CELEX: C1998/166/12
Language: en
Date: 1998-05-30 00:00:00
Title: Reference for a preliminary ruling by the Divisional Court, Queen's Bench Division, by order of that court of 31 July 1997, in the case of The Queen against The Licensing Authority Established by the Medicines Act 1968 (acting by the Medicines Control Agency), ex parte: 1) Rhône-Poulenc Rorer Ltd 2) May & Baker Ltd. (Case C-94/98)

C 166/8               EN                Official Journal of the European Communities                                     30.5.98
laws of the Member States relating to trade marks (1) (the                   continue to manufacture and market product X
Trade Mark Directive') that Member States are precluded                       in Member States other than Member State B?
from introducing or maintaining a legal position whereby
trade mark rights are exhausted where the trade mark is            2. To what extent is it relevant to the answer to
marketed outside the Community under that mark?                         Question 1 that:
(1) OJ L 40 of 11.2.1989, p. 1.                                         (i)    the marketing authorisation for medicinal
                                                                               product X ceased to have effect in Member State
                                                                               B as a result of voluntary surrender on the part
                                                                               of the person to whom it had been granted; and/
                                                                               or
                                                                        (ii)   the formulation of medicinal product Y was
Reference for a preliminary ruling by the Divisional                           developed and introduced in order to provide a
Court, Queen's Bench Division, by order of that court of                       benefit to public health which medicinal product
31 July 1997, in the case of The Queen against The                             X (manufactured according to a different
Licensing Authority Established by the Medicines Act                           formulation) does not provide; and/or
1968 (acting by the Medicines Control Agency), ex parte:
     1) Rhône-Poulenc Rorer Ltd 2) May & Baker Ltd.                     (iii) that benefit to public health would not be
                       (Case C-94/98)                                          achieved if product X and product Y are both on
                                                                               the market in Member State B at the same time;
                        (98/C 166/12)
                                                                               and/or
Reference has been made to the Court of Justice of the                  (iv) the differences between the formulations of
European Communities by an order of the Divisional                             medicinal product X and medicinal product Y
Court, Queen's Bench Division, of 31 July 1997, which                          are such that neither product may lawfully be
was received at the Court Registry on 1 April 1998, for a                      marketed under the marketing authorisation
preliminary ruling in the case of The Queen against The                        applicable to the other; and/or
Licensing Authority Established by the Medicines Act
1968 (acting by the Medicines Control Agency), ex parte:                (v)    the competent authority possesses the relevant
1) Rhône-Poulenc Rorer Ltd 2) May & Baker Ltd, on the                          data required under Directive 65/65/CEE in
following questions:                                                           relation to both product X and product Y; and/or
                                                                        (vi) the competent authority considers that the
1. In a case where medicinal product X is sought to be                         prohibition on imports of product X from
    imported from Member State A into Member State B,                          Member State A would have the effect of
    is it permissible for the person who proposes to place                     partitioning the market; and/or
    the imported product upon the market in Member
    State B to seek and obtain a marketing authorisation                (vii) the competent authority considers that there are
    from the competent authority in Member State B                             no grounds within Article 36 of the EC Treaty
    without complying with the requirements of Council                         which would justify a prohibition on imports
    Directive 65/65/EEC (1) (as amended) if:                                   and sales of product X?
    (i)   medicinal product X is the subject of a marketing        (1) Council Directive 65/65/EEC of 26 January 1965 on the
          authorisation granted in Member State A and was              approximation of provisions laid down by law, regulation or
          the subject of a marketing authorisation which               administrative action relating to proprietary medicinal
          has ceased to have effect in Member State B; and             products (OJ 22 of 9.2.1965, p. 369 (SE SER1 (65Ð66)
                                                                       p. 20)).
    (ii) medicinal product X has the same active
          ingrediens and therapeutic effect as medicinal
          product Y, but is not manufactured according to
          the same formulation as medicinal product Y; and
    (iii) medicinal product Y is the subject of a marketing        Appeal brought on 3 April 1998 by Edouard Dubois et
          authorisation granted in Member State B, but is          Fils SA against the judgment delivered on 29 January
          not the subject of a marketing authorisation             1998 by the Fifth Chamber of the Court of First Instance
          granted in Member State A; and                           of the European Communities in Case T-113/96 between
                                                                   Edouard Dubois et Fils SA, on the one hand, and Council
    (iv) the marketing authorisations referred to in (i) and       of the European Union and Commission of the European
          (iii) above were granted to different members of                             Communities, on the other
          the same group of companies and the                                              (Case C-95/98 P)
          manufacturers of medicinal products X and Y are
                                                                                             (98/C 166/13)
          also members of that group of companies; and
    (v) companies within the same group as the holder of           An appeal against the judgment delivered on 29 January
          the marketing authorisation for product X                1998 by the Fifth Chamber of the Court of First Instance