Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL implementing enhanced cooperation in the area of the creation of unitary patent protection
Date: 2011-04-13
Institutions: European Commission
Subjects: European cooperation, European patent, approximation of laws, intellectual property, patent law

EUROPEAN COMMISSION 

Brussels, 13.4.2011 
COM(2011) 215 final 

2011/0093 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

implementing enhanced cooperation in the area of the creation of unitary patent 
protection 

{COM(2011) 216 final} 
{SEC(2011) 482 final} 
{SEC(2011) 483 final}

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

1.1. 

History of the proposal 

In  the  European  Union  (EU),  patent  protection  currently  can  be  obtained  either  through  the 
national  patent  offices  of  the  Member  States,  which  grant  national  patents,  or  through  the 
European Patent Office (EPO) in the framework of the European Patent Convention (EPC)1. 
However, once a European patent is granted by the EPO, it must be validated in each Member 
State  where  protection  is  sought.  For  a  European  patent  to  be  validated  in  a  territory  of  a 
Member State, national law may inter alia require that the patent proprietor files a translation 
of the European patent into the official language of that Member State2. Therefore, the current 
patent system in the EU, in particular in terms of translation requirements, involves very high 
costs  and  complexity.  The  overall  cost  of  validation  of  an  average  European  patent  reaches 
12 500 EUR if validated only in 13 Member States and over 32 000 EUR if validated in the 
whole EU. It is estimated that the actual validation costs are around 193 million EUR per year 
in the EU. 

Both  the  Europe  2020  Strategy3  and  the  Single  Market  Act4  identified  the  creation  of  an 
economy based on knowledge and innovation as a priority. Both initiatives seek to improve 
the framework conditions for business to innovate by creating unitary patent protection in the 
EU Member States together with a unified European patent litigation system.  

Despite of broad recognition of the competitive disadvantage European business faces in the 
absence of unitary patent protection, the Union has not been able to establish unitary patent 
protection. The Commission first proposed a Council Regulation on the Community patent in 
August 20005. In 2002, the European Parliament adopted a Legislative Resolution6. In 2003, 
the  Council  adopted  a  common  political  approach7,  but  a  final  agreement  could  not  be 
reached.  Discussions  on  the  proposal  were  re-launched  in  the  Council  after  adoption  by  the 
Commission of the Communication "Enhancing the patent system in Europe" in April 20078. 
The Communication confirmed the commitment to the creation of a single Community patent.  

The  Lisbon  Treaty  introduced  a  more  specific  legal  basis  for  the  creation  of  European 
intellectual property rights. According to Article 118(1) of the Treaty on the Functioning of 
the  European  Union  (TFEU),  measures  for  the  creation  of  European  intellectual  property 
rights  are  to  be  established  by  the  European  Parliament  and  the  Council  acting  under  the 
ordinary legislative procedure. Article 118(2) TFEU, however, sets out a specific legal basis 

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http://www.epo.org  
In  order  to  reduce  the  costs  caused  by  validation  requirements,  in  2000  the  EPC  Contracting  States 
adopted the so-called "London Agreement" (Agreement on the application of Article 65 EPC, OJ EPO 
2001, 550) which is currently in force in eleven EU Member States and results in reduced translation 
requirements. 
COM(2010) 2020. 
COM(2010) 608 final/2. 
COM(2000) 412. 
European Parliament legislative resolution on the proposal for a Council regulation on the Community 
patent (COM(2000) 412 - C5-0461/2000 - 2000/0177(CNS)) (OJ C 127 E, 29.5.2003, p. 519–526). 
Council document 7159/03. 
COM(2007) 165. 

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for  the  language  arrangements  for  European  intellectual  property  rights,  which  are  to  be 
established  under  a  special  legislative  procedure  by  the  Council  acting  unanimously  after 
consulting  the  European  Parliament.  Therefore,  the  translation  arrangements  for  any  unitary 
patent system in the EU must be established by a separate regulation. 

In  December  2009,  the  Council  adopted  conclusions  on  an  "Enhanced  patent  system  for 
Europe"9  and  a  general  approach  on  the  proposal  for  a  Regulation  on  the  EU  Patent10. 
Translation arrangements, however, were not covered due to  the abovementioned  change in 
the legal basis. 

On  30  June  2010  the  Commission  adopted  a  proposal  for  a  Council  Regulation  on  the 
translation  arrangements  for  the  EU  patent11.  The  proposal  was  accompanied  by  an  Impact 
Assessment  report12  analysing  various  options  for  the  possible  translation  arrangements. 
Regardless of the significant efforts made by the Presidency of the Council, it was recorded at 
the Competitiveness Council meeting of 10 November 2010 that no unanimous agreement on 
the  translation  arrangements  could  be  reached13.  It  was  confirmed  at  the  Competitiveness 
Council  meeting  on  10  December  201014  that  insurmountable  difficulties  existed,  making  a 
decision requiring unanimity impossible now and in the foreseeable future. It follows that the 
objectives  of  the  proposed  Regulations  to  establish  unitary  patent  protection  in  the  entire 
European  Union  can  not  be  attained  within  a  reasonable  period  by  applying  the  relevant 
provisions of the Treaties.  

On  the  basis  of  the  request  of  twelve  Member  States  (Denmark,  Estonia,  Finland,  France, 
Germany, Lithuania, Luxembourg, the Netherlands, Poland, Slovenia, Sweden and the United 
Kingdom)  the  Commission  submitted  a  proposal15  to  the  Council  for  authorising  enhanced 
cooperation  in  the  area  of  unitary  patent  protection.  All  Member  States  specified  in  their 
requests that the Commission's legislative proposals within the enhanced cooperation should 
be  based  on  the  recent  negotiations  in  the  Council.  Following  the  adoption  of  the  proposal, 
Belgium, Austria, Ireland, Portugal, Malta, Bulgaria, Romania, the Czech Republic, Slovakia 
Hungary, Latvia, Greece and Cyprus also requested to join the cooperation. The proposal for 
the  authorising  decision  was  adopted  by  the  Council,  after  obtaining  the  consent  of  the 
European  Parliament,  on  10  March  2011.  The  present  regulation  implements  the  enhanced 
cooperation in the area of the creation of unitary patent protection as authorised by Council 
Decision 2011/167/EU16. 

1.2. 

Legal approach 

In  comparison  to  the  Commission's  proposal  in  2000,  this  proposal  builds  on  the  existing 
system  of  European  patents  by  providing  unitary  effect  to  European  patents  granted  for  the 
territories of the participating Member States. The unitary patent protection will be optional 

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Council document 17229/09. 
Council document 16113/09 Add 1. The terminology changed (from the "Community" to "EU" patent) 
due to the entry into force of the Lisbon Treaty. 
COM(2010) 350. 
SEC(2010) 796. 
Press  Release  of  the  Extraordinary  Council  meeting  "Competitiveness  (Internal  Market,  Industry, 
Research and Space)", 16041/10, 10.11.2010. 
See press release 17668/10. 
COM(2010) 790. 
Council Decision 2011/167/EU of 10 March 2011 authorising enhanced cooperation in the area of the 
creation of unitary patent protection (OJ L 76, 22.3.2011, p. 53). 

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and co-exist with national and European patents. The proprietors of European patents granted 
by the EPO, may submit a request to the EPO within one month after the publication of the 
mention of the grant of the European patent, asking for the registration of the unitary effect. 
Once  it  is  registered,  the  unitary  effect  will  provide  uniform  protection  and  will  have  equal 
effect  throughout  the  territories  of  all  participating  Member  States.  European  patents  with 
unitary  effect  may  only  be  granted,  transferred,  revoked  or  may  lapse  in  respect  of  those 
territories  as  a  whole.  The  participating  Member  States  shall  give  the  task  of  the 
administration of European patents with unitary effect to the EPO. 

