CELEX: C2003/171/55
Language: en
Date: 2003-07-19 00:00:00
Title: Case T-133/03: Action brought on 18 April 2003 by Shering-Plough Ltd. against the Commission of the European Communities and the European Agency for the Evaluation of Medicinal Products ("EMEA")

C 171/32               EN                          Official Journal of the European Union                                        19.7.2003
The applicant claims that the Court should:                                approved under the name ‘Allex’. This Marketing Authorisation
                                                                           (‘MA’) covers three pharmaceutical forms: film-coated tablets,
—     annul the decision of the Board of Appeal of 13 February             syrup and an oral lyophilisate.
      2003 and/or the corrigendum of the decision of the First
      Board of Appeal of 13 March 2003;
                                                                           On 2 October 2002, the applicant submitted to the EMEA an
—     order the defendant to pay all the costs associated with             application for a type I variation of the MA to change the
      these proceedings.                                                   name of the oral lyophilisate form from ‘Allex 5 mg oral
                                                                           lyophilisate’ to ‘Allex Reditabs 5 mg oral lyophilisate’. In the
                                                                           light of further explanations given by the applicant, the EMEA
                                                                           refused with the contested decision to allow the name change.
Pleas in law and main arguments
                                                                           In support of its claim, the applicant invokes violations of the
The origin of the action is the same as in Case T-380/02                   applicable legislation and of the principle of non-discrimi-
(SUCCESS-MARKETING Unternehmensberatungsgesellschaft                       nation. Furthermore, the applicant submits that its rights of
v OHIM, (OJ C 101 of 26.4.2003, p. 35)), and the pleas in law              defence have been violated and that the EMEA has violated the
and arguments correspond to those submitted in that case.                  obligation to state reasons.
                                                                           According to the applicant, the contested decision wrongfully
                                                                           applied the Judgment of the Court of First Instance in Case
                                                                           T-123/00 Thomae ( 1) to refuse the proposed name change.
                                                                           The applicant argues that the present case does not concern
                                                                           the question of whether different names can be used for the
Action brought on 18 April 2003 by Shering-Plough Ltd.                     same medicinal product but the question of whether different
against the Commission of the European Communities                         names can be used for different medicinal products covered by
and the European Agency for the Evaluation of Medicinal                    the same MA. As a consequence, the applicant submits that
                       Products (‘EMEA’)                                   the Judgment in Case T-123/00 does not apply nor can it be
                                                                           extended to apply in the present case.
                         (Case T-133/03)
                                                                           The applicant claims furthermore that the EMEA has violated
                                                                           the principle of non-discrimination. According to the appli-
                         (2003/C 171/55)
                                                                           cant, there is no objective justification to treat the Marketing
                                                                           Authorisation Holders whose two pharmaceutical forms are
                   (Language of the case: English)                         covered by the same MA and those whose two pharmaceutical
                                                                           forms are covered by two MA differently.
An action against the Commission of the European Communi-                  (1 ) Judgement of 10.12.2002, Case T-123/00 Dr. Karl Thomae
ties and the European Agency for the Evaluation of Medicinal                    GmbH v Commission (not published yet).
Products (‘EMEA’) was brought before the Court of First
Instance of the European Communities on 18 April 2003 by
Shering-Plough Ltd., Brussels, Belgium, represented by Dr.
G. Berrisch and Mr P. Bogaert, lawyers.
The applicant claims that the Court should:
                                                                           Action brought on 14 April 2003 by Sniace, S.A. against
—     annul the Decision of 14 February 2003 of the EMEA                          the Commission of the European Communities
      rejecting a so-called type I variation for the name of the
      medicinal product ‘Allex 5 mg oral lyophilisate’ into
      ‘Allex Reditabs 5 mg oral lyophilisate’.                                                     (Case T-141/03)
—     order the Defendants to pay the Applicant’s costs                                            (2003/C 171/56)
                                                                                             (Language of the case: Spanish)
Pleas in law and main arguments
The applicant is active in the field of medicinal products and             An action against the Commission of the European Communi-
is the Marketing Authorisation Holder for medicinal products               ties was brought before the Court of First Instance of the