Proposal for a Regulation (EC) No …/... of the European Parliament and of the Council of […] concerning the supplementary protection certificate for medicinal products (Codified version)
Date: 2008-06-17
Institutions: European Commission
Subjects: administrative formalities, codification of EU law, enlargement of the Union, market approval, medicinal product, pharmaceutical legislation

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 17.6.2008 
COM(2008) 369 final 

2008/0126 (COD) 

Proposal for a 

REGULATION (EC) No …/... OF THE EUROPEAN PARLIAMENT AND OF THE 
COUNCIL 

of […] 

concerning the supplementary protection certificate for medicinal products 

(Codified version) 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

In  the  context  of  a  people’s  Europe,  the  Commission  attaches  great  importance  to 
simplifying  and  clarifying  Community  law  so  as  to  make  it  clearer  and  more 
accessible to the ordinary citizen, thus giving him new opportunities and the chance 
to make use of the specific rights it gives him. 

This aim cannot be achieved so long as numerous provisions that have been amended 
several times, often quite substantially, remain scattered, so that they must be sought 
partly  in  the  original  instrument  and  partly  in  later  amending  ones.  Considerable 
research work, comparing many different instruments, is thus needed to identify the 
current rules. 

For  this  reason  a  codification  of  rules  that  have  frequently  been  amended  is  also 
essential if Community law is to be clear and transparent. 

On  1  April  1987  the  Commission  therefore  decided1  to  instruct  its  staff  that  all 
legislative acts should be codified after no more than ten amendments, stressing that 
this  is  a  minimum  requirement  and  that  departments  should  endeavour  to  codify  at 
even  shorter  intervals  the  texts  for  which  they  are  responsible,  to  ensure  that  the 
Community rules are clear and readily understandable. 

The  Conclusions  of 
the  Edinburgh  European  Council 
(December 1992) confirmed this2 stressing the importance of codification as it offers 
certainty as to the law applicable to a given matter at a given time. 

the  Presidency  of 

Codification  must  be  undertaken  in  full  compliance  with  the  normal  Community 
legislative procedure. 

Given  that  no  changes  of  substance  may  be  made  to  the  instruments  affected  by 
codification, the European Parliament, the Council and the Commission have agreed, 
by  an  interinstitutional  agreement  dated  20  December  1994,  that  an  accelerated 
procedure may be used for the fast-track adoption of codification instruments. 

is 

this  proposal 

to  undertake  a  codification  of  Council 
The  purpose  of 
Regulation (EEC)  No  1768/92  of  18  June  1992  concerning  the  creation  of  a 
supplementary  protection  certificate  for  medicinal  products.3  The  new  Regulation 
will supersede the various acts incorporated into it;4 this proposal fully preserves the 
content of the acts being codified and hence does no more than bring them together 
with only such formal amendments as are required by the codification exercise itself. 

COM(87) 868 PV. 
See Annex 3 to Part A of the Conclusions. 
Carried out pursuant to the Communication from the Commission to the European Parliament and the 
Council – Codification of the Acquis communautaire, COM(2001) 645 final. 
Annex I to this proposal. 

1. 

2. 

3. 

4. 

1 
2 
3 

4 

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5. 

The codification proposal was drawn up on the basis of a preliminary consolidation, 
in  all  official  languages,  of  Regulation  (EEC)  No  1768/92  and  the  instruments 
amending  it,  carried  out  by  the  Office  for  Official  Publications  of  the  European 
Communities, by means of a data-processing system. Where the Articles have been 
given new numbers, the correlation between the old and the new numbers is shown 
in a table set out in Annex II to the codified Regulation. 

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(cid:208) 1768/92 (adapted) 

2008/0126 (COD) 

Proposal for a 

REGULATION (EC) No …/... OF THE EUROPEAN PARLIAMENT AND OF THE 
COUNCIL 

of […] 

concerning ⌦ the ⌫ supplementary protection certificate for medicinal products 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article ⌦ 95 ⌫ thereof, 

Having regard to the proposal from the Commission, 

Having regard to the opinion of the European Economic and Social Committee1, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty2, 

Whereas: 

(1) 

Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a 
supplementary  protection  certificate  for  medicinal  products3  has  been  substantially 
amended several times4. In the interests of clarity and rationality the said Regulation 
should be codified. 