2. 

CONSULTATIONS WITH THE INTERESTED PARTIES 

In January 2006, the Commission launched a broad consultation on the future patent policy in 
Europe17.  More  than  2500  replies  were  received  from  a  variety  of  stakeholders,  including 
businesses in all sectors of the economy, business and SME associations, patent practitioners, 
public authorities and academics. Respondents were asking for a European patent system that 
provides  incentives  for  innovation,  ensures  the  diffusion  of  scientific  knowledge,  facilitates 
technology transfer, is available to all players in the market and is legally certain. The replies 
clearly  showed  stakeholders'  disappointment  with  the  lack  of  progress  in  the  Community 
patent project. In particular, nearly all respondents (the users of the patent system) rejected the 
translation  arrangements  included  in  the  Council's  2003  common  political  approach  which 
laid down that the patent holder would have to supply a translation of the claims (having legal 
effect) into all official Community languages.  

Stakeholders  expressed  an  overall  support  for  a  "unitary,  affordable  and  competitive" 
Community  patent.  This  message  was  repeated  at  a  public  hearing  held  on  12  July  2006, 
where  a  large  variety  of  stakeholders  stated  their  support  for  the  creation  of  a  truly  unitary 
high  quality  patent.  They,  however,  underlined  that  political  compromises  should  not 
undermine  the  usefulness  of  the  project.  In  particular,  the  representatives  of  small  and 
medium-sized enterprises (SMEs) highlighted the importance of moderate patenting costs. 

The  issue  of  unitary patent protection  was also addressed extensively in the consultation on 
the Small Business Act for Europe, which consisted of a range of initiatives targeted to help 
European SMEs18. Small and medium-sized businesses identified the high level of patent fees 
and the legal complexity of the patent system as major obstacles19. In their submissions to the 
consultation,  businesses  in  general  and  SME  representatives  in  particular  requested  a 
significant reduction of the costs of patenting for a future unitary patent20. 

Recent  position  papers  from  various  stakeholders  refer  to  the  unitary  patent  protection. 
European  business  associations, such  as BusinessEurope21, UEAPME22 and Eurochambres23 

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The  consultation  document,  replies  from  stakeholders  and  a  report  on  the  preliminary  findings  of  the 
consultation are available at http://ec.europa.eu/internal_market/indprop/patent/consultation_en.htm.  
COM(2008) 394. 
http://ec.europa.eu/enterprise/policies/sme/small-business-act/  
UEAPME  Expectations  on  the  Proposal  for  a  European  Small  Business  Act,  available  at 
www.ueapme.com.  Response  to  the  Consultation  on  a  Small  Business  Act  for  Europe,  available  at 
http://www.eurochambres.eu 
Views on key issues of the patent reform debate in Europe, available at http://www.businesseurope.eu 
Position  on  the  recent  policy  developments  on  the  European  Community  patent,  available  at 
http://www.ueapme.com 
Position paper on the European Patent System, available at http://www.eurochambres.eu 

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confirm that businesses, both large and small, want simplified, cost-effective and accessible 
patent protection. National business organisations in many Member States and across industry 
sectors have raises identical issues24. Stakeholders underlined that any solution for the unitary 
patent protection should build on the existing mechanisms for granting patents in Europe and 
necessitate no revision of the European Patent Convention. 

3. 

IMPACT ASSESSMENT 

This proposal is accompanied by an impact assessment which identifies the main problems in 
the  current  European  patent  system:  (i)  high  costs  related  to  translation  and  publication  of 
European patents, (ii) differences in the maintenance of patents in the Member States (annual 
renewal fees have to be paid each year in each country where the patent is validated); and (iii) 
administrative complexity of registering transfers, licences and other rights related to patents. 
As  a  consequence,  access  to  comprehensive  patent  protection  in  Europe  is  so  costly  and 
complex that it is inaccessible to many inventors and companies. 

The impact assessment analyses the impacts of the following options:  

Option 1 (Base-line scenario) – the Commission takes no action,  

Option  2  –  the  Commission  continues  to  work  with  the  other  institutions  towards  an  EU 
patent covering 27 Member States,  

Option  3  -  the  Commission  presents  proposals  for  regulations  implementing  enhanced 
cooperation: 

Sub-option 3.1 - the Commission proposes translation arrangements applicable in the area of 
unitary patent protection that correspond to its proposal of 30 June 2010, or 

Sub-option 3.2 – the Commission proposes translation arrangements applicable in the area of 
unitary patent protection based on its proposal of 30 June 2010 and incorporating elements of 
a compromise proposal discussed by the Council. 

The  analysis  carried  out  in  the  impact  assessment  has  demonstrated  that  option  3  with  sub-
option 3.2 is the preferred option. 

These  problems  can  only  be  addressed  at  EU  level,  as  without  an  EU  legal  instrument 
Member States would not sufficiently be able to establish legal effects attached to patents that 
are uniform in several Member States. 

4. 

LEGAL ELEMENTS OF THE PROPOSAL 

Council  Decision  2011/167/EU  authorised  the  Member  States  listed  in  its  Article  1  to 
establish enhanced cooperation in the area of the creation of unitary patent protection.  

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Position papers from BDI (Bundesverband der Deutschen Industrie), DIHK (Deutscher Industrie- und 
Handelskammertag),  CBI  (Confederation  of  British  Industries),  CCIP  (Chambre  de  commerce  et 
d'industrie  de  Paris),  CGPME  (Confédération  générale  des  petites  et  moyennes  entreprises), 
Unioncamere,  DigitalEurope,  Orgalime,  ACT  (Association  for  Competitive  Technology),  Cefic  and 
others. 

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Article 118 (1) TFEU provides for the legal basis for creating European intellectual property 
rights  providing  uniform protection throughout  the  Union by  means of a  regulation  adopted 
by  the  European  Parliament  and  the  Council,  acting  in  accordance  with  the  ordinary 
legislative procedure. 

5. 

BUDGETARY IMPLICATIONS 

This proposal has no impact on the Union budget.  

6. 

DETAILED DESCRIPTION 

Article 1 – Subject matter 

This  Article  defines  the  subject-matter  of  this  Regulation  which  implements  the  enhanced 
cooperation  in  the  area  of  the  creation  of  unitary  patent  protection  authorised  by  Council 
Decision  2011/167/EU.  It  is  made  clear  that  this  Regulation  constitutes  a  special  agreement 
within the meaning of Article 142 of the EPC. 

Article 2 - Definitions 

This Article provides for definitions of the main terms used in this Regulation. 

Article 3 - European patent with unitary effect  

This  Article  provides  that  European  patents  may  benefit  from  unitary  effect  in  the 
participating  Member  States  provided  that  their  unitary  effect  has  been  registered  in  the 
Register  for  unitary  patent  protection.  In  addition,  the  main  features  of  the  European  patent 
with unitary effect are laid down: unitary character, providing uniform protection and having 
equal effect in all participating Member States. It follows that, as a general rule, a European 
patent  with  unitary  effect  may  only  be  limited,  licensed,  transferred,  revoked  or  lapse  in 
respect of all the participating Member States. Finally, the unitary effect of a European patent 
shall be deemed not to have arisen to the extent that the European patent has been revoked or 
limited. 

Article 4 - Date of effect  

A European patent with unitary effect shall take effect in the participating Member States on 
the date of the publication by the EPO of the mention of the grant of the European patent. In 
case  unitary  effect  has  been  registered,  it  is  specified  that  the  participating  Member  States 
shall  take  the  necessary  measures  to  ensure  that  a  European  patent  is  deemed  not  to  have 
taken effect as a national patent in their territory on the date of the publication of the mention 
of the grant in the European Patent Bulletin. 

