CELEX: C2000/163/32
Language: en
Date: 2000-06-10 00:00:00
Title: Case C-127/00: Reference for a preliminary ruling from the Bundesgerichtshof by order of that court of 1 February 2000 in the case of Aktiebolaget Hässle v ratiopharm GmbH

C 163/18               EN                     Official Journal of the European Communities                                     10.6.2000
Reference for a preliminary ruling from the Bundesger-                   3. Is the list of grounds of invalidity in Article 15(1) of the
ichtshof by order of that court of 1 February 2000 in the                    Regulation exhaustive?
      case of Aktiebolaget Hässle v ratiopharm GmbH
                                                                             If not:
                         (Case C-127/00)                                     (a) Does it constitute a ground of invalidity that a
                                                                                  certificate was granted under the transitional provision
                                                                                  in Article 19(1) of the Regulation even though a first
                                                                                  authorisation to place the product on the market in
                         (2000/C 163/32)                                          the Community was already granted before the relevant
                                                                                  date for the Member State in which the certificate was
                                                                                  applied for and granted?
Reference has been made to the Court of Justice of the
European Communities by an order of the Bundesgerichtshof                    (b) In that case is the certificate completely invalid, or
(Federal Court of Justice) of 1 February 2000, which was                          should its duration merely be rectified accordingly?
received at the Court Registry on 3 April 2000, for a prelimi-
nary ruling in the case of Aktiebolaget Hässle v ratiopharm              4. If a breach of the transitional provision in Article 19(1) of
GmbH on the following questions on the interpretation of                     the Regulation does not constitute a ground of invalidity:
Articles 15 and 19(1) of Council Regulation (EEC) No 1768/92
of 18 June 1992 concerning the creation of a supplementary
protection certificate for medicinal products (OJ 1992 L 182,                May and must national law provide, as under Article 17(2)
p. 1):                                                                       of Regulation (EC) No 1610/96 of the European Parliament
                                                                             and of the Council of 23 June 1996 concerning the
                                                                             creation of a supplementary protection certificate for plant
1. (a) For application of the transitional provision in Article              protection products (3), for an appeal aimed at rectifying
        19(1) of the Regulation, in so far as that provision                 the duration of the protection certificate for a medicinal
        relates to the ‘first authorisation to place ... on the              product in the event of a breach of the transitional
        market ... in the Community’ before a specified relevant             provision in Article 19(1) of the Regulation?
        date, does that refer exclusively to an authorisation
        within the meaning of Directive 65/65/EEC (1) or
        Directive 81/851/EEC (2) as the case may be, or may              (1) OJ, English Special Edition 1965-1966, p. 20.
        another authorisation granted later (after the relevant          (2) OJ L 317 of 6.11.1981, p. 1.
        date) relating in particular to the prices of the medicinal      (3) OJ L 198 of 8.8.1996, p. 30.
        product also be material in this respect, if
        (aa) without such a further authorisation, for example
             one for price-law purposes, marketing of the
             medicinal product is not permissible under the law
             of the Member State concerned, or
        (bb)without such a further authorisation the medicinal
             product may in principle be marketed in the                 Reference for a preliminary ruling by the Unabhängiger
             Member State concerned, but effective marketing             Verwaltungssenat Salzburg by order of that court of
             is nevertheless not possible, in particular because         28 March 2000 in the appeal concerning Rudolf Resl, Josef
             the sickness funds reimburse the costs of the               Fleckl, Werner Karlinger, Grundverkehrsbeauftragter des
             medicinal product only if the further authorisation,        Landes Salzburg and Grundverkehrslandeskommission
             in particular for price-law purposes, has been                                     des Landes Salzburg
             granted or a determination of the price eligible for
             reimbursement has been made?
                                                                                                   (Case C-128/00)
    (b) Is the material authorisation for this purpose a first                                     (2000/C 163/33)
        authorisation in any Member State of the Community
        (as with Articles 8 and 13 of the Regulation) or the
        first authorisation in the Member State for which the            Reference has been made to the Court of Justice of the
        grant of the supplementary protection certificate has            European Communities by order of the Unabhängiger Verwal-
        been applied for?                                                tungssenat Salzburg of 28 March 2000, received at the Court
                                                                         Registry on 4 April 2000, for a preliminary ruling in the
                                                                         appeal concerning Rudolf Resl, Josef Fleckl, Werner Karlinger,
2. Is there doubt as to the validity of the transitional provision       Grundverkehrsbeauftragter des Landes Salzburg and Grundver-
    in Article 19(1) of the Regulation in so far as it lays down         kehrslandeskommission des Landes Salzburg on the following
    different relevant dates for different Member States?                question: