Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (Codified version) (Text with EEA relevance ) Basic information Dates Date of document: Date of publication: Date of effect: July 6, 2009 Entry into force - Date pub. + 20 See Art 23 Modified by Modified by: Amendment proposed by: Modifies Modifies: Repeal: Affected by case Judgment of the Court (Third Chamber), 12 December 2013. Eli Lilly and Company Ltd v Human Genome Sciences Inc. Request for a preliminary ruling from the High Court of Justice (England and Wales), Chancery Division (Patents Court). Medicinal products for human use — Supplementary protection certificate — Regulation (EC) No 469/2009 — Article 3 — Conditions for obtaining such a certificate — Concept of a ‘product protected by a basic patent in force’ — Criteria — Wording of the claims of the basic patent — Precision and specificity — Functional definition of an active ingredient — Structural definition of an active ingredient — European Patent Convention. Case C‑493/12. Judgment of the Court (Seventh Chamber) of 5 October 2016. F. Hoffmann-La Roche AG v Accord Healthcare OÜ. Request for a preliminary ruling from the Riigikohus. Reference for a preliminary ruling — Industrial and commercial property — Patent — Supplementary protection certificate — Regulation (EC) No 469/2009 — Article 21(2) — Transitional provisions — Certificate granted in accordance with the national legislation of a Member State prior to its accession to the European Union — Interpretation of Article 21(2) — Duration of validity of the certificate — Validity of Article 21(2) — Adjustment to secondary legislation resulting directly from the Act of Accession — Lack of jurisdiction of the Court. Case C-572/15. Judgment of the Court (Second Chamber) of 20 December 2017. Incyte Corporation v Szellemi Tulajdon Nemzeti Hivatala. Request for a preliminary ruling from the Fővárosi Törvényszék. Reference for a preliminary ruling — Intellectual and industrial property — Patents — Medicinal products for human use — Regulation (EC) No 469/2009 — Article 18 — Plant-protection products — Regulation (EC) No 1610/96 — Article 17(2) — Supplementary protection certificate — Duration — Fixing the date of expiry — Consequences of a judgment of the Court — Possibility or requirement to rectify the date of expiry. Case C-492/16. Order of the Court (Eighth Chamber), 14 November 2013. Astrazeneca AB v Comptroller General of Patents, Designs and Trade Marks. Request for a preliminary ruling from the High Court of Justice (England and Wales), Chancery Division (Patents Court). Medicinal products for human use — Supplementary protection certificate — Regulation (EC) No 469/2009 — Article 13(1) — Concept of ‘first authorisation to place [a product] on the market in the Community’ — Authorisation issued by the Swiss Institute for Medicinal Products (Swissmedic) — Automatic recognition in Liechtenstein — Authorisation issued by the European Medicines Agency — Period of validity of a certificate. Case C‑617/12. Judgment of the Court (Eighth Chamber) of 6 October 2015. Seattle Genetics Inc. v Österreichisches Patentamt. Request for a preliminary ruling from the Oberlandesgericht Wien. Reference for a preliminary ruling — Intellectual and industrial property — Proprietary medicinal products — Regulation (EC) No 469/2009 — Article 13(1) — Supplementary protection certificate — Duration — Concept of the ‘date of the first authorisation to place the product on the market in the European Union’ — Whether account is to be taken of the date of the decision granting authorisation or the date on which notification was given of that decision. Case C-471/14. Judgment of the Court (Seventh Chamber) of 7 December 2017. Merck Sharp & Dohme Corporation v Comptroller-General of Patents, Designs and Trade Marks. Reference for a preliminary ruling — Industrial and commercial property — Patent law — Medicinal products for human use — Regulation (EC) No 469/2009 — Article (3)(b) — Supplementary protection certificate — Conditions for obtaining — Article 10(3) — Granting of the certificate or rejection of the application for a certificate — Directive 2001/83/EC — Article 28(4) — Decentralised procedure. Case C-567/16. Judgment of the Court (Fourth Chamber) of 21 March 2019. Abraxis Bioscience LLC v Comptroller General of Patents. Request for a preliminary ruling from the High Court of Justice (England & Wales), Chancery Division (patents court). Reference for a preliminary ruling — Medicinal product for human use — Supplementary protection certificate for medicinal products — Regulation (EC) No 469/2009 — Article 3(d) — Conditions for granting — Grant of first authorisation to place the product on the market as a medicinal product — Authorisation covering a product as a medicinal product constituting a new formulation of a known active