Article 5 - Prior rights  

In the event of limitation or revocation on the ground of lack of novelty pursuant to Article 
54(3)  EPC,  the  limitation  or  revocation  of  a  European  patent  with  unitary  effect  shall  take 
effect only in respect of the participating Member State(s) designated in the earlier European 
patent application as published. 

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Article 6 - Right to prevent the direct use of the invention 

This Article lays down the right of the proprietor of a European patent with unitary effect to 
prevent third parties not having his consent from making, offering, placing on the market or 
using a product which is the subject matter of the patent, or importing or storing the product 
for  these  purposes.  In  addition,  the  patent  proprietor  can  prevent  third  parties  from  using  a 
process which is the subject matter of the patent or, when a third party knows or should have 
known  that  the  use  of  the  process  is  prohibited  without  the  consent  of  the  proprietor,  from 
offering the process for use within the participating Member States. Finally, the proprietor can 
prevent  third  parties  from  offering,  placing  on  the  market,  using,  importing  or  storing  for 
those  purposes  a  product  obtained  directly  by  a  process  which  is  the  subject  matter  of  the 
patent. 

Article 7 - Right to prevent the indirect use of the invention 

This Article lays down the right of the proprietor of a European patent with unitary effect to 
prevent third parties not having  his  consent from supplying or  offering to supply within the 
participating  Member  States  any  person,  other  than  a  party  entitled  to  exploit  the  patented 
invention,  with  means,  relating  to  an  essential  element  of  that  invention,  for  putting  it  into 
effect  therein,  when  the  third  party  knows,  or  should  have  known,  that  those  means  are 
suitable  and  intended  for  putting  that  invention  into  effect.  This  shall  not  apply,  however, 
where  the  means  are  staple  commercial  products,  except  when  the  third  party  induces  the 
person supplied to commit acts prohibited by Article 6. 

Article 8 - Limitation of the effects of the European patent with unitary effect 

This Article provides a number of limitations of the effects conferred by the European patent 
with unitary effect. In particular, such effects shall not extend to acts done privately and for 
non-commercial  purposes,  to  acts  done  for  experimental  purposes  relating  to  the  subject-
matter of the patented invention or to the extemporaneous preparation for individual cases in a 
pharmacy of a medicine in accordance with a medical prescription. Other acts allowed under 
Union law, in particular relating to veterinary medicinal products, to medicinal products for 
human  use,  to  plant  variety  rights  and  to  the  legal  protection  of  computer  programs  by 
copyright  and  of  biotechnological  inventions,  are  also  not  prohibited.  Finally,  the  effects 
conferred  by  the  European  patent  with  unitary  effect  shall  not  extend  to  the  use  of  the 
patented  invention  on  board  vessels,  aircrafts  or  land  vehicles  of  countries  other  than 
participating  Member  States,  when  such  vessels,  aircrafts  or  vehicles  temporarily  or 
accidentally  enter  the  waters  of  participating  Member  States  and  to  the  use  by  a  farmer  of 
protected  livestock  for  farming  purposes,  on  condition  that  the  breeding  animals  or  other 
animal  reproductive  material  was  sold  or  otherwise  commercialised  to  the  farmer  by  the 
patent proprietor or with his consent. 

Article 9 - Exhaustion of the rights conferred by the European patent with unitary effect  

The  rights  conferred  by  a  European  patent  with  unitary  effect  shall  not  extend  to  acts 
concerning the product covered by that patent which are carried out within the territories of 
the participating Member States after that product has been put on the market in the Union by 
the  proprietor  of  the  patent  or  with  his  consent,  unless  there  are  legitimate  grounds  for  the 
proprietor to oppose further commercialisation of the product. 

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Article 10 - Treating a European patent with unitary effect as a national patent 

A  European  patent  with  unitary  effect  as  an  object  of  property  shall  be  dealt  with  in  its 
entirety, and in all the participating Member States, as a national  patent of the  participating 
Member  State  in  which,  according  to  the  European  Patent  Register,  the  proprietor  of  the 
patent had his residence or principal place of business on the date of filing of the application 
for the patent. Where this does not apply, the European patent with unitary effect as an object 
of property shall be dealt with as a national patent of the participating Member State in which 
the proprietor had a place of business on that date. Special rules are provided for in case of 
joint  proprietors.  Where  no  proprietor  has  his  residence  or  a  place  of  business  in  a 
participating Member State, the European patent with unitary effect as an object of property 
shall be dealt with as a national patent of the State where the European Patent Organisation 
has its seat. 

The creation of unitary patent protection has to be accompanied by appropriate jurisdictional 
arrangements  responding  to  the  needs  of  the  users  of  the  patent  system.  In  order  for  the 
unitary patent protection to work properly in practice, appropriate jurisdictional arrangements 
should allow for patents to be enforced or revoked throughout the territory of the participating 
Member States and at the same time should ensure high quality judgements and legal security 
for  companies.  Specific  jurisdictional  arrangements  will  be  proposed  as  soon  as  possible, 
taking also into account the recent opinion of the Court of Justice of the European Union (A-
1/09) on the compatibility of the draft agreement on the European and EU Patents Court with 
the Treaties.  

Article 11 - Licenses of right 

This Article enables the proprietor of a European patent with unitary effect to file a statement 
with  the  EPO  that  he  is  prepared  to  allow  any  person  to  use  the  invention  as  a  licensee  in 
return for appropriate compensation (contractual license).  

Article 12 - Implementation by the participating Member States  

This  Article  lays  down  the  tasks,  within  the  meaning  of  Article  143  EPC,  which  the 
participating  Member  States  entrust  to  the  EPO.  The  EPO  shall  carry  out  these  tasks  in 
conformity  with  its  internal  rules.  The  EPO  shall  administer  requests  for  unitary  effect, 
include  and  administer  in  the  European  Patent  Register  entries  relating  to  European  patents 
with unitary effect, receive and register statements on licensing, ensure the publication of the 
translations required during the transitional period, collect and administer the renewal fees (as 
well  as  additional  fees),  the  distribution  of  a  part  of  the  collected  renewal  fees  to  the 
participating  Member  States  and  administer  a  compensation  scheme  of  translation  costs  for 
applicants  filing  European  patent  applications  in  one  of  the  official  languages  of  the  Union 
that is not an official language of the EPO.  

The participating Member States shall ensure that requests by the patent proprietor for unitary 
effect are submitted in the language of the proceedings as defined in Article 14(3) of the EPC 
no  later  than  one  month  after  the  mention  of  the  grant  is  published  in  the  European  Patent 
Bulletin. The participating Member States shall also ensure that the unitary effect is indicated 
in the Register for unitary patent protection, where the relevant conditions are fulfilled. The 
EPO shall be informed of limitations and revocations of European patents with unitary effect. 

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This  Article  also  lays  down  that  the  participating  Member  States  shall  set  up  a  Select 
Committee  within  the  framework  of  the  Administrative  Council  of  the  European  Patent 
Organisation in order to ensure the governance and supervision of the tasks entrusted to the 
EPO. Finally, the participating Member States shall ensure effective legal protection before a 
national  court  against  the  administrative  decisions  of  the  EPO  in  carrying  out  the  tasks 
entrusted to it. 

Article 13 – Principle 

This Article provides the principle that the expenses incurred by the EPO in carrying out the 
additional  tasks  shall  be  covered  by  the  fees  generated  by  European  patents  with  unitary 
effect. 

