Opinion of the Advocate General — ECLI:EU:C:2010:96
Date: 2010-02-25
Language of the case: Lithuanian
Subject matter: Intellectual, industrial and commercial property;Approximation of laws;Patents
Procedure: Reference for a preliminary ruling
Origin: Lithuania

Summary of the Pharmaceutical Sector Inquiry Report’ of 8 July 2009 (COM(2009) 351 final, pp. 10 and 11)). 20 – Paragraph 36. 21 – Case C-482/07 [2009] ECR I-7295, paragraph 35. 22 – See Spain v Council, paragraphs 35 and 36, and AHP Manufacturing, paragraphs 35 and 36. 23 – Case C-420/06 Jager [2008] ECR I-1315, paragraph 46. 24 – Ibid., paragraph 47. 25 – The relationship between those two provisions has already been explained by the Court in Case C-127/00 Hässle [2003] ECR I-14781. As the Court points out, Article 19 of the Regulation is a transitional provision which derogates from Article 7 of the Regulation. Under Article 19(2) of the Regulation, the holder of a basic patent may lodge an application for a supplementary protection certificate within six months of the date on which the Regulation enters into force in the specific cases and circumstances referred to in Article 19(1), namely: where the product, on the date on which the Regulation enters into force or on the date of the accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden, is already protected by a valid basic patent and has obtained the first authorisation to place it on the market in the Community or in the territory of those three States after 1 January 1985; if the certificate must be granted in Denmark, in Germany or in Finland, the date of 1 January 1985 is replaced by 1 January 1988; if the certificate must be granted in Belgium, in Italy or in Austria, the date of 1 January 1985 is replaced by 1 January 1982. 26 – See, in particular, Case 258/81 Metallurgiki Halyps v Commission [1982] ECR 4261, paragraph 8. 27 – See, in particular, Joined Cases C-267/95 and C-268/95 Merck and Beecham [1996] ECR I‑6285, paragraph 23 and the case-law cited; Case C-233/97 KappAhl [1998] ECR I-8069, paragraph 18 and the case-law cited; and Hässle, paragraph 52 et seq. 28 – KappAhl, paragraph 15 and the case-law cited. 29 – According to Article 12(1) of Regulation No 2309/93, a marketing authorisation which has been granted in accordance with the centralised procedure is to confer the same rights and obligations in each of the Member States as a marketing authorisation granted by a Member State in accordance with the harmonised requirements laid down by Directive 65/65. 30 – It may be asked whether, like authorisations granted by the Austrian, Finnish and Swedish authorities, authorisations granted by the Republic of Lithuania were equated, under Article 19a of the Regulation, to an authorisation granted in accordance with the requirements of Directive 65/65. In the case of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden, that was expressly laid down in Article 3 of the Regulation. That article provides that an authorisation to place the product on the market granted in accordance with the national legislation of Austria, Finland or Sweden is treated as an authorisation granted in accordance with Directive 65/65. However, there is no similar provision relating to successive accessions to the European Union. 31 – Case C-413/04 [2006] ECR I-11221, concerning the application of certain provisions of secondary Community legislation to the Republic of Estonia. 32 – The prices of generic medicinal products are generally much lower than those of originator medicinal products, making it possible to contain the budgets allocated to public health and providing a greater number of patients with access to safe and innovative medicinal products. 33 – See the Commission communication referred to in footnote 19 (p. 2). 34 – See, in particular, Metallurgiki Halyps v Commission, paragraph 8. 35 – AHP Manufacturing, paragraph 35. 36 – See point 44 of the Opinion. 37 – Under Article 12(3) of Regulation No 2309/93, the date on which the marketing authorisation is granted by the Commission is to be published in the Official Journal of the European Communities. 38 – I would recall that, under Article 13 of the Regulation, the duration of the certificate is equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community reduced by a period of five years. 39 – See point 44 of the Opinion.