AHP Manufacturing BV v Bureau voor de Industriële Eigendom.
Date: 2009-09-03
22. In that respect, the Court held at paragraph 28 of Case C‑181/95 Biogen [1997] ECR I‑357 that, where a product is protected by a number of basic patents in force, which may belong to a number of patent holders, each of those patents may be designated for the purpose of the procedure for the grant of an SPC, although only one SPC may be granted for each basic patent.
23. That statement by the Court corresponds to the provisions of Regulation No 1610/96 which, although it was adopted before the date of delivery of the Biogen  judgment, entered into force after that date. The second sentence of Article 3(2) of that Regulation provides for the possibility of granting one SPC for a product to each of two or more holders of different basic patents for that product. As set out in recital 17 in the preamble to that regulation, the detailed rules in Article 3(2) thereof, in particular, are also valid, mutatis mutandis , for the interpretation of Article 3 of Regulation No 1768/92 (C‑431/04 Massachusetts Institute of Technology [2006] ECR I‑4089, paragraph 24).
27. Next, the Court observes that the second sentence of Article 3(2) of Regulation No 1610/96 must be interpreted not solely on the basis of its wording, but also in the light of the overall scheme and objectives of the system of which it is a part (see, by analogy, Case C‑292/00 Davidoff  [2003] ECR I‑389, paragraph 24).
30. Regarding the objectives of Regulation No 1768/92, firstly, it must be noted that the fundamental objective of the Regulation, as set out in the first and second recitals in the preamble thereto, is to ensure sufficient protection to encourage pharmaceutical research, which plays a decisive role in the continuing improvement in public health (Case C‑392/97 Farmitalia [1999] ECR I‑5553, paragraph 19). In that regard, the third and fourth recitals in the preamble give as a reason for the adoption of the Regulation the fact that the period of effective protection under the patent is insufficient to cover the investment put into the pharmaceutical research. Regulation No 1768/92 thus seeks to make up for that insufficiency by creating an SPC for medicinal products. It seeks, in addition, to confer supplementary protection on the holders of national or European patents, without instituting any preferential ranking amongst them ( Biogen , paragraphs 26 and 27).
35. Second, Regulation No 1768/92, which was adopted on the basis of Article 100a of the EEC Treaty (subsequently Article 100a of the EC Treaty, and now, after amendment, Article 95 EC), establishes, as is apparent from the sixth and seventh recitals in the preamble thereto, a uniform solution at Community 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. 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 Community and thus directly affect the establishment and the functioning of the internal market (see Case C‑350/92 Spain  v Council  [1995] ECR I‑1985, paragraphs 34 and 35, and Case C‑127/00 Hässle  [2003] ECR I‑14781, paragraph 37).
36. Differences in the protection given in the Community to one and the same medicinal product would give rise to a fragmentation of the market, whereby the medicinal product would still be protected in some national markets but no longer protected in others (see Spain  v Council , paragraph 36).
39. Thirdly, apart from the objective of adequate protection to encourage research, Regulation No 1768/92 recognises, as is apparent from the ninth recital in its preamble, the necessity, in a sector as complex as the pharmaceutical sector, to take into account all the interests at stake, including those of public health (see Spain v Council , paragraph 38). For that purpose, the SPC may not be granted for a period exceeding five years. Similarly, the eighth recital in the preamble states that the holder of both a patent and an SPC should be able to enjoy an overall maximum of fifteen years of exclusivity from the time the medicinal product in question first obtains authorisation to be placed on the market in the Community.