Article 14 – Renewal fees 

Renewal fees in respect of European patents with unitary effect shall be paid to the European 
Patent Organisation. If a renewal fee is not been paid in due time, the European patent with 
unitary effect shall lapse. 

Article 15 – Level of renewal fees 

This  Article  sets  out  a  number  of  rules  and  conditions  to  be  taken  into  account  when 
determining the level of renewal fees. In particular, it provides that renewal fees for European 
patents with unitary effect shall be progressive throughout the term of the patent and shall be 
sufficient  not  only  to  cover  all  costs  associated  with  the  grant  and  administration  of  the 
unitary  patent  protection  but  also,  together  with  the  fees  to  be  paid  to  the  European  Patent 
Organisation during the pre-grant stage, to ensure a balanced budget of the Organisation. 

Finally,  the  Article  lays  down  that  the  Commission  is  empowered  to  adopt  delegated  acts 
concerning the fixing of the level of the renewal fees for European patents with unitary effect. 

Article 16 – Distribution  

The  share  for  distributing  50  percent  of  the  amount  of  the  renewal  fees  paid  for  European 
patents  with  unitary  effect  minus  the  costs  associated  with  the  administration  of  the  unitary 
patent protection among the participating Member States shall be set by the Commission on 
the basis of fair, equitable and relevant criteria listed in this Article. The participating Member 
States shall use the amount of the renewal fees allocated to them for patent-related purposes. 

The  Commission  is  empowered  to  adopt  delegated  acts  concerning  the  distribution  of  the 
renewal fees between the participating Member States. 

Article 17 – Exercise of the delegation 

This Article provides particulars relating to the power conferred on the Commission to adopt 
delegated  acts.  The  delegation  is  made  for  an  indeterminate  period  of  time  and  may  be 
revoked at any time  by the European  Parliament (EP) or by the Council.  Any delegated  act 
must be notified to the EP and to the Council that may express their objection within a period 
of 2 months. 

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Article 18 - Cooperation between the Commission and the European Patent Office 

This Article provides that the Commission shall establish close cooperation with the EPO in 
the fields covered by this Regulation. 

Article 19 - Application of competition law and the law relating to unfair competition 

This  Article  provides  that  the  Regulation  is  without  prejudice  to  the  application  of 
competition law and the law relating to unfair competition. 

Article 20 - Report on the operation of this Regulation  

Every six years the Commission shall present to the Council a report on the operation of this 
Regulation and where necessary make appropriate proposals for amending it.  

Article 21 – Notification by the participating Member States 

The  Article  requires  the  participating  Member  States  to  inform  the  Commission  of  the 
measures they adopt under Articles 4(2) and 12. 

Article 22 - Entry into force and application 

This Article provides that this Regulation shall enter into force on the twentieth day after its 
publication  in  the  Official  Journal  of  the  European  Union.  However,  since  the  language 
arrangements applicable to European patents with unitary effect would be governed Council 
Regulation …/… while the substantive provisions applicable to such patents are governed by 
this Regulation, these two Regulations should be applied jointly as of one specific date. The 
participating Member States shall ensure that the rules referred to in Articles 4(2) and 12 are 
in  place  prior  to  or  on  the  date  of  application.  Finally,  it  is  laid  down  that  unitary  patent 
protection  may  be  requested  for  any  European  patent  granted  on  or  after  the  date  on  which 
this Regulation applies.  

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2011/0093 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

implementing enhanced cooperation in the area of the creation of unitary patent protection 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  European  Union  and  the  Treaty  on  the  Functioning  of  the  European 
Union and in particular Article 118(1) thereof, 

Having regard to Council Decision 2011/167/EU of 10 March 2011 authorising enhanced cooperation 
in the area of the creation of unitary patent protection25, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national Parliaments, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

In accordance with Article 3(3) of the Treaty on European Union, the Union shall establish an 
internal  market,  shall  work  for  the  sustainable  development  of  Europe  based  on  balanced 
economic  growth  and  shall  promote  scientific  and  technological  advance.  The  creation  of  the 
legal conditions enabling undertakings to adapt their activities in manufacturing and distributing 
products  across  national  borders  and  providing  them  with  more  choice  and  opportunities 
contributes to attaining these objectives. Uniform patent protection within the internal market, 
or  at  least  a  significant  part  thereof,  should  feature  amongst  the  legal  instruments  which 
undertakings have at their disposal. 

Unitary patent protection should foster scientific and technological advance and the functioning 
of  the  internal  market  by  making  access  to  the  patent  system  easier,  less  costly  and  legally 
secure.  It  should  improve  the  level  of  patent  protection  by  providing  the  possibility  to  obtain 
uniform  patent  protection  in  the  territories  of  the  participating  Member  States  and  eliminate 
costs  and  complexity  for  undertakings  throughout  the  Union.  It  should  be  available  to  patent 
applicants  from  both  participating  Member  States  and  other  States,  regardless  of  nationality, 
residence or place of establishment. 

(3) 

Pursuant to Article 118(1) of the Treaty on the Functioning of the European Union (hereinafter 
"TFEU"), measures foreseen in the context of the establishment and functioning of the internal 

25 

OJ L 76, 22.3.2011, p. 53. 

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(4) 

(5) 

(6) 

(7) 

market  include  the  creation  of  uniform  patent  protection  throughout  the  Union  and  the 
establishment  of  centralised  Union-wide  authorisation,  coordination  and  supervision 
arrangements. 

On  10  March  2011,  the  Council  adopted  Decision  2011/167/EU  authorising  enhanced 
cooperation  between  Belgium,  Bulgaria,  the  Czech  Republic,  Denmark,  Germany,  Estonia, 
Ireland,  Greece,  France,  Cyprus,  Latvia,  Lithuania,  Luxembourg,  Hungary,  Malta,  the 
Netherlands, Austria, Poland, Portugal, Romania, Slovenia, Slovakia, Finland, Sweden and the 
United  Kingdom  (hereinafter  "participating  Member  States")  in  the  area  of  the  creation  of 
unitary patent protection. 

The Convention on the Grant of European Patents (European Patent Convention), as amended 
(hereinafter "EPC"), established the European Patent Organisation and entrusted it with the task 
of granting European patents. This task is carried out by the European Patent Office. European 
patents granted by the European Patent Office under the rules and procedures laid down in the 
EPC  should,  on  request  by  the  patent  proprietor,  benefit  from  unitary  effect  by  virtue  of  this 
Regulation in the territories of the participating Member States (hereinafter "European patents 
with unitary effect").  

It  is  foreseen  in  Part  IX  of  the  EPC  that  a  group  of  Member  States  of  the  European  Patent 
Organisation  may  provide  that  European  patents  granted  for  those  States  have  a  unitary 
character. This Regulation constitutes a special agreement within the meaning of Article 142 of 
the EPC, a regional patent treaty within the meaning of Article 45(1) of the Patent Cooperation 
Treaty  of  19  June  1970  and  a  special  agreement  within  the  meaning  of  Article  19  of  the 
Convention for the Protection of Industrial Property, signed in Paris on 20 March 1883 and last 
revised on 14 July 1967.  

The  creation  of  unitary  patent  protection  should  be  achieved  by  giving  unitary  effect  to 
European  patents  in  the  post-grant  phase  by  virtue  of  this  Regulation  and  in  respect  of  the 
participating Member States. The main feature of European patents with unitary effect should 
be  their  unitary  character,  i.e.  providing  uniform  protection  and  having  equal  effect  in  all 
participating Member States. Consequently, a European patent with unitary effect should only 
be  limited,  licensed,  transferred,  revoked  or  lapse  in  respect  of  all  the  participating  Member 
States.  To  ensure  the  uniform  substantive  scope  of  protection  conferred  by  unitary  patent 
protection, only European patents that have been granted for all the participating Member States 
with  the  same  set  of  claims  should  benefit  from  unitary  effect.  However,  to  ensure  legal 
certainty in the event of a limitation or revocation on the ground of lack of novelty pursuant to 
Article 54(3) EPC, the limitation or revocation of a European patent with unitary effect should 
take  effect  only  in  respect  of  the  participating  Member  State(s)  designated  in  the  earlier 
European  patent  application  as  published.  Finally,  the  unitary  effect  attributed  to  a  European 
patent should have an accessory nature and should cease to exist or be limited to the extent that 
the basic European patent has been revoked or limited. 

