Court of Justice of the European Communities, C-316/95
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.
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.
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.
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, for the procedure for granting a marketing authorization, corresponds to the actual average duration of such a procedure in the Member State concerned.
