Keywords

Summary



Keywords

1 Free movement of goods - Quantitative restrictions - Measures having equivalent effect - Use by a third party, with a view to obtaining a marketing authorization, of samples of a medicinal product manufactured in accordance with a patented process - Opposition on the part of the patentee - Circumstances amounting to a measure having equivalent effect - Justification - Protection of industrial and commercial property

(EC Treaty, Arts 30 and 36)

2 Free movement of goods - Quantitative restrictions - Measures having equivalent effect - Use by a third party, with a view to obtaining a marketing authorization, of samples of a medicinal product manufactured in accordance with a patented process - Obtention of authorization - Court order prohibiting marketing of the product for a specified period following expiry of the patent - Circumstances amounting to a measure having equivalent effect - Justification - Protection of industrial and commercial property - Period of prohibition exceeding that provided for in Directives 65/65 and 75/319 - Compatible with Community law

(EC Treaty, Arts 30 and 36; Council Directives 65/65, Art. 7, and 75/319, Art. 4(c))

Summary

3 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, before the expiry of the patent in question, 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 Treaty. In the absence of such a provision, it cannot be ruled out that marketing authorization, the issuing of which involves a certain delay, might already be obtained while the patent was still valid or that a medicinal product manufactured in accordance with the same procedure and legally in circulation in another Member State could consequently be imported immediately after the expiry of the patent.

Application of such a rule is none the less justified under Article 36 of the Treaty on grounds relating to the protection of industrial and commercial property. The right which it confers on a patentee relates to the specific subject-matter of the patent - which includes, in particular, allowing the holder a monopoly of first exploitation of his product - and to preclude application of a national rule providing for that right would in fact be to allow an encroachment on that monopoly.

4 When a person other than the patentee has infringed the patent laws of a Member State by submitting, before the expiry of the patent in question, 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, in so far as it prohibits the marketing in one Member State of a product lawfully sold in another Member State, a measure having equivalent effect within the meaning of Article 30 of the Treaty.

However, since the patentee, if the infringer had respected his rights, could have continued to market his product without competition throughout the period required to obtain the marketing authorization, a temporary prohibition placed by court order on the infringer, in so far as it seeks to place the proprietor of the patent in the position in which he would, in principle, have been had his rights 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.