CELEX: C1997/271/01
Language: en
Date: 1997-09-06 00:00:00
Title: JUDGMENT OF THE COURT of 9 July 1997 in Case C-316/95 (reference for a preliminary ruling from the Hoge Raad der Nederlanden): Generics BV v. Smith Kline & French Laboratories Ltd (Articles 30 and 36 of the EC Treaty - Patent - Registration of medicinal products - Infringement)

6 . 9 . 97           I EN [               Official Journal of the European Communities                                    C 271 / 1
                                                                  I
                                                            (Information)
                                               COURT OF JUSTICE
                                                        COURT OF JUSTICE
                JUDGMENT OF THE COURT                                     submission by another person of samples of medicinal
                         of 9 July 1997                                   products, manufactured in accordance with that
                                                                          process by a person other than the patentee, to the
in Case C-3 16/95 ( reference for a preliminary ruling from               authority       competent    for   issuing    marketing
the Hoge Raad der Nederlanden): Generics BV v. Smith                      authorizations, is justified under Article 36 of the EC
              Kline & French Laboratories Ltd ( ! )                       Treaty.
(Articles 30 and 36 of the EC Treaty — Patent —
     Registration of medicinal products — Infringement)               3 . When a person other than the patentee has infringed
                         ( 97/C 271 /01 )                                 the patent laws of a Member State by submitting
                                                                          samples of a medicinal product manufactured in
                                                                          accordance with a patented process to the authority
                 (Language of the case: Dutch)
                                                                          competent for issuing marketing authorizations and
                                                                          has thus obtained the authorization sought, an order
  (Provisional translation; the definitive translation will be            of a national court prohibiting the infringer from
           published in the European Court Reports)                       marketing such a product for a specified period
                                                                          following the expiry of the patent in order to prevent
In Case C-3 16/95 : reference to the Court under Article 177              him from deriving any unfair profit from his
of the EC Treaty from the Hoge Raad der Nederlanden                       infringement constitutes a measure having equivalent
( Supreme Court of the Netherlands ) for a preliminary                    effect within the meaning of Article 30 of the EC
ruling in the proceedings pending before that court                       Treaty capable of being justified under Article 36 of
between      Generics   BV    and  Smith    Kline   &   French            that Treaty.
Laboratories Ltd — on the interpretation of Articles 30
and 36 of the EC Treaty — the Court, composed of: G. C.               4 . Where the submission of samples of a medicinal
Rodriguez Iglesias, President, J. C. Moitinho de Almeida,                 product to the competent authority with a view to
J. L. Murray and L. Sevon ( Presidents of Chambers ),                     obtaining a marketing authorization has given rise to a
P. J. G. Kapteyn, C. Gulmann ( Rapporteur ), D. A. O.                     patent infringement, Community law, and in particular
Edward, G. Hirsch, P. Jann, H. Ragnemalm and M.                           Article 36 of the Treaty, does not preclude a national
Wathelet, Judges; F. G. Jacobs, Advocate General; D.                      court from prohibiting the infringer from marketing
Louterman-Hubeau, Principal Administrator, for the                        that product for 14 months after the expiry of the
Registrar, has given a judgment on 9 July 1997, in which                  patent in question, when that period, although
it has ruled :                                                            exceeding the maximum period authorized by Article 7
                                                                          of Council Directive 65/65/EEC of 26 January 1965
1 . Application of a rule of national law which gives the                 on the approximation of provisions laid down by law,
     proprietor of a patent in respect of a manufacturing                 regulation or administrative action relating to
     process for a medicinal product the right to oppose the              proprietary medicinal products, read in conjunction
     submission by another person of samples of medicinal                 with Article 4 (c) of Council Directive 75/319/EEC of
     products manufactured in accordance with that                        20 May 1975 on the approximation of provisions laid
     process to the authority competent for issuing                       down by law, for the procedure for granting a
     marketing authorizations constitutes a measure having                marketing authorization, corresponds to the actual
     equivalent effect to a quantitative restriction within               average duration - of such a procedure in the Member
     the meaning of Article 30 of the EC Treaty.                          State concerned.
2. Application of a rule of national law which gives the             (*) OJ C 315 , 25 . 11 . 1995 .
     proprietor of a patent in respect of a manufacturing
     process for a medicinal product the right to oppose the