hungarian national patent procedure. 

GRANTING OR REJECTION OF THE SPC. JUDICIAL REVIEW106 

A request for judicial review of the decisions of the HIPO can be filed by any party to 
the  procedures  before  the  HIPO;  any  person  excluded  from,  or  limited  in,  the 
inspection  of  files;  or  any  person  whose  legal  status  as  a  party  to  the  procedure  has 
been denied. 

The  request  must  be  filed  before  the  HIPO  within  thirty  days  from  the  date  of 
communication  of  the  decision  to  the  party  concerned  or  to  any  other  party  to  the 
procedure.  This  time  limit  begins  on  the  date  of  the  communication  of  the  order 
refusing, or considering not to have been filed, a request for further processing or for 
restitutio  in  integrum,  if  that  date  is  later  than  the  date  of  communication  of  the 
HIPO's  decision,  and  the  request  for  further  processing  or  restitutio  in  integrum  was 
filed to prevent the consequences of an omission which served directly as a basis for 
the HIPO's decision.  

The  HIPO will forward the request for judicial review to the  court within fifteen days, 
together with all the documents in the SPC's file. If the request for review raises legal 
questions of fundamental importance, the HIPO may make a written statement about 
such questions and forward it to the court within thirty days, together with the request 
for judicial review and all the documents in the SPC's file. 

Any person having a legal interest in the outcome of the proceedings may intervene in 
favour  of  the  party  whose  interests  he  or  she  shares,  until  such  time  as  the  court 
decision  becomes  final.  The  intervener  can  take  any  action,  except  settlement, 
admission  of  claims  and  waiver  of  rights.  The  intervener's  acts  will  have  effect  only 
where  they  do  not  conflict  with  the  acts  of  the  party  concerned.  Any  legal  dispute 
between the intervener and the party concerned may  not be decided in the course of 
the proceedings.107 

Requests  for  judicial  review  are  heard  by  the  Budapest-Capital  Regional  Court 
(Fővárosi Törvényszék).108 109 

105   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 59 by 

the HIPO. 

106   Act  No XXXIII,  Article  85,  in conjunction  with  22/A(3)  of  the  same  Act  and  Article  5(3)  of Decree  No 

26/2004. 

107   Act No XXXIII, Article 93. 
108   Act  No XXXIII,  Article  86,  in conjunction  with  22/A(3)  of  the  same  Act  and  Article  5(3)  of Decree  No 

26/2004. 

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CALCULATION  OF  THE  PATENT  AND  SPC  DURATION. 
CALCULATION OF DEADLINES. RELIEF BEFORE THE HIPO 

Calculation of the patent and SPC duration 

Act  No  XXXIII  prescribes  that  patent  protection  shall  have  a  term  of  20  years 
beginning  on  the  filing  date  of  the  application.  Performing  the  calculation  yields  an 
expiration date that corresponds to the filing date.110 111 

The SPC duration is calculated in accordance with Article 13 of the SPC Regulations. 

The  date  of  the  first  authorisation  is  understood  –  both  in  the  case  of  national  and 
centralised marketing authorisations  – as the date of the notification  to the applicant 
of  the  grant  of  the  first  authorisation  to  place  the  product  on  the  market  in  the  
EEA.112 113 

The SPC expiration date in the case of the maximum term of 5 years shall correspond 
to the filing date of the basic patent. When a term of less than 5 years is calculated, 
the  SPC  expiration  date  shall  correspond  to  the  notification  date  of  the  grant  of  the 
first authorisation to place the product on the market in the EEA. 

This  also  serves  the  purpose  of  fulfilling  the  principle  enshrined  in  Recital  9  of 
Regulation  469/2009/EC  stating  that  the  holder  of  both  a  patent  and  a  certificate 
should be able to enjoy an overall maximum of 15 years of exclusivity.  

Calculation of terms 

For the calculation of time limits, the HIPO applies similar criteria to that stated in Rule 
131 EPC. Specifically, Article 65(2) of the Administrative Proceedings and Services Act 
states that where a time limit is defined in months or years, it shall expire on the day 
that corresponds to the starting day based on its number, or if this day is not available 
in the month when the time limit expires, on the last day of the month.114 

Relief before the HIPO for missed deadlines 115 

In the event of failing to comply with a time limit vis-à-vis the HIPO, the applicant can 
either request further processing or restitutio in integrum. 

A request for further processing must be submitted within two months from the date 
of notification of the decision taken by the HIPO because of the failure to comply with 

109   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 62 by 

the HIPO. 

110   Act No XXXIII, Article 22. 
111   MPI's  Questionnaire  for  National  Patent  Offices  of  the  EU  Member  States,  answer  to  question  No  44                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     

by the HIPO. 

112   Act  CXL  of  2004  on  the  General  Rules  of  Administrative  Proceedings  and  Services  (Administrative 

Proceedings and Services Act), Article 73/A(3). 

113   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 15 by 

the HIPO. 

114   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 44 by 

the HIPO. 

115   Act  No  XXXIII,  Articles  48  and  49,  in  conjunction  with  22/A(3)  of  the  same  Act  and  Article  5(3)  of 

Decree No 26/2004. 

50 

 
 
 
 
 
 
                                                                                                                                                    
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a time limit. The omitted act must be completed simultaneously with the filing of the 
request. If the HIPO grants the request for further processing, the acts completed by 
the  party  in  default  will  be  considered  to  have  been  performed  within  the  time  limit 
not  complied  with  and  the  decision  taken  because  of  the  failure  will  be  revoked  in 
whole or in part or modified as necessary. 

A request for restitutio in integrum must be filed before the HIPO within two months, 
but at the latest within twelve months, of the unobserved time limit or the last day of 
the  time  limit  not  complied  with.116  The  omitted  act  must  be  carried  out 
simultaneously with the filing of the request. The request must be accompanied by a 
statement on the grounds for the failure to comply with the time limit and proof that 
the failure did not occur due to the negligent behaviour of the applicant. 

Should  the  HIPO  grant  restitutio  in  integrum,  the  acts  carried  out  by  the  party  in 
default  will  be  considered  to  have  been  performed  within  the  time  limit not  complied 
with; a hearing held on the date not complied with will be repeated where necessary. 
The  decision  taken  as  a  result  of  the  failure  will  be  revoked  in  whole  or  in  part, 
modified or maintained as necessary or dependent on the outcome of a new hearing. 

Restitutio in integrum is excluded in the event of failure to comply with the time limit 
referred to in Article 7 of the SPC Regulations.117 

REPRESENTATION BEFORE THE HIPO118 

Applicants with their permanent residence or domicile outside the territory of the EEA 
must be represented by an authorised patent attorney or an attorney-at-law in all SPC 
matters within the competence of the HIPO. 

According to Article 51(2) of Act No XXXIII: 

A power of attorney shall be made in writing. As to the validity of a power of attorney given to a 
patent attorney, an attorney-at-law, a patent attorneys’ office, a patent attorneys’ partnership or 
a law office – either in the country or abroad – the signature by the mandator shall be sufficient 
for  it  to  be  valid.  The  power  of  attorney  may  also  be  a  general  authorization,  on  the  basis  of 
which the representative can proceed in all patent cases under the competence of the Hungarian 
Intellectual Property Office, to which the mandator is a party. A power of attorney given to a law 
office, a patent attorneys’ office or a patent attorneys’ partnership shall be deemed to be a power 
of attorney given to any person who certifies that he/she works within the framework of the office 
or partnership. 

  POST-GRANT  AMENDMENT  OF  THE  SPC  DURATION.  POST-

GRANT LIMITATION OR REVOCATION OF THE PATENT 

General procedural rules under Hungarian law provide applicants with the possibility to 
request  a  post-grant  amendment  of  the  SPC  duration.  This  issue  has  been  recently 

116   Where  the  failure  to  comply  became  known  to  the  party  subsequently  or  the  cause  thereof  was 
removed  subsequently,  the  time  limit  will  be  reckoned  from  the  date  on  which  the  failure  to  comply 
became known or the cause thereof was removed. 

117   Decree No 26/2004, Article 5(3)(a). 
118   Act  No XXXIII,  Article  51,  in conjunction  with  22/A(3)  of  the  same  Act  and  Article  5(3)  of Decree  No 

26/2004. 

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Study on the Legal Aspects of SPCs – Annex I

referred by the Budapest-Capital Regional Court to the CJEU for a preliminary ruling in 
case C-492/16.119 120 

The post-grant amendment of the patent is expressly forbidden under Article 72(2) of 
Act  No  XXXIII,  without  prejudice  to  the  possibility  of  surrendering  claims  or  partially 
revoking the patent in cases of partial invalidity.121 

  PAYMENT OF FEES 

The  fee  for  an  application  for  the  grant  of  an  SPC  and  the  fee  for  a  request  for  the 
extension of the duration of a supplementary protection certificate is HUF 235 400. 

The  maintenance  of  the  SPC  is  subject  to  the  payment  of  annual  fees122,  which  are 
due in advance on the same calendar day on which the filing of the application for the 
basic  patent  took  place.  The  annual  fee  due  prior  to  granting  the  SPC  must  be  paid 
within  a  six-month  grace  period  after  the  granting  decision  becomes  final.  If  the  last 
year  of  the  duration  of  the  SPC  is  an  incomplete  year,  the  annual  fee  must  be  paid 
proportionately together with the total amount of the annual fee for the last complete 
year.123 

  ENFORCEMENT OF THE SPC 

Pursuant to Article 5 of the SPC Regulation the certificate shall confer the same rights 
as conferred by the basic patent and shall be subject to the same limitations and the 
same obligations. At the national level, Article 7(1) of Decree No 26/2004 states that 
the  provisions  of  Chapters  II  to  V124  of  Act  No  XXXIII  apply  mutatis  mutandis  to  the 
rights  and  obligations  resulting  from  an  SPC,  the  exploitation  licenses  concerning 
SPCs,  as  well  as  compulsory  licenses  and  infringement  of  SPCs.  In  addition,  Article 
13(1) of the SPC Regulations states that the certificate shall take effect at the end of 
the lawful term of the basic patent.  

Based on a combined interpretation of these provisions, if the grant of the SPC takes 
place  later  than  the  expiry  of  the  basic  patent,  the  protection  conferred  by  the  SPC 

119   Incyte Corporation v Szellemi Tulajdon Nemzeti Hivatala (5.12.2016 OJEU C 454/17). 
120   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 65 by 

the HIPO. 

121   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 31 by 

the HIPO. 

122   Decree  No.  19/2005.  (IV.12.)  GKM  on  the  Fees  for  Administrative  Services  in  Industrial  Property 

Procedures before the Hungarian Patent Office, Article 6: 
(2) The amount of the maintenance fee of the certificate is 
(a) HUF 293 700 for the first year; 
(b) HUF 352 000 for the second year; 
(c) HUF 411 400 for the third year; 
(d) HUF 469 700 for the fourth year; 
(e) HUF 528 000 for the fifth year; 
(f) HUF 620 400 for the sixth year. 
(3)  If  the  last  year  of  the  duration  of  the  certificate  is  an  incomplete  year,  the  amount  of  the 
maintenance fee shall be the result of multiplying the number of each commenced calendar month of 
the incomplete year by one twelfth of the maintenance fee indicated in paragraph (2) for the complete 
year having the same serial number as the incomplete year.  

123   Decree No 26/2004, Article 7(2), in conjunction with Act No XXXIII, Article 22/A(4). 
124   Concerning  rights  and  obligations  conferred  by  a  patent,  exploitation  contracts,  compulsory  licenses 

and patent infringements. 

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shall take effect retroactively, without any temporary lapse. Thus, an SPC application 
confers the same rights as the basic patent between the expiry of the basic patent and 
the grant of the SPC, provided that it is granted.125 

The  Budapest-Capital  Regional  Court  has  exclusive  competence  in  patent  litigation 
matters  and  sits  in  a  chamber  consisting  of  three  professional  judges  of  whom  two 
have technical university degrees or equivalent qualifications.126 

In  addition  to  civil  remedies  applicable  in  the  case  of  infringement,  the  patentee  can 
request  the  court,  on  conditions  relating  to  provisional  measures,  to  order 
precautionary  measures  in  accordance  with  the  provisions  of  the  Act  on  Judicial 
Execution,127 if he demonstrates circumstances likely to endanger the later satisfaction 
of  his  claim  for  damages  or  for  the  surrender  of  the  enrichment  obtained  by 
infringement; compel the infringer to communicate or present his banking, financial or 
commercial documents with a view to ordering the precautionary measures; and order 
the  lodging  of  security,  if  instead  of  demanding  discontinuance  of  the  patent 
infringement,  the  patentee  consents  to  the  continuation  of  the  allegedly  infringing 
activity  by  the  infringer.  The  court  may  order  the  lodging  of  security  even  in  the 
absence of a request of the patentee to this effect, provided that the patentee filed a 
request  for  the  discontinuance  of  patent  infringement,  which  the  court  does  not 
allow.128 

125   For  a  detailed  legal  analysis  see:  Ficsor,  M.  (2006).  Kiegészítő  megjegyzések  a  kiegészítő  oltalmi 
joggyakorlatához.  Iparjogvédelmi  és  Szerzői  Jogi  Szemle,  111(2),  p.  71-77. 

tanúsítványok 
Available at: https://www.sztnh.gov.hu/kiadv/ipsz/200604-pdf/06-ficsor-kiegeszito.pdf. 

126   Act No XXXIII, Article 104(1) in conjunction with Article 87. 
127   1994. évi LIII. törvény. Available at: 

<https://net.jogtar.hu/jr/gen/hjegy_doc.cgi?docid=99400053.TV&timeshift=fffffff4& 
txtreferer=00000001.TXT> 

128   Act No XXXIII, Article 104(5) and (6). 

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LITHUANIA 

Dovilė Tebelškytė* 

INTRODUCTION: THE SOURCES OF LAW 

Lithuania is a member of the European Union and a contracting state to the European 
Patent  Convention.  Lithuania  has  also  joined  the  Agreement  on  the  Unified  Patent 
Court.  

The  Patent  Law  of  the  Republic  of  Lithuania  contains  a  provision  (Article  37)  on  the 
supplementary protection certificates (SPCs), setting out the basic rules on paying the 
maintenance fees for SPC.  

Detailed  procedures  applicable  for  applying  for  and  granting  SPCs  are  set  out  in  the 
Rules on Granting Supplementary Protection Certificates, approved by the Director  of 
the State Patent Bureau of the Republic of Lithuania. 

INSTITUTIONAL ASPECTS 

The  State  Patent  Bureau  is  a  governmental  institution  of  public  administration  under 
the Ministry of Justice of the Republic of Lithuania. It is a budgetary institution, which 
is  responsible  for  granting  patents,  registering trademarks,  designs  and  topographies 
of semiconductor products in Lithuania, as well as for granting the SPCs. 

There  are  five  patent  examiners  in  the  State  Patent  Bureau,  all  of  whom  are  of  a 
technical  background.  Two  of  the  patent  examiners,  holding  a  doctor  degree  in  the 
field of chemistry, are currently inter alia responsible for handling SPC applications. 

The  State  Patent  Bureau  does  not  carry  out  substantial  examination  of  patent 
applications  for  novelty,  inventive  step  or  industrial  applicability  requirements.  As 
there  is  no  administrative  procedure  of  opposition  available,  these  aspects  of 
patentability are only examined by courts in cases concerning invalidation of patents. 
Evaluation  of  the  core  inventive  advance  regarding  the  SPC  application  would  be 
difficult in the light of the competence of the State Patent Bureau. 

The State Patent Bureau does not have guidelines for the examination of SPCs. 

FILING OF THE APPLICATION AND PUBLICATION 

The  requirements  for  content  of  the  SPC  application  according  to  the  Rules  on 
Granting  Supplementary  Protection  Certificates  comply  with  and  detail 
the 
requirements of Article 8 of Regulation 469/2009; the request is filed in a prescribed 
form, which inter alia includes the name of the product. Information on the application 
received  is  published  once  the  application  is  granted  the  date  of  filing  in  the  Official 

*   Dovilė  Tebelškytė  –  State  Patent  Bureau  of  the  Republic  of  Lithuania,  Head  of  Law  and  International 

Affairs Division. 

54 

 
 
 
 
 
 
                                                 
Lithuania 

Gazette  of  the  State  Patent  Bureau,  which  is  available  in  electronic  form  every  two 
weeks129  and  in  the  online  patent  database.130  There  is  no  SPC  application  file 
inspection available in the database. 

Patent Law of the Republic of Lithuania does not establish a possibility to request the 
re-establishment of rights in case the SPC application is not filed within the time limit, 
prescribed by Article 7 of Regulation 469/2009. 

FORMAL 
AUTHORISATION 

EXAMINATION.  COPY  OF 

THE  MARKETING 

Copy  of  the  marketing  authorisation  is  required  by  the  State  Patent  Bureau,  and 
failure  of  the  applicant  to  provide  it  would  result  in  rejection  of  the  application, 
according to the Rules on Granting Supplementary Protection Certificates.  

SUBSTANTIVE EXAMINATION  

According  to  the  Rules  on  Granting  Supplementary  Protection  Certificates,  the  State 
Patent  Bureau  examines,  in  the  scope  of  Article  3  of  the  Regulation  469/2009, 
whether the product, for which SPC protection is sought is covered by the basic patent 
indicated  in  the  application,  whether  the  product  has  not  yet  been  the  subject  of  an 
SPC,  also  if  a  copy  of  the  first  MA  was  furnished.  The  Rules  establish  that  the  State 
Patent Bureau does not check if the MA provided by the applicant is the first MA; the 
applicant is responsible for the truthfulness of the documents he/she provides with the 
application.  

National law does not provide any additional regulation on cases where the MA is not 
valid  at  the  date  on  which  the  SPC  application  is  filed,  in  comparison  with  the 
Regulation 469/2009, and there were no such situations noticed in practice. 

The State  Patent Bureau follows the  case law of  EUCJ on Article 3 on a case by  case 
basis, treating similar situations in a similar fashion as much as possible. 

Concerning  the  practice  following  the  EUCJ  Neurim  judgment,  there  has  been  an 
appeal  brought  to  the  Appeals  Division  of  the  State  Patent  Bureau,  where  the  SPC 
application  was  based  on  a  different  dosage  of  the  same  medical  product,  which  has 
already  been  granted  an  SPC.  The  examiner  and  Appeals  Division  have  stated  that 
different  dosage  does  not  constitute  a  different  therapeutic  application;  therefore  a 
second SPC was not issued. 

THIRD PARTY OBSERVATIONS 

Possibility  to  file  third  party  observations  is  not  established  by  national  law.  If  the 
examiner  received  information  from  third  parties,  that  is  relevant  to  the  examination 
process, he/she would consider it in the scope of the requirements of the examination. 

129   <http://www.vpb.lt/index.php?l=en&n=245>. 
130   <http://www.vpb.lt/index.php?l=en&n=238>. 

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EFFECT  ON  THE  SPC  GRANTING  PROCEDURE  OF  PENDING 

REVOCATION  OR  OPPOSITION  PROCEDURES  AGAINST  THE 
PATENT 

The issue is not regulated by national law, but the examiner would likely stay the SPC 
proceedings,  in  particular  by  the  request  of  the  applicant,  if  the  case  concerning  the 
invalidation  of  the  patent  is  brought  in  court  (there  is  no  opposition  procedure 
available). 

GRANTING  OR  REJECTION  OF  THE  SPC.  APPEAL  AND 
REVOCATION PROCEDURES 

There  are  no  hearing  proceedings  before  the  examiner  takes  a  decision  to  grant  or 
reject  an  SPC,  but  the  applicant  may  contact  the  examiner  and  provide  necessary 
documents or explanations in the course of the examination. 

There  is  a  possibility  to  file  an  appeal  to  the  Appeals  Division  of  the  State  Patent 
Bureau,  if  the  SPC  application  is  rejected,  within  3  months  from  the  respective 
decision.  The  applicant  may  request  a  verbal  hearing  instead  of  written  procedure  in 
the  Appeals  Division,  but  it  only  takes  place  if  there  are  enough  arguments  to  show 
that the case is complex or important to practice of the Appeals Division. 

The  decision  of  the  Appeals  Division  may  be  appealed  to  the  Vilnius  County  Court, 
which has exclusive competence for industrial property cases. Vilnius County Court is 
also the first instance for hearing cases on patent and SPC invalidation. 

CALCULATION  OF  THE  PATENT  AND  SPC  DURATION. 
CALCULATION OF DEADLINES. RELIEF BEFORE THE OFFICE 

Calculation of the patent and SPC duration. Calculation of terms 

Patent term lapses on the anniversary date of the application filing date. The SPC term 
is calculated according to the Article 13(1) of Regulation 469/2009; the last day of the 
SPC is the anniversary date of the grant of the MA, but the term of the SPC may not 
be longer than 5 years from the anniversary date of the lapse of the patent. 

Relief before the office for missed deadlines 

The  Patent  Law  establishes  a  possibility  to  request  the  re-establishment  of  certain 
rights  concerning  patents.  The  State  Patent  Bureau  does  not  allow  for  re-
establishment  of  rights  in  case  of  failure  to  comply  with  time  limits  for  filing  an  SPC 
application;  re-establishment  concerning  the  payment  of  maintenance  fees  could  be 
possible mutatis mutandis applying the provisions applicable to patents, but there has 
not yet been such situations in practice. 

56 

 
 
 
 
 
 
 
Lithuania 

  REPRESENTATION BEFORE THE OFFICE 

The applicant may be represented by the patent attorney of the Republic of Lithuania. 
Permanent  residents  or  companies  having  a  registered  place  of  business  in  Lithuania 
or  another  member  state  of  EEA  or  EPC  may  be  represented  by  their  employee;  all 
other  applicants  must  be  represented  by  the  patent  attorney  of  the  Republic  of 
Lithuania,  with  exception  of  filing  an  application,  paying  a  fee  or  receiving  respective 
communications  from  the  State  Patent  Bureau  –  these  actions  may  be  taken  by  the 
applicant himself. 

  POST-GRANT  AMENDMENT  OF  THE  SPC  DURATION.  POST-

GRANT LIMITATION OR REVOCATION OF THE PATENT 

  Post-grant amendment of the SPC duration 

The time limit to file an Appeal to the Appeals Division is 3 months from the relevant 
decision  by  the  examiner.  After  that  period  the  case  could  be  brought  in  court. 
However,  after  relevant  EUCJ  decisions  (e.g.  C-471/14)  the  State  Patent  Bureau  has 
allowed  rectification  of  the  duration  of  the  certificates.  The  SPC  holder  should  be 
allowed to amend the duration of certificate anytime, if it is being shortened.  

  Post-grant limitation or revocation of the patent 

Patent  may  only  be  revoked  by  court;  therefore  the  same  procedure  should  to  be 
applied in respect of the SPC. 

  SPECIFIC ISSUES CONCERNING EXTENSION PURSUANT TO ART. 

36 OF REG. 1901/2006/EC 

The  applicant  has  to  provide  data  and  documents  according  to  Article  8(d)  of  the 
Regulation 469/2009. 

57 

 
 
 
 
 
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  PAYMENT OF FEES 

There are fees to be paid for filing an SPC application and maintenance fees. Filing fee 
is to be paid during the last 2 months of last year of the patent term. Maintenance fee 
for the next year is to  be paid during the last 2 months  of the  preceding year of the 
SPC. After this term 50 percent higher maintenance fee may be paid in 6 months. 

Amounts of the fees concerning SPCs are currently as follows: 

Filing fee 

Renewal fee SPC year 1 

Renewal fee SPC year 2 

Renewal fee SPC year 3 

Renewal fee SPC year 4 

Renewal fee SPC year 5 

Table 6.1: 

115 Eur 

347 Eur 

347 Eur 

347 Eur 

347 Eur 

347 Eur 

  ENFORCEMENT OF THE SPC 

Provisions  of  national law,  applicable  for  enforcement  of  patent  rights,  are  applicable 
for  enforcement  of  SPC  rights.  National  law  does  not  regulate  rights  on  a  published 
SPC application.  

58 

 
 
 
 
 
Poland 

POLAND 

Wioleta Świerczyńska*  

INTRODUCTION: THE SOURCES OF LAW 

Poland signed the TRIPS agreement, has been Contracting State of the EPC since 2004 
and  is  a  Member  of  the  PCT  and  PLT.  Poland  does  take  part  in  the  enhanced 
cooperation in the area of the creation of unitary patent protection131, but did not sign 
UPCA. 

The  sources  of  law  that  apply  to  national  patents  are:  the  Industrial  Property  Law 132 
and  the  Regulation  of  the  Prime  Minister  of  17  September  2001133  on  filing  and 
processing of patent and utility model applications. 

To SPCs concern Articles 751 to 7510 of the Industrial Property Law. To SPCs concerns 
also the Regulation of the Prime Minister134, but it is available only in Polish. 

In  Poland  the  scope  of  protection  of  the  patent  is  regulated  by  a  provision135  with 
similar wording to that included in Art. 69 EPC and the rights conferred by the patent 
by a provision136 with wording consistent with Art. 28 TRIPS. 

Polish legislator has not made use of the option under Art. 19 Regulation 469/2009 to 
include  specific  procedural  provisions  for  SPC  applications.  Procedural  provisions,  i.e. 
litigation procedures, time limits, representatives, appeal procedure etc. are the same 
as for patents and are included in Title VI and Title VII of the Industrial Property Law. 

*   Wioleta Świerczyńska – the Patent Office of the Republic of Poland. 
131   Regulation  (EU)  1257/2012  of  the  European  Parliament  and  of  the  Council  of  17  December  2012 
implementing enhanced cooperation in the area of the creation of unitary patent protection [2012] OJ 
L361/1. 