(cid:208)  

(2) 

Pharmaceutical research plays a decisive role in the continuing improvement in public 
health. 

(cid:208) 1768/92 Recital 1 

1 
2 
3 

4 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ  L  182,  2.7.1992,  p.  1.  Regulation  as  last  amended  by  Regulation  (EC)  No  1901/2006  of  the 
European Parliament and of the Council (OJ L 378, 27.12.2006, p. 1). 
See Annex I. 

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(3)  Medicinal products, especially those that are the result of long, costly research will not 
continue to be developed in the Community and in Europe unless they are covered by 
favourable rules that provide for sufficient protection to encourage such research. 

(cid:208) 1768/92 Recital 2 

(4) 

At the moment ⌦ , ⌫ the period that elapses between the filing of an application for 
a patent for a new medicinal product and authorisation to place the medicinal product 
on the market makes the period of effective protection under the patent insufficient to 
cover the investment put into the research. 

(cid:208) 1768/92 Recital 3 (adapted) 

(5) 

This situation leads to a lack of protection which penalises pharmaceutical research. 

(cid:208) 1768/92 Recital 4 

(6)  ⌦ There  exists ⌫  the  risk  of  research  centres  situated  in  the  Member  States 

relocating to countries that offer greater protection. 

(cid:208) 1768/92 Recital 5 (adapted) 

(7) 

(8) 

(9) 

(cid:208) 1768/92 Recital 6 (adapted) 

A uniform solution at Community level should be provided for, thereby preventing the 
heterogeneous development of national laws leading to further disparities which would 
be  likely  to  create  obstacles  to  the  free  movement  of  medicinal  products  within  the 
Community and thus directly affect the functioning of the internal market. 

(cid:208) 1768/92 Recital 7 (adapted) 

Therefore,  the  ⌦ provision ⌫  of  a  supplementary  protection  certificate  granted, 
under the same conditions, by each of the Member States at the request of the holder 
of a national or European patent relating to a medicinal product for which marketing 
authorisation  has  been  granted  is  necessary.  A  Regulation  is  therefore  the  most 
appropriate legal instrument. 

(cid:208) 1768/92 Recital 8 (adapted) 

The duration of the protection granted by the certificate should be such as to provide 
adequate  effective  protection.  For  this  purpose,  the  holder  of  both  a  patent  and  a 
certificate  should  be  able  to  enjoy  an  overall  maximum  of  fifteen  years  of 
⌦ exclusivity ⌫  from  the  time  the  medicinal  product  in  question  first  obtains 
authorisation to be placed on the market in the Community. 

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(cid:208) 1768/92 Recital 9 

(10)  All the interests at stake, including those of public health, in a sector as complex and 
sensitive as the pharmaceutical sector must nevertheless be taken into account. For this 
purpose,  the  certificate  cannot  be  granted  for  a  period  exceeding  five  years.  The 
protection  granted  should  furthermore  be  strictly  confined  to  the  product  which 
obtained authorisation to be placed on the market as a medicinal product. 

(11)  Provision should be made for appropriate limitation of the duration of the certificate in 
the  special  case  where  a  patent  term  has  already  been  extended  under  a  specific 
national law, 

(cid:208) 1768/92 Recital 13 

HAVE ADOPTED THIS REGULATION: 

(cid:208) 1768/92 (adapted) 

Article 1 

Definitions 

For the purposes of this Regulation ⌦ , the following definitions shall apply ⌫: 

(a) 

(b) 

(c) 

‘medicinal product’ means any substance or combination of substances presented for 
treating  or  preventing  disease  in  human  beings  or  animals  and  any  substance  or 
combination of substances which may be administered to human beings or animals 
with a view to making a medical diagnosis or to restoring, correcting or modifying 
physiological functions in humans or in animals; 

‘product’  means  the  active  ingredient  or  combination  of  active  ingredients  of  a 
medicinal product; 

‘basic patent’ means a patent which protects a product as defined in point (b) as such, 
a process to obtain a product or an application of a product, and which is designated 
by its holder for the purpose of the procedure for grant of a certificate; 

(d) 

‘certificate’ means the supplementary protection certificate; 

(cid:208) 1901/2006 Art. 52, pt. 1) 
(adapted) 

(e) 

‘application for an extension of the duration’ means an application for an extension 
of the duration of the certificate pursuant to Article 13(3) of this Regulation and of 
Article 36 of Regulation (EC) No 1901/2006 of the European Parliament and of the 
Council5. 

