CELEX: C2004/047/01
Language: en
Date: 2004-02-21 00:00:00
Title: Judgment of the Court (Sixth Chamber) of 11 December 2003 in Case C-127/00 (Reference for a preliminary ruling from the Bundesgerichtshof): Hässle AB v Ratiopharm GmbH (Council Regulation (EEC) No 1768/92 — Medicinal products — Supplementary protection certificate — Articles 15 and 19 — Validity of Article 19 — Concept of "first authorisation to place … on the market in the Community" — Legal effects of non-compliance with the relevant date referred to in Article 19)

21.2.2004                EN                           Official Journal of the European Union                                                  C 47/1
                                                                           I
                                                                    (Information)
                                                       COURT OF JUSTICE
                                                                COURT OF JUSTICE
                 JUDGMENT OF THE COURT                                              the Community’ in Article 19(1) of Regulation No 1768/92
                                                                                    refers solely to the first authorisation required under provisions
                          (Sixth Chamber)                                           on medicinal products, within the meaning of Council Directive
                                                                                    65/65/EEC of 26 January 1965 on the approximation of
                       of 11 December 2003                                          provisions laid down by law, regulation or administrative action
                                                                                    relating to proprietary medicinal products, granted in any of the
in Case C-127/00 (Reference for a preliminary ruling                                Member States, and does not therefore refer to authorisations
from the Bundesgerichtshof): Hässle AB v Ratiopharm                                 required under legislation on pricing of or reimbursement for
                               GmbH (1)                                             medicinal products.
(Council Regulation (EEC) No 1768/92 — Medicinal prod-                        3.    A supplementary protection certificate which, contrary to the
ucts — Supplementary protection certificate — Articles 15                           requirements of Article 19 of Regulation No 1768/92, has
and 19 — Validity of Article 19 — Concept of ‘first                                 been delivered where the first marketing authorisation in the
authorisation to place ... on the market in the Community’                          Community was obtained prior to the relevant date fixed by
— Legal effects of non-compliance with the relevant date                            that provision is invalid pursuant to Article 15 thereof.
                      referred to in Article 19)
                                                                              (1) OJ C 163 of 10.6.2002.
                           (2004/C 47/01)
                    (Language of the case: German)
(Provisional translation; the definitive translation will be published
                    in the European Court Reports)                                               JUDGMENT OF THE COURT
                                                                                                        of 13 January 2004
In Case C-127/00: Reference to the Court under Article 234
EC by the Bundesgerichtshof (Germany) for a preliminary                       in Case C-440/00 (Reference for a preliminary ruling from
ruling in the proceedings pending before that court between                   the Bundesarbeitsgericht ): Gesamtbetriebsrat der Kühne
Hässle AB and Ratiopharm GmbH, on the interpretation of                        & Nagel AG & Co. KG v Kühne & Nagel AG & Co. KG (1)
Articles 15 and 19 of Council Regulation (EEC) No 1768/92
of 18 June 1992 concerning the creation of a supplementary                    (Social policy — Articles 4 and 11 of Directive 94/45/EC —
protection certificate for medicinal products (OJ 1992 L 182,                 European Works Councils — Informing and consulting
p. 1), the Court (Sixth Chamber), composed of: V. Skouris,                    employees in Community-scale undertakings — Group of
acting for the President of the Chamber, C. Gulmann,                          undertakings whose central management is not located in a
J.N. Cunha Rodrigues, R. Schintgen and F. Macken (Rappor-                                                  Member State)
teur), Judges; C. Stix-Hackl, Advocate General; D. Louterman-
Hubeau, Head of Division, for the Registrar, has given a                                                  (2004/C 47/02)
judgment on 11 December 2003, in which it has ruled:
                                                                                                   (Language of the case: German)
1.    Consideration of the second question referred has disclosed no
      factor capable of affecting the validity of Article 19 of Council
      Regulation (EEC) No 1768/92 of 18 June 1992 concerning                  (Provisional translation; the definitive translation will be published
      the creation of a supplementary protection certificate for                                   in the European Court Reports)
      medicinal products.
2.    So far as concerns medicinal products for human use, the                In Case C-440/00: Reference to the Court under Article 234
      concept of ‘first authorisation to place ... on the market ... in       EC by the Bundesarbeitsgericht (Germany) for a preliminary