CELEX: C2003/158/28
Language: en
Date: 2003-07-05 00:00:00
Title: Case C-207/03: Reference for a preliminary ruling by the High Court of Justice (England and Wales), Chancery Division, Patents Court by order of that court dated 6 May 2003, in the case of 1) Novartis AG 2) University College London 3) Institute of Microbiology and Epidemiology against Comptroller General of Patents, Designs and Trade Marks for the United Kingdom

5.7.2003               EN                         Official Journal of the European Union                                            C 158/17
Reference for a preliminary ruling by the High Court of                   The Commission of the European Communities claims that
Justice (England and Wales), Chancery Division, Patents                   the Court should:
Court by order of that court dated 6 May 2003, in the
case of 1) Novartis AG 2) University College London
3) Institute of Microbiology and Epidemiology against
Comptroller General of Patents, Designs and Trade Marks                   1.    declare that, by applying a prior authorisation procedure
                     for the United Kingdom                                     to personal imports, not effected by personal transport,
                                                                                of medicinal products lawfully prescribed in France,
                                                                                authorised under amended Directive 65/65/EEC (1)
                          (Case C-207/03)                                       (replaced by Directive 2001/83/EC) ( 2), both in France
                                                                                and in the Member State of the European Community
                          (2003/C 158/28)                                       where they are purchased, the French Republic has failed
                                                                                to fulfil its obligations under Article 28 of the Treaty
                                                                                establishing the European Community;
Reference has been made to the Court of Justice of the
European Communities by an order of the High Court of                     2.    declare that, by applying a prior authorisation procedure
Justice (England and Wales), Chancery Division, Patents Court                   to personal imports, not effected by personal transport,
dated 6 May 2003, which was received at the Court Registry                      of homeopathic medicinal products lawfully prescribed
on 14 May 2003, for a preliminary ruling in the case of                         in France and registered in a Member State of the
1) Novartis AG 2) University College London 3) Institute of                     European Community pursuant to Directive 92/73/
Microbiology and Epidemiology and Comptroller General of                        EEC (3) (replaced by Directive 2001/83/EC), the French
Patents, Designs and Trade Marks for the United Kingdom on                      Republic has failed to fulfil its obligations under Article 28
the following questions:                                                        of the Treaty establishing the European Community;
1)     Is the date of the granting of a marketing authorisation
       in Switzerland, which is automatically recognised in
       Liechtenstein, to be considered as the first authorisation         3.    declare that, by applying a disproportionate prior author-
       to place a medicinal product on the market, for the                      isation procedure to personal imports, not effected by
       purpose of calculating the duration of a supplementary                   personal transport, of medicinal products lawfully pre-
       protection certificate as provided in Article 13 of Regu-                scribed in France, not authorised in that country but only
       lation 1768/92 ( 1) (as amended by the EEA Agreement)?                   in the Member State of the European Community where
                                                                                they are purchased, the French Republic has failed to
2)     Is a competent authority within the EEA obliged to rectify               fulfil its obligations under Article 28 of the Treaty
       any existing supplementary protection certificates, the                  establishing the European Community;
       duration of which has been erroneously calculated?
                                                                          4.    order the French Republic to pay the costs.
( 1) Council Regulation (EEC) No 1768/92 of 18 June 1992 concern-
     ing the creation of a supplementary protection certificate for
     medicinal products OJ L 182, 02.07.1992, p. 1.
                                                                          Pleas in law and main arguments
Action brought on 15 May 2003 by the Commission of
  the European Communities against the French Republic
                          (Case C-212/03)                                 The Commission alleges the existence of measures having an
                                                                          effect equivalent to quantitative restrictions on imports of
                                                                          medicinal products, consisting of the imposition of a prior
                          (2003/C 158/29)                                 authorisation procedure relating to the personal importation
                                                                          into France, not effected by personal transport, of lawfully
                                                                          prescribed medicinal products, in breach of Article 28 EC.
                                                                          Such authorisation is required by the articles of the French
An action against the French Republic was brought before the              Public Health Code relating to the importation into French
Court of Justice of the European Communities on 15 May                    customs territory of medicinal products, including those
2003 by the Commission of the European Communities,                       having the status of Community goods. In many cases, that
represented by H. Støvlbæk and B. Stromsky, acting as Agents,             prior authorisation procedure cannot be justified on the basis
with an address for service in Luxembourg.                                of Article 30 EC.