5 

OJ L 378, 27.12.2006, p. 1. 

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(cid:208) 1768/92 

Article 2 

Scope 

(cid:208) 1768/92 (adapted) 

Any  product  protected  by  a  patent  in  the  territory  of  a  Member  State  and  subject,  prior  to 
being  placed  on  the  market  as  a  medicinal  product,  to  an  administrative  authorisation 
procedure  as  laid  down  in  Directive ⌦ 2001/83/EC  of  the  European  Parliament  and  of  the 
Council ⌫6 or Directive ⌦ 2001/82/EC of the European Parliament and of the Council ⌫7 
may,  under  the  terms  and  conditions  provided  for  in  this  Regulation,  be  the  subject  of  a 
certificate. 

(cid:208) 1768/92 

Article 3 

Conditions for obtaining a certificate 

A certificate shall be granted if, in the Member State in which the application referred to in 
Article 7 is submitted and at the date of that application: 

(a) 

the product is protected by a basic patent in force; 

(b) 

(c) 

(d) 

a valid authorisation to place the product on the market as a medicinal product has 
been  granted  in  accordance  with  Directive  ⌦ 2001/83/EC ⌫  or  Directive 
⌦ 2001/82/EC ⌫, as appropriate; 

(cid:208) 1768/92 (adapted) 

the product has not already been the subject of a certificate; 

(cid:208) 1768/92 

the authorisation referred to in point (b) is the first authorisation to place the product 
on the market as a medicinal product. 

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OJ ⌦ L 311 ⌫, ⌦ 28.11.2001 ⌫, p. ⌦ 67 ⌫.  
OJ L ⌦ 311 ⌫ , ⌦ 28.11.2001 ⌫, p. 1.  

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Article 4 

Subject-matter of protection 

Within the limits of the protection conferred by the basic patent, the protection conferred by a 
certificate  shall  extend  only  to  the  product  covered  by  the  authorisation  to  place  the 
corresponding medicinal product on the market and for any use of the product as a medicinal 
product that has been authorised before the expiry of the certificate. 

Article 5 

Effects of the certificate 

Subject to the provisions of Article 4, 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. 

Article 6 

Entitlement to the certificate 

The certificate shall be granted to the holder of the basic patent or his successor in title. 

Article 7 

Application for a certificate 

1. The application for a certificate shall be lodged within six 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. 

2. Notwithstanding paragraph 1, where the authorisation to place the product on the market is 
granted  before  the  basic  patent  is  granted,  the  application  for  a  certificate  shall  be  lodged 
within six months of the date on which the patent is granted. 

(cid:208) 1901/2006 Art. 52, pt. 2 
(adapted) 

3. The application for an extension of the duration may be made when lodging the application 
for  a  certificate  or  when  the  application  for  the  certificate  is  pending  and  the  appropriate 
requirements of Article 8(1)(d) or ⌦ Article ⌫ 8(2), respectively, are fulfilled. 

4.  The  application  for  an  extension  of  the  duration  of  a  certificate  already  granted  shall  be 
lodged not later than two years before the expiry of the certificate. 

5.  Notwithstanding  paragraph  4,  for  five  years  following  the  entry  into  force  of 
Regulation (EC)  No  1901/2006,  the  application  for  an  extension  of  the  duration  of  a 
certificate already granted shall be lodged not later than six months before the expiry of the 
certificate. 

