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61995J0316 European Court reports 1997 Page I-03929 1
Judgment of the Court
of 9 July 1997
Generics BV v Smith Kline & French Laboratories Ltd.
Reference for a preliminary ruling: Hoge Raad - Netherlands.
Articles 30 and 36 of the EC Treaty - Patent - Registration of medicinal products - Infringement.
Case C-316/95.
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))
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
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