132   Act of 30 June 2000, Industrial Property Law as amended by act of 23 January 2004 and act of 29 June 

2007. http://www.uprp.pl/akty-prawne/Lead03,13,1315,1b,index,pl,text/podstawowe-obowiazujace-  
akty-prawne/Lead03,50,262,1b,index,pl,text/ 

133   Regulation  of  the  Prime  Minister  of  17  September  2001  on  filing  and  processing  of  patent  and  utility 

model applications. http://uprp.pl/akty-prawne/Lead03,13,1315,1b,index,pl,text/podstawowe- 
obowiazujace-akty-prawne/Lead03,50,262,1b,index,pl,text/ 

134   Rozporządzenie Prezesa Rady Ministrów z dnia 9 września 2016 r. w sprawie składania i rozpatrywania 
wniosków o udzielenie dodatkowego prawa ochronnego dla produktów leczniczych i produktów ochrony 
roślin. http://uprp.pl/uprp/_gAllery/78/75/78758/dodatkowe_prawo_ochronne_dla_produktow_  
leczniczych_i_produktow_ochrony_roslin_poz._1482.pdf 

135   Art.  63  (2):  The  scope  of  the  protection  sought  shall  be  determined  by  the  claims  contained  in  the 

patent specification. The patent specification and drawings may be used to interpret the claims. 

136   Art.  66:  1.  The  patent  holder  shall  have  the  right  to  prevent  any  third  party  not  having  his  consent 
from  exploiting  his  invention  for  profit  or  for  professional  purposes  by  way  of  performing  the  acts 
consisting of: 
(i) making, using, offering, putting on the market a product that is the subject matter of the invention, 
or importing the product for such purposes, or 
(ii) employing a process that is the subject matter of the invention, as well as using, offering, putting 
on the market or importing for such purposes the product directly obtained by that process.  
2.  The  patent  holder  shall  have  the  right  to  authorise  (license)  another  party  to  exploit  his  invention 
(license agreement).  

59 

 
 
 
 
 
                                                 
 
 
  
  
  
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INSTITUTIONAL ASPECTS 

The  Patent  Office  of  the  Republic  of  Poland  is  the  authority  that  pursuant  to  Art.  9 
Regulation 469/2009 is entrusted with examination. 

In accordance with Title VIII Part I of the Industrial Property Law, Patent Office of the 
Republic  of  Poland  is  a  central  government  agency  responsible  in  industrial  property 
matters. Patent Office is subordinated to the Council of Ministers. Supervision over the 
Patent Office’s activities is exercised by a minister competent in economy. 

The  Patent  Office  of  the  Republic  of  Poland  is  an  examining  office.  It  undertakes 
substantive  examination  of  patent  applications  with  respect  to  all  requirements  of 
protection. Polish applicants can apply for national patents before the Patent Office of 
the Republic of Poland or, in accordance with Art. 40 of the Industrial Property Law, if 
they wish to seek patent protection in another country, they can do so after applying 
for protection with the Patent Office of the Republic of Poland. 

Guidelines  for  the  examination  are  included  in  “Poradnik  wynalazcy”137  edited  by 
Andrzej  Pyrża,  Warszawa  2017,  published  by  the  Patent  Office  of  the  Republic  of 
Poland.  This  handbook  concerns  examination  procedures  in  all  fields  of  industrial 
property,  including  SPCs.  This  handbook  is  available  only  in  Polish  and  only  in  paper 
version. 

Patent  examiners  have  a  technical  background.  Examiners  entrusted  with  the 
examination of SPCs hold higher education degree in the field of chemistry, biology or 
biotechnology. 

FILING OF THE APPLICATION AND PUBLICATION 

The SPC application must be filed in Polish. 

The  information  about  the  SPC  application  is  published  in  Wiadomości  Urzędu 
Patentowego (WUP)138 just after finishing the formal procedure. 

The SPC application can be filed by the patent holder or his/her representative. 

The  Office  asks  the  SPC  applicant  about  the  product  definition,  which  should  be 
included in the title of the SPC application. 

If  the  proposed  definition  is  “compound  in  all  acceptable  salts  and  derivatives”,  the 
Office  does  not  accept  “all”  in  the  definition  if  it  is  not  present  in  the  claims  of  the 
basic patent. The term “derivatives” is unclear so the kinds of derivatives have to be 
specified in the product definition, for example esters, solvates etc. 

In  the  case  of  a  process  patent,  the  Office  grants  SPC  for  “Product  obtained  by  a 
method in accordance with the patent no. ...”. 

137   Poradnik  wynalazcy.  Procedury  zgłoszeniowe  w  systemie  krajowym,  europejskim,  miedzynarodowym. 

Redakcja Andrzej Pyrża. Wydanie III-uzupełnione. Stan prawny na dzień 1 stycznia 2017 r. 

138   Wiadomości Urzędu Patentowego (WUP). http://portal.uprp.pl/wydawnictwa.html 

60 

 
 
 
 
                                                 
Poland 

In  the  case  of  second  medical  use,  the  use  has  to  be  indicated  in  the  SPC  product 
definition.  The  Office  grants  SPC  for  “The  product  for  use...”,  where  the  use  is 
specified  in  accordance  with  a  content  of  the  basic  patent  claim.  If  this  kind  of  the 
product  definition  is  inconvenient,  the  SPC  is  granted  for  “Product  for  use  in 
accordance with the patent no. ...”. 

We  have  not  had  SPC  applications  that  include  in  some  form  possible  future 
biosimilars.  

The  SPC  application  must  contain  a  copy  of  MA,  which  includes  Summary  of  Product 
Characteristics  for  medicinal  products  or  summary  of  data  for  plant  protection 
products.  If  the  MA  to  place  the  product  on  the  market  in  Poland  is  not  the  first  to 
place  the  product  on  the  market  of  the  European  Union,  the  application  must  also 
contain the statement of the product’s identity, the legal provision under which the MA 
was granted and a copy of the notice publishing the MA, if it was published. 

The  time  limit  for  filing  the  SPC  application  is  that  indicated  in  Article  7  Reg. 
469/2009.  After  expiry  of  the  6  month  time  limit,  the  SPC  application  cannot  be 
accepted. 

Regarding the centralised MA, the reference day is a day of notification. In the case of 
national MA, the reference day is a day of granting. 

If exist two MAs with the same date, both of them are mentioned in the decision about 
granting SPC. The variations or extension of existing MAs can be used as a first MA in 
accordance  with  Art.  7  Reg.  469/2009.  They  are  not  considered  as  the  same  global 
MAs only in the case of the basic patents for a new medical application.  

Formal examination  

Patent Office of the Republic of Poland accepts the SPC application if it is complete. If 
the application is incomplete, also in the case of lacking the copy of the MA, or if the 
fee  is  not  paid,  the  Patent  Office  invites  the  applicant  in  order  to  furnish  it,  within  a 
fixed  time  limit  and  under  pain  of  discontinuance  of  the  proceedings,  missing 
documents or information. If the deficiency is remedied within the time limit, the date 
of filing of the incomplete application is deemed to be the filing date. If the deficiency 
is not rectified on time, proceedings are discontinued. 

If the SPC application is lack of the copy  of the MA, the  Office invite the applicant in 
order  to  furnish  it  based  on  Art.  42(1)  in  connection  with  Art.  753  of  the  Industrial 
Property  Law.  In  accordance  with  the  Art.  242(1)  of  the  Industrial  Property  Law,  the 
time limit is one month if the applicant has domicile or seat in Poland, or two months 
if the she/he has domicile or seat in another country. In reasonable cases, the Office 
can fix a longer time limit, but not longer than 3 months (Art. 242(2) of the Industrial 
Property Low).  In accordance with Art. 242(3), the mentioned above time limits may 
be lengthen by two months.  

In  accordance  with  the  Polish  legislation,  based  on  Art.  244-245  and  248,  the 
applicant has also the possibility to ask about re-examination or lodge a complaint to 
the administrative court.  

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Study on the Legal Aspects of SPCs – Annex I

SUBSTANTIVE EXAMINATION  

Although  in  the  Polish  legislation  is  no  deadline  within  which  the  SPC  application 
should be granted or rejected, in practice we try to grant or reject the SPC application 
two years before the expiration date of the basic patent.  

The  Patent  Office  of  the  Republic  of  Poland  examines  all  requirements  under  Art.  3 
Regulation  469/2009.  After  publication  about  filling  the  SPC  application,  the  principle 
of ex officio applied to the examination procedure. 

Guidelines  for  the  examination  of  the  SPC  applications  are  included  in  the  handbook 
under  the  title  “Poradnik  wynalazcy”  mentioned  above.  This  publication  also  contains 
information about the Patent Office practice in terms of the CEJU case law on Art. 3 a. 

In  accordance  with  Polish  examining  guidelines,  SPC  can  be  granted  relating  to  only 
these  active  ingredients  which  are  specified in the  wording  of  the  claims  of  the  basic 
patent. On the same condition, SPC can be granted relating to the combination of the 
active  ingredient.  If  the  basic  patent  protects  different  combinations  of  the  active 
ingredients,  each  of  these  combinations  involves  separate  SPC.  SPC  can  protect 
derivatives of the active ingredient, such as salts or esters, if they are specified in the 
wording of the claims of the basic patent. 

In  the  case  of  a  process  patent  SPC  can  be  granted  only  for  product  obtained  by  a 
method protected by this patent, what has to be clearly indicated in the decision. 
SPC  can  be  granted  for  the  active  ingredient  X,  if  the  basic  patent  protects 
composition containing this active ingredient X for use as a drug. 

SPC  cannot  be  granted  for  the  active  ingredient  X,  if  the  basic  patent  protects 
composition of the active ingredients X + Y. 

If the basic patent protects active ingredient X, but medicinal product includes active 
ingredients X + Y, the SPC can be granted only for active ingredient X.  

Another SPCs cannot be granted for the same active ingredient in the case where the 
basic patent protects a new dosage form or a new medical indication. The exception is 
a  situation  where  the  basic  patent  protects  new  medical  use  of  the  active  ingredient 
which has not been protected as such by a patent (C-130/11 Neurim).  In  accordance 
with  Art.  4  of  the  Regulation  469/2009, if  the active  ingredient  was  earlier  protected 
by  a  patent,  this  protection  included  also  all  applications  of  this  ingredient,  even  the 
later. If the SPC is granted for second medical use, this fact has to be clearly indicated 
in the decision. 

SPC cannot be granted for medical devices. 

In the Polish Patent Office the judgement C-322/10 Medeva is applied strictly. SPC can 
be granted only relating to active ingredients which are specified in the wording of the 
claims  of  the  basic  patent.  SPC  can  be  also  granted  relating  to  a  combination  of  two 
active ingredients, corresponding to that specified in the wording of the claims of the 
basic patent, where the medicinal product for which the MA is submitted contains not 
only that combination of the two active ingredients but also other active ingredients. 

62 

 
 
 
 
Poland 

At  this  moment  in  time  the  Office  still  does  not  have  established  practice  concerning 
the judgement C-493/12 Eli Lilly. SPC applications, for which this judgement could be 
applied, are at the very beginning of the examination.  

The  Patent  Office  position  on  the  judgement  C-130/11  Neurim  is  that  SPC  for  a  new 
medical  use  can  be  granted  only  in  a  situation  where  the  active  ingredient  has  not 
been previously protected by a patent. 

The MA must be in force at the date on which the SPC application is field. 

THIRD PARTY OBSERVATIONS 

Third  parties  can  send  their  comments  which  are  taken  into  consideration  in  the 
course  of  examining  of  the  application.  The  legal  basis  for  this  right is  Art.  44  (1)  of 
the  Industrial  Property  Law.  The  observations  can  be  also  filed  anonymously.  During 
examining proceedings we do not quote third party observations in the official letters 
sent to SPC applicants. If the Patent Office decides to grant an SPC despite third party 
observation opposing the grant, the decision is not provided with reasons. 

The Patent Office does not inform the applicant about the third part observations. 

EFFECT  ON  THE  SPC  GRANTING  PROCEDURE  OF  PENDING 

REVOCATION  OR  OPPOSITION  PROCEDURES  AGAINST  THE 
PATENT 

In the jurisdiction of Poland we can suspend the SPC granting procedure in the case of 
pending revocation or opposition procedures against the patent. It can be done only at 
applicant’s request.  In real terms, we usually stop the  examining procedure and wait 
for the result of the revocation or opposition procedure. 

GRANTING  OR  REJECTION  OF  THE  SPC.  APPEAL  AND 
REVOCATION PROCEDURES 

In  the  jurisdiction  of  Poland  is  no  deadline  prescribed  by  law  when  the  Office  must 
grant or reject the SPC. 

All decisions of the Patent Office can be appealed. 

Decisions about grant or rejection of the SPC of the Patent Office are liable to a party’s 
request  for  re-examination  of  the  matter  within  the  meaning  of  the  Code  of 
Administrative  Procedure139  (Art.  244-245  of  the  Industrial  Property  Law)  and 
decisions are subject to complaint lodged to the administrative court (Art. 248 of the 
Industrial Property Law).  

139   Journal of Laws 1960 No. 30, item 168, Act of 14 June 1960, Code of Administrative Procedure. 

63 

 
 
 
 
 
 
                                                 
Study on the Legal Aspects of SPCs – Annex I

Since June 2017, if the applicant does not agree with the decision of the Patent Office, 
she/he has two options. The first option is a request for re-examination by the Office 
at first and next, if the applicant still does not agree with decision, it can be a subject 
to  complaint  lodged  to  the  administrative  court.  In  the  second  option,  the  applicant 
can  resign  from  re-examination  of  decision  and  lodge  the  complaint  to  the 
administrative court.  

Before June 2017, applicants did not have such a choice, and always had to ask for re-
examination at first. 

CALCULATION  OF  THE  PATENT  AND  SPC  DURATION. 
CALCULATION OF DEADLINES. RELIEF BEFORE THE OFFICE 

Calculation of the patent and SPC duration 

The  term  of  a  patent  is  20  years  counted  from  the  date  of  filing  of  the  patent 
application with the Patent Office. 

For example, if the patent application was filed 1 July 2001, the ending day is 1 July 
2021. Yes, in terms calculating we apply the same rules as included in Rule 131 EPC. 

Calculation  of  the  SPC  duration  is  based  on  the  application  date  of  the  patent 
application  and  on  the  date  of  the  first  MA.  The  SPC  enters  into  effect  as  of  the  last 
day  in  which  the  patent  is  in  force.  For  example,  for  a  patent  filed  on  15  October 
2015, the expiry date of the basic patent is 15 October 2035, the start date of the SPC 
is 15 October 2035, the maximum expiry date of the SPC is 15 October 2040.  

The  Patent  Office  does  not  grant  SPC  for  negative  protection  period,  but  waits  for  a 
potential application for paediatric extension. 

Calculation of terms 

In  accordance  with  the  Art.  242  of  the  Industrial  Property  Law,  in  the  course  of 
proceedings  the  Patent  Office  fixes  one  month  time  limit,  where  the  party  has  its 
domicile or seat in Poland, or two months’ time limit, where the party has its domicile 
or  seat  in  another  country.  When  reasonable,  the  Patent  Office  fixes  a  time  limit 
longer, however of no more than three months. Any act may be performed within two 
months  after  the  expiry  of  a  fixed  time  limit,  if  before  its  expiry  the  Patent  Office  is 
notified in writing by the party on the reasons of non-observance of that limit. 

An  application  shall  be  deemed  to  have  been  filed  at  the  date  at  which  it  has  been 
received by the Patent Office. 

In  the  course  of  proceedings  the  fixed  terms  start  at  the  date  on  which  an  act  is 
served to the party. The deadline is considered to be met if the post stamp has been 
made not later than the deadline set.  

If a period is measured in days or commences with a certain event, the calculation of 
the period shall not include the date  on which the event occurred.  The deadline shall 
be deemed to have expired at the end of the last of the number of days calculated. If 

64 

 
 
 
 
 
Poland 

the deadline falls on a public holiday or Saturday, the deadline shall be deemed to be 
the  next  business  day.  Deadlines  which  are  set  in  months  shall  expire  at  the  end  of 
the day in the last month which corresponds to the first day of the period, and if there 
is no such day in the last month on the last day of that month. 

Relief before the office for missed deadlines 

The  Industrial  Property  Law  (Art.  243)  includes  provisions  for  re-establishment  of 
rights similar to those included in Art. 122 EPC. They also apply to SPC applications. It 
refers  to  the  terms  not  complied  with  during  the  procedure  of  examining  the 
application. The term for lodging an application shall not be restorable. 

REPRESENTATION BEFORE THE OFFICE 

In  proceedings  before  the  Patent  Office  in  matters  relating  to  patents  and  SPCs, 
patent  attorney  or  a  person  providing  cross-border  activity  may  act  as  a 
representative.  This  obligation  to  use  a  professional  representative  does  not  apply  to 
parties  in  proceedings  before  the  Patent  Office,  who  have  a  domicile  or  seat  in  the 
territory  of  the  EU,  EFTA  Member  State  –  party  to  the  agreement  on  the  European 
Economic Area or the Swiss Confederation. 

A natural person may also be represented by a joint right holder or spouse, parents, 
siblings,  descendants  of  the  party  or  persons  in  the  relation-by-adoption  with  the 
party. 

  POST-GRANT  AMENDMENT  OF  THE  SPC  DURATION.  POST-

GRANT LIMITATION OR REVOCATION OF THE PATENT 

  Post-grant amendment of the SPC duration 

Art.  17(2)  Regulation  1610/96  has  not  been  implemented  in  our  legislation.  The 
duration  of  the  certificate  can  be  rectified  at  the  request  of  the  applicant  within  two 
months from a day on which the party has received the decision of a grant of an SPC. 
Later, the duration of the certificate can be rectified in accordance with Art. 155 of the 
Code  of  Administrative  Procedure.  According  to  this  provision  “a  final  decision  by 
which  a  party  has  acquired  rights  can  at  any  time  with  the  consent  of  the  party  be 
revoked  or  amended  by  the  public  administration  body  which issued it,  or  the  higher 
body, if other regulations do not forbid such revocation or amendment and if this is in 
the  public  interest  or  the  proper  interests  of  the  party;  and  Article  154  §  2140  shall 
apply accordingly.”  

Yes, Art. 17(2) Regulation 1610/96 has been applied directly. 

140   Art. 154: § 1. A final decision by which no party has acquired any right may be revoked or amended at 
any  time  by  the  public  administration  body  which  issued  it  or  by  the  higher  body,  if  this  in  public 
interest or the proper interests of the party.  
§ 2. In the situation referred to in § 1 the proper body shall issue a decision in the matter of revocation 
or amendment of the current decision.  
§  3.  In  cases  pertaining  to  the  duties  of  local  government,  local  government  bodies  shall  have 
jurisdiction to amend or revoke the decision referred to in § 1 and Article 155. 

65 

 
 
 
 
 
                                                 
  
  
Study on the Legal Aspects of SPCs – Annex I

  Post-grant limitation of the patent 

A  patent  may  be  declared  invalid  in  whole  or  in  part  at  the  request  of  any  person 
having a legitimate interest therein before the Boards Hearing in Litigious Cases of the 
Polish  Patent  Office.  Patent  could  be  invalidated  as  a  consequence  of  filing  of 
opposition,  which  is  claimed  by  the  right  holder  to  be  unjustified.  (Art.  89,  246  and 
255 of the Industrial Property Law). 

After grant the patent can be limited only in the case where patent claims contain at 
least two independent claims. In such a case the limitation is done by removing one or 
more independent claims. The patent cannot be limited by changing the content of the 
independent  claim.  Consequently,  the  patent  which  includes  only  one  independent 
claim cannot be limited. 

  Specific  issues  concerning  extension  pursuant  to  Art.  36  of  Reg. 

1901/2006/EC 

In  Poland  it  is  possible  to  apply  for  an  extension  of  the  SPC  term,  pursuant  to  Art. 
8(1)(d) of Regulation 469/2009 in conjunction with Art. 36 Regulation 1901/2006. The 
documentation  required  by  the  aforementioned  provisions  can  be  partially  filed  after 
the filing of the request for extension within the time limit provided the Polish Patent 
Office.  

  Payment of fees 

SPC  applicant  pays  application  fee  and  fee  for  publication  of  granting  SPC.  The  SPC 
holder must also pay annual fees for every entered year of SPC protection.  

The fees* are the following: 

Application fee: 129 EUR 

Fee for every following year: 1401 EUR 

  Enforcement of the SPC application 

The  SPC  owner  can  enforce  his  or  her  SPC  the  same  way  as  the  basic  patent  but 
limited to the product covered by the marketing authorisation. 

*Approximate fees in Euros.  

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Portugal 

PORTUGAL 

Inês Cristóvão da Silva* 

 INTRODUCTION: THE SOURCES OF LAW 

Portugal  has  signed  and  ratified  almost  all  relevant  European  and  International 
agreements  in  the  field  of  patents.  Portugal  is  a  contracting  state  of  the  European 
Patent  Convention  (EPC)  since  1992,  as  well  as  a  member  of  the  Patent  Cooperation 
Treaty  (PCT),  the  Strasbourg  Convention,  the  Paris  Convention  and  the  TRIPS 
Agreement. Furthermore, Portugal has signed and ratified the Agreement on a Unified 
Patent  Court  (UPCA)  and  takes  part  in  the  enhanced  cooperation  in  the  area  of  the 
creation  of  unitary  patent  protection141.  An  exception is the  Patent  Law  Treaty  (PLT), 
which has signed in 2000 but not yet ratified. 

Patent protection in Portugal can be obtained by filing a national patent application at 
the National Institute of Industrial Property (hereinafter INPI), or by filing a European 
patent  application  at  the  EPO  with  subsequent  validation  in  Portugal.  In  both  cases, 
filing is also possible via the PCT route (national or regional phase entry respectively). 

In Portugal, patents are regulated under the Industrial Property Code (CPI) approved 
by Decree-law 36/2003 and amended by Decree-law 318/2007, Decree-law 360/2007, 
Decree-law  143/2008  and  law  16/2008,  in  which  Articles  115,  115-A  and  116  are 
dedicated to SPCs. 

The  scope  of  protection  of  national  patents142  and  the  rights  conferred  by  such 
patents143  are  regulated  by  provisions  with  similar  wording  to  that  of  Article  69  EPC 
and Article 28 TRIPS Agreement respectively. 

The  Industrial Property  Code is harmonized with the  EPC, in particular the provisions 
regarding patentability144 and sufficiency of disclosure.145 

Portugal  did  not  make  use  of  the  option  provided  by  Article  19  of  Regulation  (EC) 
nº469/2009 and Article 18 of Regulation (EC) nº 1610/96 to include in the Portuguese 
law some special procedural provisions on SPCs.  

Inês Cristóvão da Silva - Head of Patent and Utility Model Department of the Portuguese NPO. 

*  
141   See Regulation (EU) 1257/2012 of the European Parliament and of the Council of 17 December 2012 
implementing enhanced cooperation in the area of the creation of unitary patent protection [2012] OJ 
L361/1. 

142   Article  97(1)  CPI  “1  The  extent  of  the  protection  conferred  by  a  patent  shall  be  determined  by  the 

content of the claims and the description and drawings shall serve to interpret them”. 

143   Article 101 CPI. 
144   Article 55 CPI. 
145   Article 62 (4) “The description shall give a brief, clear indication, with no reservations or omissions, of 
everything making up the 108 Industrial Property Code invention and contain a detailed explanation of 
at least one way of making the invention, so that any person skilled in the art may carry it out.” 

67 

 
 
 
 
 
 
 
                                                 
Study on the Legal Aspects of SPCs – Annex I

INSTITUTIONAL ASPECTS 

The National Institute of Industrial Property (INPI) was created under the aegis of the 
Ministry of Foreign Trade on 28th July, 1976, by Decree-Law nº. 632, as a reform to 
the  old  Department  of  Industrial  Property  and  currently  has  108  employees.  INPI  is 
now  an  Autonomous  Government  Institution,  with  legal  personality  as  well  as 
administrative and financial autonomy, and independent assets. It functions under the 
supervision  and  guidance  of  the  Minister  of  Justice,  with  regards  to  the  definition  of 
specific  policies  relating  to  industrial  property,  and  the  overseeing  of  their 
implementation. 

The  Department  of  Patents  and  Utility  Models  (DPMU)  has  20  examiners,  with 
licentiate,  master  and  doctoral  degrees  in  several  scientific  areas,  such  as  Chemical 
Engineering,  Physics,  Biological  Engineering,  Mechanical  Engineering,  Civil 
Engineering,  Environmental  Engineering,  among  others.  These  examiners  are 
organized  in  clusters  which  are:  Chemistry  and  Biotechnology  (CQB),  Technological 
Physics (CFT), Structures and Construction (CEC) and Industry and Mechanics (CIM). 

INPI  is  also  the  examining  and  granting  authority  for  SPCs  and  paediatric  extensions 
according to article 9(1) of SPC Regulation. 

Examination of SPCs and paediatric extensions are done by 2 senior examiners of the 
CQB  cluster,  so  that  they  can  be  aware  of  the  entire  subject  matter  concerning  this 
area  and,  therefore,  obtain  an  improvement  in  the  procedure  implemented.  The 
background  of  these  examiners  is  chemistry  and  biotechnology  and  the  examiners 
have only technical training. However, when is necessary, the legal department gives 
support to the examiners146. 

FILING OF THE APPLICATION AND PUBLICATION 

In  Portugal,  an  SPC  and/or  the  extension  must  be  filled  by  the  owner  of  the  basic 
patent  or  by  an  authorized  representative  before  the  INPI,  in  Portuguese,  within  the 
legal time limit (defined in Article 7 of the SPC Regulations) and upon fee payment147. 

Applications  for  SPCs  shall  include  an  application  form  containing  all  the  prescribed 
information under Article 8 of the SPC Regulations, including: the name and address of 
the  applicant  (and  of  the  representative);  the  patent  number  and  title  of  the 
invention; the number and date of the first market authorization in Portugal, if this is 
not  the  first  marketing  authorization  in  the  European  economic  area,  the  name  and 
date  of  that  authorization  and  a  copy  of  both  authorizations;  and  a  summary  of 
product characteristics in Portuguese. 

In  addition,  the  SPC  application  must  include  information  regarding  the  name  of  the 
product  for  which  the  grant  of  the  SPC  is  sought,  which  must  comply  with  the 
definition of Article 1 of Regulation EC/1610/96 (“the active substance or combination 
of  active  substances  of  a  plant  protection  product”)  and  in  Article  1(b)  of  Regulation 

146   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question Nº 52 and 

54 by the INPI. 