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(cid:208) 1768/92 

Article 8 

Content of the application for a certificate 

1. The application for a certificate shall contain: 

(a) 

a request for the grant of a certificate, stating in particular: 

(i) 

the name and address of the applicant; 

(ii) 

if  he  has  appointed  a  representative,  the  name  and  address  of  the 
representative; 

(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,  as  referred  to  in  Article  3(b)  and,  if  this  authorisation  is  not  the  first 
authorisation  for  placing  the  product  on  the  market  in  the  Community,  the 
number and date of that authorisation; 

(cid:208) 1768/92 (adapted) 

a  copy  of  the  authorisation  to  place  the  product  on  the  market,  as  referred  to  in 
Article 3(b), in which the product is identified, containing in particular the number 
and date of the authorisation and the summary of the product characteristics listed in 
Article  ⌦ 11 ⌫  of  Directive  ⌦ 2001/83/EC ⌫  or  Article  ⌦ 14 ⌫  of 
Directive ⌦ 2001/82/EC ⌫; 

(cid:208) 1768/92 

if the authorisation referred to in point (b) is not the first authorisation for placing the 
product  on  the  market  as  a  medicinal  product  in  the  Community,  information 
regarding  the  identity  of  the  product  thus  authorised  and  the  legal  provision  under 
which  the  authorisation  procedure  took  place,  together  with  a  copy  of  the  notice 
publishing the authorisation in the appropriate official publication. 

(b) 

(c) 

d) 

where  the  application  for  a  certificate  includes  a  request  for  an  extension  of  the 
duration: 

(cid:208) 1901/2006 Art. 52, pt. (3)(a) 

(i) 

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; 

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(ii)  where  necessary,  in  addition  to  the  copy  of  the  authorisations  to  place  the 
product on the market as referred to in point (b), proof that it has authorisations 
to place the product on the market of all other Member States, as referred to in 
Article 36(3) of Regulation (EC) No 1901/2006. 

(cid:208) 1901/2006 Art. 52, pt. (3)(b) 

2. Where an application for a certificate is pending, an application for an extended duration in 
accordance with Article 7(3) shall include the particulars referred to in paragraph 1(d) of this 
Article and a reference to the application for a certificate already filed. 

3.  The  application  for  an  extension  of  the  duration  of  a  certificate  already  granted  shall 
contain  the  particulars  referred  to  in  paragraph  1(d)  and  a  copy  of  the  certificate  already 
granted. 

4 Member States may provide that a fee is to be payable upon application for a certificate and 
upon application for the extension of the duration of a certificate. 

(cid:208) 1901/2006 Art. 52, pt. (3)(c) 

(cid:208) 1768/92 

Article 9 

Lodging of an application for a certificate 

1.  The  application  for  a  certificate  shall  be  lodged  with  the  competent  industrial  property 
office of the Member State which granted the basic patent or on whose behalf it was granted 
and in which the authorisation referred to in Article 3(b) to place the product on the market 
was obtained, unless the Member State designates another authority for the purpose. 

The  application  for  an  extension  of  the  duration  of  a  certificate  shall  be  lodged  with  the 
competent authority of the Member State concerned. 

(cid:208) 1901/2006 Art. 52, pt. (4)(a) 

2. Notification of the application for a certificate shall be published by the authority referred 
to in paragraph 1. The notification shall contain at least the following information: 

(cid:208) 1768/92 

(a) 

(b) 

(c) 

(d) 

the name and address of the applicant; 

the number of the basic patent; 

the title of the invention; 

the number and date of the authorisation to place the product on the market, referred 
to in Article 3(b), and the product identified in that authorisation; 

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(e) 

where relevant, the number and date of the first authorisation to place the product on 
the market in the Community; 

(f) 

where  applicable,  an  indication  that  the  application  includes  an  application  for  an 
extension of the duration. 

(cid:208) 1901/2006 Art. 52, pt. (4)(b) 

3.  Paragraph  2  shall  apply  to  the  notification  of  the  application  for  an  extension  of  the 
duration of a certificate already granted or where an application for a certificate is pending. 
The  notification  shall  additionally  contain  an  indication  of  the  application  for  an  extended 
duration of the certificate. 

(cid:208) 1901/2006 Art. 52, pt. (4)(c) 

(cid:208) 1768/92 (adapted) 

Article 10 

Grant of the certificate or rejection of the application ⌦ for a certificate ⌫ 

1.  Where  the  application  for  a  certificate  and  the  product  to  which  it  relates  meet  the 
conditions laid down in this Regulation, the authority referred to in Article 9(1) shall grant the 
certificate. 