(8) 

In  accordance  with  the  general  principles  of  patent  law  and  Article  64(1)  of  the  EPC,  unitary 
patent protection should take effect retroactively in the territories of the participating Member 
States as of the date of the publication of the mention of the grant of the European patent in the 
European  Patent  Bulletin.  Where  unitary  effect  takes  effect,  the  participating  Member  States 
should ensure that the European patent is deemed not to have taken effect on their territory on 
the  date  of  the  publication  of  the  mention  of  the  grant  as  a  national  patent  to  avoid  any 

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duplication  of  patent  protection  on  their  territories  stemming  from  the  same  European  patent 
granted by the European Patent Office. 

(9) 

In  matters  not  covered  by  this  Regulation  or  Council  Regulation 
.../...  [translation 
arrangements],  the  provisions  of  the  EPC  and  national  law  including  rules  of  private 
international law shall apply. 

(10)  The  rights  conferred  by  the  European  patent  with  unitary  effect  should  enable  the  patent 
proprietor to prevent any third party not having his consent from the direct and indirect use of 
the  invention  on  the  territories  of  the  participating  Member  States.  However,  a  number  of 
limitations of the patent proprietor's rights should enable third parties to use the invention, for 
instance  for  private  and  for  non-commercial  purposes,  for  experimental  purposes,  for  acts 
allowed specifically under Union law (in the area of veterinary medicinal products, medicinal 
products  for  human  use,  plant  variety  rights,  the  legal  protection  of  computer  programs  by 
copyright  and  the  legal  protection  of  biotechnological  inventions)  under  international  law  and 
for the use by a farmer of protected livestock for farming purposes. 

(11) 

In accordance with the case law of the Court of Justice of the European Union, the principle of 
the  exhaustion  of  rights  should  be  applied  also  in  relation  to  European  patents  with  unitary 
effect.  Therefore,  rights  conferred  by  a  European  patent  with  unitary  effect  should  also  not 
extend to acts concerning the product covered by that patent, which are carried out within the 
territories of the participating Member States after that product has been put on the market in 
the Union by the proprietor of the patent. 

(12)  As  an  object  of  property,  a  European  patent  with  unitary  effect  should  be  dealt  with  in  its 
entirety,  and  in  all  the  participating  Member  States,  as  a  national  patent  of  the  participating 
Member State in which, according to the European Patent Register, the proprietor of the patent 
had his residence or principal place of business on the date of filing of the patent application. If 
the  proprietor  of  the  patent  did  not  have  his  residence  or  a  place  of  business  in  any  of  the 
participating Member State, the European patent  with unitary effect  should  be dealt with as a 
national  patent  of  the  Member  State  where  the  European  Patent  Organisation  has  its 
headquarters.  

(13) 

In  order  to  promote  and  facilitate  the  economic  exploitation  of  inventions  protected  by 
European patents with unitary effect, the patent proprietor should be able to offer its patent to be 
licensed to anyone complying with the terms and conditions set out by the patent proprietor in 
return for appropriate compensation. To that end the patent proprietor may file a statement with 
the  European  Patent  Office  that  he  is  prepared  to  grant  a  license  in  return  for  appropriate 
compensation. In that case, the proprietor should, after receipt of that statement, benefit from a 
reduction of the renewal fees. 

(14)  The group of Member States making use of Part IX of the EPC may give tasks to the European 
Patent  Office  and  set  up  a  Select  Committee  of  the  Administrative  Council  of  the  European 
Patent Organisation (hereinafter "Select Committee"). 

(15)  The participating Member States should give the European Patent Office certain administrative 
tasks relating to European patents with unitary effect, in particular as regards administration of 
requests  for  unitary  effect,  the  registration  of  unitary  effect  and  of  any  limitation,  licence, 
transfer,  revocation  or  lapse  of  European  patents  with  unitary  effect,  the  collection  and 

EN 

12 

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redistribution of renewal fees, the publication of translations for information purposes during a 
transitional  period  and  the  administration  of  a  compensation  scheme  of  translation  costs  for 
applicants  filing  European  patent  applications  in  a  language  other  than  one  of  the  official 
languages  of  the  European  Patent Office.  The  participating  Member  States  should  ensure  that 
requests  for  unitary  effect  are  filed  with  the  European  Patent  Office  within  one  month  of  the 
date of the publication of the mention of the grant in the European Patent Bulletin and that they 
are  submitted  in  the  language  of  the  proceedings  before  the  European  Patent  Office  together 
with  the  translation  prescribed  for,  during  a  transitional  period,  by  Council  Regulation…/… 
[translation arrangements]. 

(16)  Patent  proprietors  should  pay  one  common  annual  renewal  fee  for  European  patents  with 
unitary effect. Renewal fees should be progressive throughout the term of the patent protection 
and, together with the fees to be paid to the European Patent Organisation during the pre-grant 
stage,  should  cover  all  costs  associated  with  the  grant  of  the  European  patent  and  the 
administration  of  the  unitary  patent  protection.  The  level  of  the  renewal  fees  should  be  fixed 
with  the  aim  of  facilitating  innovation  and  fostering  the  competitiveness  of  European 
businesses. It should also reflect the size of the market covered by the patent and be similar to 
the  level  of  the  national  renewal  fees  for  an  average  European  patent  taking  effect  in  the 
participating Member States at the time where the level of the renewal fees is first fixed by the 
Commission. 

(17) 

In order to determine the appropriate level and distribution of renewal fees and to ensure that all 
costs of the tasks in relation to the unitary patent protection entrusted on the European Patent 
Office are fully covered by the resources generated by the European patents with unitary effect 
and that, together with the fees to be paid to the European Patent Organisation during the pre-
grant stage, the revenues from the renewal fees ensure a balanced budget of the European Patent 
Organisation. 

(18)  Renewal  fees  should  be  paid  to  the  European  Patent  Organisation.  50  percent  thereof  minus 
expenses incurred by the European Patent Office in carrying out tasks in relation to the unitary 
patent protection shall be distributed among the participating Member States, which should be 
used  for  patent-related  purposes.  The  share  of  distribution  should  be  set  on  the  basis  of  fair, 
equitable and relevant criteria namely the level of patent activity and the size of the market. The 
distribution should provide compensation for having an official language other than one of the 
official  languages  of  the  European  Patent  Office,  having  a  disproportionately  low  level  of 
patenting  activity  and  having  acquired  membership  of  the  European  Patent  Organisation 
relatively recently. 

(19) 

In order to ensure the appropriate level and distribution of renewal fees in compliance with the 
principles set out in this Regulation, the power to adopt acts in accordance with Article 290 of 
the Treaty on the Functioning of the European Union should be delegated to the Commission in 
respect  of  the  level  of  the  renewal  fees  for  European  patents  with  unitary  effect  and  the 
distribution  of  such  fees  between  the  European  Patent  Organisation  and  the  participating 
Member  States.  It  is  of  particular  importance  that  the  Commission  carry  out  appropriate 
consultations  during  its  preparatory  work,  including  at  expert  level.  The  Commission,  when 
preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate 
transmission of relevant documents to the European Parliament and Council. 