147   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question Nº 52 and 

54 by the INPI. 

68 

 
 
 
 
                                                 
Portugal 

EC/469/2009 (“the active ingredient or combination of active ingredients of medicinal 
product”). 

If  the  application  includes  a  request  for  pediatric  extension,  required  documentation 
pursuant to article 8(1) of Regulation (CE) 469/2009 must also be included. 

FORMAL AND SUBSTANTIVE EXAMINATION 

INPI examines ex officio all the substantive requirements provided under for Article 3 
of Regulation (EC) 469/2009 or Article 3 of Regulation (EC) 1610/96. The examination 
is performed by examiners who belong, as mentioned above, to the CQB cluster. The 
decision of granting or rejecting a SPC is validated by the Head of Department and by 
the Director. 

Article 3(a) 

According  to  Article  3(a),  the  product  for  which  an  application  for  the  grant  of  a 
certificate  is  filed,  must  be  protected  by  a  basic  patent  in  force  at  the  date  of  that 
application.  That  means  that  the  basic  patent  must  not  have  lapsed,  withdrawn  or 
declared  invalid  at  the  time  of  filing  the  application  for  the  certificate  and  that  the 
product is specified in the wording of the claims of the basic patent in accordance with 
the Medeva and Georgetown case law. 

When  the  product  is  a  combination  of  two  substances  and  only  one  of  them  is 
specified in the claims the SPC cannot be granted. 

Regarding  Markush  formulae,  the  product  is  considered  to  meet  the  requirement  of 
Article  3(a)  of  the  SPC  Regulations  if  it  appears  to  be  covered  by  the  Markush 
formulae identified in the claims, even if the  product is not precisely identified in the 
wording of the claims or in the description. 

Article 3 (b) 

As  regards  the  assessment  of  Article  3(b),  the  marketing  authorization  has  been 
granted and still in force at the date of filling of the SPC application, and, in particular, 
has  not  lost  validity  by  revocation,  withdrawal  or  expiry  of  the  term  of  the 
authorization. 

INPI recognizes provisional authorizations to place a product on the market as a plant 
protection  product,  granted  under  Article  8(1)  of  the  Directive  91/414/EEC 
(implemented in Section 15c Plant Protection Act), as valid first authorizations within 
the  meaning  of  Article  3(1)(b)  of  Regulation  (EC)  no.  1610/96  (CJEU  C-229/09 
Lovells/Bayer). 

Article 3 (c) 

INPI interprets the requirement of Article 3 (c) in the light of Article 3(2) of Regulation 
1610/96 and recital 17. Therefore, in Portugal it cannot be granted a certificate for the 
same  product  to  the  same  applicant.  However,  INPI  will  grant  a  SPC  to  different 
holders of a basic patent that protects the same product. 

69 

 
 
 
 
 
 
 
Study on the Legal Aspects of SPCs – Annex I

The examiners who study the SPC conduct a search for certificates that have already 
have been filed. 

Article 3 (d) 

Pursuant  to  Article  3(d)  a  certificate  shall  be  granted  only  if  the  furnished 
authorization  to  place  the  product  on  the  market  is  the  first  authorization  for  this 
product in the market. INPI does not verify this condition; however the applicant must 
be  truthful  on  its  claims,  so  it  is  generally  assumed  that  the  statements  of  the 
applicant are accurate. 

THIRD PARTY OBSERVATIONS 

INPI  accepts  third  parties  observations  during  the  SPC  granting  procedure  and  the 
examiners  can  take  these  observations  into  account  when  examining  an  application, 
however  these  observations  only  play  an  informative  role  in  the  examination 
procedure. In this case INPI informs the applicant that third parties observations were 
filed and sends a copy of it to the applicant. 

These observations should be filed through a front man, because the third party must 
fill out a form with its personal data in order to present the observations.  

The Portuguese law provides that if no decision has been issued on an application and 
it is necessary to clarify the procedure, additional expositions may be accepted. 

GRANTING  OR  REJECTION  OF  THE  SPC.  APPEAL  AND 
REVOCATION PROCEDURES 

If the SPC application (or the paediatric extension) fulfils the conditions set forth in the 
SPC  regulations,  INPI  grants  the  SPC  (or  the  paediatric  extension)  and  publishes  the 
request  and  the  decision  of  granting  it  in  the  Industrial  Property  Bulletin.  This 
publication  includes  the  information  required  pursuant  to  Article  11  (1)  of  the  SPC 
Regulations, in addition to the number and date of filing of the SPC application.  

INPI, also, notifies the SPC owner the decision by specifying the date and the number 
of the Industrial Property Bulletin in which the decision will be published. 

If  the  SPC  application  (or  the  paediatric  extension)  does  not  fulfil  the  conditions  set 
forth in the SPC regulations, INPI gives two months to the applicant for the correction 
of  the  irregularities  found  in  the  examination.  If  the  applicant  does  not  comply  with 
the  notification,  INPI  refuses  the  SPC  (or  the  paediatric  extension)  and  notifies  the 
applicant  to  inform  of  the  rejection.  This  rejection  decision  is  also  published  in  the 
Industrial Property Bulletin, according to Article 11(2) of the SPC Regulations. 

The  Portuguese  law  does  not  provide  the  applicant  the  right  to  request  a  hearing 
before the  examiner who takes a decision to grant or  reject a SPC,  but the applicant 

70 

 
 
 
 
 
Portugal 

can  contact  or  have  meetings  with  the  examiner  and  to  provide  the  necessary 
documents or explanations during the examination.148 

Pursuant  to  Article  23º  of  CPI  it  is  possible  to  change  the  final  decision,  within  two 
months of publication of a decision. The request will be submitted to a higher authority 
(it is understood to be  the immediate superior of the person  who actually signed the 
decision  to  be  altered)  along  with  all  the  known  facts  that  justify  reversal  of  the 
decision made. 

Furthermore, the decision regarding the grant or rejection of the SPC can be appealed 
before the Portuguese courts (Tribunal da Propriedade Intelectual or Tribunal Arbitral) 
within 2 months from its communication. 

EFFECT  ON  THE  SPC  GRANTING  PROCEDURE  OF  PENDING 

REVOCATION  OR  OPPOSITION  PROCEDURES  AGAINST  THE 
PATENT 

If  revocation  or  opposition  procedures  against  the  basic  patent  are  pending  the 
examiner informs the applicant that the study of the SPC is stayed for the duration of 
such procedures or until the continuity of the study is requested by the applicant. 

CALCULATION  OF  THE  PATENT  AND  SPC  DURATION. 
CALCULATION OF THE TERMS. RELIEF BEFORE THE INPI 

Calculation of the patent and SPC duration 

According  to  Article  99  of  CPI  “the  duration  of  a  patent  is  20  years  from  date  of 
application”.  The  patent  expires  on  the  anniversary  date  of  the  application’s  filling 
date;  for  example,  a  patent  filed  on  10.10.2005  expires  on  10.10.2025.  This 
calculation is in line with Rule 131 EPC. 

Regarding  the  calculation  of  SPC  duration,  according  to  Article  13  of  the  SPC 
Regulations,  the  certificate  takes  effect  at  the  end  of  the  lawful  term  of  the  basic 
patent  for  a  period  equal  to  the  elapsed  period  between  the  date  on  which  the 
application  for  a  basic  patent  was  lodged  and  the  date  of  the  first  authorization  to 
place the product on the market in the Community, reduced by a period of five years. 
The maximum duration of the certificate may not exceed five years. 

The SPC enters into effect on the following day of the last day in which the patent is in 
force. For example, for a patent filled on 10 October 2005, the expiry date of the basic 
patent is 10 October 2025, so the starting date of the SPC is 11 October 2025 and the 
maximum expiry date of the SPC is 10 October 2030. 

Since the CJUE decision, regarding the Seattle Generics case, INPI considers that the 
notification date is the  MA’s date used for the  calculation of the SPC  duration. In the 
case of a centralized MA (granted by the European Commission) the notification date 

148   INPI answer to the MPI Questionnaire’s Question 55. 

71 

 
 
 
 
 
 
                                                 
Study on the Legal Aspects of SPCs – Annex I

is easily detected in the EU Official Journal but in the case of a national MA it is more 
difficult to know the correct date and in this case the  examiners ask  the applicant to 
provide them with the necessary proof in order to establish the correct date.  

Furthermore,  INPI  grants  SPC  for  negative  protection  period  to  allow  a  possible 
paediatric extension, in accordance with CJEU Merck decision. 

INPI recognizes provisional authorizations to place a product on the market as a plant 
protection  product,  granted  under  Article  8(1)  of  the  Directive  91/414/EEC 
(implemented in Section 15c Plant Protection Act), as valid first authorizations within 
the  meaning  of  Article  3(1)(b)  of  Regulation  (EC)  no.  1610/96  (CJEU  C-229/09 
Lovells/Bayer). In this case, the calculation of the duration is based on the provisional 
marketing authorization. 

Calculation of terms 

For  the  calculation  of  terms,  INPI  applies  the  following  rules  defined  in  Portuguese 
law149: 

 

 

 

the  day  on  which  the  event  from  which  the  period  starts  to  run,  it  is  not 
included in the count; 
the  fixed  term  is  suspended  on  Saturdays,  Sundays  and  holidays,  except  for 
periods of more than 6 month;  
the end of the period coinciding with the day on which the service before which 
the act is to be performed is not open to the public or does not work during the 
normal period, shall be transferred to the next working day. 

Relief before the INPI  

Article  8  of  CPI  allows  an  applicant  who,  in  spite  of  all  the  attention  required  by  the 
circumstances,  have  failed  to  respect  a  time  limit,  non-compliance  with  which  may 
result on loss of a right or affect its validity, and the cause is not directly imputable to 
them, can submit before INPI a justified request for re-establishment of rights within 
two  months  of  the  cessation  of  the  circumstance  that  prevented  compliance  with  the 
time limit,  but  at  the latest  within  one  year  of  the  end  of  the  time limit  missed.  This 
provision is for all industrial property rights, including SPCs. 

REPRESENTATION BEFORE THE INPI 

Pursuant  to  Article  9  of  CPI  “those  who  have  an  interest  in  the  legal  acts  have  the 
legitimacy to perform them before the INPI” so the election of a representative is not 
necessary. 

If  an  interested  party  or  owner  of  the  right  is  established  or  domiciled  in  a  foreign 
country shall indicate an address in Portugal or an e-mail. 

149   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question Nº 45 by 

the INPI. 

72 

 
 
 
 
 
                                                 
Portugal 

  POST-GRANT  AMENDMENT  OF  THE  SPC  DURATION.  POST-

GRANT LIMITATION OR REVOCATION OF THE PATENT 

  Post-grant amendment of the SPC duration 

After  the  decision  of  the  CJEU  (C-471/14),  INPI  has  allowed  rectifications  of  the 
duration of the granted certificates, based on the application of Article 17, paragraph 2 
of Regulation 1610/96, when the conditions set forth in this article are met and when 
such amendment is requested by the holder, his agent or other interested parties by 
means of a substantiated request, in which the date of the notification and a proof of 
such date must be provided. INPI considers that this rectification can be promoted at 
any time, taking into account the exceptional nature of article 17(2) Reg. 1610/96/EC 
and the absence of an express time limit.150 

  Post-grant limitation or revocation of the patent  

According to Article 101(5), the patent owner may ask the INPI, on payment of a fee, 
to  limit  the  scope  of  protection  of  the  invention  by  altering  the  claims.  If  the 
examination  shows  that  the  request  for  limitation  can  be  granted,  the  INPI  shall 
promote the publication of a notice of this alteration. 

Article 15 of Regulation EC/469/2009 defines that revocation of the basic patent after 
the grant of the SPC and, in certain circumstances, its limitation, constitutes a ground 
for  the  invalidation  of  the  SPC.  However,  since  INPI  is  not  a  competent  body  under 
Portuguese  law  to  invalidate  a  patent,  any  request  for  the  invalidation  of  the  SPC  on 
these  grounds  may  only  be  referred  to  the  Portuguese  Court,  in  accordance  with 
Article  15  in  fine  of  the  Regulation.  However,  INPI  will  publish  “CCP  S/EFEITOS-
CADUCID.DA PAT.BASE” that according to Article 15 of the SPC regulations states that 
the SPC has no effects when the basic patent was revoked or invalidated. 

  SPECIFIC ISSUES CONCERNING EXTENSION PURSUANT TO ART. 

36 OF REG. 1901/2006/EC 

As  mentioned  in  section  3  above,  INPI  is  also  responsible  for  the  issuance  of  SPC 
paediatric  extensions.  The  SPC  owner  or  applicant  has  the  possibility  to  apply  for  a 
six-month  extension  of  the  SPC  term  in  the  case  of  medicinal  products  for  paediatric 
use. 

A  request  for  an  extension  may  be  submitted  to  INPI  at  the  time  of  submission  of  a 
request for a SPC, while it is pending or, if a certificate has already been granted, up 
to two years before it expires. 

According  to  Art.  8(1)(d)  of  Reg.  469/2009/EC,  the  following  documents  must  be 
attached to the application: copy of the certification of compliance with an approved, 
completed  paediatric  research  plan  and,  in  the  case  of  the  procedures  set  forth  in 

150   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question Nº 65 by 

the INPI. 

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Study on the Legal Aspects of SPCs – Annex I

Decree-Law  176/2006  of  30  August  and  a  proof  of  marketing  authorisations  for  all 
European Union Member States. 

If the required documents are (partially) not filed with the request the examiner sends 
a  notification  to  the  applicant  in  order  for  him/her  to  send  the  missing  information, 
within  two  months.  However,  there  are  some  cases  in  which  a  request  for  an 
extension  is  granted  with  some  of  documents  still  missing  but  the  applicant  has  to 
send  evidence  of  its  existence  as  for  example  that  MAs  have  been  requested  in  all 
member states but they have not yet been issued in all of them. In these  cases, the 
applicant can deliver the missing information after the granting of the SPC.  

INPI  does  not  revoke  the  paediatric  extension  if  the  patent/SPC  is  revoked.  We  only 
inform  that  the  basic  patent/SPC  was  revoked  so  the  extension  cannot  enter  into 
force.151 

151   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question Nº 69 by 

the INPI. 

74 

 
 
 
 
                                                 
Portugal 

  PAYMENT OF FEES 

There  are  fees  for  filling  an  SPC  application  and  SPC  extension  application  and  also 
maintenance fees for granted SPCs which are152: 

SPC 

SPC application 

1st annuity 

2nd annuity 

3th annuity 

4th annuity 

5th annuity 

Extension 

Table 8.1: 

online 

209,14€ 

731,98€ 

784,28€ 

836,56€ 

888,86€ 

941,14€ 

679,70 € 

paper 

418,29€ 

731,98€ 

784,28€ 

836,56€ 

888,86€ 

941,14€ 

679,70€ 

  ENFORCEMENT OF THE SPC 

According  to  Articles  4  and  5  of  the  SPC  Regulations,  the  SPC  owner  can  enforce  his 
exclusivity  rights  against  third  parties  in  the  same  way  as  in  relation  to  the  basic 
patent, but limited to the product covered by the marketing authorization. 

According  to  Article  102  of  CPI  the  following  acts  are  exempted  from  the  exclusive 
rights: 

a)  Acts performed in private and not for commercial purposes;  
b)  The preparation of medicinal products performed at the time and for individual 
cases  on  the  basis  of  a  doctor’s  prescription  at  pharmaceutical laboratories  or 
acts relating to the medicinal products prepared in this way;  

c)  Acts  performed  exclusively  for  trial  or  experimental  purposes,  including 
experiments  for  the  preparation  of  the  administrative  processes  required  for 
the approval of products by the competent official bodies, though industrial or 
commercial exploitation of these products may not commence before expiry of 
the patent protecting them;  

d)  Use  on  board  ships  from  other  countries  belonging  to  the  Union  or  WTO  of  a 
patented invention in the hull, machinery, rigging, gear or other accessories of 
the  ship,  if  they  temporarily  or  accidentally  enter  the  waters  of  the  country, 
provided that said invention is used exclusively to serve the ship’s need;  

e)  The  use  of  a  patented  invention  in  the  construction  or  operation  of  aircraft  or 
land  vehicles  of  other  countries  belonging  to  the  Union  or  WTO  or  their 
accessories, if they temporarily or accidentally enter national territory;  

f)  The  acts  set  forth  in  Article  27  of  the  Convention  of  7  December  1944 
concerning  international  civil  aviation  if  they  have  regard  to  aircraft  from 
another state to which the provisions of said article apply. 

152   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question Nº 71 by 

the INPI. 

75 

 
 
 
 
 
                                                 
Study on the Legal Aspects of SPCs – Annex I

ROMANIA 

Mirela Georgescu* María Victoria Rivas Llanos** 

INTRODUCTION: THE SOURCES OF LAW 

Romania is a Contracting State of the EPC since 2003, as well as a Member of the PCT 
and the PLT. In addition, it takes part in the enhanced  cooperation in the area of the 
creation of unitary patent protection153 and has signed but not yet ratified the UPCA. 

Romania  has  signed  the  TRIPS  Agreement,  but  it  is  not  a  Member  of  the  Strasbourg 
Convention.  However,  the  domestic  provisions  are  consistent  with  the  substantive 
provisions of the latter Convention, since they have been harmonised with the EPC. 

In Romania, patents are regulated under Patent Law No 64/1991,154 as republished in 
2014, and its Implementing Regulations, as republished in 2008.155 

The  scope  of  protection  of  national  patents156  and  the  rights  conferred  by  such 
patents157  are  regulated  by  provisions  with  similar  wording  to  that  of  Article  69  EPC 
and Article 28 TRIPS Agreement respectively. 

The  requirements  for  patentability  are  the  same  as  those  of  the  EPC.158  The  same  is 
true  regarding  the  requirement  of  sufficiency  of  disclosure159  and  the  possibility  of 
amending the patent application.160 

Although Article 30(3) of Law 64/1991 foresees the possibility of granting an SPC for 
medicaments and plant protection products,161 the Romanian legislator has not made 
use of the  option provided by Article 19 of Regulation 469/2009/EC and Article 18 of 

*   Mirela  Georgescu  -  Head  of  the  Chemistry  Pharmaceutical  Division,  State  Office  for  Inventions  and 

Trademarks. 

**   María  Victoria  Rivas  Llanos  -  doctoral  student  and  junior  research  fellow,  Max  Planck  Institute  for 

Innovation and Competition. 

153   See Regulation (EU) 1257/2012 of the European Parliament and of the Council of 17 December 2012 
implementing enhanced cooperation in the area of the creation of unitary patent protection [2012] OJ 
L361/1. 

154   Official Gazette of Romania, Part I, No 613/19 August 2014. 
155   Official Gazette of Romania, Part I, No 456/18.VI.2008. 
156   Law  64/1991,  Article  31(3):  ‘The  extent  of  the  protection  conferred  by  the  patent  or  the  patent 
application  shall  be  determined  by  the  content  of  the  claims.  At  the  same  time,  the  invention 
description and drawings shall be used to interpret the claims’. 

157   Law 64/1991, Article 31: 

(1)  The  patent  shall  confer  on  its  owner  an  exclusive  right  of  exploitation  throughout  its  entire 
duration. 
(2) It is prohibited to perform, without the owner’s consent, the following acts: 
a) manufacturing, using, offering for sale, selling or importing for the purpose of using, offering for sale 
or selling, where the subject-matter of the patent is a product; 
b)  using  the  process  and  using,  offering  for  sale,  selling  or  importing  for  those  purposes  the  product 
directly obtained by the patented process, where the subject-matter of the patent is a process. 

158   Law 64/1991, Articles 6 to 12.  
159   Law  64/1991,  Article  17(1):  ‘The  invention  shall  be  disclosed  in  the  patent  application  in  a  manner 

sufficiently clear and complete for it to be carried out by a person skilled in the art’. 

160   Law  64/1991,  Article  26(5):  ‘At  the  request  of  OSIM  or  on  his  own  initiative,  the  applicant  or  his 
successor in title may, until such time as a decision is made, modify the patent application, provided 
that the disclosure of the invention does not extend beyond the content of the patent application on the 
filing date’. 

161   This  possibility  was  introduced  only  after  the  amendment  of  Law  No  64/1991  in  2007.  See  Official 

Gazette of Romania, Part I, no. 851/ 12 December 2007. 

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Romania 

Regulation  1901/2006/EC  to  include  in  the  national  law  special  procedural  provisions 
on  SPCs.  Nonetheless,  the  State  Office  for  Inventions  and  Trademarks  (hereinafter 
OSIM)  has  enacted  guidelines  both  for  applicants  and  for  the  examination  of  SPC 
applications, under Instruction No 146 of 28 December 2006.162  

INSTITUTIONAL ASPECTS 

OSIM  is  a  specialised  body  of  the  central  public  administration,  subordinated  to  the 
Ministry  of  Economy,163  with  legal  personality  and  authority  in  the  field  of  industrial 
property protection within the territory of Romania.164 

Applicants have the option to apply for national patents before the OSIM pursuant to 
the  national  law165  or  for  European  patents  before  the  EPO  under  the  EPC  rules.  The 
OSIM  can  also  act  as  receiving  office  for  patent  applications  internationally  filed  by 
Romanian applicants under the PCT procedure.166 

The  OSIM  is  an  examining  office.  It  undertakes  a  substantive  examination  of  patent 
applications  with  respect  to  all  requirements  for  protection.167  The  examination  takes 
place upon request and is subject to fee payment.168 

The  examiners  involved  in  the  examination  of  SPC  applications  have  a  technical 
background in the field of Chemistry, Biochemistry or Pharmacy.169 

FILING OF THE APPLICATION AND PUBLICATION 

The  patent  owner  or  his  successor  in  title170  must  file  the  SPC  application  before  the 
OSIM in Romanian language.171 

The SPC application must contain an application form designed according to the formal 
requirements stipulated under Article 8 of the SPC Regulations, including the following 
information:  

i. 

The  name  and  address  of  the  applicant  and  his  representative  -when 
representation is required-;172 

162   Instruction  Concerning 

the  Supplementary  Protection  Certificate 

the 
Supplementary  Protection  Certificate  for  Plant  Protection  Products,  issued  by  the  Director  General  of 
the State Office for Inventions and Trademarks and Based on Art. 6(3) of the Government Decision No. 
573/07.09.1998  Concerning  the  Organisation  and  Functioning  of  the  State  Office  for  Inventions  and 
Trademarks, published in the Romanian Official Gazette no.345 of 11 September 1998.  

for  Medicaments  and 

163   Government  Decision  No.  63  of  23  February  2017  for  the  modification  of  Government  Decision  No. 

573/1998 concerning organisation and functioning of the OSIM. 

164   Law 64/1991, Article 65. 
165   Law 64/1991, Article 66(b).  
166   Law 64/1991, Article 66(d). 
167   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 52 by 

the OSIM. 

168   Law 64/1991, Article 24(1), in conjunction with its Implementing Regulations, Article 42(1). 
169   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 54 by 

the OSIM. 

170   Instruction No 146/28.12.2006, Article 2(7) and (8). The SPC application can be filed by the registered 
licensee; MPI's Questionnaire for National Patent Offices of the EU Member States, answer to questions 
No 3 and 4 by the OSIM. 

171   Instruction No 146/28.12.2006, Article 2(1). 
172   See heading 15.2.7.6 below. 

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Study on the Legal Aspects of SPCs – Annex I

The number of the basic patent and the title of the invention; 

ii. 
iii.  The  number  and  date  of  the  first  authorisation  to  place  the  product  on  the 
market  in  Romania,  the  number  and  date  of  the  first  authorisation  to  place 
the  product  on  the  market  in  the  EEA  -if  the marketing  authorisation  for  the 
territory of Romania was not the first one in the EEA-; 

iv.  The product173 identified by the marketing authorisation for which the grant of 
the  SPC  is  requested,  and  the  Regulation174  based  on  which  the  SPC  is 
requested).175 

it  must 

v.  The SPC application form must be accompanied by a copy of the authorisation 
to place the product on the market in Romania176 valid on the date of filing of 
the  SPC  application  and 
indicate  the  product's  name,  the 
authorisation's  number  and  date,  a  summary  of  the  product  characteristics 
and  the  authorisation's  validity  term.177  If  the  authorisation  to  place  the 
product  on  the  market  in  Romania  is  not  the  first  one  in  the  EEA,  the 
application  must  also  be  accompanied  by  the  latter,  indicating  the  product's 
name  and  the  legal  provision  under  which  the  authorisation  was  granted, 
together  with  a  copy  of  the  notice  publishing  the  authorisation  in  an  official 
gazette.178 

The  time  limit  for  filing  the  application  is  that  indicated  in  Article  7  of  the  SPC 
Regulations,179  calculated  according  to  national  law.  If  the  first  marketing 
authorisation  in  the  EEA  is  granted  before  the  basic  patent  and  the  latter  is  a 
European  patent,  the  six-month  time  limit  provided  for  in  Article  7(2)  of  the  SPC 
Regulations is calculated from the date on which the translation into Romanian of the 
European patent specification was filed before the OSIM.180 

FORMAL 
AUTHORISATION 

EXAMINATION.  COPY  OF 

THE  MARKETING 

The  OSIM will consider the application and will enter the  certificate application in the 
Register, if the information requested in the application form is completed. If the OSIM 
finds  any  deficiency  in  relation  to  said  information,  it  will  give  the  applicant  the 
opportunity  to  rectify  it  within  one  month  from  the  OSIM’s  notification  of  the 
deficiency.181 If the deficiency is remedied within the time limit, the date of reception 
of the rectified application will be considered the date of filing. If the deficiency is not 
rectified on time, the application will be considered not to have been filed.182 

If  a  copy  of  the  first  authorisation  to  place  the  product  on  the  market  in  Romania 
and/or,  as  the  case  may  be,  a  copy  of  the  first  marketing  authorisation  to  place  the 

173   Both  the  INN  and  the  chemical  formula  of  the  product  -  active  substance  or  combination  of  active 
substances.  In  addition  to  information  regarding  the  protection  of  the  product  by  the  basic  patent 
(claims, description). See Instruction 146/28.12.2006, Article 2(5). 