2. The authority referred to in Article 9(1) shall, subject to paragraph 3, reject the application 
for  a  certificate  if  the  application  or  the  product  to  which  it  relates  does  not  meet  the 
conditions laid down in this Regulation. 

3. Where the application for a certificate does not meet the conditions laid down in Article 8, 
the authority referred to in Article 9(1) shall ask the applicant to rectify the irregularity, or to 
settle the fee, within a stated time. 

4. If the irregularity is not rectified or the fee is not settled under paragraph 3 within the stated 
time, the authority shall reject the application. 

5.  Member  States  may  provide  that  the  authority  referred  to  in  Article  9(1)  is  to  grant 
certificates without verifying that the conditions laid down in Article 3(c) and (d) are met. 

6.  Paragraphs  1  to  4  shall  apply  mutatis  mutandis  to  the  application  for  an  extension  of  the 
duration. 

(cid:208) 1901/2006 Art. 52, pt. (5) 

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(cid:208) 1768/92 

Article 11 

Publication 

1.  Notification  of  the  fact  that  a  certificate  has  been  granted  shall  be  published  by  the 
authority  referred  to  in  Article  9(1).  The  notification  shall  contain  at  least  the  following 
information: 

(a) 

(b) 

(c) 

(d) 

(e) 

the name and address of the holder of the certificate; 

the number of the basic patent; 

the title of the invention; 

the number and date of the authorisation to place the product on the market referred 
to in Article 3(b) and the product identified in that authorisation; 

where relevant, the number and date of the first authorisation to place the product on 
the market in the Community; 

(f) 

the duration of the certificate. 

2.  Notification  of  the  fact  that  the  application  for  a  certificate  has  been  rejected  shall  be 
published by the authority referred to in Article 9(1). The notification shall contain at least the 
information listed in Article 9(2). 

3.  Paragraphs  1  and  2  shall  apply  to  the  notification  of  the  fact  that  an  extension  of  the 
duration of a certificate has been granted or of the fact that the application for an extension 
has been rejected. 

(cid:208) 1901/2006 Art. 52, pt. (6) 

(cid:208) 1768/92 (adapted) 

Article 12 

Annual fees 

Member States may require that the certificate be subject to the payment of annual fees. 

Article 13 

Duration of the certificate 

1. The certificate shall take 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 

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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. 

2. Notwithstanding paragraph 1, the duration of the certificate may not exceed five years from 
the date on which it takes effect. 

3. The periods laid down in paragraphs 1 and 2 shall be extended by six months in the case 
where Article 36 of Regulation (EC) No 1901/2006 applies. In that case, the duration of the 
period laid down in paragraph 1 of this Article may be extended only once. 

(cid:208) 1901/2006 Art. 52, pt. (7) 

⌦ 4.Where  a  certificate  is  granted  for  a  product  protected  by  a  patent  which,  before  the 
2 January 1993, has had its term extended or for which such extension was applied for, under 
national  patent  law,  the  term  of  protection  to  be  afforded  under  this  certificate  shall  be 
reduced by the number of years by which the term of the patent exceeds 20 years. ⌫ 

(cid:208) 1768/92 (adapted) 

(cid:208) 1768/92 

Article 14 

Expiry of the certificate 

The certificate shall lapse: 

(a) 

(b) 

(c) 

(d) 

at the end of the period provided for in Article 13; 

if the certificate-holder surrenders it; 

if the annual fee laid down in accordance with Article 12 is not paid in time; 

(cid:208) 1768/92 (adapted) 

if and as long as the product covered by the certificate may no longer be placed on 
the  appropriate  authorisation  or 
the  market  following 
authorisations 
with 
Directive ⌦ 2001/83/EC ⌫  or  Directive  ⌦ 2001/82/EC ⌫.  The  authority 
referred to in Article 9(1) of this Regulation may decide on the lapse of the certificate 
either of its own motion or at the request of a third party. 

the  withdrawal  of 

the  market 

accordance 

place 

on 

in 

to 

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(cid:208) 1768/92 (adapted) 

Article 15 

Invalidity of the certificate 

1. The certificate shall be invalid if: 

(a) 

(b) 

(c) 

it was granted contrary to the provisions of Article 3; 

the basic patent has lapsed before its lawful term expires; 

the  basic  patent  is  revoked  or  limited  to  the  extent  that  the  product  for  which  the 
certificate was granted would no longer be protected by the claims of the basic patent 
or, after the basic patent has expired, grounds for revocation exist which would have 
justified such revocation or limitation. 

