Kirin Amgen Inc. v Lietuvos Respublikos valstybinis patentų biuras.
Date: 2010-09-02
18. Bearing in mind the very purpose of an adversarial procedure, which is to prevent the Court from being influenced by arguments which the parties have been unable to discuss, the Court may of its own motion, on a proposal from the Advocate General or at the request of the parties, order that the oral procedure be reopened, in accordance with Article 61 of its Rules of Procedure, if it considers that it lacks sufficient information or that the case must be dealt with on the basis of an argument which has not been debated between the parties (see, inter alia, the order in Case C-17/98 Emesa Sugar  [2000] ECR I-665, paragraph 18, and Case C‑42/07 Liga Portuguesa de Futebol Profissional and Bwin International  [2009] ECR I‑7633, paragraph 31 and the case-law cited).
21. It is apparent from the order for reference and, in particular, from the first two questions asked by the national court that the latter considers that the outcome of the main proceedings depends essentially on the interpretation of Article 19 of Regulation No 1768/92. The Court has already held that the European Union legislature included that article in the regulation’s transitional provisions in order to limit the adverse consequences of the expiry or reduction of the six-month period laid down in Article 7(1) of the regulation and to make it possible for products which had already obtained authorisation to be placed on the market as medicinal products on the date on which the regulation entered into force to take advantage of the scheme established by the regulation. Article 19(2) operates, in the circumstances provided for in Article 19(1), as a derogation from Article 7 of the regulation (see, to this effect, Case C-110/95 Yamanouchi Pharmaceutical  [1997] ECR I-3251, paragraph 19, and Case C‑127/00 Hässle  [2003] ECR I‑14781, paragraph 29).
22. The Court has also held that it was in order to take account of differences in Member States’ assessments that Article 19 of Regulation No 1768/92 set, as a transitional measure, different relevant dates for different Member States as regards the obtaining of the first marketing authorisation, the setting of such dates thus appearing to be justified inasmuch as each of them reflects the assessment made by each Member State in the light, in particular, of its health system, the organisation and financing of which vary from one Member State to the next (see, to this effect, Hässle , paragraphs 39 and 40). That provision therefore reflects the result of negotiations and establishes specific mechanisms for different Member States.
27. In the procedure laid down by Article 267 TFEU providing for cooperation between national courts and the Court of Justice, it is for the latter to provide the national court with an answer which will be of use to it and enable it to determine the case before it. To that end, the Court may have to reformulate the questions referred to it. The Court has a duty to interpret all provisions of Community law which national courts need in order to decide the actions pending before them, even if those provisions are not expressly indicated in the questions referred to the Court of Justice by those courts (see Joined Cases C-329/06 and C-343/06 Wiedemann and Funk  [2008] ECR I‑4635, paragraph 45 and the case-law cited).
30. As a transitional provision derogating from Article 7 of Regulation No 1768/92, Article 19a(e) of that regulation, just like Article 19, is intended to limit the adverse consequences of the expiry or reduction of the period referred to in Article 7 for applying for an SPC in Lithuania and makes it possible for products which had already obtained a national authorisation to be placed on the market as medicinal products on the date on which the regulation entered into force to take advantage of the scheme established by the regulation (see, by analogy, Hässle , paragraph 29).
31. It is settled case-law that derogations laid down by acts of accession must be interpreted strictly (see, to this effect, Joined Cases C-267/95 and C-268/95 Merck and Beecham [1996] ECR I‑6285, paragraph 23, and Case C-233/97 KappAhl  [1998] ECR I‑8069, paragraph 18).
33. Under Article 19a(e) of Regulation No 1768/92, an SPC may be granted only in respect of a product for which a first authorisation to place it on the market as a medicinal product has been obtained in Lithuania. This provision does not lay down any derogation concerning products which have been the subject of a Community marketing authorisation. Since the provision is couched in clear and unambiguous terms, it must, in accordance with the rule that transitional provisions are to be interpreted strictly, be construed in a manner which accords with its wording and which reflects the will of the European Union legislature as resulting from the negotiations which led to the 2003 Act of Accession.
36. According to Article 7(1) of Regulation No 1768/92, read in conjunction with Article 3(b) and (d) thereof, an application for an SPC must be lodged within six months of the date on which the first authorisation to place the product on the market as a medicinal product is granted in the Member State for which the application is made (see Hässle , paragraph 26).
41. In the absence of a definition of ‘grant’ in Regulation No 1768/92, it follows from the Court’s settled case‑law that, in interpreting a provision of European Union law, it is necessary to consider not only its wording but also the context in which it occurs and the objectives pursued by the rules of which it is part (see, inter alia, Case 292/82 Merck  [1983] ECR 3781, paragraph 12; Case C‑34/05 Schouten  [2007] ECR I‑1687, paragraph 25; Case C-466/07 Klarenberg  [2009] ECR I-803, paragraph 37; and Case C-433/08 Yaesu Europe  [2009] ECR I‑0000, paragraph 24).
45. As regards the objective pursued by Regulation No 1768/92, it is admittedly true that the regulation establishes a uniform solution at European Union level by creating an SPC which may be obtained by the holder of a national or European patent under the same conditions in each Member State and by providing, in particular, for a uniform duration of protection (see, by analogy, Case C-350/92 Spain  v Council  [1995] ECR I-1985, paragraph 34, and Hässle , paragraph 37). As is apparent from the sixth recital in its preamble, that regulation seeks thereby to prevent the heterogeneous development of national laws leading to disparities likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the establishment and the functioning of the internal market.
46. Nevertheless, certain Member States wished, in accordance with the 10th recital in the preamble to that regulation, to safeguard for a longer period the achievement of other legitimate objectives, concerning their public-health policies, and, in particular, ensure the financial stability of their health system by supporting the generic medicinal product manufacturing industry (see, to this effect, Hässle , paragraph 38).
47. In order to take account of those differences in assessment, Articles 19 and 19a of Regulation No 1768/92 contain different relevant dates as a transitional measure. The setting of those dates according to the Member State thus appears to be justified inasmuch as each of them shows the assessment made by each Member State in the light, in particular, of its health system, the organisation and financing of which vary from one Member State to the next (see, by analogy, Hässle , paragraphs 39 and 40).
48. It follows from the foregoing that the objective pursued by Regulation No 1768/92 of according uniform protection for a medicinal product throughout the European Union does not preclude transitional provisions, resulting from the accession negotiations, which may mean that it is not possible to apply for an SPC for certain medicinal products in certain Member States. This outcome, which may impede, even if only temporarily, that objective and the functioning of the internal market, is justified by the legitimate objectives concerning health policies, including, as the case may be, the financial stability of the health systems of the Member States (see, to this effect, Hässle , paragraph 46).