174   Regulation 469/2009/EC or Regulation 1901/2006/EC. 
175   Instruction No 146/28.12.2006, Article 2(4)(a). 
176   If  the  marketing  authorisation  holder  and  the  applicant  are  not  the  same person  and  the  applicant  is 
unable  to  provide  a  copy  of  the  marketing  authorisation,  the  OSIM  will  search  for  the  marketing 
authorisation  in  the  Official  Journal  of  the  European  Union  and/or  in  the  European  Commission 
Register.  

177   Instruction No 146/28.12.2006, Article 2(4)(b). 
178   In absence of an official publication, the applicant must present a document proving the grant of the 
marketing authorisation, the date of grant, the identity of the authorised product and the EEA Member 
State  where  it  was  granted.  Instruction  No  146/28.12.2006,  Article  2(4)(c).  MPI's  Questionnaire  for 
National Patent Offices of the EU Member States, answer to question No 5 by the OSIM. 

179   Instruction No 146/28.12.2006, Article 2(2). 
180   Instruction No 146/28.12.2006, Article 2(3). 
181   Instruction No 146/28.12.2006, Article 3(2) or/and 3(4). 
182   Instruction No 146/28.12.2006, Article 3(1)-(3). 

78 

 
 
 
                                                 
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product  in  the  territory  of  the  EEA  (should  it  be  earlier  than  the  marketing 
authorisation granted in Romania) have not been filed or the application fees183 have 
not been paid, the OSIM will invite the applicant by a written notification to submit the 
missing documents and pay the corresponding fees within the time limit of one month. 
If  the  applicant  does  not  comply  with  such  invitation  within  the  given  time  limit,  the 
application will be considered withdrawn.184 

The OSIM will then examine whether the application was filed on time and it included 
all  the  required  information  and  documentation.  In  addition,  the  OSIM  will  examine 
whether  the  basic  patent  was  in  force  on  the  date  of  the  application  for  an  SPC  and 
that  the  SPC  applicant  is  the  same  person  as  the  holder  of  the  basic  patent  or  his 
successor  in  title  (in  the  latter  case,  a  document  proving  succession  must  be 
submitted  together  with  the  SPC  application).185  If  the  OSIM  finds  any  deficiency  in 
this  regard,  it  will  inform  the  applicant  accordingly  and  invite  him  to  remedy  such 
deficiency  within  60  days  from  the  date  of  the  notification.  If  the  applicant  fails  to 
comply  with  said  invitation  within  the  time  limit,  the  application  will  be  rejected. 186 
After the date of filing of the SPC application, the OSIM will not allow the applicant to 
change neither the basic patent nor the product covered by the SPC.187 

Once  the  above-mentioned  requirements  have  been  met,  the  OSIM  will  publish  the 
SPC application in the Official Industrial Property Bulletin, mentioning at least the SPC 
application  number  and  date;  the  applicant's  identification  data;  the  number  of  the 
basic patent; the title of the invention; the name of the product for which the SPC is 
requested;  the  number,  date  and  authority  of  the  first  marketing  authorisation 
granted  in  Romania;  and,  where  appropriate,  the  number,  date  and  country  of  the 
first authorisation to place the product on the market in the EEA.188 

SUBSTANTIVE EXAMINATION  

Subsequently,  the  OSIM  will  examine  whether  the  requirements  of  Article  3,  letters 
(a),  (b)  and  (c)  of  Regulation  469/2009/EC  or  Article  3(1),  letters  (a),(b)  and  (c)  of 
Regulation  1610/96/EC  have  been  met  (i.e.  that  the  product  for  which  the  SPC  is 
requested is protected  by the basic patent, the authorisation to place the product on 
the market in Romania is valid and the product has not already been the subject of an 
SPC in Romania).189  

The  OSIM  will  not  examine  whether  the  requirement  of  Article  3(d)  of  Regulation 
469/2009/EC  or  Article  3(1)(d)  of  Regulation  1610/96/EC  (i.e.  that  the  authorisation 
to  place  the  product  on  the  market  in  Romania  is  the  first  authorisation  granted  for 
that  product  in  the  EEA)  is  met.  However,  the  OSIM  is  able  to  check  in  the  national 
authorisation  whether  it  is  the  first  one  or  it  is  a  re-authorisation.  If  the  marketing 
authorisation  has  been  granted  by  the  EMA  through  the  centralised  procedure,  the 

183   The  fees  for  filing  and  examining  the  SPC  application,  and  for  issuing  the  SPC.  See  Instruction  No 

146/28.12.2006, Article 6(1). 

184   Instruction No 146/28.12.2006, Article 3(4) and (5). 
185   Indstruction No 146/28.12.2006, Article 4(1). 
186   Instruction No 146/28.12.2006, Article 4(2). 
187   Instruction No 146/28.12.2006, Article 4(3). 
188   Instruction No 146/28.12.2006, Article 4(4), and SPC Regulations, Article 9(2). 
189   Instruction No 146/28.12.2006, Article 4(5). 

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OSIM checks in the Patent Register of the European Patents the authorisation granted 
in other Member States with regard to the SPC application and to the basic patent. 

The  OSIM's  SPC  Examination  Staff  is  composed  by  five  examiners  with  technical 
background and a jurist which carries out the formal examination of SPC applications. 
The  decision  on  the  grant  or  rejection  of  the  SPC  application  is  taken  by  the  SPC 
Examination  Board  composed  by  three  members,  the  President  of  the  Board,  the 
examiner  of  the  SPC  application  and  the  jurist.  The  OSIM  will  publish  its  decision  in 
the Official Industrial Property Bulletin190 within one month from the date of expiry of 
the  time limit  to  file  an  appeal  against  said  decision191  or  within  one  month  from  the 
communication of the decision of the Board of Appeal. If the SPC is granted, a copy of 
the  authorisation  to  place  the  product  on  the  market  in  Romania  will  be  made 
available to the public at the OSIM's premises.192 

THIRD PARTY OBSERVATIONS 

Third parties have the possibility of filing observations before the OSIM during the SPC 
granting  procedure;  however  these  observations  play  only  an  informative  role  in  the 
examination procedure.193 

If  the  OSIM  receives  a  third  party  observation  arguing  that  the  SPC  application  does 
not satisfy the requirements of Article 3 of the SPC Regulations and decides anyway to 
grant  the  SPC,  the  OSIM  does  not  provide  in  the  decision  to  grant  with  reasons  why 
the  third  party  observations  were  not  taken  into  account.  The  same  approach  is  in 
case of a decision of rejection. 

Within the examination proceedings, there is only a dialog between the applicant and 
the OSIM. Third parties cannot participate in this dialog and have no  right to hear of 
the manner in which their observations have been taken into account. Nor does their 
observation give them the status of party in the proceedings. 

EFFECT  ON  THE  SPC  GRANTING  PROCEDURE  OF  PENDING 

REVOCATION  OR  OPPOSITION  PROCEDURES  AGAINST  THE 
PATENT 

According  to  the  OSIM’s  answer  to  question  No  59  of  the  MPI's  Questionnaire  for 
National  Patent  Offices  of  the  EU  Member  States,  the  OSIM  will  usually  suspend  the 
SPC examination procedure if a revocation proceeding against the patent is pending.  

190   The mention of the decision to grant shall contain the following information: the identification data of 
the SPC holder and, when appropriate, of his patent attorney; the number of the basic patent and the 
title  of  the  invention;  the  name  of  the  product  for  which  the  authorisation  was  issued;  the  number, 
date  and  authority  that  issued  the  marketing  authorisation  for  the  territory of Romania;  the  number, 
date  and  Member  State  that  issued  the  first  marketing  authorisation  for  the  EEA;  and  the  date  on 
which  the  SPC  protection  starts  and  the  SPC  duration.  See  Instruction  No  146/28.12.2006,  Article 
4(10). 

191   See Instruction No 146/28.12.2006, Article 9(2). 
192   See Instruction No 146/28.12.2006, Article 4(9). 
193   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 57 by 

the OSIM. 

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The OSIM follow the same approach in case of a pending opposition procedure against 
the  patent,  considering  the  opposition  of  the  basic  patent  as  a  prejudicial  cause, 
because  the  patent  can  be  revoked  or  altered  in  such  a  way  that  the  product  is  no 
longer  protected  by  the  basic  patent.  In  case  of  a  European  patent  for  example,  the 
OSIM will suspend the SPC analysis until the EPO comes to a final decision. 

GRANTING  OR  REJECTION  OF  THE  SPC.  APPEAL  AND 
REVOCATION PROCEDURES 

The decision of the OSIM's Examination Board regarding the grant or rejection of the 
SPC can be appealed before the OSIM within three months from its communication to 
the applicant.194 

Within  six  months  from  the  date  of  publication  of  the  mention  to  grant,  any  person 
may apply for the revocation of the SPC pursuant to the invalidity grounds indicated in 
Article 15 of the SPC Regulations.195 

CALCULATION  OF  THE  PATENT  AND  SPC  DURATION. 
CALCULATION OF DEADLINES. RELIEF BEFORE THE OSIM 

Calculation of the patent and SPC duration 

The  patent  term  is  of  20  years  as  from  the  filing  date  of  the  patent  application, 
meaning that the date of filing counts as day one of the 20-year period.196 197 

According to the practice of the OSIM, the date of the first marketing authorisation in 
the  EEA  as  referred  to  in  Article  13  of  the  SPC  Regulations  for  the  calculation  of  the 
SPC  term  is  the  date  of  grant  of  the  marketing  authorisation  written  down  in  the 
respective  national  marketing  authorisation,198  which  must  be  indicated  by  the 
applicant  in  the  SPC  application.  In  case  of  a  European  MA,  OSIM  applies  Seattle 
Genetics  to  art.  13  Reg.  469/2009,  considering  the  date  of  the  notification  as  the 
relevant date of the MA for calculation of duration of the SPC.199 

Calculation of terms 

Regarding  the  general  calculation  of  time  limits,  Article  3  of  Law  64/1991's 
Implementing Regulations states that: 

(1) The time limits shall be expressed in days, months or years. 

194   Instruction No 146/28.12.2006, Article 9(2). 
195   Instruction No 146/28.12.2006, Article 9(3). 
196   Law 64/1991, Article 30(1). 
197   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 44 by 

the OSIM. 

198   In Romania, a marketing authorisation issued by the National Agency of Medicines and Medical Devices 
takes  effect  on  the  date  of  grant.  MPI's  Questionnaire  for  National  Patent  Offices  of  the  EU  Member 
States, answer to question No 15 by the OSIM. 

199   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 13 by 

the OSIM. 

81 

 
 
 
 
 
 
 
                                                 
Study on the Legal Aspects of SPCs – Annex I

(2) The time limit expressed in days shall not contain either the day when the period started or 
the day when the period ended. 
(3) The time limit expressed in months or years shall expire in the relevant subsequent day of the 
month or year corresponding to the starting day. 
(4) The time limit starting on the dates of 29, 30 or 31 of the month and expiring in a month not 
having  a  day  with  the  same number shall  be  deemed  to end  on  the  last  day of  the month;  the 
time limit which expires on a statutory holiday or when the office is closed for the public shall be 
extended until the end of the first working day that follows. 

Relief before the OSIM for missed deadlines 

With  similar  wording  to  Article  12  PLT  and  Article  122  EPC,  Law  64/1991200  foresees 
the  possibility  for  the  applicant  or  patent  owner  to  have  his  rights  re-established 
when, for legitimate grounds, he was unable to observe a time limit in the proceeding 
before the OSIM resulting on the loss of a right in respect of the patent application or 
the  patent.  The  request  for  re-establishment  of  rights  must  be  filed  before  the  OSIM 
within  two  months  of  the  removal  of  the  cause  of  non-compliance,  but  at  the  latest 
within one year of expiry of the unobserved time limit. Such a request is subject to fee 
payment. 

If  the  loss  of  rights  was  due  to  delayed  payment  of  the  SPC  maintenance  fees,  the 
applicant must file the request for re-establishment of rights within six months of the 
date of publication of the loss of rights in the Official Industrial Property Bulletin.201  

Law  64/1991's  provisions  regulating  re-establishment  of  rights  are  also  applicable  to 
SPCs.202  

  REPRESENTATION BEFORE THE OSIM 

Representation203  is  compulsory  in  proceedings  before  the  OSIM  when  the  applicant, 
assignor  or  patent  owner  has  his  domicile  or  registered  office  outside  the  territory  of 
Romania,  with  exception  of  the  filing  of  the  patent  application  with  the  purpose  of 
being  accorded  a  filing  date,  the  payment  of  a  fee,  the  submission  of  a  copy  of  the 
previous application and the issuance of a notification by the OSIM with respect of one 
of these procedures.204 

  POST-GRANT  AMENDMENT  OF  THE  SPC  DURATION.  POST-

GRANT LIMITATION OR REVOCATION OF THE PATENT 

  Post-grant amendment of the SPC duration 

Article  17(2)  of  Regulation  1610/96/EC  has  been  used  in  the  Romanian  appeal 
procedures,  opening  the  possibility  for  the  applicant  to  file  an  appeal  against  the 
OSIM’s decision aimed at rectifying the duration of the SPC. Such appeal is not subject 

200   Law 64/1991, Article 41, in conjunction with its Implementing Regulations, Article 53. 
201   Law 64/1991, Article 35 in conjunction with Article 40(3). 
202   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 48 by 

the OSIM. 

203   On the basis of a power of attorney filed with the OSIM. 
204   Law 64/1991, Article 37(1) and (2). 

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to deadlines but the SPC must be still valid at the date on which the appeal is filed and 
is subject to fee payment. 

  Post-grant limitation or revocation of the patent 

A patent may be limited post-grant as a consequence of an appeal procedure initiated 
before the OSIM's Board of Appeal against a decision made by the OSIM's Examination 
Board.  The  appeal  must  be  filed  within  three  months  from  the  communication  of  the 
Examination Board's decision, according to the procedure set down in Article 48 of Law 
64/1991 in conjunction with Article 57(4) of its Implementing Regulations. 

Any interested person can file a request for revocation of a granted patent before the 
OSIM,  within  six  months  of  the  publication  of  the  patent's  mention.  The  revocation 
must  be  based  on  the  non-patentability  of  the  subject-matter  of  the  patent, 
insufficiency  of  disclosure,  or  the  fact  that  the  subject-matter  of  the  patent  exceeds 
the content of the patent application as filed.205 If the grounds for revocation relate to 
a part of the patent, the patent will be only partially revoked.206 

Article 9(1) of Instruction No 146/28.12.2006 states that ‘According to Art. 15 (2) and 
Art.17 of the Regulations, the Patent Law provisions concerning the appeal, revocation 
and cancellation of patents shall also apply to the certificates’. 

  SPECIFIC ISSUES CONCERNING EXTENSION PURSUANT TO ART. 

36 OF REG. 1901/2006/EC 

In  Romania,  it  is  possible  to  apply  for  an  extension  of  the  SPC  term,  pursuant  to 
Article 8(2)(d) of Regulation 469/2009/EC in conjunction with Article 36(1) and (3) of 
Regulation 1901/2006/EC.  

The  OSIM  has  enacted  guidelines  both  for  the  applicants  and  for  the  examination  of 
applications for the extension of the SPC term, under the Order of the Director General 
No 23 of 19 June 2012.  

The  statement 
indicating  compliance  with  an  agreed  completed  paediatric 
investigation  plan  required  by  the  aforementioned  provisions  can  be  filed  after  the 
filing  of  the  request  for  extension  within  the  time  limit  provided  the  OSIM.  This  time 
limit can be extended if all the diligences for obtaining and filing of the documentation 
have been taken.  

  PAYMENT OF FEES 

The filing, examining and issuing of the SPC are subject to fee payment. In addition, 
the  SPC  holder  must  pay  annual  fees,  which  are  due  on  the  first  day  of  the  year  of 
SPC protection. The amount of said fees is indicated in Annex 1, paragraphs 24 and 25 

205   Law 64/1991, Article 49(1). See also Law 64/1991’s Implementing Regulations, Article 57(5). 
206   Law 64/1991, Article 49(2). 

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of  Government  Ordinance  41/1998  concerning  fees  to  be  paid  in  the  industrial 
property protection field, as amended by Law 381/2005.207  

If the grant of the SPC takes place after the expiry of the basic patent, the annual fee 
for the first years of protection must be paid on the date of publishing the mention of 
the decision to grant the SPC.208 

  ENFORCEMENT OF THE SPC 

The  publication  of  the  SPC  application  in  the  Official  Gazette  is  merely  to  inform  the 
public.  It  does  not  have  the  effect  of  provisional  protection.  Publication  serves  as  a 
warning and provides transparency for third parties, with the result that third parties 
can assess the product for which a certificate can be issued and for what duration. 

Third  parties  cannot  benefit  from  an  intervening  right  during  the  period  between  the 
expiry of the basic patent and the grant of the certificate. 

According  to  Article  56  of  Law  64/1991,  patent  infringement  is  punished  with 
imprisonment  from  three  months  to  two  years  or  with  a  fine.  In  addition,  the  patent 
holder  or  the  licensee  is  entitled  to  claim  the  damages  foreseen  by  civil  law  and  can 
request  to  the  competent  court  order  the  infringing  products  to  be  confiscated  or 
destroyed. 

Pursuant  to  Article  62(2)  of  Law  64/1991  ‘Customs  competence  concerning  the 
enforcement  of  patent/SPC  rights  at  the  borders  belongs  to  the  National  Agency  for 
Fiscal  Administration,  according  to  Law  344/2005  Concerning  Certain  Measures  for 
Ensuring the Enforcement of Intellectual Property Rights within Customs Operations’. 

207   Official Gazette No 6 of 4 January 2006. See Instruction No 146/28.12.2006, Article 6(1)-(4). 
208   Instruction No 146/28.12.2006, Article 6(5). 

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Spain 

  SPAIN 

Gabriel González Limas* María Victoria Rivas Llanos** 

  INTRODUCTION: THE SOURCES OF LAW 

Spain is a Contracting State of the EPC, as well as a Member of the PCT, the PLT and 
the TRIPS Agreement. Although it is not a Member of the Strasbourg Convention, the 
domestic  provisions  are  consistent  with  the  substantive  provisions  of  the  latter 
Convention, since they have been harmonised with the EPC. Spain has not signed the 
UPCA and does not take part in the enhanced cooperation in the area of the creation 
of unitary patent protection.209 

Patents  are  regulated  under  Law  24/2015  of  Patents  of  24  July  2015210  and  under 
Royal  Decree  316/2017  of  31  March  2017211  approving  Law  24/2015's  Implementing 
Regulations.  Both  Law  24/2015  and  Royal  Decree  316/2017  entered  into  force  on  1 
April 2017. 

The  scope  of  protection  of  national  patents212  and  the  rights  conferred  by  such 
patents213  are  regulated  by  provisions  with  similar  wording  to  that  of  Article  69  EPC 
and Article 28 TRIPS Agreement respectively.  

The  requirements  for  patentability  are  the  same  as  those  of  the  EPC.214  The  same  is 
true  regarding  the  requirement  of  sufficiency  of  disclosure215  and  the  possibility  of 
amending the patent application.216 

*   Gabriel  González  Limas  -  Head  of  the  Chemical  Patents  Division,  Spanish  Patents  and  Trademarks 

Office. 

**   María  Victoria  Rivas  Llanos  -  doctoral  student  and  junior  research  fellow,  Max  Planck  Institute  for 

Innovation and Competition. 

209   See Regulation (EU) 1257/2012 of the European Parliament and of the Council of 17 December 2012 
implementing enhanced cooperation in the area of the creation of unitary patent protection [2012] OJ 
L361/1. 

210   Boletín Oficial del Estado (BOE) Núm 177, Sec I, p 62765. 
211   BOE Núm 78, Sec I, p 25281. 
212   Law 24/2015, Article 68(1): ‘El alcance de la protección conferida por la patente o por la solicitud de 
patente se determina por las reivindicaciones. La descripción y los dibujos servirán para interpretar las 
reivindicaciones’. 

213   Law 24/2015, Article 59(1): 

La  patente  confiere  a  su  titular  el  derecho  a  impedir  a  cualquier  tercero  que  no  cuente  con  su 
consentimiento: 
a)  La  fabricación,  el  ofrecimiento  para  la  venta,  la  introducción  en  el  comercio  o  la  utilización  de  un 
producto  objeto  de  la  patente  o  la  importación  o  posesión  del  mismo  para  alguno  de  los  fines 
mencionados. 
b) La utilización de un procedimiento objeto de la patente o el ofrecimiento de dicha utilización, cuando 
el tercero sabe, o las circunstancias hacen evidente que la utilización del procedimiento está prohibida 
sin el consentimiento del titular de la patente. 
c)  El  ofrecimiento  para  la  venta,  la  introducción  en  el  comercio  o  la  utilización  del  producto 
directamente obtenido por el procedimiento objeto de la patente o la importación o posesión de dicho 
producto para alguno de los fines mencionados. 

214   See Law 24/2015, Articles 4 to 9. 
215   Law  24/2015,  Article  27(1):  ‘La  invención  debe  ser  descrita  en  la  solicitud  de  patente  de  manera 

suficientemente clara y completa para que un experto sobre la materia pueda ejecutarla’. 

216   Law 24/2015, Article 48(5): ‘La solicitud de la patente o la patente no podrán modificarse de manera 

que su objeto exceda del contenido de la solicitud tal como se haya presentado inicialmente’. 

85 

 
 
 
                                                 
  
  
  
  
Study on the Legal Aspects of SPCs – Annex I

As  SPCs  are  concerned,  some  procedural  matters  especially  applicable  to  them  are 
regulated  under  Articles  45  to  47  of  Law  24/2015  and  Articles  54  to  57  of  its 
Implementing  Regulations.  The  SPTO  has  not  enacted  specific  Guidelines  for  the 
examination of SPC applications.217 

The  national  procedural  provisions  applicable  to  patents  apply  also  to  the  SPC,  even 
when the basic patent  designated for the procedure is a European patent. This is so, 
because  the  SPTO  understands  the  referral  of  Article  19  of  Regulation  469/2009/EC 
and  Article  18  of  Regulation  1901/2006/EC  as  a  referral  to  the  national  procedure 
even if the basic patent was granted by the EPO on the basis of the EPC's provisions 
and not by the SPTO on the basis of the national provisions. 

Before the  entry into force of Law 24/2015, its predecessor  -Law 11/1986 of Patents 
of 20 March 1986218- did not include any provision related to SPCs, the legal term of 
an  ordinary  patent  was  –and  still is  under  Law  24/2015-  of  20  non-extendable  years 
from  the  date  of  filing.219  The  creation  of  an  SPC  title  through  Regulation  EEC  No 
1768/92,220  directly  applicable  in  Spain,  opened  the  possibility  of  obtaining  SPCs 
before the Spanish national authorities. 

  INSTITUTIONAL ASPECTS 

In Spain, the patent applicant has the option to apply: 

a)  For  a  national  patent  before  the  Spanish  Patent  and  Trademark  Office  (SPTO) 
or  the  competent  body  of  one  of  the  Spanish  autonomous  regions221  pursuant 
to Law 24/2015;  

b)  For  a  European  patent  before  the  EPO  under  the  EPC  rules  or  before  the 

SPTO/the competent body of one of the Spanish autonomous regions.  

Despite  the  foregoing,  in  the  case  of  European  patent  applications  related  to 
inventions  made  in  Spain  and  which  do  not  claim  priority  of  any  previous  deposit  in 
Spain,  the  application  must  be  necessarily  filed  before  the  SPTO.  If  the  applicant  is 
either domiciled or has his registered office or is habitually resident in Spain, this will 
be prima facie evidence of the fact that the invention was carried out in Spain.222 

The  SPTO  can  also  act  as  receiving,  designated  or  elected  office223  as  well  as 
international  searching  authority  and  international  preliminary  examining  authority224 
for international applications filed under the PCT procedure. 

The  SPTO  is  governed  by  Law  17/1975,  of  2  May  1975,  on  the  creation  of  the 
autonomous agency Register of the Industrial Property225 (today SPTO); Law 21/1992, 

217   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 2 by 

the SPTO. 

218   BOE Núm 73, of 26 March 1986, p 11188-11208. 
219   Article 58 of Law 24/2015 regulated the duration of the patent with identical wording to Article 49 of 

Law 11/1986. 

220   Oficial Journal of the European Comunities No L 182/2. 
221   See Law 24/2015, Articles 22 and 32. 
222   Law 24/2015, Article 152(2). 
223   Law 24/2015, Article 162 et seq. 
224   Law 24/2015, Article 174. 
225   BOE Núm 107, of 5 May 1975, p 9421-9423. 

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of  16  July  1992,  of  Industry;226  General  Tax  Law  58/2003,  of  18  December  2003;227 
and by any other legal provision applicable to the autonomous agencies of the Central 
State's Administration.228 

The SPTO is an autonomous agency within the Spanish Ministry of Industry of Energy, 
Tourism  and  Digital  Agenda229  It  has  legal  personality,  as  well  as  economic  and 
administrative  autonomy  for  the  attainment  of its  objectives  and  the management  of 
its assets and the funds assigned to it.230 

Law 24/2015 introduced for the first time in Spain substantive examination as the only 
available  system  for  the  concession  of  patents.231  The  substantive  examination,  also 
called  preliminary  examination  of  novelty  and  inventive  step,  is  undertaken  by  the 
SPTO's  patent  examiners,  who  have  a  technical  background  and  also  a  legal  training 
on industrial property. 

The SPTO is also the authority competent pursuant to Article 9 of the SPC Regulations 
to  grant  SPCs.  A  substantive  examination  is  provided  also  for  SPC  applications.  The 
examiners  concerned  are  graduated  in  chemistry  or  biology  and  have  also  a  legal 
training on industrial property.232 

  FILING OF THE APPLICATION 

In Spain, an SPC application must be filed before the SPTO by the owner of the basic 
patent.233 If the patent is owned by more entities, the SPC application must be filed by 
an  elected  common  representative,  usually  an  industrial  property  agent  officially 
accredited by the SPTO.  