2. Any person may submit an application or bring an action for a declaration of invalidity of 
the certificate before the body responsible under national law for the ⌦ revocation ⌫ of the 
corresponding basic patent. 

(cid:208) 1901/2006 Art. 52, pt. (8) 

Article 16 

Revocation of an extension of the duration 

1. The extension of the duration may be revoked if it was granted contrary to the provisions of 
Article 36 of Regulation (EC) No 1901/2006. 

2. Any person may submit an application for revocation of the extension of the duration to the 
body responsible under national law for the revocation of the corresponding basic patent. 

(cid:208) 1768/92 
(cid:206)1 1901/2006 Art. 52, pt. (9)(a) 

Article 17 

Notification of lapse or invalidity 

(cid:206)1 1.  If the certificate lapses in accordance with Article 14(b), (c) or (d), or is invalid in 
accordance with Article 15, notification thereof shall be published by the authority referred to 
in Article 9(1). 

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2.  If  the  extension  of  the  duration  is  revoked  in  accordance  with  Article  16,  notification 
thereof shall be published by the authority referred to in Article 9(1). 

(cid:208) 1901/2006 Art. 52, pt. (9)(b) 
(adapted) 

(cid:208) 1901/2006 Art. 52, pt. (10) 

Article 18 

Appeals 

The  decisions  of  the  authority  referred  to  in  Article  9(1)  or  of  the  bodies  referred  to  in 
Articles 15(2)  and  16(2)  taken  under  this  Regulation  shall  be  open  to  the  same  appeals  as 
those  provided  for  in  national  law  against  similar  decisions  taken  in  respect  of  national 
patents. 

(cid:208) 1768/92 

Article 19 

Procedure 

1.  In  the  absence  of  procedural  provisions  in  this  Regulation,  the  procedural  provisions 
applicable under national law to the corresponding basic patent shall apply to the certificate, 
unless that law lays down special procedural provisions for certificates. 

2. Notwithstanding paragraph 1, the procedure for opposition to the granting of a certificate 
shall be excluded. 

(cid:208) 2003 Act of Accession Art. 20 
and Annex II pt. 4.C.II.1.(a), 
p. 342 (adapted) 

Article 20 

Additional provisions relating to the enlargement of the Community 

Without  prejudice  to  the  other  provisions  of  this  Regulation,  the  following provisions shall 
apply: 

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(cid:208) 2003 Act of Accession Art. 20 
and Annex II, pt. 4.C.II.1.(a), 
p. 342 (adapted) 

(a)  ⌦ any  medicinal  product  protected  by  a  valid  basic  patent  in  the  Czech  Republic 
and for which the first authorisation to place it on the market as a medicinal product 
was obtained: ⌫ 

(i)  ⌦ in  the  Czech  Republic,  after  10  November  1999,  may  be  granted  a 
certificate, provided that the application for a certificate was lodged within six 
months of the date on which the first market authorisation was obtained; ⌫ 

(ii)  ⌦ in the Community, not earlier than six months prior to 1 May 2004, may be 
granted a certificate, provided that the application for a certificate was lodged 
within  six  months  of  the  date  on  which  the  first  market  authorisation  was 
obtained; ⌫ 

(b) 

any  medicinal  product  protected  by  a  valid  basic  patent  and  for  which  the  first 
authorisation to place it on the market as a medicinal product was obtained in Estonia 
prior  to  ⌦ 1  May  2004 ⌫  may  be  granted  a  certificate,  provided  that  the 
application for a certificate was lodged within six months of the date on which the 
first market authorisation was obtained or, in the case of those patents granted prior 
to  1  January  2000,  within  the  six  months  provided  for  in  the  Patents  Act  of 
October 1999; 

(c)  ⌦ any ⌫ medicinal product protected by a valid basic patent and for which the first 
authorisation to place it on the market as a medicinal product was obtained in Cyprus 
prior  to  ⌦ 1  May  2004 ⌫  may  be  granted  a  certificate,  provided  that  the 
application for a certificate was lodged within six months of the date on which the 
first market authorisation was obtained; notwithstanding the above, where the market 
authorisation was obtained before the grant of the basic patent, the application for a 
certificate  must  be  lodged  within  six  months  of  the  date  on  which  the  patent  was 
granted; 