ingredient. Case C-443/17. Order of the Court (Eighth Chamber) of 14 November 2013. Glaxosmithkline Biologicals SA and Glaxosmithkline Biologicals, Niederlassung der Smithkline Beecham Pharma GmbH & Co. KG v Comptroller General of Patents, Designs and Trade Marks. Reference for a preliminary ruling: High Court of Justice (England & Wales), Chancery Division (Patents Court) - United Kingdom. Medicinal products for human use - Supplementary protection certificate - Regulation (EC) No 469/2009 - Concepts of ‘active ingredient’ and ‘combination of active ingredients’ - Adjuvant. Case C-210/13. Judgment of the Court (Third Chamber), 12 December 2013. Actavis Group PTC EHF and Actavis UK Ltd v Sanofi. Request for a preliminary ruling from the High Court of Justice (England and Wales), Chancery Division (Patents Court). Medicinal products for human use — Supplementary protection certificate — Regulation (EC) No 469/2009 — Article 3 — Conditions for obtaining such a certificate — Successive marketing of two medicinal products containing, wholly or partially, the same active ingredient — Combination of active ingredients, one of which has already been marketed in the form of a medicinal product with a single active ingredient — Whether it is possible to obtain a number of certificates on the basis of the same patent and two marketing authorisations. Case C‑443/12. Judgment of the Court (Fourth Chamber), 19 July 2012. Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents. Reference for a preliminary ruling from the Court of Appeal (England and Wales) (Civil Division). Medicinal products for human use — Supplementary protection certificate — Regulation (EC) No 469/2009 — Article 3 — Conditions for obtaining a supplementary protection certificate — Medicinal product having obtained a valid marketing authorisation — First authorisation — Product successively authorised as a veterinary medicinal product and a human medicinal product. Case C‑130/11. Order of the Court (Fourth Chamber) of 25 November 2011. Yeda Research and Development Company Ltd and Aventis Holdings Inc. v Comptroller General of Patents, Designs and Trade Marks. Reference for a preliminary ruling: Court of Appeal (England & Wales) (Civil Division) - United Kingdom. Article 104(3), first subparagraph, of the Rules of Procedure - Medicinal products for human use - Supplementary protection certificate - Regulation (EC) No 469/2009 - Article 3 - Conditions for obtaining a certificate - Concept of a ‘product protected by a basic patent in force’ - Criteria - Marketing authorisation - Medicinal product placed on the market containing only one active ingredient whereas the patent claims a combination of active ingredients. Case C-518/10. Order of the Court (Eighth Chamber) of 9 February 2012. Novartis AG v Actavis UK Ltd. Reference for a preliminary ruling — High Court of Justice (Chancery Division) — Interpretation of Articles 4 and 5 of Regulation (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 2009 L 152, p. 1) — Scope of the certificate — Protection only of medicinal products containing the protected active ingredient alone or protection also of medicinal products containing the protected active ingredient in combination with another active ingredient. The first subparagraph of Article 104(3) of the Rules of Procedure — Medicinal products for human use — Supplementary protection certificate — Regulation (EC) No 469/2009 — Articles 4 and 5 — Sole active ingredient for which such a certificate is granted — Scope of protection — Medicinal product containing more than one active ingredient, including the active ingredient which is the subject of a certificate. Case C‑442/11. Order of the Court (Fourth Chamber) of 25 November 2011. Daiichi Sankyo Company v Comptroller General of Patents, Designs and Trade Marks. Reference for a preliminary ruling: High Court of Justice (England & Wales), Chancery Division (Patents Court) - United Kingdom. Article 104(3), first subparagraph, of the Rules of Procedure - Medicinal products for human use - Supplementary protection certificate - Regulation (EC) No 469/2009 - Articles 3 and 4 - Conditions for obtaining a certificate - Concept of a ‘product protected by a basic patent in force’ - Criteria - Existence of further or different criteria for a medicinal product comprising more than one active ingredient. Case C-6/11. Judgment of the Court (Grand Chamber) of 9 July 2020. Santen SAS v Directeur général de l’Institut national de la propriété industrielle. Request for a preliminary ruling from the Cour d'appel de Paris. Reference for a preliminary ruling — Medicinal product for human use — Supplementary protection certificate for medicinal products — Regulation (EC) No 469/2009 — Article 3(d) — Conditions for the grant of a certificate — Obtaining the first authorisation to place the product