Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products Basic information Dates Date of document: Date of publication: Date of effect: January 2, 1993 Entry into force - Date pub. + 180 See Art 23 Date of end of validity: Modified by Modified by: Act concerning the conditions of accession of the Republic of Bulgaria and Romania and the adjustments to the Treaties on which the European Union is founded - Annex III:List referred to in Article 19 of the Act of Accession: adaptations to acts adopted by the institutions - 1.Company law - Industrial property rights - II.Supplementary protection certificates
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detail Protocol concerning the conditions and arrangements for admission of the Republic of Bulgaria and Romania to the European Union - Annex III:List referred to in Article 16 of the Protocol: adaptations to acts adopted by the institutions - 1.Company law - Industrial property rights - II.Supplementary protection certificates
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detail Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded - Annex II: List referred to in Article 20 of the Act of Accession - 4. Company law - C. Industrial property rights - II. Supplementary protection certificates
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detail ACT concerning the conditions of accession of the Kingdom of Norway, the Republic of Austria, the Republic of Finland and the Kingdom of Sweden and the adjustments to the Treaties on which the European Union is founded, ANNEX I - List referred to in Article 29 of the Act of Accession - XI. INTERNAL MARKET AND FINANCIAL SERVICES - F. INTELLECTUAL PROPERTY AND PRODUCT LIABILITY - I. PATENTS
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detail Regulation (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 (Text with EEA relevance)
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detail Repealed by: Modifies Affected by case Judgment of the Court (Second Chamber) of 8 December 2011. Merck Sharp & Dohme Corp. v Deutsches Patent- und Markenamt. Reference for a preliminary ruling: Bundespatentgericht - Germany. Intellectual and industrial property - Patents - Regulation (EEC) No 1768/92 - Article 13 - Supplementary protection certificate for medicinal products - Possibility of granting that certificate where the period that has elapsed between the date of the lodging of the basic patent application and the first marketing authorisation in the European Union is less than five years - Regulation (EC) No 1901/2006 - Article 36 - Extension of the duration of the supplementary protection certificate. Case C-125/10. Judgment of the Court (Sixth Chamber) of 12 June 1997. Yamanouchi Pharmaceutical Co. Ltd v Comptroller-General of Patents, Designs and Trade Marks. Reference for a preliminary ruling: High Court of Justice, Chancery Division, Patents Court - United Kingdom. Council Regulation (EEC) No 1768/92 - Supplementary protection certificate for medicinal products - Scope of Article 19. Case C-110/95. Judgment of the Court (Third Chamber) of 3 September 2009. AHP Manufacturing BV v Bureau voor de Industriële Eigendom. Reference for a preliminary ruling: Rechtbank 's-Gravenhage - Netherlands. Patent law - Proprietary medicinal products - Regulations (EEC) No 1768/92 and (EC) No 1610/96 - Supplementary protection certificate for medicinal products - Conditions for granting certificates to two or more holders of basic patents for the same product - Clarification on the existence of pending applications. Case C-482/07. Judgment of the Court (Sixth Chamber) of 11 December 2003. Hässle AB v Ratiopharm GmbH. Reference for a preliminary ruling: Bundesgerichtshof - Germany. Council Regulation (EEC) No 1768/92 - Medicinal products - Supplementary protection certificate - Articles 15 and 19 - Validity of Article 19 - Concept of first authorisation to place ... on the market in the Community - Legal effects of non-compliance with the relevant date referred to in Article 19. Case C-127/00. Judgment of the Court (Second Chamber) of 28 July 2011. Generics (UK) Ltd v Synaptech Inc. Reference for a preliminary ruling: Court of Appeal (England & Wales) (Civil Division) - United Kingdom. Patent law - Medicinal products - Supplementary protection certificate for medicinal products - Regulation (EEC) No 1768/92 - Article 2 - Scope. Case C-427/09. Judgment of the Court (Sixth Chamber) of 23 January 1997. Biogen Inc. v Smithkline Beecham Biologicals SA. Reference for a preliminary ruling: Tribunal de commerce de Nivelles - Belgium. Council Regulation (EEC) No 1768/92 - Supplementary protection