(d) 

(e) 

(f) 

any  medicinal  product  protected  by  a  valid  basic  patent  and  for  which  the  first 
authorisation to place it on the market as a medicinal product was obtained in Latvia 
prior to ⌦ 1 May 2004 ⌫ may be granted a certificate. In cases where the period 
provided for in Article 7(1) has expired, the possibility of applying for a certificate 
shall be open for a period of six months starting no later than ⌦ 1 May 2004 ⌫; 

any  medicinal  product  protected  by  a  valid  basic  patent  applied  for  after 
1 February 1994 and for which the first authorisation to place it on the market as a 
medicinal  product  was  obtained  in  Lithuania  prior  to  ⌦ 1  May  2004 ⌫  may  be 
granted  a  certificate,  provided  that  the  application  for  a  certificate  is  lodged  within 
six months ⌦ from 1 May 2004 ⌫; 

any  medicinal  product  protected  by  a  valid  basic  patent  and  for  which  the  first 
authorisation  to  place  it  on  the  market  as  a  medicinal  product  was  obtained  after 
1 January 2000 may be granted a certificate in Hungary, provided that the application 
for a certificate is lodged within six months ⌦ from 1 May 2004 ⌫; 

EN 

16 

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(g) 

(h) 

(i) 

(j) 

(k) 

(l) 

any  medicinal  product  protected  by  a  valid  basic  patent  and  for  which  the  first 
authorisation to place it on the market as a medicinal product was obtained in Malta 
prior to ⌦ 1 May 2004 ⌫ may be granted a certificate. In cases where the period 
provided for in Article 7(1) has expired, the possibility of applying for a certificate 
shall be open for a period of six months starting no later than ⌦ 1 May 2004 ⌫; 

any  medicinal  product  protected  by  a  valid  basic  patent  and  for  which  the  first 
authorisation  to  place  it  on  the  market  as  a  medicinal  product  was  obtained  after 
1 January 2000 may be granted a certificate in Poland, provided that the application 
for  a  certificate 
than 
⌦ 1 May 2004 ⌫; 

lodged  within  six  months  starting  no 

later 

is 

any  medicinal  product  protected  by  a  valid  basic  patent  and  for  which  the  first 
authorisation  to  place  it  on  the  market  as  a  medicinal  product  was  obtained  in 
Slovenia prior to ⌦ 1 May 2004 ⌫ may be granted a certificate, provided that the 
application  for  a  certificate  is  lodged  within  six  months  ⌦ from  1  May  2004 ⌫, 
including in cases where the period provided for in Article 7(1) has expired; 

(cid:208) Act of Accession of 2003 
Art. 20 and Annex II, pt. 
4.C.II.1.(a), p. 342 

any  medicinal  product  protected  by  a  valid  basic  patent  and  for  which  the  first 
authorisation  to  place  it  on  the  market  as  a  medicinal  product  was  obtained  in 
Slovakia  after  1  January  2000  may  be  granted  a  certificate,  provided  that  the 
application for a certificate was lodged within six months of the date on which the 
first  market  authorisation  was  obtained  or  within  six  months  of  1  July  2002  if  the 
market authorisation was obtained before that date; 

(cid:208) 2005 Act of Accession Art. 16 
and Annex III, pt 1 II.1(a) 
(adapted) 

any  medicinal  product  protected  by  a  valid  basic  patent  and  for  which  the  first 
authorisation  to  place  it  on  the  market  as  a  medicinal  product  was  obtained  after  1 
January 2000 may be granted a certificate in Bulgaria, provided that the application 
for a certificate is lodged within six months ⌦ from 1 January 2007 ⌫; 

any  medicinal  product  protected  by  a  valid  basic  patent  and  for  which  the  first 
authorisation  to  place  it  on  the  market  as  a  medicinal  product  was  obtained  after  1 
January  2000  may  be  granted  a  certificate  in  Romania.  In  cases  where  the  period 
provided for in Article 7(1) has expired, the possibility of applying for a certificate 
shall be open for a period of six months starting no later than ⌦ 1 January 2007 ⌫. 