The  application  must  be  accompanied  by  an  application  form  designed  according  to 
the formal requirements stipulated under Article 8 of the SPC Regulations,234 including 
the following information: 

i. 

The  name  and  address  of  the  applicant  and  his  representative  -when 
representation is required-; 
The number of the basic patent and title of the invention;  

ii. 
iii.  The  number,  date  and  Member  State  of  the  first  authorisation  to  place  the 
product  on  the  market  in the  EEA  -when  the  marketing  authorisation  for  the 
territory of Spain was not the first one in the EEA-; and the number and date 
of  the  first  marketing  authorisation  to  place  the  product  on  the  market  in 
Spain,  accompanied  by  a  copy  either  of  both  authorisations  or  a  copy  of  the 
Spanish authorisation together with a copy and a translation of the publication 
of the EEA authorisation in the corresponding official gazette. 

226   BOE Núm 176, of 23 July 1992, p 25498-2550. 
227   BOE Núm 302, of 18 December 2003, p 44987-45065. 
228   Royal Decree 903/2017, Article 2(1). 
229   Royal Decree 903/2017, Article 2(1). 
230   Law 17/1975, Articles 1(2) and 8. 
231   Under its predecessor, Law 11/1986 of Patents, substantive examination was an optional system rarely 
used by the national applicants; transferring the burden of invaliding the patent to the competitor. See 
Explanatory Memorandum to Law 24/2015, Section I, paragraph 9, and Section IV, paragraph 5 and 6.  
232   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 54 by 

the SPTO. 

233   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to questions No 3 and 

4 by the SPTO.  

234   Law 24/2015, Article 45(1) in conjunction with Royal Decree 316/2017, Article 54(1). 

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Moreover, the application must contain the title of the product235 for which the SPC is 
requested and information236 proving that the product is protected by the basic patent 
indicated by its proprietor for the purposes of obtaining the SPC.  

Finally,  the  application  must  include  proof  of  payment  of  the  application  fee.  If  the 
application  includes  a  request  for  paediatric  extension,  it  must  be  accompanied,  in 
addition  to  the  documentation  required  pursuant  to  Article  8(1)(d)  of  Regulation 
469/2009/EC,  by  a  statement  on  the  content  of  such  documentation  indicating  the 
EEA Member States to which it corresponds.237 

The  application  must  be  filed  within  the  timeframe  indicated  in  Article  7  of  the  SPC 
Regulations. The deadline is calculated according to national law. 

  FORMAL EXAMINATION 

Upon reception of the application, the SPTO verifies that the application fee has been 
paid  and  that  the  application  contains  the  necessary  information  for  its  publication 
according to Article 9(2) of the SPC Regulations (namely the name and address of the 
applicant; the number of the basic patent, the title of the invention; the number and 
date of the first marketing authorisation to place the product on the market in Spain; 
and  where  relevant,  the  number  and  date  of  the  first  authorisation  to  place  the 
product on the market in the EEA). 

If within the information provided to the SPTO there is any missing data required for 
the SPC application to be published pursuant to Article 9 of the SPC  Regulations, the 
applicant  will  be  notified  on  this  issue  and  informed  that  the  application  will  be 
rejected if the missing data are not provided within 10 days from the publication date 
of  such  a  notification  in  the  Official  Industrial  Property  Gazette.238  Once  the  formal 
examination  has  been  successfully  passed  and  within  three  months  from  such  date, 
the  SPTO  will  publish  the  application  in  the  Spanish  Official  Industrial  Property 
Gazette.239 

  SUBSTANTIVE EXAMINATION  

Once the SPC application is published, the SPTO will examine whether the application 
for an SPC (as well as its extension, if a paediatric extension was requested together 
with  the  SPC  application)  and  the  product  covered  by  the  marketing  authorisation 
meet  all  the  substantive  requirements  prescribed  in  the  SPC  Regulations.  The 
examination is generally performed by a single examiner. However, if the examiner in 
charge  of  the  SPC  application  finds  any  particularly  difficult  issue  or  has  any  doubt 

235   Directed  at  the  name  of  the  active  substance  or  combination  of  active  substances  included  in  the 

marketing authorisation in any of the forms enjoying the protection of the basic patent. 

236   Typically, this information is provided in a document furnished as an annex explaining which claims in 
the basic patent refer to the product for which the SPC is sought. The SPTO does not have any special 
requirement about how comprehensive the information provided should be. This requirement is based 
on  Article  54.1.a).ii)  for  medicinal  products  or  Article  54.1.b).ii)  for  plant  protection  products,  Royal 
Decree 316/2017, published 31 March 2017. 

237   Royal Decree 316/2017, Article 54(1)(c). 
238   Law 24/2015, Article 46(2) in conjunction with Royal Decree 316/2017, Article 55(1). 
239   Law 24/2015, Article 46(2) in conjunction with Royal Decree 316/2017, Article 55(2). 

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regarding  the  application,  a  group  of  three  examiners  will  meet  to  decide  on  how  to 
proceed. 

The SPTO will examine the requirements under Article 3(a), (b) and (c) of Regulation 
469/2009/EC or Article 3(1)(a), (b) and (c) of Regulation 1610/96/EC. However, it will 
not  verify  ex  officio  whether  the  requirement  of  Article  3(d)  of  Regulation 
469/2009/EC  or  Article  3(1)(d)  of  Regulation  1610/96/EC  has  been  met240  and  thus, 
can grant the SPC in absence of such requirement. 

Regarding  the  requirement  of  Article  3(a)  of  Regulation  469/2009/EC  and  Article 
3(1)(a)  of  Regulation  1610/96/EC,  the  SPTO  requires  that  the  product  is  specified  in 
the  claims  of  the  patent,  however,  it  has  not  adopted  guidelines  or  developed  a 
particular criteria in this regard. Every SPC application is considered on a case-by-case 
basis, taking into account the rulings of the CJEU, in particular “Medeva” (C-322/10), 
“University of Queensland” (C-630/10) and “Eli Lilly” (C-493/12). 

As  the  requirement  of  Article  3(b)  of  Regulation  469/2009/EC  and  Article  3(1)(b)  of 
Regulation  1610/96/EC  is  concerned,  the  SPTO  requires  that  the  marketing 
authorisation has been granted and is still in force (“vigente”) at the date on which the 
SPC application has been filed.241 Further, the marketing authorisation must be still in 
force  at  the  date  on  which  the  decision  to  grant  or  reject  the  SPC  is  taken  by  the 
Office. However, whether or not the marketing authorisation is still valid at the SPC’s 
date of grant is not checked by the SPTO. 

If the Office finds any irregularity in the submitted documentation (for instance, if the 
copy of the marketing authorisation is missing242) or if the application or its object do 
not meet the requirements of the SPC Regulations,243 the existence of such irregularity 
will be published in the Spanish Official Industrial Property Gazette  and the applicant 
will  be  notified  and  informed  that  the  application  will  be  rejected  if  the  irregularity is 
not  rectified  within  two  months  (with  the  possibility  of  requesting  two  additional 
months) from the date of said publication of the existence of an irregularity.244 Should 
the deficiency be remedied within the time limit, the date of reception of the rectified 
application will not be  considered as the date  of filing. That is to say,  the application 
date does not change when the SPTO receives the rectified application. 

The decision of the SPTO245 on the grant or rejection of the SPC -and, as the case may 
be,  also  the  paediatric  extension-  is  published  in  the  Spanish  Official  Industrial 

240   Law 24/2015, Article 46(1) in conjunction with its Implementing Regulations, Article 56(1); and MPI's 
Questionnaire for  National  Patent  Offices  of  the  EU  Member  States,  answer  to question No  53  by  the 
SPTO. See also heading 15.2.8.6 below with regard to third party observations. 

241   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 26 by 

the SPTO. 

242   If  the  applicant  can  prove  that  he  is  not  able  to  provide  the  SPTO  with  a  copy  of  the  marketing 
authorisation because the marketing authorisation is hold by a different subject, who is not willing to 
provide the patent holder with a copy, the SPTO will not reject the SPC application on this ground alone 
(in this regard, the SPTO follows the CJEU’s ruling in Case C-181/95, “Biogen”). 

243   At  this  stage  of  the  granting  procedure  the  irregularities  might  be  related  to  the  conditions  for 
obtaining a certificate according to Articles 3, 6, 7 and 8 of the SPC Regulations or Articles 54 and 56 of 
the  Spanish  Patent  Law  24/2015  (e.g.  the  SPC  application  does  not  include  a  copy  of  the  marketing 
authorisation, the product is not protected by the basic patent in force, the applicant is not the holder 
of the basic patent, or applicant has not provided information proving that the product is protected by 
the basic patent). 

244   Law 24/2015, Article 46(2) in conjunction with Royal Decree 316/2017, Article 56(2). 
245   Before the decision on the grant or rejection of the SPC is taken, the applicant can request an informal 

hearing in order to discuss on the SPC application. 

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Property  Gazette,  according  to  Article  11  of  the  SPC  Regulations.246  In  addition, 
information  on  the  application  for  an  SPC  -and,  as  the  case  may  be,  the  paediatric 
extension- and its grant is entered in the SPTO's Patents Register.247 

  THIRD PARTY OBSERVATIONS 

The  new  Spanish  Law  24/2015,  in  conjunction  with  its  Implementing  Regulations, 
provides  for  a  complete  regulation  of  the  SPC  granting  procedure.  In  the  wording  of 
these two legal provisions it is not explicitly foreseen the possibility for any third party 
to  file  observations  before  the  SPTO  during  the  SPC  granting  procedure,  after 
publication of the application in the Official Industrial Property Gazette.248  

However,  it  is  a  customary  practice  to  file  third  party  observations  before  the  SPTO 
during  the  SPC  granting  procedure  and  to  carefully  assess  such  observations  from 
interested third parties. 

These observations can help the SPTO to find out deficiencies in the application that it 
would  not  be  capable  of  identifying  on  its  own  motion  (e.g.,  that  the  marketing 
authorisation indicated in the SPC application was not the first authorisation granted in 
the EEA according to Article 3(d) of the SPC Regulations).249 Nevertheless, it is worth 
noting that, since the third party is not considered a party in the proceeding, the SPTO 
does  not  have  any  legal  obligation  to  take  such  observations  into  consideration  or  to 
provide the granting decision with reasons why the third party observations were not 
taken into account or why they were not convincing enough. 

  EFFECT  ON  THE  SPC  GRANTING  PROCEDURE  OF  PENDING 

REVOCATION  OR  OPPOSITION  PROCEDURES  AGAINST  THE 
PATENT 

According to Article 3(a) of Regulation 469/2009/EC and Article 3(1)(a) of Regulation 
1610/96/EC, an SPC  shall be granted if the product is protected by a basic patent in 
force.  For  this  reason,  as  long  as  there  is  no  final  decision  on  a  revocation  or 
opposition  procedure,  the  SPTO  consider  that  the  basic  patent  is  still  in  force. 
Therefore, a pending revocation or opposition procedure against the basic patent does 
not have any effect on the SPC granting procedure before the SPTO. 

246   Law 24/2015, Article 46(2) in conjunction with Royal Decree 316/2017, Articles 56(3) and 57. 
247   Royal Decree 316/2017, Article 72(4). 
248   Article  36  under  its  predecessor,  Law 11/1986.  MPI's Questionnaire  for  National  Patent  Offices of  the 
EU Member States, answer to question No 57 by the SPTO. As pointed out by SPTO: “[l]egal grounds 
for  filing  third  party  observations  is  a  much-debated  issue  in  the  SPTO.  It  is  true  that  third  party 
observations were filed based on Article 36 grounds when the prior Spanish Law 11/1986 was in force. 
This article provided that any person could submit duly reasoned and documented observations to the 
report on the state of the art. This provision is similar to those of Articles 38 of the Law 24/2015 and 
Article 32 of its Implementing Regulations. In addition, Article 38 also makes it explicit that these third 
parties  will  not  be  considered  part  to  the  patent  grant  proceedings.  However,  we  [SPTO]  indeed 
expect[s] third party observations to be filed based on Article 38 of the Law 24/2015 and Article 32 of 
its Implementing Regulations.” 

249   José  Macías  Martín,  'Certificados Complementarios de  Protección'  in  Alberto  Bercovitz  Rodríguez-Cano 
and  Raúl  Bercovitz  Álvarez  (eds),  La  Nueva  Ley  de  Patentes:  Ley  24/2015,  de  24  de  julio  (Thomson 
Reuters 2015). 

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  GRANTING OR REJECTION OF THE SPC. APPEAL PROCEDURE 

Against  the  decisions  of  the  SPTO  is  possible  to  file  an  appeal  (“recurso  de  alzada”) 
before the director of the SPTO within one month from the publication of the Office's 
decision.250 

Any  interested  party  can  file  this  kind  of  appeal.  The  concept  of  interested  party  is 
understood in an ample way, including anyone who has a legitimate interest that can 
be affected by the SPTO's decision.251 Nevertheless, it is worth noting that this kind of 
appeal  shall  only  be  allowed  on  grounds  of  what  the  SPTO  examines  ex  officio  (Law 
24/2015, Article 46).  

The decision of the director of the SPTO regarding the aforementioned appeal can be 
challenged  at  a  second  instance  by  filing  an  appeal  (“recurso  contentencioso-
lo 
administrativo”)  before  the  national  administrative  courts  (“tribunales  de 
contencioso-administrativo”).252 

  CALCULATION  OF  THE  PATENT  AND  SPC  DURATION. 

CALCULATION OF TERMS. RELIEF BEFORE THE SPTO 

  Calculation of the patent and SPC duration 

Pursuant  to  Article  58  of  Law  24/2015,  the  patent  duration  is  of  20  years,  counted 
from the date of filing of the application.253  

According to the practice of the SPTO, the date of the first marketing authorisation in 
the  EEA  as  referred  to  in  Article  13  of  the  SPC  Regulations  for  the  calculation  of  the 
SPC term is the date of issue of the marketing authorisation.254 

  Calculation of terms 

For the general calculation of time limits indicated in Law 24/2015 or its Implementing 
Regulations,  Law  39/2015  on  the  Common  Administrative  Procedure  of  the  Public 

250   Law  24/2015,  Article  46(2)  and  First  Additional  Provision,  in  conjunction  with  Law  39/2015,  Articles 

121 and 122. 

251   Oficina Española de Patentes y Marcas, Guía de Recursos Administrativos (11.11.2014). Available at: 

<https://www.oepm.es/es/invenciones/modelo_utilidad/Informacion_adicional/ 
GuiaRecursosAdministrativos.html> 

252   Law 24/2015, Article 54; and MPI's Questionnaire for National Patent Offices of the EU Member States, 

answer to question No 62 by the SPTO. 

253   The period is computed from date to date being the first one the date of filing of the patent application 
and the second one the same day of the month as that of the filing date 20 years later. For instance, 
for a patent filed on 15 October 2015: 
i)   expiry date of the basic patent; 
ii)   start date of the SPC; 
iii)   maximum  expiry  date  of  the  SPC  without  paediatric 

15 October 2035 
16 October 2035 
15 October 2040  

extension, (maximum five year term); 

iv)   maximum  expiry  date  of  the  SPC  with  paediatric 

15 April 2041  

extension (the extended five year term); 

254   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 15 by 
the SPTO. As pointed out by Spanish NPO: “[it] refers only to Spanish MA. However, when it comes to 
the first national MA in the EEA, after the CJEU´s ruling in case C-471/14 (Seattle Genetics Case) if the 
applicant  can  give  reliable  evidence  of  the  date  of  the  MA  notification,  the  SPTO  would  consider  that 
notification date as relevant. So far this has only happened once.” 

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Administration255 applies.256 Article 30(3)-(5) of Law 39/2015 regulates the calculation 
of  time  limits  in  similar  terms  to  Rule  131(2)  and  (3)  of  the  EPC.  When  a  period  is 
expressed  in  days,  computation  will  start  on  the  day  following  the  day  on  which  the 
notification or the publication of the relevant administrative act took place. When fixed 
in  months  or  years,  the  term  starts  on  the  day  following  the  date  of  notification  or 
publication of the corresponding act and ends on the same day in the month or year of 
expiration.  If  in  the  month  of  expiration  there  was  no  day  equivalent  to  the  one  in 
which the computation begins, it will be understood that the term expires on the last 
day  of  the  month.  When  the  last  day  of  the  term  is  a  non-working  day,  it  will  be 
extended to the next working day. 

  Relief before the SPTO for missed deadlines 

Article 53 of Law 24/2015 in conjunction with Articles 70 and 71 of its  Implementing 
Regulations foresees the possibility that the patent applicant (or any other party in a 
proceeding  regulated  under  Law  24/2015)  requests  re-establishment  of  rights  when, 
in  spite  of  all  due  care  required  by  the  circumstances  having  been  taken,  he  was 
unable to observe a time limit vis-à-vis the SPTO and the non-observance of this time 
limit had the direct consequence of causing the refusal of the patent application or of a 
request, or the deeming of the application to have been withdrawn, or the revocation 
of the patent, or the loss of any other right or means of redress. 

The  above-mentioned  provision  is  a  common  provision  for  all  proceeding  regulated 
under  Law  24/2015,  including  that  of  the  SPC  applications  (in  particular,  with  regard 
to the deadline to file an SPC application pursuant to Article 7 of the SPC Regulations 
and  the  deadline  to  pay  the  SPC  maintenance  fee  pursuant  to  Article  184(5)  of  Law 
24/2015). 

The request for re-establishment of rights must be filed in writing within two months 
of the removal of the cause of non-compliance or within twelve months of the date of 
expiry  of  the  missed  time  limit,  whichever  is  earlier.  The  omitted  act  must  also  be 
completed  within  this  time.  If  the  request  for  re-establishment  is  due  to  the  lack  of 
payment of the maintenance fee, the deadline for filing the request is twelve months 
from  the  date  of  expiry  of  the  deadline  of  six  months  with  surcharge  established  in 
Article 185(2) of Law 24/2015.257 

The request for re-establishment of rights will not be deemed to have been filed until 
the prescribed fee258 has been paid.  

The  decision  of  the  SPTO  regarding  the  grant  or  rejection  of  the  request  will  be 
published  in  the  Spanish  Official  Industrial  Property  Gazette  and  is  open  to  appeal, 
which  must  be  filed  before  the  director  of  the  SPTO  within  one  month  from  its 
publication. 

255   BOE Núm 236, Sec I, p 89343. 
256   Royal Decree 316/2017, Article 68(1). 
257   Law 24/2015, Articles 53(2)(ii). 
258   Law 24/2015, Annex 1.1. 

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  REPRESENTATION BEFORE THE SPTO 

Pursuant to Article 175 of Law 24/2015, the representation of the applicant before the 
SPTO is only mandatory if he is not resident in an EU Member State. If the applicant 
has  his  residence  outside  the  EU,  he  must  be  represented  by  an  industrial  property 
agent  officially  accredited  by  the  SPTO  pursuant  to  Article  179  of  Law  24/2015  and 
according to the requirements of Articles 176 and 177 of the same Law. 

  POST-GRANT  AMENDMENT  OF  THE  SPC  DURATION.  POST-

GRANT LIMITATION OR REVOCATION OF THE PATENT 

  Post-grant amendment of the SPC duration 

According  to  the  reply  of  the  SPTO  to  question  No  65  of  MPI's  Questionnaire  for 
National  Patent  Offices  of  the  EU  Member  States,  the  post-grant  amendment  of  the 
SPC  duration  is  not  contemplated  under  the  Spanish  Patent  Law  or  its  Implementing 
Regulation and thus, this possibility currently does not exist in Spain. 

  Post-grant limitation or revocation of the patent 

According  to  Article  105  of  Law  24/2015,  the  patent  owner  can  file  a  request  before 
the SPTO to post-grant limit the patent -through the amendment of the patent claims- 
or to revoke it, at any point during the life time of the patent and also during the SPC 
term.259  

The  SPTO  will  grant  the  request  for  limitation  of  the  patent  as  long  as  the  modified 
patent claims are clear and concise and the limitation does not extend the protection 
conferred by the patent.260 

The SPTO will reject the request for limitation or revocation of the patent if there are 
existing  rights  in  rem,  call  options,  seizure  rights  or  licences  inscribed  in  the  Patents 
Register and the owners of those rights have not given their consent to such limitation 
or  revocation. The SPTO will also reject the post-grant limitation or revocation of the 
patent  if  there  is  a  judicial  action  claiming  the  ownership  of  the  patent  or  other 
property rights over the patent are inscribed in the Patents Register and the claimant 
has not given his consent. 

If  there  is  a  pending  judicial  proceeding  regarding  the  validity  of  the  patent,  the 
request to limit the patent must be authorised by the court seized of the case. 

Pursuant  to  Article  107  in  conjunction  with  Article  104  of  Law  24/2015,  both  the 
limitation and the revocation of the basic patent have retroactive effect. The amended 
claims will determine the protection conferred by the patent, which will determine the 
protection  conferred  by  the  SPC  to  the  extent  that  the  limitation  of  the  basic  patent 

259   This was not possible before the entry into  force of Law 24/2015, since its predecessor Law 11/1986 

did not allow it. 

260   Law 24/2015, Article 106(1) in conjunction with Articles 28 and 48(6). See also Articles 84 and 123(3) 

EPC. 

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affects  the  product  protected  by  the  SPC.261  The  retroactive  effect  of  the 
limitation/revocation of the basic patent will not affect final decisions regarding patent 
infringement 
limitation/revocation. 
Notwithstanding the foregoing, it is possible to request compensation for damages and 
reimbursement of the amounts paid under the above-mentioned contract.262 

concluded 

contracts 

before 

such 

or 

  SPECIFIC ISSUES CONCERNING EXTENSION PURSUANT TO ART. 

36 OF REG. 1901/2006/EC 

The  SPC  applicant  has  the  possibility  to  apply  for  a  six-month  extension  of  the  SPC 
term when the product covered by the marketing authorisation is a medicinal product 
directed  at 
the  paediatric  population  according  Article  1(2)  of  Regulation 
1901/2006/EC. 

The  applicant  can  file  the  application  for  an  extension  of  the  SPC  term  together  with 
the  SPC  application  or  separately,  no  later  than  two  years  before  the  expiry  of  the 
SPC.263 

For the SPTO to grant such extension, the application must meet the requirements of 
Article 8(1)(d) of Regulation 469/2009/EC in conjunction with Article 36 of Regulation 
1901/2006/EC.  If  the  SPTO  finds  any  error  or  deficiency  in  the  documentation 
submitted  by  the  applicant  according  to  Article  8(1)(d)  of  Regulation  469/2009/EC, 
the Office will give the applicant two months from the notification of such irregularity -
with the possibility of requesting two additional months- to rectify it. If the irregularity 
is  not  corrected  within  the  given  time  limit,  the  extension  of  the  SPC  term  will  be 
rejected.264 

The  extension  of  the  SPC  term  is  subject  to  revocation  under  the  circumstance 
foreseen in Article 16(1) of Regulation 469/2009/EC (i.e. when it was granted contrary 
to the provisions of Article 36 of Regulation 1901/2006/EC). The SPTO is however not 
allowed to revoke a granted extension of the SPC term on its own motion.265 

  PAYMENT OF FEES 

According  to  Article  8(4)  of  Regulation  469/2009/EC  and  Article  8(2)  of  Regulation 
1610/96/EC,  the  Member  States  may  provide  that  a  fee  is  to  be  payable  upon 
application for an SPC and the extension of its duration. In line with these provisions, 
Law  24/2015  requires  the  payment  of  such  fees,  the  amount  of  which  is  specified  in 
Annex 1.1. 

261   See Regulation 469/2009/EC and Regulation 1610/96/EC, Article 15(1)(c). 
262   Law 24/2015, Article 104(3). 
263   Regulation 469/2009/EC, Article 7(3) and (4). 
264   MdPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 69 by 

the SPTO. 

265   MPI's Questionnaire for National Patent Offices of the EU Member States, answer to question No 70 by 

the SPTO. 

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In addition, as foreseen by Article 12 of the SPC Regulations, the maintenance of the 
SPC  is  subject  to  fee  payment.  Before  the  SPTO,  this  fee  must  be  paid  in  one 
instalment and its amount is determined according to the duration of the SPC.266 

The  time  frame  for  the  payment  of  the  maintenance  fee  for  the  SPC  or  its  extension 
starts  on  the  date  of  its  entry  into  force.  If  such  a  date  is  earlier  than  the  date  of 
publication of the grant of the SPC or of its extension in the Spanish Official Industrial 
Property  Gazette,  the  payment  must  be  made  within  three  months  from  such  a 
publication  date.  If  the  date  of  entry  into  force  is  the  same  or  later  than  the 
publication  date  of  the  grant,  the  payment  must  be  completed  within  three  months 
from the date of entry into force.267  

If  the  deadline  for  payment  of  the  maintenance  fee  has  expired  without  its  amount 
having been made effective, it can still be paid with a 25 percent surcharge within the 
first three months of delay and with a 50 percent surcharge within the following three 
months, until a maximum of six months of delay.268 

  ENFORCEMENT OF THE SPC 

According to Article 5 of the SPC Regulations, a granted SPC confers the same rights 
as conferred by the basic patent but limited  to the product covered by the marketing 
authorisation. Under Law 24/2015, this includes the rights to stop others from making 
or selling the product269, right to compensation for damages, seizure of the infringing 
product, etc.270 

In addition, pursuant to Article 67.1 of Law 24/2015: 

From  the  date  of  its  publication,  the  patent  application  confers  on  its  holder  the  right  to  a 
provisional  protection,  consisting  on  the  right  to  request  a  compensation,  reasonable  and 
adequate to the circumstances, from any third party that, between the date of publication of the 
patent application and the date of publication of the patent grant, has made use the invention in 
a way that would be forbidden after such period by virtue of the patent.  

Accordingly, a published SPC application creates an expectation of a future right in the 
same way as a published patent application provides a provisional protection. 