EN 

13 

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(20)  An  Enhanced  partnership  between  the  European  Patent  Office  and  central  industrial  property 
offices  of  the  Member  States  should  enable  the  European  Patent  Office  to  make  regular  use, 
where appropriate, of the result of any search carried out by central industrial property offices 
on a national patent application the priority of which is claimed in a subsequent European patent 
application.  All  central  industrial  property  offices,  including  those  which  do  not  perform 
searches in the course of a national patent granting procedure, can have an essential role under 
the enhanced partnership, inter alia by giving advice and support to potential patent applicants, 
in  particular  small  and  medium-sized  enterprises,  by  receiving  applications,  by  forwarding 
applications to the European Patent Office and by disseminating patent information. 

(21)  This Regulation should be complemented by Council Regulation .../... implementing enhanced 
cooperation in the area of the creation of unitary patent protection with regard to the applicable 
translation  arrangements,  adopted  by  the  Council  in  accordance  with  Article  118(2)  of  the 
TFEU. 

(22)  This  Regulation  should  be  without  prejudice  to  the  right  of  Member  States  to  grant  national 
patents and should not replace Member States' laws on patents. Patent applicants should remain 
free to obtain either a national patent, a European patent with unitary effect, a European patent 
taking  effect  in  one  or  more  of  the  Contracting  States  to  the  EPC  or  a  European  patent  with 
unitary effect validated in addition in one or more other Contracting States to the EPC which 
are not among the participating Member States. 

(23)  Since the objective of this Regulation, namely the creation of uniform patent protection, can, by 
reasons of the scale and effects of this Regulation, be better achieved at Union level, the Union 
may adopt measures by means of enhanced cooperation where appropriate, in accordance with 
the  principle  of  subsidiarity  as  set  out  in  Article 5  of  the  Treaty  on  European  Union.  In 
accordance with the principle of proportionality, as set out in that Article, this Regulation does 
not go beyond what is necessary in order to achieve this objective, 

HAVE ADOPTED THIS REGULATION: 

CHAPTER I 
GENERAL PROVISIONS 

Article 1 
Subject matter 

This  Regulation  implements  the  enhanced  cooperation  in  the  area  of  the  creation  of  unitary  patent 
protection authorised by Council Decision 2011/167/EU.  

This Regulation constitutes a special agreement within the meaning of Article 142 of the Convention 
on the Grant of European Patents (European Patent Convention), as amended (hereinafter "the EPC").  

For the purposes of this Regulation the following definitions shall apply: 

Article 2 
Definitions 

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(a) 

(b) 

(c) 

(d) 

(e) 

"Participating  Member  State"  means  a  Member  State  which  participates,  at  the  time 
when  the  request  for  unitary  effect  as  referred  to  in  Article  12  is  made,  in  enhanced 
cooperation in the area of the creation of unitary patent protection by virtue of Council 
Decision 2011/167/EU, or by virtue of a decision adopted in accordance with the second 
or third subparagraph of Article 331(1) of the TFEU; 

"European patent" means a patent granted by the European Patent Office under the rules 
and procedures laid down in the EPC;  

"European  patent  with  unitary  effect"  means  a  European  patent  which  benefits  from 
unitary  effect  in  the  territories  of  the  participating  Member  States  by  virtue  of  this 
Regulation; 

"European Patent Register" means the register kept by the European Patent Office under 
Article 127 of the EPC; 

"European Patent Bulletin" means the periodical publication provided for in Article 129 
of the EPC. 

Article 3 
European patent with unitary effect  

European  patents granted with an identical scope of protection in respect of all participating 
Member States shall benefit from unitary effect in the participating Member States provided 
that  their  unitary  effect  has  been  registered  in  the  Register  for  unitary  patent  protection 
referred to in Article 12(1)(b).  

European  patents  that  were  granted  with  different  sets  of  claims  for  different  participating 
Member States shall not benefit from unitary effect. 

A European patent with unitary effect shall have a unitary character. It shall provide uniform 
protection and shall have equal effect in all participating Member States.  

Without  prejudice  to  Article  5,  a  European  patent  with  unitary  effect  may  only  be  limited, 
licensed, transferred, revoked or lapse in respect of all the participating Member States. 

The unitary effect of a European patent shall be deemed not to have arisen to the extent that 
the European patent has been revoked or limited. 

Article 4 
Date of effect  

A  European  patent  with  unitary  effect  shall  take  effect  in  the  territories  of  the  participating 
Member States on the date of the publication, by the European Patent Office, of the mention of 
the grant of the European patent in the European Patent Bulletin.  

The participating Member States shall take the necessary measures to ensure that, where the 
unitary effect of a European patent has been registered, the European patent is deemed not to 

1. 

2. 

3. 

1. 

2. 

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have  taken  effect  as  a  national  patent  in  their  territory  on  the  date  of  the  publication  of  the 
mention of the grant in the European Patent Bulletin. 

Article 5 
Prior rights  

In the event of a limitation or a revocation on the ground of lack of novelty pursuant to Article 54(3) of 
the EPC, the limitation or revocation of a European patent with unitary effect shall take effect only in 
respect  of  the  participating  Member  State(s)  designated  in  the  earlier  European  patent  application  as 
published. 

CHAPTER II 
EFFECTS OF THE EUROPEAN PATENT WITH UNITARY EFFECT 

Article 6 
Right to prevent the direct use of the invention 

The  European  patent  with  unitary  effect  shall  confer  on  its  proprietor  the  right  to  prevent  any  third 
party not having the proprietor's consent from the following: 

(a) 

(b) 

 making, offering, placing on the market or using a product which is the subject matter of 
the patent, or importing or storing the product for those purposes; 

 using a process which is the subject matter of the patent or, where the third party knows, 
or should have known, that the use of the process is prohibited without the consent of the 
proprietor  of  the  patent,  from  offering  the  process  for  use  within  the  participating 
Member States; 

(c) 

 offering, placing on the market, using, importing or storing for those purposes a product 
obtained directly by a process which is the subject matter of the patent. 

Article 7 
Right to prevent the indirect use of the invention 

1. 

2. 

3. 

The European patent with unitary effect shall confer on its proprietor the right to prevent any 
third  party  from  supplying  or  offering  to  supply  within  the  participating  Member  States  any 
person  without  the  proprietor's  consent,  other  than  a  party  entitled  to  exploit  the  patented 
invention,  with  means,  relating  to  an  essential  element  of  that  invention,  for  putting  it  into 
effect  therein,  when  the  third  party  knows,  or  should  have  known,  that  those  means  are 
suitable and intended for putting that invention into effect. 

Paragraph 1 shall not apply when the means are staple commercial products, except where the 
third party induces the person supplied to perform any of the acts prohibited by Article 6. 

Persons  performing  the  acts  referred  to  in  Article 8(a)  to  (d)  shall  not  be  considered  to  be 
parties entitled to exploit the invention within the meaning of paragraph 1. 

