Master's Program 2004/2005 Technical and Fiscal Barriers ... - Lexnet

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61995J0316 European Court reports 1997 Page I-03929 2 been respected, cannot in itself be held to be a disproportionate form of reparation and is thus capable of being justified under Article 36 of the Treaty on grounds relating to the protection of industrial and commercial property. Community law, and in particular Article 36 of the Treaty, does not preclude such a court order from being imposed for 14 months after the expiry of the patent, when that period, although exceeding the maximum period authorized by Article 7 of Directive 65/65 read in conjunction with Article 4(c) of Directive 75/319, both relating to proprietary medicinal products, corresponds to the actual average duration of such a procedure in the Member State concerned. The effect of such a period of prohibition is to place the proprietor of the patent in the position in which he would in principle have been if his rights had been respected. In addition, the circumstance that the 14-month period exceeds the period provided for in the directives cannot be relied on by an infringer as against the proprietor of the patent without accepting the risk of favouring the infringer over the victim of the infringement. In Case C-316/95, REFERENCE to the Court under Article 177 of the EC Treaty by the Hoge Raad der Nederlanden for a preliminary ruling in the proceedings pending before that court between Generics BV and Smith Kline & French Laboratories Ltd on the interpretation of Articles 30 and 36 of the EC Treaty, THE COURT, composed of: G.C. Rodríguez Iglesias, President, J.C. Moitinho de Almeida, J.L. Murray and L. Sevon (Presidents of Chambers), P.J.G. Kapteyn, C. Gulmann (Rapporteur), D.A.O. Edward, G. Hirsch, P. Jann, H. Ragnemalm and M. Wathelet, Judges, Advocate General: F.G. Jacobs, Registrar: D. Louterman-Hubeau, Principal Administrator, after considering the written observations submitted on behalf of: - Generics BV, by G. van der Wal, of the Hague Bar, - Smith Kline & French Laboratories Ltd, by C.J.J.C. van Nispen and D.B. Schutjens, of the Hague Bar, and E.H. Pijnacker Hordijk, of the Amsterdam Bar, - the German Government, by A. Dittrich, Regierungsdirektor in the Federal Ministry of Justice, and B. Kloke, Oberregierungsrat in the Federal Ministry of the Economy, acting as Agents, - the Greek Government, by K. Grigoriou, Legal Agent to the State Legal Council, and L. Pneumatikou, Specialist Adviser in the Special Community Legal Affairs Department of the Ministry of Foreign Affairs, acting as Agents, - the United Kingdom Government, by L. Nicoll, of the Treasury Solicitor's Department, acting as Agent, and - the Commission of the European Communities, by H. van Lier, Principal Legal Adviser, and B.J. Drijber, of its Legal Service, acting as Agents, having regard to the Report for the Hearing, © An extract from a JUSTIS database 204
61995J0316 European Court reports 1997 Page I-03929 3 after hearing the oral observations of Generics BV, represented by G. van der Wal; of Smith Kline & French Laboratories Ltd, represented by C.J.J.C. van Nispen and E.H. Pijnacker Hordijk; of the Greek Government, represented by K. Grigoriou and V. Kontolaimos, Deputy Legal Adviser to the State Legal Council, acting as Agent; of the United Kingdom Government, represented by L. Nicoll and M. Silverleaf QC; and of the Commission, represented by B.J. Drijber, at the hearing on 7 January 1997, after hearing the Opinion of the Advocate General at the sitting on 27 February 1997, gives the following Judgment Costs 35 The costs incurred by the German, Greek and United Kingdom Governments and the Commission of the European Communities, which have submitted observations to the Court, are not recoverable. Since these proceedings are, for the parties to the main proceedings, a step in the proceedings pending before the national court, the decision on costs is a matter for that court. On those grounds, THE COURT, in answer to the questions referred to it by the Hoge Raad der Nederlanden, by judgment of 29 September 1995, hereby rules: 1. Application of a rule of national law which gives the proprietor of a patent in respect of a manufacturing process for a medicinal product the right to oppose the submission by another person of samples of medicinal products manufactured in accordance with that process to the authority competent for issuing marketing authorizations constitutes a measure having equivalent effect to a quantitative restriction within the meaning of Article 30 of the EC Treaty. 2. Application of a rule of national law which gives the proprietor of a patent in respect of a manufacturing process for a medicinal product the right to oppose the submission by another person of samples of medicinal products, manufactured in accordance with that process by a person other than the patentee, to the authority competent for issuing marketing authorizations, is justified under Article 36 of the EC Treaty. 3. When a person other than the patentee has infringed the patent laws of a Member State by submitting samples of a medicinal product manufactured in accordance with a patented process to the authority competent for issuing marketing authorizations and has thus obtained the authorization sought, an order of a national court prohibiting the infringer from marketing such a product for a specified period following the expiry of the patent in order to prevent him from deriving any unfair profit from his infringement constitutes a measure having equivalent effect within the meaning of Article 30 of the EC Treaty capable of being justified under Article 36 of that Treaty. 4. Where the submission of samples of a medicinal product to the competent authority with a view to obtaining a marketing authorization has given rise to a patent infringement, Community law, and in particular Article 36 of the Treaty, does not preclude a national court from prohibiting the infringer from marketing that product for 14 months after the expiry of the patent in question, when that period, although exceeding the maximum period authorized by Article 7 of 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, read in conjunction with Article 4(c) of Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, for the © An extract from a JUSTIS database 205
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