The  national  Civil  and  Criminal  Courts  according  to  the  scope  of  their  respective 
competences-  will  hear  all  disputes  rose  as  a  consequence  of  the  enforcement  of 
actions derived from the provisions contained in Law 24/2015.271 

266   Law 24/2015, Article 47 and Annex 2.1.1. 
267   Law 24/2015, Article 184(5). 
268   Law 24/2015, Article 185(2). 
269   Law  24/2015,  Article  59(1).  Please  note  that  the  so-called  experimental  use  exception  and  the  Bolar 

exemption are foreseen under Law 24/2015, Article 61(b) and (c). 

270   Law 24/2015, Articles 70-78. 
271   Law 24/2015, Article 116. 

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  SWEDEN 

Mr. Joakim Sånglöf* Mr. Andreas Gustafsson**Mrs. Carolina Palmcrantz*** Mrs. Terese 
Sandström**** 

  INTRODUCTION: SOURCES OF LAW 

Sweden  has  signed  and  ratified  all  relevant  agreements  in  the  field  of  patents,  both 
European  and  international.  This  includes  TRIPS,  the  EPC,  the  PCT,  the  PLT  and  the 
Strasbourg Convention. Sweden is also a Contracting Member State  of the UPCA and 
is a party to the enhanced cooperation for the creation of a unitary patent protection. 

You  may  obtain  a  patent  in  Sweden  by  filing  a  national  patent  application  either 
directly  to  the  Swedish  Patent  and  Registration  Office  (PRV)  or  as  a  national  phase 
entry  of  a  PCT  application.  You  may  also  obtain  a  patent  by  filing  a  European  patent 
application at the EPO  directly or as a  regional phase entry of a PCT  application. The 
provisions  governing  both  the  national  and  European  (Swedish)  patents  and 
applications are set out in the Swedish Patents Act.272 

Since the national patent law is aligned with the provisions of the EPC, the provisions 
and  conditions  for  national  and  European  patents  are  to  a  large  degree  uniform.  The 
scope  of  protection  of  national  patents  and  the  rights  conferred  by  such  patents  are 
regulated  by  provisions  with  wording  similar  to  that  of  Article  69  EPC  and  Article  28 
TRIPS agreement respectively273. 

The  scope  of  protection  of  European  patents  is  governed  in  national  proceedings  by 
Article 39 of the Swedish Patents Act which is equivalent to Article 69 EPC. The rights 
conferred  by  the  European  patents  are  subject  to  the  same  provisions  that  apply  to 
national patents.  

The Swedish provisions governing the patentability of an invention are similar to those 
in Articles 52 to 57 EPC (see Articles 1 and 2 of the Swedish Patents Act). The same 
goes  for  the  revocation  grounds  in  Article  138  EPC  that  are  aligned  with  Swedish 
provision in Article 52 of the Swedish Patents Act. 

The SPC system was introduced in Sweden when Regulation (EEC) 1768/92 came into 
force. 

Sweden  has  six  procedural  provisions  that  are  explicitly  for  SPCs.  These  concern  the 
payment  of  fees  and  the  time  limit  to  submit  a  written  reply  to  a  notice  etc.  274 
Furthermore,  many  of  the  procedural  provisions  that  are  applicable  to  patent 

*   Mr. Joakim Sånglöf - PRV, Swedish Patent and Registration Office, Lawyer. 
**   Mr. Andreas Gustafsson - PRV, Swedish Patent and Registration Office, Senior Patent Examiner.  
***   Mrs. Carolina Palmcrantz - PRV, Swedish Patent and Registration Office, Senior Patent Examiner.  
****   Mrs. Terese Sandström - PRV, Swedish Patent and Registration Office, Senior Patent Examiner. 
272   An  unofficial  translation  of  the  Swedish  Patents  Act  can  be  found  at:  https://www.prv.se/ 
globalassets/dokument/patent/informationsmaterial/the-patents-act---unofficial-translation.pdf.  

273   For the Swedish provisions please see for example Article 3 or 39 of the Swedish Patents Act. 
274   The  procedural  provisions  explicitly  for  SPCs  can  be  found  in  Articles  105  and  106  of  the  Swedish 
Patents Act, Articles 67 and 68 of the Swedish Patents Decree and Articles 56 and 59 of the Swedish 
Patent Regulations. 

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applications  and  patents  are  also  applicable  on  SPCs  as  specified  in  Article  19  of  the 
Regulation (EC) 469/2009 and Article 18 of the Regulation (EC) 1610/96. 

  INSTITUTIONAL ASPECTS 

PRV was created in 1885, financing has changed over time. From January 1, 2017 PRV 
is a government financed authority under the supervision of the Ministry of Enterprise 
and Innovation. 

PRV  employs  around  350  persons  and  has  two  offices,  one  in  Stockholm  and  one  in 
Söderhamn. 

PRV  is  the  government  authority  for  intellectual  property  rights  in  Sweden  including 
the  examination  and  granting  of  applications  for  said  rights,  namely  trademarks, 
designs and patents. Copyright issues also fall within our area of operation. PRV is also 
the national competent authority to examine and grant SPCs according to Article 9(1) 
of the SPC regulations. 

PRV  is  a  patent  search  and  examination  authority  that  performs  all  the  steps  in  the 
patent  process.  Under 
first 
administrative/formal  examination,  directs  the  application  to  the  relevant  technical 
department, within the authority, for a substantive examination. Our patent examiners 
all have a technical background with an expertise in the technical field they work.  

the  national  patent  procedure,  PRV,  after  a 

Since PRV is the authority for examining and granting both patents and SPCs we have 
the  advantage  of  having  highly  experienced  and  technically  qualified  personnel  to 
examine  the  SPC  applications.  Examination  of  SPCs  is  entrusted  to  a  small  group  of 
examiners  (2  lawyers  and  4  patent  examiners).  The  lawyers  and  patent  examiners 
work closely together, the lawyers handling all the legal aspects of the application and 
the  examiners  doing  the  substantive  examination.  The  four  examiners  are  all  senior 
patent  examiners  with  many  years  of  experience  (two  are  specialized  in  organic 
chemistry / medicinal chemistry and two are specalized in biotechnology).  

  FILING OF THE APPLICATION 

It is the owner of the basic patent, or an authorized representative, that is eligible to 
file a SPC application in Sweden. If there are several proprietors they must all have a 
common  representative  in  the  SPC  application.  The  requirements  in  Article  8  of  the 
SPC regulations must be fulfilled and the application must also contain information on 
where, in the basic patent, the product is protected. If the application is submitted by 
a representative, we also need a duly signed Power of Attorney from the proprietor(s).  

The  application  must  be  filed  within  6  months  from  the  date  on  which  the  patent  is 
granted  or  within  6  months  from  the  date  on  which  the  market  authorization  is 
granted  (Article  7  of  the  SPC  regulations).  As  mentioned  above  many  of  the 
procedural  rules  applicable  to  patents  and  patent  applications  are  also  applicable  to 
SPC  applications.  Thus  for  example  an  applicant  may  ask  for  a  re-establishment  of 
rights if said time limit has lapsed and no application has been filed. However they, of 
course, need a legitimate reason.  

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Finally, a proof of payment of the application fee is to be included in the application. 

If the application includes a  request for paediatric extension, required documentation 
pursuant to Article 8(1) (d) of Regulation (EC) 469/2009 must also be included. 

The  SPC  applications  are  published  in  “Svensk  Patenttidning”  within  four  weeks  of 
their  filing.  The  same  goes  for  an  application  for  an  SPC  extension.  The  applications 
and their status are also available via the Swedish Patent Database and file inspection 
on the PRV website: www.prv.se.  

In  the  application  form,  a  product  definition  specifying  for  which  product  the  SPC  is 
sought  should  be  given.  The  naming  of  the  product  is  preferably  identical  to  the 
naming  of  the  active  ingredient(s)  in  the  marketing  authorization,  however,  other 
ways  of  naming  the  active  ingredient(s)  may  also  be  used  as  long  as  the  product  is 
clearly defined, e.g. both the INN name and chemical name are accepted. References 
to nonactive ingredient(s), such as adjuvants and excipients, are not permitted in the 
product definition. 

According  to  Swedish  practice,  the  expression  “in  all  acceptable  salts” is  accepted  on 
the basis of Regulation (EC) 1610/96, recital 13 where salts are explicitly mentioned, 
provided  that  all  acceptable  salts  are  protected  by  the  basic  patent.  However,  we  do 
not  accept  general  expressions  such  as  “in  any  form  protected  by  the  basic  patent”, 
“derivatives”,  “biosimilars”  and  “therapeutic  equivalents”  in  the  product  definition. 
These  expressions  are  not  considered  to  clearly  identify/define  the  product  and, 
consequently, Article 3 cannot be assessed.  

We have the same practice regarding the product definition regardless of whether the 
basic patent is based on a product, process or use, i.e., in principle, the definition of 
the  product  shall  be  the  same  as  the  naming  of  the  active  ingredient(s)  in  the 
marketing  authorization.  In  case  of  a  process  patent,  if  it  is  not  evident  that  the 
product  is  possible  to  obtain  by  the  claimed  process,  the  applicant is invited  to  show 
that this is the case. In this context, it does not matter whether it is possible to obtain 
the product directly as a result of the claimed process. In case of a second medical use 
patent,  the  use  shall  not  (and  cannot)  be  present  in  the  product  definition.  Only  a 
product  (active  ingredient(s))  may  be  the  subject  of  a  certificate  (Regulation  (EC) 
469/2009, Article 2).  

  FORMAL EXAMINATION 

The SPC examination is divided in primarily two steps, the formal examination and the 
substantive examination. If during the formal examination an irregularity is observed, 
eg. the marketing authorization is missing, the applicant is notified of the irregularity 
and  is  given  a  three-month  time  limit  (you  may  ask  for  a  two-month  extension)  to 
rectify  this  irregularity.  Once  the  formal  examination  is  over  and  all  necessary 
documents  and  information  are  in  order  the  application  is  directed  to  the  patent 
examiners for the substantive examination. 

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  SUBSTANTIVE EXAMINATION 

The Swedish Patent and Registration Office (PRV) examines  ex officio the substantive 
requirements  for  granting  SPCs.  The  examination  is  carried  out  by  four  patent 
examiners  with  qualifications 
in  organic  chemistry/medicinal  chemistry  and 
biotechnology. Any legal aspects are handled by a lawyer. 

The substantive examination includes an assessment of Articles 3(a)-3(d). 

As regards the assessment of Article 3(a), the claims shall be interpreted in the light 
of the description according to Article 39 of the Swedish Patents Act and Article 69 EPC 
and the Protocol on the interpretation of that provision, respectively. An SPC may only 
be granted if the claims, when applying the above interpretation, relate implicitly, but 
necessarily and specifically to the product (active ingredient(s)) in question. This test 
is  also  valid  when  the  product  is  defined  in  functional  terms.  The  assessment  also 
includes  considering  whether  the  product  is  protected  “as  such”  by  the  claims,  i.e. 
whether the product falls within the core inventive advance of the basic patent. 

As  regards  the  assessment  of  Article  3(b),  the  marketing  authorization  has  to  be  in 
force at the date of filing of the SPC application. 

As  regards  the  assessment  of  Article  3(d),  the  CJEU  case  C-130/11  (Neurim)  is 
interpreted  so  that  the  first  marketing  authorization  is  the  first  in  which  the  product 
has  been  approved  for  a  therapeutic  indication  that  corresponds  to  the  indication 
protected  by  the  basic  patent.  The  therapeutic  indication  is  interpreted  as  being  a 
disease condition. We apply this practice irrespective of whether the earlier marketing 
authorization  was  for  veterinary  or  for  human  use.  The  marketing  authorization 
according  to  Article  3(d)  does  not  have  to  be  in  force  on  the  filing  date  of  the  SPC 
application.  The  examination  regarding  Article  3(d)  includes  a  search  for  earlier 
marketing  authorizations  on  the  Swedish  Medical  Products  Agency’s  website  and  in 
their register. 

As  regards  the  assessment  of  Article  3(c),  we  consider  it  applicable  in  the  case  an 
applicant  applies  for  an  SPC  for  a  product  for  which  the  same  applicant  has  already 
been granted an SPC. In this respect it is irrelevant whether the second SPC relies on 
a later marketing authorization, (i.e. another therapeutic indication) since it has been 
established by the CJEU that the Neurim case does not influence the definition of the 
concept “product”. 

The practice applied by PRV is found in our guidelines which are available in Swedish 
on the PRV website.  

  THIRD PARTY OBSERVATIONS 

According to Swedish administrative law any relevant information that is submitted in 
a  matter  must  be  considered  before  taking  a  decision.  Thus,  if  a  third  party  submits 
observations in an SPC application the examiner must consider whether the submitted 
observations  are  of  relevance  to  the  matter.  If  it is  relevant  the  examiner  must  take 
the  observation  into  consideration  when  taking  the  decision.  Observations  that  are 
considered  of  less  importance  may  just  be  disregarded  without  any  requirement  to 

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communicate the reasons (i.e. there is no need for a decision to grant with reasons). 
If a third party has submitted observations in an SPC application, this party is still not 
regarded as a party in the matter. Therefore, PRV is not obligated to provide any third 
party with a reason to the decision. 

  DECISION TO GRANT OR TO REFUSE 

If the SPC application may be granted PRV notifies the SPC owner of the decision and 
also notifies the owner of the date and number of “Svensk Patenttidning” in which the 
decision will be published (Article 11(1) of the SPC regulations). The grant of the SPC 
is  also  registered  in  the  Swedish  patent  register  and  made  available  in  the  Swedish 
Patent Database. 

If the opposite occurs and the SPC application is rejected PRV notifies the applicant of 
the  rejection.  However,  before  a  final  decision  is  taken,  the  applicant  is  notified 
regarding the obstacles to the grant of the SPC and is given the opportunity to submit 
comments  and  arguments  before  the  final  decision  is  taken.  In  the  same  way  as  for 
grants, the rejected decision is then published in “Svensk Patenttidning” (Article 11(2) 
of  the  SPC  regulations)  and  registered  in  the  Swedish  patent  register  and  made 
available in the Swedish Patent Database. 

The  applicant  has  the  right  to  request  a  hearing  before  a  panel  of  examiners  before 
any  decision  is  made  (Article  10  decree  (2007:1111)  with  instructions  to  the  Patent 
and Registration office). 

  PAYMENT OF FEES 

Anyone  who  applies  for  an  SPC  or  extension  of  the  period  for  an  SPC  shall  pay  an 
application  fee  (Article  105  of  the  Swedish  Patents  Act).  Also  an  annual  fee  shall  be 
paid  for  the  SPC.  The  fee  year  is  computed  from  the  date  when  the  protection 
commenced to be valid and thereafter from the corresponding date (Article 105 of the 
Swedish Patents Act). The annual fee is always due on the last day of the same month 
as the SPC entered into force. The fees are as follows: 

Application fee 

Annual fee 

Application fee for paediatric extension 

Table 11.1:    

5000 SEK 

10 000 SEK 

3000 SEK 

  APPEAL AGAINST THE DECISION OF THE OFFICE 

According to Article 26 of the Swedish Patents Act the applicant of a patent application 
has the right to appeal a final decision of PRV. The appeal must be submitted to PRV 
within  two  months  from  the  date  of  the  decision.  Thus,  as  specified  in  Article  18  of 
Regulation (EC) 469/2009 and Article 17 of Regulation (EC) 1610/96 the applicant for 
an SPC also has the right to appeal. The appeal shall be addressed to the Patent and 
Market  Court,  but  sent  to  PRV.  PRV  will  then  forward  the  appeal  to  the  Patent  and 

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Market  Court,  provided  the  appeal  has  been  submitted  in  time.  If  ordered  to  by  the 
Patent and Market Court, PRV will submit observations to the Court during the appeal 
procedure. 

Regarding  Article  17(2)  of  Regulation  (EC)  1610/96 it  has  been  tried by  the  Swedish 
Patent and Market Court whether said article allows the applicant to appeal a decision 
at  any  time  (based  on  the  grounds  of  said  article)  regardless  of  the  deadline  of  two 
months  for  any  other  appeal.275  The  court’s  reasoning  was  that  looking  at  17(1)  it 
would  not  be  clear  whether  an  incorrect  duration  of  an  SPC  could  constitute  grounds 
for an appeal. This is because the decision to grant an SPC is a positive decision and 
might  therefore  exclude  the  possibility  to  appeal  on  said  grounds  (since  in  some 
jurisdiction  one  may  only  appeal  a  negative  decision).  But  because  of  Article  17(2), 
the court continued, one may appeal a granted SPC solely based on the fact that the 
duration  is  incorrect,  no  matter  whether  the  decision  to  grant  is  a  positive  decision. 
However  the  court  stated  that  an  appeal  based  on  17(2)  is  still  subject  to  the  same 
deadlines for appeals etc. as any other national Swedish matter. 

Thus,  the  Patent  and  Market  Court  stated  that  said  article  does  not  provide  the 
applicant with the right to amend at any time the duration of the certificate. There is a 
pending  case  at  the  Swedish  Patent  and  Market  Court  of  Appeal  regarding  inter  alia 
the application of Article 17(2) and the outcome of this case will be very interesting. 

  CALCULATION  OF  THE  PATENT  AND  SPC  DURATION. 
CALCULATION  OF  TERMS.  REINSTATEMENT  OF  RIGHTS  BEFORE 
PRV 

According  to  Article  40  of  the  Swedish  Patents  Act  a  granted  patent  may  be  kept  in 
force  until  twenty  years  have  passed  from  the  date  when  the  patent  application  was 
filed. The patent expires on the date  of its application, eg. a patent filed 2017-08-08 
expires at midnight on 2037-08-08. 

According to Article 13 of the SPC regulations, the certificate takes effect at the end of 
the  lawful  term  of  the  basic  patent  for  a  period  equal  to  the  elapsed  period  between 
the  date  on  which  the  application  for  a  basic  patent  was  lodged  and  the  date  of  the 
first authorization to place the product on the market in the Community, reduced by a 
period  of  five  years.  The  maximum  duration  of  the  certificate  may  not  exceed  five 
years. 

The  date  of  a  Swedish  marketing  authorization  is  the  date  of  the  decision,  but  in 
accordance  with  the  CJEU  Seattle  Genetics276  decision,  if  the  first  marketing 
authorization in the EU as referred to in Article 13 of the SPC regulations is a European 
marketing authorization, its date is considered to be the date of notification. PRV also 
apply  Seattle  Genetics  on  any  other  national  marketing  authorization  if  the  applicant 
can  prove  that  the  marketing  authorization  enters  into  force  on  the  date  of 
notification,  and  if  the  applicant  can  indicate  said  date  through  any  official 
documentation. 

275   See case, PMÄ 10959-16, 10962-16, 10963-16, 10969-16, 10971-16. 
276   Case C-471/14 Seattle Genetics Inc. [2015]. 

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In  accordance  with  CJEU  Merck277  PRV  grants  SPCs  with  negative  duration  to  allow  a 
possible paediatric extension. 

PRV uses the following method in calculating the duration of the SPC: 

  Date  of  issuance  of  the  marketing  authorization  (notification  or  granting 

according to Seattle Genetics case) + 15 years minus 1 day.  

  Thus, if the patent is filed on 2006-05-02 and it lapses on 2026-05-02 and the 
date  of  issuance  of  the  marketing  authorization  is  2015-06-24  the  duration  of 
the SPC will be between 2026-05-03 to 2030-06-23. 

However of course, as stated above, the duration of an SPC can never be more than a 
maximum of 5 years. 

As  mentioned  above  an  applicant  may  request  for  a  re-establishment  of  rights  if  the 
applicant  has  not  complied  with  a  time  limit.  Article  72  of  the  Swedish  Patents  Act 
state that: 

If  the  applicant  or  the  patent  holder  has,  despite  having  observed  all  due  care  required  by  the 
circumstances, suffered a loss of rights because he or she has not performed an act at the Patent 
Authority within the time limit prescribed in this Act or under the authority of this Act and then he 
or she performs the act within two months from the removal of the cause of the non-compliance, 
but at the latest within one year from the expiry of the respite, the Patent Authority shall declare 
the act to have been performed in due time. If the applicant or the patent holder wishes to obtain 
such  a  declaration,  he  or  she  shall  within  the  time  limit  prescribed  above, file  a  request  to  that 
effect with the Patent Authority and pay a fee. 

This provision also applies to SPCs. 

  GRANT  OF  A  REQUEST  FOR  PAEDIATRIC  EXTENSION  PURSUANT 
TO  ARTICLE  9  OF  SPC  REGULATION  (EC)  469/2009  AND 
ARTICLE 36 OF REGULATION (EC) 1901/2006 

As  mentioned  in  section  3  above,  PRV  is  also  the  responsible  authority  for  the 
examining and granting of SPC paediatric extensions. The application usually does not 
need  any  substantial  examination  instead  the  examination  aims  to  check  that  the 
application is  filed  no  later  than  two  years  before  the  expiry  of  the  SPC,  and  that  all 
required documents have been submitted. The following documents must be attached 
to the application:  

  a  copy  of  the  statement  indicating  compliance  of  the  marketing  authorization 
with an agreed completed paediatric investigation plan as referred to in Article 
36(1) of Regulation (EC) 1901/2006 

  and the proof of marketing authorization in all the Member States 

If  there  is  an  irregularity  in  the  application  PRV  will  notify  the  applicant  and  the 
applicant  is  given  3  months  to  rectify  said  irregularity  (with  a  possible  2-month 
extension) otherwise PRV will reject the application. A granted paediatric extension is 
published  in  “Svensk  Patenttidning”  within  one  month  and  the  same  goes  if  said 

277   Case C-555/13 Merck Canada Inc. [2014]. 

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application is rejected. The paediatric extension is subject to revocation in accordance 
with Article 16(1) of Regulation (EC) 469/2009. PRV is not the competent authority to 
invalidate  SPCs  with  a  paediatric  extension.  Such  a  request  must  be  referred  to  the 
Patent and Market Court. 

  POST-GRANT LIMITATION OR REVOCATION OF THE PATENT 

The owner of a patent may according to Article 40a of the Swedish Patents Act request 
to limit or to revoke the patent. The amendment has a retroactive effect on the scope 
of protection conferred by the patent. 

If an SPC has been granted and the basic patent of said SPC is limited or revoked in 
such  a  way  that  the  product  covered  by  the  SPC  is  no  longer  protected  by  the  basic 
patent, then according to Article 15(c) of the SPC regulations the SPC is invalid. PRV is 
not the competent authority to invalidate the SPC which mean PRV will not decide to 
invalidate the SPC, however PRV will publish in “Svensk Patenttidning” that according 
to Article 15 of the SPC regulations said SPC is no longer valid. 

The  proprietor  of  an  SPC  may  also  surrender  the  SPC  causing  said  right  to  expire 
(Article  14  b  of  the  SPC  regulations),  this  will  also  be  published  in  “Svensk 
Patenttidning”.  

  EFFECT  ON  THE  SPC  GRANTING  PROCEDURE  OF  PENDING 

REVOCATION  OR  OPPOSITION  PROCEDURES  AGAINST  THE 
PATENT 

It is quite usual for SPC applicants to request a stay of the SPC proceedings because 
of pending opposition or revocation proceedings against the basic patent. PRV usually 
deny said requests since each matter to which a person is a party shall be handled as 
simply,  rapidly  and  economically  as  is  possible  without  jeopardising  legal  security, 
according  to  Article  7  of  the  Administrative  Procedure  Act.  Said  article  means  that  a 
delay  of  a  matter  can  only  be  tolerated  if  it  is  absolute  necessary  in  order  for  the 
decision  to  be  based  on  a  satisfactory  basis  (JO  Decision  No.  1792-2007).  Also  in  a 
decision from 2013 from the Court of Patent Appeals, a pending opposition proceeding 
did not constitute grounds for a stay in the SPC proceedings.278 

If  the  SPC  is  granted  and  the  basic  patent  is  later  revoked  or  limited  so  that  the 
product of the SPC is no longer covered by said patent, then according to Article 15 of 
the  SPC  regulations  said  SPC  is  no  longer  valid  and  PRV  will  proceed  as  mentioned 
above. 

  ENFORCEMENT OF THE SPC 

According to Article 106 of the Swedish Patents Act and in conjunction with Articles 4 
and 5 of the SPC  regulations, the provisions in Chapter 9 of the Swedish Patents Act 

278   PBR Case No. 09-265. 

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Study on the Legal Aspects of SPCs – Annex I

on  liability  shall  also  apply  to  SPCs.  Thus  the  holder  of  a  SPC  or  the  licensee  can 
enforce  his  rights,  limited  to  the  product  covered  by  the  SPC,  in  the  same  way  as  a 
holder of a patent.  

According to Article 3 of the Swedish Patents Act the following acts are exempted from 
the exclusive right: 

1. use which is not commercial, 
2. use of a product protected by patent which is put on the market within the European Economic 
Area by  the  holder of  the  patent  or  with  his  consent;  as  regards  biological  material  this  applies 
also to uses in the form of reproduction or multiplication of a product when the reproduction or 
multiplication is a necessary element of the use for which the biological material has been put on 
the  market,  provided  that  the  product  obtained  is  not  later  used  for  further  reproduction  or 
multiplication. 
3. use of the invention for experiments which relate to the invention itself,  
4. studies, tests, examinations and practical measures which concern a reference medicine to the 
extent that these are necessary for obtaining an approval for the sale of a medicine according to 
Article 8 of the Act (1992:859) on Medicinal Products or for other proceedings for approval based 
on Article 10.1–4 of the Directive 2001/83/EC of the European Parliament and of the Council of 6 
November 2001 on the Community Code 
relating  to  Medicinal  Products  for  Human  Use,  as  last  amended by Directive 2004/27/EC,  of  the 
European  Parliament  and  of  the  Council,  or  Article  13.1–13.5  of  Directive  2001/82/EC  of  the 
European Parliament and of the Council of 6 November 2001 on the Community Code Relating to 
Veterinary  Medicinal  Products,  as  last  amended  by  Directive  2004/28/EC  of  the  European 
Parliament and the Council, 
5. preparation in pharmacies of medicines in accordance with a prescription by a physician in an 
individual case or acts relating to medicines prepared in such cases (Act 2006:254) 

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The Netherlands 

  THE NETHERLANDS 

Dr. M.W. Martijn de Lange* Peter R. Slowinski** 

  INTRODUCTION: THE SOURCES OF LAW 

The  Netherlands  is  one  of  the  contracting  states  to  the  European  Patent  Convention. 
Furthermore the Netherlands is a member of the European Union and signed on to the 
Agreement on the Unitary Patent Court Agreement. Although it is possible to apply for 
an SPC on the basis of a national patent granted under the Dutch Patent Act, this has 
seldom happened and  practically all basic patents have been issued  by the  European 
Patent Office. 