certificate for medicinal products - Refusal by the holder of the marketing authorization to provide a copy to the applicant for the certificate. Case C-181/95. Case C-66/09: Judgment of the Court (Second Chamber) of 2 September 2010 (reference for a preliminary ruling from the Lietuvos Aukščiausiasis Teismas (Republic of Lithuania)) — Kirin Amgen Inc. v Lietuvos Respublikos valstybinis patentų biuras (Patent law — Proprietary medicinal products — Regulation (EEC) No 1768/92 — Articles 7, 19 and 19a(e) — Supplementary protection certificate for medicinal products — Period for lodging the application for such a certificate) {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 19 {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 7 Case C-482/07: Judgment of the Court (Third Chamber) of 3 September 2009 (Reference for a preliminary ruling from the Rechtbank te ’s-Gravenhage (Netherlands)) — AHP Manufacturing BV v Bureau voor de Industriële Eigendom (Patent law — Proprietary medicinal products — Regulations (EEC) No 1768/92 and (EC) No 1610/96 — Supplementary protection certificate for medicinal products — Conditions for granting certificates to two or more holders of basic patents for the same product — Clarification on the existence of pending applications) {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 7.1 {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 3 PT C) {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 7.2 Judgment of the Court (Fifth Chamber) of 16 September 1999. Farmitalia Carlo Erba Srl. Reference for a preliminary ruling: Bundesgerichtshof - Germany. Proprietary medicinal products - Supplementary protection certificate. Case C-392/97. Judgment of the Court (Second Chamber) of 2 September 2010. Kirin Amgen Inc. v Lietuvos Respublikos valstybinis patentų biuras. Reference for a preliminary ruling: Lietuvos Aukščiausiasis Teismas - Lithuania. Patent law - Proprietary medicinal products - Regulation (EEC) No 1768/92 - Articles 7, 19 and 19a(e) - Supplementary protection certificate for medicinal products - Period for lodging the application for such a certificate. Case C-66/09. Judgment of the Court (Second Chamber) of 21 April 2005. Novartis AG, University College London and Institute of Microbiology and Epidemiology v Comptroller-General of Patents, Designs and Trade Marks for the United Kingdom (C-207/03) and Ministre de l'Économie v Millennium Pharmaceuticals Inc. (C-252/03). References for a preliminary ruling: High Court of Justice (England & Wales), Chancery Division (Patents Court) - United Kingdom and Cour administrative - Luxembourg. Patent law - Medicinal products - Supplementary protection certificate for medicinal products. Joined cases C-207/03 and C-252/03. Judgment of the Court (Second Chamber) of 4 May 2006. Massachusetts Institute of Technology. Reference for a preliminary ruling: Bundesgerichtshof - Germany. Patent law - Medicinal products - Regulation (EEC) No 1768/92 - Supplementary protection certificate for medicinal products - Concept of 'combination of active ingredients'. Case C-431/04. Judgment of the Court (Second Chamber) of 28 July 2011. Synthon BV v Merz Pharma GmbH & Co. KGaA. Reference for a preliminary ruling: High Court of Justice (England & Wales), Chancery Division (Patents Court) - United Kingdom. Patent law - Medicinal products - Supplementary protection certificate for medicinal products - Regulation (EEC) No 1768/92 - Article 2 - Scope - Safety and efficacy testing laid down by Directive 65/65/EEC - Absence - Invalidity of the certificate. Case C-195/09. Judgment of the Court (Fifth Chamber) of 19 October 2004. Pharmacia Italia SpA, formerly Pharmacia & Upjohn SpA. Reference for a preliminary ruling: Bundesgerichtshof - Germany. Regulation (EEC) No 1768/92 - Medicinal products - Supplementary protection certificate - Transitional arrangements - Successive authorisations as a veterinary medicinal product and a medicinal product for human use. Case C-31/03. Judgment of the Court of 13 July 1995. Kingdom of Spain v Council of the European Union. Action for annulment - Council Regulation (EEC) Nº 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products. Case C-350/92. Legal basis TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY, PART FIVE - INSTITUTIONS OF THE COMMUNITY, TITLE I - PROVISIONS GOVERNING THE INSTITUTIONS, CHAPTER 1: THE INSTITUTIONS, SECTION 2: THE COUNCIL, ARTICLE 149 undefined EuroVoc Vocabulary Public health Internal market - Principles Medicinal product Pharmaceutical legislation Free movement of goods Proprietary medicinal products Public health Marketing standard Free movement of goods