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(cid:208) 1768/92 (adapted) 
(cid:206)1 2003 Act of Accession Art. 20 
and Annex II, pt. 4.C.II.1(b) p. 342 

Article 21 

⌦ Transitory provisions ⌫ 

(cid:206)1 1.   This  Regulation  shall  not  apply  to  certificates  granted  in  accordance  with  the 
national legislation of a Member State before ⌦ 2 January 1993 ⌫ or to applications for a 
certificate filed in accordance with that legislation before ⌦ 2 July 1992 ⌫. 

(cid:208) 1994 Act of Accession Art. 29 
and Annex I, XI.F.I(c) p. 233 
(adapted) 

With  regard  to  Austria,  Finland  and  Sweden,  this  Regulation  shall  not  apply  to  certificates 
granted in accordance with their national legislation before . ⌦ 1January 1995 ⌫ 

(cid:208) 2005 Act of Accession Art. 16 
and Annex III, pt.1 II.1(b) 
(adapted) 

2. This Regulation shall apply to supplementary protection certificates granted in accordance 
with the national legislation of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Malta, 
Poland,  Slovenia  and  Slovakia  prior  to  ⌦ 1  May  2004  and  the  national  legislation  of 
Romania prior to 1 January 2007 ⌫. 

(cid:208)  

Article 22 

Repeal 

Regulation (EEC) No 1768/92 is repealed. 

References to the repealed Regulation shall be construed as references to this Regulation and 
shall be read in accordance with the correlation table in Annex II. 

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(cid:208) 1768/92 (adapted) 

Article 23 

Entry into force 

This  Regulation  shall  enter  into  force  ⌦ on  the  twentieth  day  following  that  of ⌫  its 
publication in the Official Journal of the European ⌦ Union ⌫ . 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels, […] 

For the European Parliament 
The President 
[…] 

For the Council 
The President 
[…]

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(cid:207) 

ANNEX I 

Repealed Regulation with list of its successive amendments 

Council Regulation (EEC) No 1768/92 
(OJ L 182, 2.7.1992, p. 1) 

Annex I, point XI.F.I, of the 1994 Act of Accession 
(OJ C 241, 29.8.1994, p. 233) 

Annex II, point 4.C.II, of the 2003 Act of Accession 
(OJ L 236, 23.9.2003, p. 342) 

Annex III, point 1.II, of the 2005 Act of Accession 
(OJ L 157, 21.6.2005, p. 56) 

Regulation (EC) No 1901/2006 of the European 
Parliament and of the Council 
(OJ L 378, 27.12.2006, p. 1) 

Only Article 52 

_____________ 

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ANNEX II 

CORRELATION TABLE 

Regulation (EEC) No 1768/92 

This Regulation 

Article 1 

Article 2 

Article 1 

Article 2 

Article 3, introductory words 

Article 3, introductory words 

Article 3(a) 

Article 3(b), first sentence 

Article 3(a) 

Article 3(b) 

Article 3(b), second sentence 

— 

Article 3(c) and (d) 

Article 3(c) and (d) 

Articles 4 to 7 

Article 8(1) 

Article 8(1a) 

Article 8(1b) 

Article 8(2) 

Articles 9 to 12 

Articles 4 to 7 

Article 8(1) 

Article 8(2) 

Article 8(3) 

Article 8(4) 

Articles 9 to 12 

Article 13(1), (2) and (3) 

Article 13(1), (2) and (3) 

Articles 14 and 15 

Articles 14 and 15 

Article 15a 

Article 16 

Articles 16, 17 and 18 

Articles 17, 18 and 19 

Article 19 

— 

Article  19a,  introductory  words,  point  (a)(i) 
and (ii) 

Article  20,  introductory  words,  point  (a) 
introductory words, and points (i) and (ii) 

Article 19a(b) to (l) 

Article 20(b) to (l) 

Article 20 

Article 21 

Article 22 

EN 

Article 21 

— 

Article 13(4) 

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— 

Article 23 

— 

— 

Article 22 

Article 23 

Annex I 

Annex II 

_____________ 

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