Articles  92  to  98  of  the  Dutch  Patent  Act  contain  a  few  provisions  on  SPCs.  In 
particular they designate the Netherlands Patent Office as the authority to process SPC 
applications  and  allow  fees  to  be  levied  on  the  filing  of  an  SPC  application  and 
maintenance fees after grant of the SPC.  

The  General  Administrative  Law  Act  (Dutch:  Algemene  Wet  Bestuursrecht)  is  also 
relevant  when  it  comes  to  procedural  provisions  which  the  SPC  regulation  does  not 
provide. 

  INSTITUTIONAL ASPECTS 

The  Netherlands  Patent  Office  is  part  of  the  Netherlands  Enterprise  Agency  (Dutch: 
Rijksdienst  voor  Ondernemend  Nederland  or  RVO),  which  is  part  of  the  Ministry  of 
Economic Affairs.  

There are currently 4 technical examiners and 1 legal examiner involved in SPCs. They 
all devote only a minor part of their time to SPCs. The technical examiners all hold a 
doctorate  in  chemistry,  biology  or  biotechnology.  Although  a  Dutch  national  patent 
cannot  be  refused  or  invalidated  by  the  Dutch  Patent  Office  on  substantive  grounds, 
the examiners will write search opinions on patent applications and invalidity opinions 
on granted patents, and therefore are still experienced in this area. Decisions at first 
instance are always taken by a technical examiner. The appeals division consists of 3 
members one of whom is the legal examiner.  

The  Netherlands  Patent  Office  has  not  issued  any  guidelines  on  the  examination  of 
SPCs.  

*   Dr. M.W. Martijn de Lange - Netherlands Patent Office. 
**   Peter R. Slowinski, J.S.M. (Stanford) - doctoral student and junior research fellow, Max Planck Institute 

for Innovation and Competition. 

105 

 
 
 
                                                 
Study on the Legal Aspects of SPCs – Annex I

  FILING OF THE APPLICATION AND PUBLICATION 

The  filing  of  the  application  is  published  in  the  Patent  Bulletin  (Dutch:  Hoofdblad 
Industriële  Eigendom),  which  appears  weekly,  and  in  the  online  patent  register,279 
which is updated daily and also includes inspection of the entire file.  

The  Netherlands  Patent  Office  provides  application  forms  on  their  website.  They 
include  a  box  for  the  name  of  the  product,  which  the  applicant  can,  and  always  will, 
enter. 

If  the  deadline  for  filing  the  application  under  article  7  of  the  Regulation  has  been 
missed  a  re-establishment  of  right  procedure  may  be  started,  just  as  one  could  for 
failure to observe a particular time limit regarding a patent.  

  FORMAL 

EXAMINATION.  COPY  OF 

THE  MARKETING 

AUTHORISATION 

The  Netherlands  Patent  Office  has  yet  to  encounter  a  situation  where  in  an  SPC 
application  procedure  the  applicant  was  unable  to  furnish  a  copy  of  the  marketing 
authorisation, which was the subject of the CJEU case C-181/95 from the 1990s.  

In the case of SPC extensions based on national marketing authorisations sometimes 
the  applicant is  unable to  furnish  a  copy  of  the  updated  marketing  authorisation, i.e. 
the marketing authorisation which includes the results of the paediatric investigations. 
The  reason  is  that  some  national  health  authorities  do  not  prioritise  the  issuance  of 
such  updated  authorizations,  although  they  are  instructed  to  do  so  within  30  days in 
the  end-of-procedure  notification  from  the  reference  member  state.  The  Netherlands 
Patent Office has decided that this should not unnecessarily obstruct the grant of the 
SPC extension. 

  SUBSTANTIVE EXAMINATION  

The  Netherlands  Patent  Office  verifies  all  the  requirements  under  the  Regulation  and 
does not solely rely on the information provided by the applicant. The databases of the 
European  Medicines  Agency  and  the  Netherlands  Medicines  Evaluation  Board  will  be 
consulted  to  see  if  earlier  marketing  authorizations  for  the  same  product  have  been 
granted.  The  Netherlands  Patent  Office  does  not  routinely  check  the  equivalent 
databases in all the other member states.  

Currently (June 2017) some very fundamental issues concerning the interpretation of 
articles  3(a),  3(c)  and  3(d),  are  pending  before  the  Court  of  Justice  of  the  European 
Union and/or the Dutch courts. The examination of SPC applications which are similar 
to those cases may be put on hold pending the outcome of such court proceedings.  

The Netherlands Patent Office is compelled to treat similar cases in a similar fashion. 
It is however not possible to articulate our view on the conditions of article 3 and the 
case law here in just a few sentences.  

279   <http://mijnoctrooi.rvo.nl/fo-eregister-view/>. 

106 

 
 
                                                 
The Netherlands 

MPI has posed us the specific question if the marketing  authorization must still be in 
force  at  the  date  on  which  the  SPC  application  is  filed  or  is  it  sufficient  that  it  was 
granted before this date. 

Our answer is that this is not required under article 3, but we may warn the applicant 
that  the  office  may,  after  grant,  immediately  declare  the  SPC  to  have  lapsed  under 
article 14(d) of the SPC Regulation. 

  THIRD PARTY OBSERVATIONS 

Third  parties  may  file  observations.  In  practice  the  objections  will  be  similar  to  what 
the examiner has already put to the applicant. 

  EFFECT  ON  THE  SPC  GRANTING  PROCEDURE  OF  PENDING 

REVOCATION  OR  OPPOSITION  PROCEDURES  AGAINST  THE 
PATENT 

The  applicant  usually  asks  for  a  stay  of  the  SPC  proceedings  if  the  patent  is  under 
attack, which the Netherlands Patent Office will grant. 

  GRANTING  OR  REJECTION  OF  THE  SPC.  APPEAL  AND 

REVOCATION PROCEDURES 

Leading up to a decision at first instance there may be a first office action setting out 
the objections, a written response from the applicant followed by a hearing.  

The applicant can file an appeal against the grant or refusal of the application within 6 
weeks  of the decision, a term  set by the General Administrative Law Act. The appeal 
will  be  handled  by  a  three  member  panel  of  the  Office.  It  usually  also  includes  a 
hearing.  

The decision on appeal has to be appealed to the Administrative Court of the Hague. 
Finally the decision of the Administrative Court may be appealed to the Administrative 
division of the Council of State.  

The specialised patent chambers of the Court of The Hague and the Appeals  Court of 
the  Hague  have  the  exclusive  authority in  the  Netherlands  to  handle patent  and  SPC 
invalidity actions. 

107 

 
 
 
Study on the Legal Aspects of SPCs – Annex I

  CALCULATION  OF  THE  PATENT  AND  SPC  DURATION. 

CALCULATION OF DEADLINES. RELIEF BEFORE THE OFFICE 

  Calculation of the patent and SPC duration 

The expiry date of the patent, i.e. the last day of protection, is calculated as 20 years 
minus 1 day from the filing date of the patent. E.g. a patent filed 1 January 2000 will 
be valid up to and including 31 December 2019. 

The  expiry  date  of  the  SPC,  i.e.  the  last  day  of  protection,  is  calculated  as  15  years 
minus 1 day from the relevant date of the marketing authorization or 25 years minus 
1 day from the filing date of the patent, whichever is the shortest. 

  Calculation of terms 

This issue is not controversial in the Netherlands. 

  Relief before the office for missed deadlines 

As mentioned under 15.2.8.3 a re-establishment of right procedure may be started if 
the application is not filed on time.  

Deadlines  set  by  the  office  in  their  communications  have  always  been  observed  by 
applicants. 

  REPRESENTATION BEFORE THE OFFICE 

Representatives must be registered as Dutch patent attorneys or lawyers. 

  POST-GRANT AMENDMENT OF THE SPC DURATION.  

Requests  for  rectification  of  the  SPC  duration  under  Article  17(2)  of  Regulation 
1610/96/EC may be filed at any time. 

  SPECIFIC ISSUES CONCERNING EXTENSION PURSUANT TO ART. 

36 OF REG. 1901/2006/EC 

In  principle  updated  (with  paediatric  information)  marketing  authorisations  in  all 
member  states  are  necessary.  Only  when  the  national  health  authorities  fail  to  issue 
these authorisations on time the applicant may rely on an older authorisation. 

Withdrawal of the orphan designation (art. 36(3)) is not a condition listed in the SPC 
Regulation  and  therefore  not  part  of  the  examination.  It  can  however  be  ground  for 
invalidity. 

108 

 
 
The Netherlands 

  PAYMENT OF FEES 

There  are  fees  for  filing  an  SPC  application  or  SPC  extension  application  (544  Euro 
each)  and  maintenance  fees  for  granted  SPCs  ranging  from  1,600  Euro  in  year  1  to 
2,400 Euro in year 5 and 1,300 Euro for a paediatric extension in year 6. 

  ENFORCEMENT OF THE SPC 

The SPC may be enforced on the basis of the same provisions that exist for patents. 

There  is  no  specific  provision  in  the  Dutch  Patent  Act  that  confers  a  right  on  a 
published SPC application.  

109 

 
 
 
 
Study on the Legal Aspects of SPCs – Annex I

  UNITED KINGDOM  

Fiona  Warner*  Michael  Warren**  Jason  Bellia***  Philip  Mountjoy****  Lawrence 
Cullen*****  

  INTRODUCTION: THE SOURCES OF LAW 

The UK has signed and ratified all relevant European and international agreements in 
the  field  of  patents,  including  TRIPS,  the  EPC,  the  PCT,  the  PLT  and  the  Strasbourg 
Convention. The UK is also a Signatory State of the UPCA and is party to the enhanced 
cooperation for the creation of unitary patent protection. 

Patent protection in the UK is obtainable by filing a European patent application (at the 
EPO,  either  directly  or  as  a  regional  phase  entry  of  a  PCT  application),  or  by  filing  a 
national  patent  application  (at  the  Intellectual  Property  Office,  either  directly  or  as  a 
national phase entry of a PCT application). The provisions governing both national and 
European (UK) patents and patent applications are set out in the Patents Act 1977 (as 
amended)280. 

Harmonisation  of  UK  law  with  various  provisions  of  the  EPC  (as  well  as  the  CPC  and 
PCT)  is  ensured  by  Section  130(7)  of  the  Patents  Act,  which  declares  that  certain 
provisions are “so framed as to have, as nearly as practicable, the same effects in the 
United  Kingdom  as  the  corresponding  provisions  of  the  European  Patent  Convention, 
the  Community  Patent  Convention  and  the  Patent  Co-operation  Treaty  have  in  the 
territories  to  which  those  Conventions  apply”.  Provisions  covered  by  this  section 
include  those  governing  patentability,  the  meaning  of  infringement,  extent  of 
invention and grounds for revocation. 

Thus,  for  example,  the  extent  of  protection  afforded  by  national  patents281  is 
interpreted  in  accordance  with  Article  69  EPC  and  its  associated  Protocol.  Also, 
infringement rights conferred by national patents282 are, where relevant, interpreted in 
accordance with Articles 29 to 31 CPC. Further, Sections 77 and 78 of the Patents Act 
ensure that the same interpretations apply to EP(UK) patents and patent applications. 

Similarly,  patentability  requirements283  and  the  grounds  for  revocation284  are  entirely 
consistent with corresponding provisions of the EPC (namely, Articles 52 to 57 EPC for 
patentability and Articles 138 and 139 EPC for revocation). 

The  UK  is  one  of  several  EPC  Contracting  States  that  interprets  the  term  specified  in 
Article  63(1)  EPC  (“20  years  from  the  date  of  filing  of  the  application”)  as  meaning 

* 
Fiona Warner - Senior Policy Adviser, UK NPO.  
**   Michael Warren - Senior Legal Adviser, UK NPO. 
***   Jason Bellia - Senior patent and SPC examiner, UK NPO. 
****   Phiip Mountjoy - Senior patent and SPC examiners, UK NPO. 
*****  Lawrence Cullen - Deputy Director & Hearing Officer, UK NPO. 
280   An unofficial consolidation of the Patents Act as currently amended (produced by Patents Legal Section) 

can be viewed at: http://bit.ly/2tqiD3r. 

281   Section 125 of the Patents Act. 
282   Section 60 of the Patents Act. 
283   Sections 1(1) to 1(4) and 2 to 6 of the Patents Act. 
284   Section 72(1) and (2) of the Patents Act. 

110 

 
 
                                                 
United Kingdom 

that the last day that a patent can be in force is the day before the 20th anniversary of 
its  filing.  Other  EPC  Contracting  States  take  the  view  that  the  last  day  that  a  patent 
can  be  in  force  is  the  20th  anniversary  of  its  filing.  As  discussed  in  section  9a  below, 
the UK’s approach to calculating patent term reads onto the calculation of SPC term. 

In  addition  to  directly  applicable  provisions  of  Regulations  nos.  469/2009  and 
1610/96, UK law on SPCs is governed by Section 128B and Schedule 4A of the Patents 
Act,  as  well  as  various  relevant  provisions  of  the  Patents  Rules  2007  (as  amended), 
most notably Rule 116. 

Numerous provisions of the Patents Act are applied to SPCs by way of paragraph 1(2) 
of  Schedule  4A.  Amongst  other  things,  these  cover  aspects  of  pre-  and  post-grant 
procedure,  including:  making  of  application285;  general  power  to  amend  application 
before  grant286;  reinstatement  of  applications287;  observations  by  third  party  on 
patentability288;  general  power  to  amend  specification  after  grant289;  surrender  of 
patents290; opinions by the Patent Office291; administrative provisions292; and rules293. 

  INSTITUTIONAL ASPECTS: THE GRANTING AUTHORITY 

For  the  UK,  the  granting  authority  specified in  Article  9(1)  of  Regulation  469/2009  is 
the  Intellectual  Property  Office  (IPO).  This  is  reflected  in  paragraph  1(2)  of  Schedule 
4A,  which,  by  specifying  Section  14(1)  of  the  Patents  Act  as  one  of  the  provisions 
applying to SPCs, requires every SPC application to be made in the prescribed form at 
the Patent Office (of which IPO is the operating name). 

The  IPO is an official UK government body. More specifically, the IPO is an executive 
agency of the Department for Business, Energy & Industrial Strategy294. 

In addition to handling the examination and grant of SPCs, the IPO is responsible for: 
the examination and grant of UK patent applications; and the provision (upon request) 
of  non-binding  opinions  on  the  infringement  or  validity  of  a  patent  or  an  SPC. 
Examination  of  SPCs  is  entrusted  to  a  small  number  of  examiners  (currently  2)  who 
specialise  in  SPCs,  but  who  also  retain  responsibilities  for  examining  patent 
applications in the relevant technology. 

For  those  SPC  applications  where  the  applicant  requests  a  hearing  at  the  IPO, 
decisions upon grant or rejection are taken by a designated (senior) officer at the IPO 
(a  so-called  “Hearing  Officer”).  At  present,  the  IPO  assigns  hearings  on  SPCs  to  a 
Hearing  Officer  having  detailed  knowledge  of  the  law  relating  to  SPCs  and  the 
technology involved. 

285   Section 14(1), (9) and (10). 
286   Section 19(1). 
287   Sections 20A and 20B. 
288   Section 21. 
289   Section 27. 
290   Section 29. 
291   Sections 74A and 74B. 
292   Sections 117 to 118. 
293   Section 123. 
294   https://www.gov.uk/government/organisations/intellectual-property-office. 

111 

 
 
 
                                                 
Study on the Legal Aspects of SPCs – Annex I

All  SPC  examiners  and  Hearing  Officers  at  the  IPO  are  entrusted  with  reaching 
decisions upon SPC validity in connection with all aspects of Article 3 (and Article 2) of 
the  SPC  Regulations;  however,  only  Hearing  Officers  have  the  authority  to  reach  a 
decision to refuse an SPC application in situations where the applicant disputes such a 
decision being made (as discussed further in section 8 below).295  

  FILING OF THE APPLICATION. 

The  deadlines  for  filing  SPC  applications  in  the  UK  are  governed  by  Article  7  of 
Regulations nos. 469/2009 and 1610/96. The IPO calculates time periods expressed in 
Article  7  of  the  two  Regulations  in  accordance  with  the  Euratom  Regulation  (No. 
1182/71)296.  

In  accordance  with  Article  19  of  Regulation  469/2009  (and  Article  18  of  Regulation 
1610/96),  the  IPO  applies  to  SPCs  many  of  the  same  procedural  provisions  that  are 
applicable to UK patents and patent applications. These provisions include Rule 108(1) 
of  the  Patents  Rules  2007  (as  amended),  which  provides  the  IPO  with  discretion  to 
extend certain time limits. 

Amongst  the  time  limits  that  may  be  extended  under  Rule  108(1)  are  the  filing 
deadlines  specified  in  Article  7  of  the  SPC  Regulations297.  The  IPO  has  exercised  its 
discretion  (and  excused  the  late  filing  of  an  SPC  application)  in  circumstances  where 
an  application  was  late-filed  due  to  “unforeseen  circumstances”,  and  where  the 
applicant “acted promptly to rectify the situation”298. 

Under  current  practice,  the  view  of  the  IPO  is  that  Article  3(b)  only  requires  a  valid 
Marketing Authorisation (MA) to have been granted, but that there is no requirement 
for  the  MA  to  still  be  in  force  on  the  date  that  the  SPC  application  is  filed.  Thus,  it 
appears that an SPC application may still be filed even if the MA has been withdrawn 
(or has lapsed) prior to date of filing of the application299. 

With  regard  to  an  SPC  application,  the  view  of  the  IPO  is  that  all  substantive 
requirements,  as  specified  in  Article  3,  must  be  satisfied  at  the  time  of  filing  of  the 
application300. In this respect, if no MA has been granted in the UK by the date of filing 
of the application, the absence of that MA is not viewed by the IPO as an “irregularity” 
that can be corrected after filing301. 

By  way  of  contrast,  the  IPO  views  the  absence  of  documents  required  to  perfect  an 
SPC  extension  application  (those  specified  in  Article  8(d)  of  Regulation  469/2009)  as 
representing  an  “irregularity”  that  can  be  corrected  after  filing302.  However,  under 

295   Manual  of  Patent  Practice  (MoPP)  (https://www.gov.uk/guidance/manual-of-patent-practice-mopp), 

130.05, Schedule. 

296   MoPP, SPM 7.03. 
297   MoPP, SPM 7.01. 
298   Abbott Laboratories’ SPC application, BL O/302/02. 
299   MoPP, SPM 3.03. 
300   MoPP, SPM 3.01. 
301   Merck Sharp & Dohme’s SPC application, BL O/117/16. 
302   E I Du Pont Nemours & Co. v UK Intellectual Property Office [2009] EWCA Civ 966. 

112 

 
 
                                                 
United Kingdom 

current practice, such an “irregularity” must be corrected before the expiry date of the 
(unextended) SPC303. 

According  to  Rule  116,  Patents  Form  SP1  must  be  used  for  the  filing  of  an  SPC 
application, and Patents Form SP4 for the filing of an SPC extension application. Each 
such form must contain a request for grant and be accompanied by the prescribed fee, 
as set out in Schedule 1 of the Patents (Fees) Rules 2007 (as amended). 

For  filing  an  SPC  application,  Patents  Form  SP1  demands  the  provision  of  the 
following. 

a)  The  information  and  documentation  stipulated  in  Article  8(1)(a)  to  (c)  of  the 

SPC Regulations. 

b)  Additional information comprising: 

i. 

the  EC  Regulation  (469/2009  or  1610/96)  under  which  the  application  is 
made; 
the expiry date of the basic patent; 

ii. 
iii.  the date of grant of the basic patent (if later than the date of the first UK 

authorisation for the product); and 

iv.  a definition of the product in respect of which an SPC is sought. 

Also,  except  in  situations  where  it  is  self-evident,  the  IPO  expects  applicants  to 
provide  whatever  information  is  necessary  to  confirm  that  the  product  in  question  is 
protected  by  the  basic  patent  (e.g.  by  specifying  a  claim  of  the  basic  patent  that 
“reads on” to the product, or by explaining how the product falls within the scope of a 
general formula in the claim)304. 

In  the  UK,  definition  of  the  “product”  by  reference  to  the  proprietary  name  for  the 
medicinal product is objectionable because it includes substances other than the active 
ingredient(s). IPO practice requires that the “product” be defined by reference to the 
relevant International Non-proprietary Name(s) (INN) – if available - or a formal (e.g. 
IUPAC)  chemical  name(s)  (where  no  INN  has  been  assigned).  For  biological  active 
ingredients, the IPO also accepts the use of common names. Finally, in relation to the 
decision in Farmitalia (C-392/97) which states that an SPC is "capable of covering the 
product in any of the forms enjoying the protection of the basic patent", UK practice is 
to require applicants to specify the forms identified in the basic patent in the product 
definition;  e.g.  if  the  basic  patent  claims  "pharmaceutically  acceptable  salts  and 
esters",  this  would  form  part  of  the  product  definition.  This  practice  extends  to  both 
chemical and biological active ingredients.  

The  IPO  has  no  standard  accepted  form  of  words  to  admit  biosimilars  to  the  product 
definition,  and  would  consider  what  forms  are  protected  by  the  basic  patent  when 
making this assessment. 

As regards the product definition for process claims, UK practice is not to consider the 
process as part of the product definition, in line with the judgment in  Queensland (C-
630/10).  Similarly,  as  regards  medical  use  claims,  in  order  to  abide  by  both  Yissum 
and  Neurim,  the  UK  does  not  accept  incorporation  of  the  therapeutic  indication  into 
the product definition.  

303   Otsuka Pharmaceuticals’ SPC application, BL O/098/15. 
304   MoPP, SPM 8.06. 

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For  filing  an  SPC  extension  application,  Patents  Form  SP4  demands  the  provision  of 
the following. 

a)  The documentation stipulated in Article 8(1)(d) of Regulation 469/2009. 
b)  Additional information / documents comprising: 

the name and address of the applicant and his agent (if any); 
the number, title and expiry date of the basic patent; 

i. 
ii. 
iii.  the number and date of the MA containing the statement of compliance; 
iv.  an  indication  of  whether  the  product  has  been  authorised  in  all  Member 

States by way of a “centralised” MA or by way of national MAs; 

v.  a definition of the product in respect of which an SPC extension is sought; 
vi.  the  number  of  the  SPC  or  SPC  application  that  is  to  be  extended  (if  that 

number exists at the time of filing); and 

vii.  where  the  SPC  to  be  extended  has  been  granted,  a  copy  of  the  granted 

certificate. 

For  SPC  extension  applications,  the  IPO  may  require  the  provision  of  further 
information  if  it  is  not  immediately  apparent  that  the  product  in  question  has 
completed the agreed Paediatric Investigation Plan and been authorised in all Member 
States  (e.g.  where  the  “decentralised”  procedure  has  been  used).  Such  further 
information may include, for example, a list of relevant national MAs for the medicinal 
product in all Member States305. 

Especially  for  medicinal  products  authorised  by  the  European  Medicines  Agency,  it  is 
possible  that  all  of  the  documents  required  to  support  an  SPC  extension  application 
may  be  publicly  available.  Thus,  in  theory,  there  is  nothing  (other  than  practical 
difficulties  in  obtaining  certain  documentation,  e.g.  for  products  authorised  through 
the  “decentralised”  route)  to  prevent  extensions  being  awarded  in  respect  of  SPCs 
held by parties other than the sponsor of the clinical trials in the paediatric population. 
However, the IPO’s Manual of Patent Practice does not comment on this issue. 

  FORMAL EXAMINATION  

Formal examination by the IPO306 determines whether an SPC application: 

is in the required form; 
is accompanied by the prescribed fee; 

 
 
  was lodged within the period prescribed by Article 7; 
 
 

contains the information prescribed by Article 8(1)(a); 
is  accompanied  by  a  copy  of  the  (or  each)  first  MA  as  specified  in  Article 
8(1)(b); and 
contains,  where  appropriate,  the  information  and  notice  specified  in  Article 
8(1)(c) regarding the first MA in the Community. 

 

The IPO also determines whether the basic patent was in force on the date of filing of 
the SPC application. 

Similar checks are carried out for SPC extension applications, as is a determination of 
whether the application: 

305   MoPP, SPM 8.12. 
306   MoPP, SPM 10.01. 

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contains the information and documents specified in Article 8(1)(d); and 

 
  with  regard  to  the  SPC  to  be  extended,  specifies  a  pending  application  (as 
required by Article 8(2)) or provides a copy of a granted certificate (as required 
by Article 8(3))307. 

The procedure of the IPO in circumstances where the MA supporting the application is 
missing is described in section 5 below. 

  SUBSTANTIVE EXAMINATION  

The  IPO  usually  conducts  substantive  examination  at  the  same  time  as  formalities 
examination308. For an SPC application, substantive examination invariably includes an 
assessment  of  compliance  with  the  requirements  of  Articles  3(a),  3(b)  and  3(c).  The 
IPO  also  considers  compliance  with  Article  3(d)  as  required,  as  discussed  further 
below. 

Under  its  current  practice,  the  IPO  will  accept  that  an  SPC  application  complies  with 
Article  3(a)  if  the  product  for  the  application  is  specified/identified  in  the  wording  of 
the  claims  of  the  basic  patent  and,  “having  regard  to  the  normal  canons  of  claim 
interpretation” it is: 

indicated in a claim; 
encompassed by a Markush formula; 

i. 
ii. 
iii.  shown to result from the process protected by the basic patent; or 
iv.  encompassed by a functional definition309. 

The IPO may ask the applicant to provide evidence in respect of point (iii) or point (iv) 
above, for example evidence in the form of a witness statement310. 

