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You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> Pharmacia Italia (anciennement Pharmacia & Upjohn) (Approximation of laws) [2004] EUECJ C-31/03 (19 October 2004) URL: https://www.bailii.org/eu/cases/EUECJ/2004/C3103.html Cite as: [2004] EUECJ C-31/3, [2004] EUECJ C-31/03, [2005] RPC 27, [2004] ECR I-10001 |
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JUDGMENT OF THE COURT (Fifth Chamber)
19 October 2004 (1)
(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)
In Case C-31/03,REFERENCE for a preliminary ruling under Article 234 EC from the Bundesgerichtshof (Germany), made by decision of 17 December 2002, received at the Court on 27 January 2003, in the proceedings brought by Pharmacia Italia SpA, formerly Pharmacia & Upjohn SpA,THE COURT (Fifth Chamber),
after hearing the Opinion of the Advocate General at the sitting on 29 April 2004,
gives the following
-˜Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in Council Directive 65/65/EEC or Directive 81/851/EEC may, under the terms and conditions provided for in this Regulation, be the subject of a certificate.-™
- Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ, English Special Edition 1965-1966, p. 20), replaced by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), - Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (OJ 1981 L 317, p. 1), replaced by Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ 2001 L 311, p. 1).
-˜A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application: (a) the product is protected by a basic patent in force; (b) a valid [marketing authorisation for the product] as a medicinal product has been granted in accordance with Directive 65/65/EEC or Directive 81/851/EEC, as appropriate; (c) the product has not already been the subject of a certificate; (d) the authorisation referred to in (b) is the first [marketing authorisation for the product] as a medicinal product.-™
-˜Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the [marketing authorisation for the corresponding product] and for any use of the product as a medicinal product that has been authorised before the expiry of the certificate.-™
-˜1. Any product which, on the date on which this regulation enters into force, is protected by a valid basic patent and for which the first [marketing authorisation] in the Community was obtained after 1 January 1985 may be granted a certificate. In the case of certificates to be granted in Denmark and in Germany, the date of 1 January 1985 shall be replaced by that of 1 January 1988. -¦ -™
- Pharmacia was the holder of German Patent No 31 12 861 lodged on 31 March 1981 which had since expired. The first patent claim covered ergoline derivatives and their pharmaceutically acceptable salts obtained by the addition of organic or inorganic acids. The second sub claim covered a compound known by the international non-proprietary name of -˜Cabergoline-™; - on 15 June 1994, the medicinal product -˜Dostinex-™ was authorised in Germany. That was the first marketing authorisation at national level for the product protected as a medicinal product. The authorisation identifies the active ingredient of the medicinal product as being -˜Cabergoline-™. That active ingredient had been first authorised as a medicinal product for human use on 21 October 1992 in the Netherlands. The veterinary medicinal product -˜Galastop-™ which also contains the active ingredient -˜Cabergoline-™, had been authorised in Italy on 7 January 1987; - on 13 December 1994 Pharmacia applied for a certificate to the Deutsches Patentamt. That application for a certificate was primarily in respect of the active ingredient -˜Cabergoline-™ in the form of the free base or salt obtained by addition of an acid and, in the alternative, in respect of the active ingredient of the medicinal product -˜Dostinex-™ in all forms protected by the basic patent.
-˜Is the grant of a supplementary protection certificate in a Member State of the Community on the basis of a medicinal product for human use authorised in that Member State precluded by a [marketing authorisation for that product] as a veterinary medicinal product granted in another Member State of the Community before the date specified in Article 19(1) of the Regulation No 1768/92, or is the sole determining factor the date on which the product was authorised in the Community as a medicinal product for human use?-™
- on the date of entry into force of the regulation, namely 2 January 1993, the product is protected by a valid basic patent, and - the first marketing authorisation was obtained for the product as a medicinal product in the Community after a certain date (in the case of Germany, 1 January 1988).
- the first marketing authorisation in the Community referred to by that article is not intended to take the place of the marketing authorisation provided for in Article 3(b) of the abovementioned regulation; instead, it constitutes a further condition applying in the event that the latter authorisation is not the first authorisation to place the product on the market as a medicinal product in the Community (paragraph 73); - the words -˜first marketing authorisation-™ must not be interpreted differently depending on the provision of Regulation No 1768/92 in which they appear. The same is particularly true of the words -˜first marketing authorisation -¦ in the Community-™ (paragraph 72).
- pursuant to Article 1(b) of the regulation, the term product as used in the regulation is defined as an active ingredient or combination of active ingredients of a medicinal product; - pursuant to Article 3 of the regulation, the certificate is to be granted, inter alia, provided that the product has been granted a marketing authorisation as a medicinal product in accordance with Directive 65/65 or Directive 81/851; and - pursuant to Article 4 of the regulation, the protection conferred by a certificate is to extend only to the product covered by the marketing authorisation for the corresponding medicinal product for any use of the product as a medicinal product that has been authorised before the expiry of the certificate.
1 - Language of the case: German.