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Article 8 
Limitation of the effects of the European patent with unitary effect 

The  rights  conferred  by  the  European  patent  with  unitary  effect  shall  not  extend  to  any  of  the 
following:  

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

 acts done privately and for non-commercial purposes; 

 acts  done  for  experimental  purposes  relating  to  the  subject  matter  of  the  patented 
invention; 

 acts  carried  out  solely  for  the  purpose  of  conducting  the  necessary  tests  and  trials  in 
accordance  with  Article 13(6)  of  Directive  2001/82/EC26  or  Article  10(6)  of  Directive 
2001/83/EC27 in respect of any patent covering the product within the meaning of either 
of those Directives; 

 the  extemporaneous  preparation  for  individual  cases  in  a  pharmacy  of  a  medicine  in 
accordance with a medical prescription nor acts concerning the medicine so prepared; 

 the  use  on  board  vessels  of  countries  other  than  participating  Member  States  of  the 
patented  invention,  in  the  body  of  the  vessel,  in  the  machinery,  tackle,  gear  and  other 
accessories,  when  such  vessels  temporarily  or  accidentally  enter  the  waters  of 
participating Member States, provided that the invention is used there exclusively for the 
needs of the vessel; 

 the  use  of  the  patented  invention  in  the  construction  or  operation  of  aircraft  or  land 
vehicles or other means of transport of States other than participating Member States, or 
of accessories to such aircraft or land vehicles, when these temporarily or accidentally 
enter participating Member States; 

 the  acts  specified  in  Article  27  of  the  Convention  on  International  Civil  Aviation  of  7 
December  194428,  where  these  acts  concern  the  aircraft  of  a  country  other  than  a 
participating Member State; 

 acts as covered by the farmers privilege pursuant to Article 14 of Regulation (EC) No. 
2100/9429 which applies mutatis mutandis; 

 the  use  by  a  farmer  of  protected  livestock  for  farming  purposes,  on  condition  that  the 
breeding  animals  or  other  animal  reproductive  material  were  sold  or  otherwise 
commercialised to the farmer by the patent proprietor or with his/her consent. Such use 
includes  the  provision  of  the  animal  or  other  animal  reproductive  material  for  the 

26 

27 

28 
29 

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 (OJ L 311, 28.11.2001, p. 1), as amended. 
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 (OJ L 311, 28.11.2001, p. 67), as amended. 
International Civil Aviation Organization (ICAO), "Chicago Convention", Document 7300/9 (9th edition, 2006) 
Council  Regulation  (EC)  No  2100/94  of  27 July 1994  on  Community  plant  variety  rights  (OJ  L 227,  1.9.1994, 
p. 1). 

EN 

17 

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purposes of his/her agricultural activity, but not the sale in the framework of or for the 
purpose of commercial reproductive activity; 

(j) 

(k) 

the  acts  and  the  use  of  the  obtained  information  as  allowed  under  Articles  5  and  6  of 
Council  Directive  91/250/EEC30,  in  particular,  by  its  provisions  on  decompilation  and 
interoperability; and 

 the  acts  allowed  pursuant  to  Article  10  of  Directive  98/44/EC  of  the  European 
Parliament and of the Council31. 

Article 9 
Exhaustion of the rights conferred by the European patent with unitary effect  

The rights conferred by a European patent with unitary effect shall not extend to acts concerning the 
product covered by that patent which are carried out within the territories of the participating Member 
States after that product has been put on the market in the Union by the proprietor of the patent or with 
to  oppose  further 
legitimate  grounds  for 
his/her  consent,  unless 
commercialisation of the product. 

the  proprietor 

there  are 

CHAPTER III 
A EUROPEAN PATENT WITH UNITARY EFFECT AS AN OBJECT OF 
PROPERTY 

Article 10 
Treating a European patent with unitary effect as a national patent 

A European patent with unitary effect as an object of property shall be treated in its entirety 
and  in  all  the  participating  Member  States  as  a  national  patent  of  the  participating  Member 
State in which, according to the European Patent Register: 

(a) 

(b) 

the patent proprietor had his/her residence or principal place of business on the date of 
filing of the application for the patent; or 

where  subparagraph  (a)  does  not  apply,  the  proprietor  had  a  place  of  business  on  that 
date. 

Where  two  or  more  persons  are  mentioned  in  the  European  Patent  Register  as  joint 
proprietors, paragraph 1(a) shall apply to the joint proprietor indicated first. Where this is not 
possible, paragraph 1(a) shall apply to the next joint proprietor indicated in the order of entry. 
Where paragraph 1(a) does not apply to any of the joint proprietors, paragraph 1(b) shall apply 
accordingly. 

Council  Directive  91/250/EEC  of  14  May  1991  on  the  legal  protection  of  computer  programs  (OJ  L 122, 
17.5.1991, p. 42). 
Directive  98/44/EC  of  the  European  Parliament  and  of  the  Council  of  6 July 1998  on  the  legal  protection  of 
biotechnological inventions (OJ L 213, 30.7.1998, p. 13). 

1. 

2. 

30 

31 

EN 

18 

   EN 

 
                                                 
3. 

Where  no  proprietor  has  his/her  residence  or  a  place  of  business  in  a  participating  Member 
State  for  the  purposes  of  paragraphs  1  or  2,  the  European  patent  with  unitary  effect  as  an 
object of property shall be dealt with in its entirety and in all the participating Member States 
as a national patent of the State where the European Patent Organisation has its headquarters 
in accordance with Article 6(1) of the EPC. 

4. 

The acquisition of a right may not be dependent on any entry in a national patent register. 

Article 11 
Licenses of right 

1. 

The proprietor of a European patent with unitary effect may file a statement with the European 
Patent Office that he/she is prepared to allow any person to use the invention as a licensee in 
return for appropriate compensation. 

2. 

A license obtained under this Regulation shall be treated as a contractual license. 

CHAPTER IV 
INSTITUTIONAL PROVISIONS 

Article 12 
Implementation by the participating Member States 

1. 

The participating Member States shall give, within the meaning of Article 143 of the EPC, the 
European  Patent  Office  the  following  tasks  to  be  carried  out  in  conformity  with  the  internal 
rules of the European Patent Office: 

(a) 

(b) 

(c) 

(d) 

(e) 

the administration of requests for unitary effect by proprietors of European patents; 

the  inclusion  and  administration  of  a  Register  for  unitary  patent  protection  registering 
unitary  effect  as  well  as  any  limitation,  license,  transfer,  revocation  or  lapse  of  a 
European patent with unitary effect, within the European Patent Register;  

receiving  and  registering  statements  on  licensing  referred  to  in  Article  11,  their 
withdrawal  and  licensing  commitments  undertaken  in  international  standardisation 
bodies; 

the  publication  of  the  translations  referred  to  in  Article  6  of  Council  Regulation  …/… 
[translation arrangements] during the transitional period referred to in that Article; 

the  collection  and  administration  of  renewal  fees  for  European  patents  with  unitary 
effect,  in  respect  of  the  years  following  the  year  in  which  the  Register  referred  to  in 
point b) mentions their grant; the collection and administration of additional fees paid in 
cases of late payment of renewal fees within six months of the due date, as well as the 
distribution  of  a  part  of  the  collected  renewal  fees  to  the  participating  Member  States; 
and 

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(f) 

the  administration  of  a  compensation  scheme  of  translation  costs  for  applicants  filing 
European patent applications in one of the official languages of the Union that is not an 
official language of the European Patent Office.  

For the purposes of point a), the participating Member States shall ensure that requests by the 
patent  proprietor  for  unitary  effect  for  a  European  patent  are  filed  in  the  language  of  the 
proceedings as defined in Article 14(3) of the EPC no later than one month after the mention 
of the grant is published in the European Patent Bulletin. 

For  the  purposes  of  point  b),  the  participating  Member  States  shall  ensure  that  the  unitary 
effect  is  indicated  in  the  Register  for  unitary  patent  protection,  where  a  request  for  unitary 
effect  has  been  filed  and,  during  the  transitional  period  provided  for  in  Article  6  of  Council 
Regulation …/… [translation arrangements], has been submitted together with the translations 
referred to in that Article; and that the European Patent Office is informed of limitations and 
revocations of European patents with unitary effect. 

2. 

3. 