on the market as a medicinal product — Authorisation to place on the market a new therapeutic application of a known active ingredient. Case C-673/18. Judgment of the Court (Fourth Chamber) of 24 November 2011. Medeva BV v Comptroller General of Patents, Designs and Trade Marks. Reference for a preliminary ruling: Court of Appeal (England & Wales) (Civil Division) - United Kingdom. Medicinal products for human use - Supplementary protection certificate - Regulation (EC) No 469/2009 - Article 3 - Conditions for obtaining a certificate - Concept of a ‘product protected by a basic patent in force’ - Criteria - Existence of further or different criteria for a medicinal product comprising more than one active ingredient or for a vaccine against multiple diseases (‘Multi-disease vaccine’ or ‘multivalent vaccine’). Case C-322/10. Judgment of the Court (Eighth Chamber) of 15 January 2015. Arne Forsgren v Österreichisches Patentamt. Request for a preliminary ruling from the Oberster Patent- und Markensenat. Reference for a preliminary ruling — Medicinal products for human use — Supplementary protection certificate — Regulation (EC) No 469/2009 — ‘Active ingredient’ — Pneumococcal conjugate vaccine — Paediatric use — Carrier protein — Covalent binding. Case C-631/13. Order of the Court (Eighth Chamber) of 9 February 2012. Novartis AG v Actavis Deutschland GmbH & Co KG and Actavis Ltd. Reference for a preliminary ruling — Landgericht Düsseldorf — Interpretation of Articles 4 and 5 of Regulation (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 2009 L 152, p. 1) — Scope of the certificate — Protection solely of medicinal products consisting only of the protected active ingredient or protection extended to medicinal products consisting of the protected active ingredient in combination with another active ingredient. The first subparagraph of Article 104(3) of the Rules of Procedure — Medicinal products for human use — Supplementary protection certificate — Regulation (EC) No 469/2009 — Articles 4 and 5 — Sole active ingredient for which such a certificate is granted — Scope of protection — Medicinal product containing more than one active ingredient, including the active ingredient which is the subject of a certificate. Case C‑574/11. Order of the Court (Eighth Chamber), 13 February 2014. Merck Canada Inc. v Accord Healthcare Ltd and Others. Request for a preliminary ruling from the Tribunal Arbitral necessário. Reference for a preliminary ruling — ‘Court or tribunal’ for the purposes of Article 267 TFEU — Tribunal Arbitral necessário — Admissibility — Regulation (EC) No 469/2009 — Article 13 — Supplementary protection certificate for medicinal products — Period of validity of a certificate — Maximum period of exclusivity. Case C‑555/13. Order of the Court (Fourth Chamber) of 25 November 2011. University of Queensland and CSL Ltd v Comptroller General of Patents, Designs and Trade Marks. Reference for a preliminary ruling: High Court of Justice (England & Wales), Chancery Division (Patents Court) - United Kingdom. Article 104(3), first subparagraph, of the Rules of Procedure - Medicinal products for human use - Supplementary protection certificate - Regulation (EC) No 469/2009 - Article 3 - Conditions for obtaining a certificate - Concept of a ‘product protected by a basic patent in force’ - Criteria - Existence of further or different criteria for a medicinal product comprising more than one active ingredient or for a vaccine against multiple diseases (‘Multi-disease vaccine’ or ‘multivalent vaccine’). Case C-630/10. Judgment of the Court (Third Chamber), 12 December 2013. Georgetown University v Octrooicentrum Nederland. Request for a preliminary ruling from the Rechtbank ‘s-Gravenhage. Medicinal products for human use — Supplementary protection certificate — Regulation (EC) No 469/2009 — Article 3 — Conditions for obtaining such a certificate — Whether it is possible to obtain a number of supplementary protection certificates on the basis of just one patent. Case C‑484/12. Judgment of the Court (Eighth Chamber) of 12 March 2015. Actavis Group PTC EHF and Actavis UK Ltd v Boehringer Ingelheim Pharma GmbH & Co. KG. Request for a preliminary ruling from the High Court of Justice of England and Wales, Chancery Division (Patents Court). Reference for a preliminary ruling — Medicinal products for human use — Regulation (EC) No 469/2009 — Article 3 — Supplementary protection certificate — Conditions for obtaining such a certificate — Medicinal products containing in whole or in part the same active ingredient — Medicinal products placed on the market in succession — Combination of active ingredients — Active ingredient previously marketed in the form of a medicinal product with a single active ingredient — Conditions for obtaining several certificates on the basis of the same patent — Modification of the active ingredients of a basic patent. Case C-577/13. Judgment of the Court (Grand Chamber) of 25 July 2018. Teva UK Ltd and Others v Gilead Sciences Inc. Request for a preliminary ruling from the High Court of Justice (England & Wales), Chancery Division (Patents Court). Reference for a preliminary ruling — Medicinal products for human use — Treatment of human immunodeficiency virus (HIV) — Originator medicines and generic medicines — Supplementary protection certificate — Regulation (EC) No 469/2009 — Article 3(a) — Conditions for obtaining — Concept of a ‘product protected by a basic patent in force’ — Criteria for assessment. Case C-121/17. Judgment of the Court (Fourth Chamber) of 24 November 2011. Georgetown University and Others v Comptroller General of Patents, Designs and Trade Marks. Reference for a preliminary ruling: High Court of Justice (England & Wales), Chancery Division (Patents Court) - United Kingdom. Medicinal products for human use - Supplementary protection certificate - Regulation (EC) No 469/2009 - Article 3 - Conditions for obtaining a certificate - Concept of a ‘product protected by a basic patent in force’ - Criteria - Existence of further or different criteria for a medicinal product comprising more than one active ingredient or for a vaccine against multiple diseases (‘Multi-disease vaccine’ or ‘multivalent vaccine’). Case C-422/10. Judgment of the Court (Ninth Chamber) of 25 October 2018. Proceedings brought by Boston Scientific Ltd. Reference for a preliminary ruling — Intellectual and industrial property — Supplementary protection certificate for medicinal products — Regulation (EC) No 469/2009 — Scope — Medical device incorporating as an integral part a substance which, used separately, may be considered to be a medicinal product — Directive 93/42/EEC — Article 1(4) — Concept of ‘administrative authorisation procedure’. Case C-527/17. Case C-239/19: Reference for a preliminary ruling from the High Court of Justice (Chancery Division) (United Kingdom) made on 20 March 2019 — Eli Lilly and Company v Genentech Inc. Case C-149/22: Reference for a preliminary ruling from the Supreme Court (Ireland) made on 2 March 2022 — Merck Sharp & Dohme Corp v Clonmel Healthcare Limited article 3 point (a) article 3 point (c) Case C-121/17: Reference for a preliminary ruling from the High Court of Justice (Chancery Division) (United Kingdom) made on 8 March 2017 — Teva UK Ltd, Accord Healthcare Ltd, Lupin Ltd, Lupin (Europe) Ltd, Generics (UK) trading as ‘Mylan’ v Gilead Sciences Inc. Case C-527/17: Request for a preliminary ruling from the Bundespatentgericht (Germany) lodged on 5 September 2017 — LN Case C-119/22: Request for a preliminary ruling from the Markkinaoikeus (Finland) lodged on 17 February 2022 — Teva B.V. and Teva Finland Oy v Merck Sharp & Dohme Corp. article 3 point (a) article 3 point (c) Case C-650/17: Request for a preliminary ruling from the Bundespatentgericht (Germany) lodged on 21 November 2017 — QH Case C-443/17: Reference for a preliminary ruling from High Court of Justice (Chancery Division) (United Kingdom) made on 24 July 2017 — Abraxis Bioscience LLC v Comptroller General of Patents Case C-114/18: Reference for a preliminary ruling from Court of Appeal (England & Wales) (Civil Division) made on 14 February 2018 — Sandoz Ltd, Hexal AG v G.D. Seale LLC, Janssen Sciences Ireland Case C-572/15: Request for a preliminary ruling from the Riigikohus (Estonia) lodged on 2 November 2015 — F. Hoffmann-La Roche AG v Accord Healthcare OÜ Case C-567/16: Reference for a preliminary ruling from High Court of Justice (Chancery Division) (United Kingdom) made on 10 November 2016 — Merck Sharp v Comptroller-General of Patents, Designs and Trade Marks article 3 point (b) article 10 paragraph 3 Case C-354/19: Request for a preliminary ruling from the Svea Hovrätt, Patent- och marknadsöverdomstolen (Sweden) lodged on 3 May 2019 — Novartis AG v Patent-och registreringsverket Case C-181/24, Genmab: Request for a preliminary ruling from the Fővárosi Törvényszék (Hungary) lodged on 6 March 2024 - Genmab A/S article 3 point (d) article 3 point (b) Legal basis Treaty establishing the European Community (consolidated version) Part Five - Institutions of the Community TITLE I - Provisions governing the institutions Chapter 2 - Provisions common to several institutions Article 251 Treaty establishing the European Community (consolidated version) Part Three - Community policies TITLE VI - Common rules on competition, taxation and approximation of laws Chapter 3 - Approximation of laws Article 95 EuroVoc Vocabulary Market approval Administrative formalities Codification of EU law Enlargement of the Union Pharmaceutical legislation Medicinal product Internal market - Principles Public health Free movement of goods Proprietary medicinal products