Annexes to COM(2023)231 - Supplementary protection certificate for medicinal products (recast) - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2023)231 - Supplementary protection certificate for medicinal products (recast). |
|---|---|
| document | COM(2023)231 |
| date | April 27, 2023 |
4Council conclusions on intellectual property policy of 10 November 2020 https://www.consilium.europa.eu/media/46671/st-12750-2020-init.pdf.
5European Parliament, Committee on Legal Affairs, Report on an intellectual property action plan to support the EU’s recovery and resilience (2021/2007(INI)), https://www.europarl.europa.eu/doceo/document/A-9-2021-0284_EN.html.
6Human and veterinary medicinal products.
7Discussions in this regard have been taken to the World Intellectual Property Organisation (WIPO), where national/regional patent offices were invited to share information on their collaborations with publicly accessible databases of patent status information concerning medicines and vaccines, such as MedsPaL. See: WIPO, Standing Committee on the Law of Patents, 32nd session, SCP/32/7, 2020.
8European Commission, Commission Communication – HERA Incubator: Anticipating together the threat of COVID-19 variants, COM/2021/78, 2021.
9European Commission, ‘Questions and answers : HERA incubator – Anticipating together the threat of COVID-19 variants’, 2021 (https://ec.europa.eu/commission/presscorner/detail/en/qanda_21_642).
10Case C-58/08 ECLI:EU:C:2010:321.
11 https://ec.europa.eu/docsroom/documents/29464
12https://ec.europa.eu/docsroom/documents/29524
13https://op.europa.eu/en/publication-detail/-/publication/94cb20ea-2ff0-11ed-975d-01aa75ed71a1/language-en
14More precisely, filed with the competent industrial property office of the Member State concerned, unless another authority was designated for that purpose.
15For a full list of cases, see Table 5.5. of the second MPI study.
16Further clarifications are, however, necessary in certain areas as indicated by two referrals in 2022, cases C-119/22 and C-149/22.
17Where the related basic patent or the SPC itself has not been opted-out from the competence of the UPC and where no action has already been brought before a national court (as far as those Member States in which the patent has unitary effect are concerned).
18OJ C […], […], p. […].
19OJ C […], […], p. […].
20See Annex I.
21Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ L 152, 16.6.2009, p. 1).
22See Annex I.
23Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1).
24Regulation (EU) No 1257/2012 of the European Parliament and of the Council of 17 December 2012 implementing enhanced cooperation in the area of the creation of unitary patent protection (OJ L 361, 31.12.2012, p. 1).
25Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (OJ L 154, 16.6.2017, p. 1).
26Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
27Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).
28Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (OJ L 153, 11.6.2019, p. 1).
29Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (OJ L 157, 30.4.2004, p. 45).
30Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC) No 1383/2003 (OJ L 181, 29.6.2013, p. 15).
31Directive 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).
32Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (OJ L 32, 9.2.2016, p. 1).
33Regulation of the European Parliament and of the Council on the unitary supplementary protection certificate for medicinal products [COM(2023) 222].
34Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making (OJ L 123, 12.5.2016, p. 1).
35Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
36Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
37Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1) OJ L 378, 27.12.2006, p. 1.
38Convention on the Grant of European Patents of 5 October 1973, as revised on 17 December 1991 and on 29 November 2000
39Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (OJ L 32, 9.2.2016, p. 1).';
40Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).
41Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).
42Regulation of the European Parliament and of the Council concerning the unitary supplementary protection certificate for medicinal products [COM(2023) 222].
43Council Regulation No 1 determining the languages to be used by the European Economic Community (OJ 17, 6.10.1958, p. 385).
44Regulation (EEC, Euratom, ECSC) No 259/68 of the Council of 29 February 1968 laying down the Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Commission and instituting special measures temporarily applicable to officials of the Commission (OJ L 56, 4.3.1968, p. 1.).
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