In  their  capacity  as  Contracting  States  to  the  EPC,  the  participating  Member  States  shall 
ensure  the  governance  and  supervision  of  the  activities  related  to  the  tasks  referred  to  in 
paragraph 1 by the European Patent Office. To that end they shall set up a Select Committee 
of  the  Administrative  Council  of  the  European  Patent  Organisation  within  the  meaning  of 
Article 145 of the EPC. 

The participating Member States shall ensure effective legal protection before a national court 
against  the  decisions  of  the  European  Patent  Office  in  carrying  out  the  tasks  referred  to  in 
paragraph 1. 

CHAPTER V 
FINANCIAL PROVISIONS 

Article 13 
Principle 

The expenses incurred by the European Patent Office in carrying out the additional tasks given, within 
the  meaning  of  Article  143  of  the  EPC,  by  Member  States  to  the  European  Patent  Office  shall  be 
covered by the fees generated by the European patents with unitary effect. 

Article 14 
Renewal fees 

1. 

2. 

Renewal  fees  and  additional  fees  for  the  late  payment  of  renewal  fees  for  European  patents 
with unitary effect shall be paid to the European Patent Organisation by the patent proprietor. 
Those fees shall be due in respect of the years following the year in which the European Patent 
Register  mentions  the  grant  of  the  European  patent  which  benefits  from  unitary  effect  by 
virtue of this Regulation. 

A European patent with unitary effect shall lapse if a renewal fee and, where applicable, any 
additional fee have not been paid in due time. 

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3. 

In  the  case  of  Article  11(1),  renewal  fees  for  the  patent  which  fall  due  after  receipt  of  the 
statement shall be reduced. 

Article 15 
Level of renewal fees 

1. 

Renewal fees for European patents with unitary effect shall be  

(a) 

(b) 

(c) 

progressive throughout the term of the unitary patent protection, and  

sufficient not only to cover all costs associated with the grant of the European patent and 
the administration of the unitary patent protection but also,  

sufficient together with the fees to be paid to the European Patent Organisation during 
the pre-grant stage, to ensure a balanced budget of the European Patent Organisation.  

2. 

The level of the renewal fees shall be fixed with the aim of 

(a) 

(b) 

(c) 

facilitating innovation and fostering the competitiveness of European businesses, 

reflecting the size of the market covered by the patent and 

being  similar  to  the  level  of  the  national  renewal  fees  for  an  average  European  patent 
taking  effect  in  the  participating  Member  States  at  the  time  where  the  level  of  the 
renewal fees is first fixed by the Commission. 

3. 

In order to reach these objectives set out in this Chapter, the Commission shall set the level of 
renewal fees at a level that  

(a) 

(b) 

(c) 

 is equivalent to the level of renewal fee to be paid for the average geographical coverage 
of current European patents, 

reflects the renewal rate of current European patents, and  

the number of requests for unitary protection. 

The Commission shall be empowered to adopt delegated acts in accordance with paragraphs 
1-3 and Article 17 concerning the fixing of the level of the renewal fees for European patents 
with unitary effect. 

Article 16 
Distribution 

The  part  of  the  collected  renewal  fees  to  be  distributed  to  the  participating  Member  States 
referred to in Article 12(1)(e) shall be 50 percent of the renewal fees referred to in Article 14 
paid  for  European  patents  with  unitary  effect  minus  the  costs  associated  with  the 
administration of the unitary patent protection referred to in Article 12. 

4. 

1. 

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2. 

In order to reach these objectives set out in this Chapter, the Commission shall set the share of 
distribution of renewal fees referred to in paragraph 1 among the participating Member States 
on the basis of the following fair, equitable and relevant criteria:  

(a) 

(b) 

(c) 

the number of patent applications, 

the size of the market expressed in the number of population, 

provision of compensation to Member States for having an official language other than 
one of the official languages of the European Patent Office, having a disproportionately 
low level of patenting activity and having acquired membership of the European Patent 
Organisation relatively recently. 

The  participating  Member  States  shall  use  the  amount  allocated  to  them  in  accordance  with 
paragraph 1 to patent-related purposes. 

The Commission shall be empowered to adopt delegated acts in accordance with paragraphs 
1-3  and  Article  17  concerning  the  setting  of  the  distribution  of  renewal  fees  between  the 
participating Member States. 

Article 17 
Exercise of the delegation 

The power to adopt delegated acts is conferred on the Commission subject to the conditions 
laid down in this Article. 

The  delegation  of  power  referred  to  in  Articles  15  and  16  shall  be  conferred  for  an 
indeterminate period of time from the [date of entry into force of this Regulation]. 

The delegation of powers referred to in Articles 15 and 16 may be revoked at any time by the 
European  Parliament  or  by  the  Council.  A  decision  of  revocation  shall  put  an  end  to  the 
delegation  of  the  power  specified  in  that  decision.  It  shall  take  effect  the  day  following  the 
publication  of  the  decision  in  the  Official  Journal  of  the  European  Union  or  at  a  later  date 
specified therein. It shall not affect the validity of any delegated acts already in force. 

As  soon  as  it  adopts  a  delegated  act,  the  Commission  shall  notify  it  simultaneously  to  the 
European Parliament and to the Council. 

A  delegated  act  adopted  pursuant  to  Articles  15  and  16  shall  enter  into  force  only  if  no 
objection has been expressed either by the European Parliament or the Council within a period 
of 2 months of notification of that act to the European Parliament and the Council or if, before 
the  expiry  of  that  period,  the  European  Parliament  and  the  Council  have  both  informed  the 
Commission  that  they  will  not  object.  That  period  shall  be  extended  by  2  months  at  the 
initiative of the European Parliament or the Council. 

3. 

4. 

1. 

2. 

3. 

4. 

5. 

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CHAPTER VI 
FINAL PROVISIONS 

Article 18 
Cooperation between the Commission and the European Patent Office 

The Commission shall establish a close cooperation through a working agreement with the European 
Patent Office in the fields covered by this Regulation. This cooperation shall include regular exchanges 
of views on the functioning of the working agreement and in particular on the issue of renewal fees and 
the impact on the budget of the European Patent Organisation. 

Article 19 
Application of competition law and the law relating to unfair competition 

This Regulation is without prejudice to the application of competition law and the law relating to unfair 
competition. 

Article 20 
Report on the operation of this Regulation  

1. 

2. 

Not later than six years from the date on which the first European patent with unitary effect 
takes effect in the territories of the participating Member States, the Commission shall present 
to  the  Council  a  report  on  the  operation  of  this  Regulation  and,  where  necessary,  make 
appropriate proposals for amending it. Subsequent reports on the operation of this Regulation 
shall be presented by the Commission every six years. 

The Commission shall submit reports regularly on the functioning of the renewal fees referred 
to in Article 14 with particular emphasis on the continued compliance with the principles set 
out in Article 15. 

Article 21 
Notification by the participating Member States 

The participating Member States shall notify the Commission of the measures adopted in accordance 
with Articles 4(2) and 12 by the date set in Article 22(2). 

Article 22 
Entry into force and application 

1. 

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

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2. 

3. 

4. 

It shall apply from [a specific date will be set and it will coincide with the date of application 
of Council Regulation …/… on the implementation of enhanced cooperation in the area of the 
creation of unitary patent protection with regard to the applicable translation arrangements]. 

The participating Member States shall ensure that the rules referred to in Articles 4(2) and 12 
are in place prior to or on the date set in paragraph 2. 

Unitary  patent  protection  may  be  requested  for  any  European  patent  granted  on  or  after  the 
date set out in paragraph 2. 

This  Regulation  shall  be  binding  in  its  entirety  and  directly  applicable  in  the  participating  Member 
States in accordance with the Treaties. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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