Medeva BV v Comptroller General of Patents, Designs and Trade Marks.
Date: 2011-11-24
22. At paragraph 26 of Farmitalia , the Court stated that, as Community law then stood – a situation which has not substantially changed in the context of European Union law – the provisions concerning patents had not yet been made the subject of harmonisation at European Union level or of an approximation of laws.
24. It should be noted that Regulation No 469/2009 establishes a uniform solution at European Union level by creating a SPC which may be obtained by the holder of a national or European patent under the same conditions in each Member State. It thus aims to prevent the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the European Union and thus directly affect the establishment and functioning of the internal market (see Case C‑350/92 Spain v Council [1995] ECR I‑1985, paragraphs 34 and 35; Case C‑127/00 Hässle [2003] ECR I‑14781, paragraph 37; and Case C‑482/07 AHP Manufacturing [2009] ECR I‑7295, paragraph 35).
30. First, it must be noted that the fundamental objective of Regulation No 469/2009 is to ensure sufficient protection to encourage pharmaceutical research, which plays a decisive role in the continuing improvement in public health (see Farmitalia , paragraph 19, and AHP Manufacturing , paragraph 30).
31. The reason given for the adoption of that regulation is the fact that the period of effective protection under the patent is insufficient to cover the investment put into pharmaceutical research and the regulation thus seeks to make up for that insufficiency by creating a SPC for medicinal products (see Case C‑181/95 Biogen  [1997] ECR I‑357, paragraphs 26, and AHP Manufacturing , paragraph 30).
32. Moreover, as is apparent in particular from subparagraphs 4 and 5 of paragraph 28 of the explanatory memorandum, the protection conferred by a SPC is largely intended to cover the cost of research leading to the discovery of new ‘products’, that term being used as a common denominator covering the three different types of patent which can confer entitlement to a SPC. Further, if the conditions laid down in Regulation No 469/2009 are met, even a patent protecting the process by which a ‘product’ within the meaning of the regulation is obtained may, in accordance with Article 2 of the regulation, enable a SPC to be granted and, in that case, in accordance with Article 5 of the regulation and as stated at paragraph 44 of the explanatory memorandum, the SPC confers the same rights as conferred by the basic patent as regards the process by which the product is obtained, and, if the law applicable to that patent so provides, the protection of the process by which the product is obtained will be extended to the product thus obtained.
33. As the Court of Appeal stated and as is apparent from the observations submitted to the Court, at present medicinal products placed on the market, in particular for complex diseases, often consist of combinations of active ingredients for multiple therapeutic uses which can be administered to patients in a single preparation. Similarly, vaccines are often developed, in particular having regard to the recommendation of the health authorities of the Member States, in the form of multivalent vaccines.
34. If the holder of such a basic patent relating to an innovative active ingredient or an innovative combination of active ingredients were to be refused a SPC on the ground that, in the commercial version of the medicinal product which places that active ingredient or that combination on the market for the first time, the active ingredient or the combination coexists in the medicinal product alongside other active ingredients or combinations which have other therapeutic purposes and may or may not be protected by another basic patent in force, the fundamental objective of Regulation No 469/2009, which is to ensure sufficient protection to encourage pharmaceutical research and play a decisive role in the continuing improvement in public health, could be undermined.
36. It is clear that such an outcome cannot be compatible with the fundamental objectives pursued by Regulation No 469/2009 by the creation of a SPC for medicinal products.
37. The requirement in Regulation No 469/2009 that the ‘product’ must be covered, as a medicinal product, by a MA confirms that approach in that that requirement does not in itself rule out the possibility that the MA may cover other active ingredients contained in such a medicinal product. Moreover, in accordance with Article 4 of Regulation No 469/2009, a SPC is intended to protect the ‘product’ covered by the MA, not the medicinal product as such.
38. Furthermore, such a situation corresponds to that described at paragraphs 34 and 39 of the explanatory memorandum, in which the Commission of the European Communities stated, first, that the requirement that the product must have obtained a valid MA is met ‘if the proprietary medicinal product containing it has been granted the [MA] concerned’ and, second, that in such a situation, ‘where the product authorised consists of a combination of compound X and another active ingredient, only compound X will be protected by the certificate’.
39. In accordance with Article 5 of Regulation No 469/2009, a SPC thus granted in connection with such a product confers, upon the expiry of the patent, the same rights as were conferred by the basic patent in relation to the product, within the limits of the protection conferred by the basic patent, as provided for in Article 4 of the regulation. Accordingly, if, during the period in which the patent was valid, the patent holder could oppose, on the basis of his patent, all use or certain uses of his product in the form of a medicinal product consisting of such a product or containing it, the SPC granted in relation to that product would confer on the holder the same rights for all uses of the product, as a medicinal product, which were authorised before the expiry of the certificate.
40. However, it should be added that, in a situation such as that in the main proceedings, first, only the authorisation in respect of the first medicinal product placed on the European Union market comprising, among its active ingredients, the combination of the two active ingredients identified in the wording of the claims of the patent, namely pertactin and filamentous haemagglutinin, may be regarded as the first MA for that ‘product’ as a medicinal product within the meaning of Article 3(d) of Regulation No 469/2009.
41. Second, where a patent protects a product, in accordance with Article 3(c) of Regulation No 469/2009, only one certificate may be granted for that basic patent (see Biogen , paragraph 28).