For  assessing  compliance  with  Article  3(a)  (and/or  Article  3(c))  for  a  product  defined 
as  a  combination  of  active  ingredients,  the  current  practice  of  the  IPO  is  to  consider 
whether  the  combination  is  “protected  as  such”  by  the  claims  of  the  basic  patent.  In 
doing  this,  the  IPO  may  assess  whether  the  combination  forms  “part  of  the  subject 
matter  or  innovation  of  the  patent”,  and  whether  it  falls  within  “the  core  inventive 
advance” of the patent311. 

For  claims  in  process  format,  the  IPO  assesses  compliance  with  Article  3(a)  by 
determining  whether  “the  product  identified  in  the  patent  claims  is  the  product 
deriving  from  the  process  protected  by  that  patent”.  For  the  purposes  of  that 
determination, the view of the IPO is that it does not matter whether it is possible to 
obtain  the  product  directly  as  a  result  of  the  claimed  process.  Thus,  the  IPO  will  not 
require  the  applicant  to  provide  evidence  of  whether  a  product  that  is  suitably 
“identified”  in  a  process  claim  has  been  (or  could  be)  produced  by  the  process  steps 
recited that claim312.  

307   MoPP, SPM 10.08. 
308   MoPP, SPM 10.04. 
309   MoPP, SPM 3.02.5. 
310   MoPP, SPM 3.02.5. 
311   MoPP, SPM 3.02.6. 
312   MoPP, SPM 3.02.4. 

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This approach  stems  from the decision of the  CJEU in  Queensland (C-630/10), which 
made this point specifically in its ruling313. It reflects the consistent distinction that is 
made in CJEU case law between the requirements necessary to grant an SPC in terms 
of  what  the  basic  patent  specifies  or  identifies  and,  once  granted,  what  protection  is 
offered  by  the  SPC  derived  from  that  basic  patent.  This  distinction  is  discussed  in 
Icahn  School  of  Medicine  at  Mount  Sinai  BL  O/552/14,  in  which  the  Hearing  Officer 
applied  Queensland  in  granting  an  SPC  for  a  biological  product  where  the  authorised 
product did not have to be prepared by the process disclosed in the basic patent  – it 
was  considered  necessary  simply  to  determine  if  they  both  related  to  the  same 
product for the purposes of granting an SPC. 

However,  for  the  purposes  of  determining  the  protection  offered  by  such  a  granted 
SPC for infringement purposes, it is not yet known what scope will be afforded to an 
SPC granted on the basis of a claim to a process that is not used in the production of 
the  authorised  medicinal  product.  This  is  because  the  scope  afforded  to  any  SPC 
granted on the basis of a process claim has not yet been tested in the UK courts. The 
SPC  may  provide  the  necessary  protection  in  so  far  as  it  relates  to  the  active 
ingredient in the authorised product when it is made by the process  of the claim. On 
the other hand, it is possible that it may be considered that (a) it does not provide any 
effective  scope  of  protection  (e.g.  where  the  process  cannot  be  used  to  produce  the 
authorised product), or (b) will provide a scope of protection that does not encompass 
the authorised product (e.g. where the process can be used, but is in fact not used, to 
produce that product). 

If, in connection with a particular product, the claims of a basic patent do not comply 
with  Article  3(a),  the  IPO  will  permit  the  applicant  to  make  post-grant  amendments 
with  a  view  to  rectifying  this  deficiency.  The  current  practice  of  the  IPO  is  to  permit 
such amendments even after the SPC application has been filed314. 

In  connection  with  SPC  applications  for  which  the  authorised  product  is  a  medical 
device, the practice of the IPO is to view EC design examination certificates relating to 
such devices as not meeting the requirements of Article 3(b)315. 

The  IPO  interprets  the  requirements  of  Article  3(c)  in  the  light  of  Article  3(2)  of 
Regulation  1610/96.  Thus,  with  respect  to  a  single  product,  the  IPO  will  grant  a 
certificate to each different holder of a basic patent that protects the product (but will 
not  grant  more  than  one  certificate  to  a  single  applicant  holding  multiple  patents 
protecting that product)316. 

Currently,  the  IPO  does  not  establish  compliance  of  SPC  applications  with  the 
provisions of Article 3(d) by conducting a formal search. Instead, if there is reason to 
do  so,  the  IPO  will  consider  in  detail  whether  the  requirements  of  Article  3(d)  are 
satisfied by way of an “informal” (basic internet) search. The  IPO might do this upon 
the basis of information provided to it: by the applicant; in third party observations; or 
in  another  SPC  application  for  the  same  product317.  If  the  examiner  at  the  IPO  does 

313   C-630/10, paragraphs 40-41. 
314   MoPP, SPM 3.02.1. 
315   MoPP, SPM 3.02.3. 
316   MoPP, SPM 3.04.2. 
317   MoPP, SPM 10.05. 

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require further information in order to make a determination in relation to Article 3(d), 
the applicant is asked to furnish this within a prescribed period.  

Under  its  current  practice,  the  IPO  grants  SPCs  in  respect  of  applications  having 
similar underlying fact patterns to the Neurim case (i.e. where there is a “new” patent 
for a medical indication of a product for which a certificate has already been granted). 
However, in such cases, the IPO may ask the applicant to show that the indication in 
the  MA  is  within  the  scope  of  protection  of  the  basic  patent,  in  accordance  with 
paragraph 26 of the CJEU’s judgment in  Neurim318. Whilst the IPO’s Manual of Patent 
Practice  does  not  comment  on  the  matter,  it  is  not  expected  that  the  authorisation 
used  to  support  a  “Neurim-style”  SPC  will need  to  be  a  separate  authorisation  falling 
outside  of  the  concept  of  “global  marketing  authorisation”  (for  the  purposes  of 
Directive 2001/83). In this respect, the IPO has granted “Neurim-style” SPCs upon the 
basis of a variation of an existing MA wherein the date of authorisation is the date of 
the variation to incorporate the indication in the MA as protected by the basic patent. 

In accordance with paragraph 25 of the CJEU’s judgment, the  IPO considers that the 
scope  of  a  “Neurim-style”  SPC  extends  only  to  the  authorised  use.  Although  the  UK 
courts  have  approved  of  this  interpretation,  they  have  nonetheless  submitted 
questions  to  the  CJEU  to  determine  if  a  Neurim-style  SPC  may  also  extend  to  new 
formulations  (Abraxis  Bioscience  LLC  v  The  Comptroller  General  of  Patents  [2017] 
EWHC 14 (Pat)). Furthermore, the IPO will not seek to include the authorised medical 
use in the definition of the product319. 

For  SPC  extension  applications,  the  IPO  conducts  substantive  examination  on  the 
requirements  of  Article  8(1)(d)  of  Regulation  469/2009  and  Article  36  of  Regulation 
1901/2006. In particular, the IPO examines whether: 

 

 

the  MA  identified  includes  the  required  compliance  statement  (as  specified  in 
Article  36(2)  of  Regulation  1901/2006  and  Article  8(1)(d)(i)  of  Regulation 
469/2009); 
the product is authorized in all Member States (as required by Article 36(3) of 
Regulation 1901/2006); and 

  as required by Article 36(3) and (4) of Regulation 1901/2006, the product has 
not  already  been  the  subject  of  an  alternative  reward  of  extended  Orphan 
Market Exclusivity or extended Regulatory Data Protection320. 

In cases where the IPO requires further information in order to make a determination, 
the applicant is set a deadline for furnishing that information. Under the provisions of 
Rule  108(1)  of  the  Patents  Rules  2007  (as  amended),  the  IPO  has  the  discretion  to 
extend any such deadline. 

The IPO will not reject an SPC application solely on the ground that a copy of the MA 
mentioned  in  Article  8(1)(b)  is  not  provided  together  with  the  application.  Whilst  the 
IPO can take action of its own accord to make good the absence of the copy of the MA, 

318   MoPP, SPM 3.05.2. 
319   MoPP, SPM 3.05.2. 
320   MoPP, SPM 10.09. 

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it  will  not  do  so  unless  and  until  the  applicant  has  established  that  he  is  unable  to 
provide the missing copy321. 

Thus, where an applicant is unable to obtain a copy of the MA from the person holding 
it,  the  IPO  will  first  require  evidence  of  this.  It  will  then  require  the  provision  of 
information  from  the  MA  issuing  authority  (such  as  a  gazette  notice,  a  letter  or  an 
extract from a database) that is sufficient to enable the IPO to verify both the date of 
the  MA  and  the  identity  of  the  authorised  product.  The  IPO  will  then  seek  from  the 
issuing  authority  a  copy  of  the  Summary  of  Product  Characteristics  (SmPC)  for  the 
authorised  product.  This  is  usually  conducted  on  a  confidential  basis,  such  that  the 
copy of the SmPC is made available neither to the applicant nor to the public322. 

If  the  notice  specified  in  Article  8(1)(c)  does  not  exist,  the  requirements  of  Article 
8(1)(c)  may  instead  be  met  by  provision  of  a  copy  of  the  MA  itself,  or  any  other 
document proving that the MA has been issued. Documents in a language other than 
English language should be accompanied by a translation (which need not be verified, 
unless there is reason to doubt the accuracy of the translation)323. 

As mentioned in section 3 above, if an SPC extension application is filed without one or 
more  of  the  documents  specified  in  Article  8(1)(d),  the  missing  documents  can  be 
supplied  after  filing  (as  the  correction  of  an  “irregularity”),  but  only  before  expiry  of 
the unextended SPC. 

The  IPO  will  consider  requests  for  accelerated  examination  that  are  supported  by  a 
reasoned  statement  for  the  request.  However,  the  allowance  of  a  request  for 
accelerated  examination  cannot  lead  to  grant  of  a  certificate  until  at  least  three 
months  have  elapsed  from  the  date  that  the  notice  of  filing  of  the  application  was 
published  in  the  Patents  Journal.  This  is  to  allow  for  the  filing  of  third-party 
observations (discussed in section 7 below)324. 

In  a  dedicated  section  of  its  Manual  of  Patent  Practice,  the  IPO  publishes  (regularly 
updated) information on its practices regarding the examination of SPC applications. 

  PUBLICATION OF THE APPLICATION  

The  practice  of  the  IPO  is  to  publish  SPC  applications,  as  well  as  SPC  extension 
applications, promptly after their filing. Details of SPC applications are published in the 
Patents Journal. However, details of such applications are often available at an earlier 
date via the IPO’s online registers. Where an SPC has been filed in respect of a basic 
patent,  a  link  to  an  entry  on  the  IPO’s  register  of  SPCs  is  added  to  the  entry  for  the 
basic  patent  on  Ipsum  (IPO’s  Online  Patent  Information  and  Document  Inspection 
Service), and vice versa. 

For an SPC application, the publication in the Patents Journal includes the date of filing 
of  the  application  and  the  details  prescribed  by  Article  9(2),  based  upon  the 
information  provided  by  the  applicant  (on  Form  SP1).  The  published  information 

321   MoPP, SPM 8.04.1. 
322   MoPP, SPM 8.04.1. 
323   MoPP, SPM 8.05.1. 
324   MoPP, SPM 10.04.1. 

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includes  the  generic  name  of  the  product,  which  the  IPO  determines  by  reference  to 
the  MA  document  if  it  is  not  provided  by  the  applicant  on  Form  SP1325.  The  same 
information  is  published  in  the  Patents  Journal  for  SPC  extension  applications,  with 
any additional information necessary being taken from Form SP4326. 

The IPO also publishes details of any corrections that it considers to be allowable and 
that affect details of the SPC application that have already been published327. 

Copies of documents filed in connection with SPC applications cannot (yet) be viewed 
via any of the IPO’s online databases. However, in accordance with Rules 48 and 54, 
copies of such documents can be obtained by submitting a written request to the IPO 
(in  the  prescribed  form,  accompanied  by  the  prescribed  fee).  This  does  not  apply  to 
documents covered by Rule 51 or Rule 53, including “internal” documents prepared by 
the  IPO  and  documents  in  respect  of  which  a  request  for  confidentiality  has  been 
granted. 

  THIRD PARTY OBSERVATIONS 

The IPO will consider any third party observations that: 

a)  address  the  question  whether  a  published  SPC  application  is  valid  application 
having  regard  to  Article  3,  8(1)(d)  as  applied  to  SPCs  and  extensions 
respectively; 

b)  are in writing; and 
c)  are made before the SPC in question in granted328. 

In this respect, the IPO follows the same practice for SPCs as it does for patents under 
Section 21 of the Patents Act. Under this practice, and in accordance with Rule 29 of 
the Patents Rules, the IPO will raise objections based upon third party observations if: 

 

 

in  the  light  of  those  observations,  the  examiner  is  persuaded  that  the  SPC 
application  does  not  comply  with  the  specified  requirements  of  the  relevant 
Regulation; and 
the IPO has not raised the relevant objections in a previous examination report. 

Under  Rule  33,  the  applicant  is  sent  a  copy  of  any  observations  that  are  filed  by  a 
third party before grant of the SPC. 

By  filing  observations,  the  third  party  does  not  become  a  party  to  the  proceedings. 
Thus,  even  if  such  observations  are  filed,  proceedings  for  the  examination  of  SPC 
applications  remain  ex  parte.  In  this  respect,  if  the  IPO  decides  to  grant  the 
application, they are under no formal obligation to explain either why objections raised 
by the third party were unpersuasive, or how those objections were overcome by the 
applicant’s arguments. Nevertheless, the IPO’s reasoning on such points may emerge 
from  the  written  record  if,  at  any  point,  the  examiner  raises  any  objections  based 
upon (or in accordance with) the third party observations. 

325   MoPP, SPM 9.02. 
326   MoPP, SPM 9.02.1. 
327   MoPP, SPM 10.14. 
328   MoPP, SPM 10.06 and SPM 10.10. 

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As discussed in section 8 below, the applicant for an SPC is able to request a hearing 
before  the  IPO  reaches  a  final  decision  to  either  grant  or  reject  the  application.  In 
accordance with Rule 84, any such hearings that take place are normally open to the 
public  (unless  the  application  has  not  been  published,  or  where  the  IPO  agree  that 
there  are  good  reasons  to  grant  a  request  from  the  applicant  for  the  hearing  to  be 
held  in  private).  Also,  under  Rule  75,  the  IPO  publishes  advance  notice  of  hearings. 
Thus,  in  theory,  and  provided  that  the  IPO  is  informed  in  advance,  third  parties  are 
able  to  attend  hearings  relating  to  SPC  applications.  However,  as  mere  observers, 
third parties are not permitted to make submissions (oral or otherwise) at the hearing. 

After  grant  of  an  SPC,  third  parties  may  apply  to  the  IPO  for  a  declaration  of  lapse 
(Article  14(d))329  or  invalidity  (Article  15  or,  for  SPC  extensions,  Article  16)330. 
Applications  for  such  declarations  must  be  submitted  using  Form  SP3.  Alternatively, 
third parties may ask the IPO (under the provisions of Section 74A of the UK Patents 
Act) to provide a non-binding opinion on validity of the SPC 331. 

  GRANT / REFUSAL PROCEDURE 

A certificate (and/or extension thereof) is granted if: (a) the applicant overcomes (by 
way  of  amendments,  corrections  and/or  submissions)  all  objections  raised  on  formal 
and/or substantive grounds; and (b) at least three months have elapsed from the date 
that  the  notice  of  filing  of  the  SPC  application  was  published  in  the  Patents  Journal 
(see section 5 above). 

However,  if  the  applicant’s  written  submissions  do  not  persuade  the  IPO  that  the 
conditions  for  grant  of  the  SPC  are  met,  the  IPO  will  either  pursue  the  outstanding 
objection(s)  or  initiate  the  rejection  procedure.  Further  objections,  if  pursued,  are 
typically  outlined  in  written  correspondence.  Nevertheless,  telephone  or  in-person 
interviews are also possible332. 

If inclined to reject the SPC application, the IPO informs the applicant in writing of the 
examiner’s opinion and the reasons therefor. Unless the applicant requests a hearing, 
or a decision based on the correspondence on file, the application is then rejected333. 

If  the  applicant  requests  a  hearing,  the  IPO  agrees  a  date  for  the  hearing  with  the 
applicant.  After  the  date  for  the  hearing  has  been  fixed,  the  substantive  examiner  at 
the  IPO  will  (if  necessary)  write  to  the  applicant  to  set  out  the  issues  to  be  decided 
and  to  provide  advance  notice  of  any  precedents  that  the  IPO  intends  to  rely  upon. 
Hearings  are  usually  conducted  at  the  IPO’s  premises  (in  Newport  or  sometimes  in 
London),  though  they  may  be  conducted  by  telephone  or  video  conference,  provided 
that those attending are content to do so. 

Whilst  the  substantive  examiner  may  be  present  at  the  hearing,  it  is  a  designated 
(senior)  officer  at  the  IPO  (a  so-called  “Hearing  Officer”)  who  has  responsibility  for 
deciding upon grant or rejection of the application at the hearing. 

329   MoPP, SPM 14.03. 
330   MoPP, SPM 15.02 and SPM 15.05. 
331   MoPP, SPM 15.05. 
332   MoPP, SPM 10.16. 
333   MoPP, SPM 10.17. 

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If the applicant requests that the decision be made on the basis of the correspondence 
on file, the Hearing Officer will issue a written decision without a hearing taking place. 

  CALCULATION OF THE PATENT AND SPC DURATION 

As discussion in section 1 above, the last day that a patent can be in force in the UK is 
the day before the 20th anniversary of its filing. 

With  regard  to  the  calculation  of  SPC  duration,  the  IPO’s  Manual  of  Patent  Practice 
expresses  the  view  that  the  maximum  period  defined  by  Article  13  of  the  SPC 
Regulations is either: 

a)  a period of 15 years from the date of the first MA to place the product on the 

market in the Community; or 

b)  a period of 5 years from the date on which the SPC takes effect, 

whichever is the lesser334. 

In practice, this means that the expiry date of SPCs in the UK is the earlier of: 

(a1) the  day  before  the  15th  anniversary  the  date  of  the  first  MA  to  place  the 

product on the market in the Community; and 

(b1) the day before the 25th anniversary of the filing date of the basic patent. 

The  terms  specified  in  (a1)  and  (b1)  above  arise  from  the  UK  interpretation  of  the 
term afforded to patents in the UK (i.e. determination of SPC duration according to the 
formula  specified  in  Article  13,  as  opposed  to  by  direct  application  of  the  15  year 
period specified in Recital (9) of Regulation 469/2009).  

In  support  of  this,  the  decision  of  the  Hearing  Officer  in  Genzyme  Corporation  (BL 
O/418/13) states that “the 15 years of exclusivity referred to in recital (9) is made up 
of  (a)  the  remaining  protection  provided  by  the  patent  once  the  marketing 
authorisation has taken effect and (b) up to a total of an additional five years further 
protection  provided  by  the  SPC  which  takes  effect  once  the  patent  protection  has 
expired”. It further notes that the formula is a calculation of an interval between two 
dates, which calculated duration is applied to the end of the patent term.  

The expiry date of an SPC for which an extension has been granted is 6 months later 
than the earlier of dates (a1) and (b1) above335. 

It  is  possible  for  an  SPC  to  expire  earlier  than  either  of  the  dates  mentioned  in  (a1) 
and (b1) above, but only if the applicant elects to pay some (but not all of) the annual 
fees for the SPC before it comes into effect336. It may also expire early as a result of 
the certificate holder surrendering the SPC.337 

334   MoPP, SPM 13.04. 
335   MoPP, SPM 13.07. 
336   MoPP, SPM 12.02 and SPM 12.03. 
337   MoPP, SPM 14.09-14.12. 

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With  regard  to  the  annual  fees,  the  IPO  provides  the  certificate  holder  with  at  least 
two months’ notice of the date on which the fees are payable338. 

  CALCULATION OF TERMS. RELIEF BEFORE THE IPO FOR MISSED 

DEADLINES 

The  IPO  calculates  the  time  periods  expressed  in  Article  7  in  accordance  with 
Regulation (EEC, Euratom) No 1182/71339. However, those periods may, in theory, be 
subject to a discretionary extension of time (under Rule 108(1), see section 3 above).  

As  discussed  in  section  3  above,  extensions  of  time  do  not  apply  to  the  substantive 
requirements for an SPC application as specified in Article 3 of the Regulations. Thus, 
those  requirements  must  be  satisfied  at  the  time  of  filing  of  the  application.  On  the 
other  hand,  if  documents  as  specified  in  Article  8(d)  of  Regulation  469/2009  are 
absent  at  the  time  of  filing  an  SPC  extension  application,  their  absence  can  be 
corrected as an “irregularity” between filing of the extension application and expiry of 
the unextended SPC. 

As discussed in section 5 above, Rule 108(1) also provides the IPO with the ability to 
extend (at its discretion) any period of time that it sets for responding to objections or 
correcting deficiencies in connection with SPC applications. 

Further,  because  Schedule  4A  makes  Sections  20A  and  20B  of  the  Patents  Act 
applicable  to  SPC  applications,  it  is  at  least  theoretically  possible  to  reinstate  such 
applications  that  have  been  refused  or  deemed  withdrawn  due  to  failure  of  the 
applicant  to  meet  certain  requirements  by  a  deadline  set  by  the  IPO.  Amongst  other 
things,  the  request  for  reinstatement  must  satisfy  the  IPO  that  the  failure  of  the 
applicant to meet certain requirements by the original deadline was “unintentional”. 

The IPO does not grant extensions of time in respect of the period specified for paying 
the  (annual)  fees  necessary  to  bring  the  SPC  into  effect  –  there  is  a  period  of  six 
months after the period when the fees should be paid where they can be paid with a 
penalty  for  late  payment.  This  is  not  an  extension  of  time  as  such,  but  a  statutory 
additional  period  provided  by  paragraph  5(b)  of  Schedule  4A.  The  decision  in  Tulane 
Education  Fund  v  Comptroller  General  of  Patents  [2012]  EWHC  932  (Pat)  concluded 
that, once this additional period has expired, there is no opportunity for the owner to 
restore the SPC, as section 28 of the Patents Act (which allows this for patents on the 
“unintentional” test) is not made applicable to SPCs in Schedule 4A.340. 

There  is  no  set  deadline  by  which  examination  of  an  SPC  application  must  be 
concluded.  Thus,  for  example,  it  is  possible,  but  not  common,  for  examination  of  an 
SPC  application  to  be  concluded  sometime  after  expiry  of  the  basic  patent. 
Nevertheless,  the  practice  of  the  IPO  is  to  prioritise  the  examination  of  SPC 
applications for which the basic patent has expired, or is about to expire341. 

338   MoPP, SPM 12.08. 
339   MoPP, SPM 7.03. 
340   MoPP, SPM 12.14.1. 
341   MoPP, SPM 10.04. 

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United Kingdom 

For  a  certificate  that  has  lapsed  under  Article  14(d)  (i.e.  due  to  withdrawal  of  the 
MA(s)  upon  which  the  certificate  is  based),  the  view  of  the  IPO  is  that  such  a 
certificate automatically takes effect again from the date of a new MA that places the 
product  on  the  market.  The  exception  to  this  general  practice  is  where,  prior  to  the 
date of the new MA, the certificate has also been declared invalid or lapsed on another 
ground342. 

  APPEAL PROCEDURE 

As  discussed  in  section  8  above,  the  applicant  has  the  option  to  request  a  hearing 
before  the  IPO  reaches  an  adverse  decision  in  connection  with  a  SPC  application. 
Whether  or  not  the  applicant  requests  such  a  hearing,  they  have  the  right  to  file  an 
appeal  against  any  adverse  decision  taken  by  the  IPO343.  All  such  appeals  must  be 
filed  at  the  Patents  Court  (which  is  part  of  the  High  Court  of  England  and  Wales), 
within a fixed period (usually 28 days) from the IPO’s decision. 

  ARTICLE 17(2) 

The  IPO  has  not  established  a  bespoke  procedure  for  appeals  under  Article  17(2)  of 
Regulation 1610/96 that are aimed at rectifying the duration of the certificate (where 
the date of the first MA in the Community is incorrect). Nevertheless, in practice, the 
IPO: 

  does not impose any time limit with regard to the filing of such appeals; 
  accepts appeals lodged either by the applicant or by a third party; and 
  publishes (in the Patents Journal) the new expiry date of the SPC if the appeal 

results in a corrected maximum expiry date. 

  ENFORCEMENT OF THE SPC 

The  protection  provided  by  an  SPC  may  be  enforced  by  action  for  infringement  as  if 
the  SPC  were  a  patent.  This  has  the  consequence  that,  in  England  and  Whales,  Rule 
63 of the Civil Procedure Rules dictates that claims for infringement of SPCs must be 
started in either the Patents Court or the Intellectual Property Enterprise Court (IPEC). 
That  rule  does  not  apply  to  proceedings  in  Scotland  or  Northern  Ireland,  where 
different  (local)  courts  have  jurisdiction  to  hear  actions  for  infringement.  If  both 
parties  agree,  it  is  also  possible  for  an  infringement  action  to  be  started  before  the 
Comptroller (see Section 61(3) of the Patents Act), although this has not been used to 
date. 

Paragraph  4(2)  of  Schedule  4A  of  the  Patents  Act  applies  to  SPCs  the  provision 
(Section 69(2) of the Patents Act) that forms the basis of “provisional protection” for 
unpublished  applications.  Thus,  once  a  certificate  has  granted,  the  proprietor  is 
entitled  to  bring  proceedings  for  infringement  in  respect  of  acts  that  “would,  if  the 
certificate  had  been  granted  on  the  date  of  the  publication  of  the  application,  have 

342   MoPP, SPM 14.06. 
343   MoPP, SPM 10.17. 

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infringed  not  only  the  certificate  as  granted  but  also  the  certificate  for  which  the 
application  was  made”.  By  virtue  of  Paragraph  1(1)(b)(ii)  of  Schedule  4A,  similar 
rights apply to applications for SPC extensions. 

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Study on the Legal Aspects of 
Supplementary Protection 
Certificates in the EU 

Annex I: National Reports EU 

DOI:10.2873/419320