CELEX: C2003/171/54
Language: en
Date: 2003-07-19 00:00:00
Title: Case T-128/03: Action brought on 18 April 2003 by SUCCESS-MARKETING Unternehmensberatungsgesellschaft m.b.H. against the Office for Harmonisation in the Internal Market (Trade Marks and Design) (OHIM)

19.7.2003             EN                          Official Journal of the European Union                                          C 171/31
Action brought on 10 April 2003 by Pfizer Limited                         in the sense intended in Article 30. Second, the applicant
  against the Commission of the European Communities                      claims he has neither been clearly informed of the question
                                                                          which has been referred to the CPMP, nor has he received a
                                                                          satisfactory explanation of the issues raised. Third, the
                         (Case T-123/03)                                  appliquant invokes the absence of any question of quality,
                                                                          safety and/or efficacy of the product. The absence of genuine
                                                                          public health reasons could be inferred from the failure to
                        (2003/C 171/53)
                                                                          include generic versions of ‘Lopid’ in the referral to the CPMP.
                  (Language of the case: English)
                                                                          Furthermore, the applicant claims that the Commission has
                                                                          violated the principle of good administration and/or misused
                                                                          its powers. Referring to the Judgment of the Court of First
An action against the Commission of the European Communi-                 Instance of the European Communities in Case Artegodan et
ties was brought before the Court of First Instance of the                al v Commission ( 1), the applicant submits that an Article 30
European Communities on 10 April 2003 by Pfizer Limited,                  referral can not lead to a binding Commission decision.
Sandwich, United Kingdom, represented by D. Anderson QC,                  Furthermore, the applicant submits that it is extremely unlikely
Mr K. Bacon, Barrister, Mr I. Dodds-Smith and Mr T. Fox,                  that all of the national competent authorities would abandon
Solicitors.                                                               their views in face of the non-binding CPMP opinion. The
                                                                          applicant then concludes that the Article 30 referral was
                                                                          made for a purpose which cannot be achieved and that the
                                                                          Commission’s failure to take this into account leads to a
The applicant claims that the Court should:                               breach of the principle of good administration. Further or
                                                                          alternatively, the approach of the Commission amounts to
—     annul the Decision of 6 January 2003 of the Commission              misuse of powers.
      initiating a referral ‘Lopid’ to the Committee for Pro-
      prietary Medicinal Products (‘CPMP’) under article 30 of
      the Community Code on human medicines.                              (1 ) Case T-74/00; Currently under appeal by the Commission: Case
                                                                               C-39/03 P.
—     order the Defendant to pay the Applicant’s costs.
Pleas in law and main arguments
The applicant is active in the field of medicinal products. The
applicant represents various companies that are the Marketing             Action brought on 18 April 2003 by SUCCESS-MARKET-
Authorisation Holders (‘MAH’) for ‘Lopid’ throughout the EU               ING Unternehmensberatungsgesellschaft m.b.H. against
and Iceland. The authorisations in the EU were obtained under             the Office for Harmonisation in the Internal Market
national marketing procedures. As a result, there are some                               (Trade Marks and Design) (OHIM)
differences between the EU authorisations. Due to the diver-
gence of national decisions, the Commission notified the
European Agency for the Evaluation of Medicinal Products                                           (Case T-128/03)
(‘EMEA’) of an official referral under Article 30 of the
Community Code on human medicines with the object of
producing a harmonised Summary of Product Characteristics                                          (2003/C 171/54)
(‘SPC’). The EMEA notified this Decision of the Commission to
the applicant by letter dated 27 January 2003.
                                                                          (Language of the case to be determined pursuant to Article 131(2)
                                                                          of the Rules of Procedure — Language in which the application was
                                                                                                  submitted: German)
In support of its claim, the applicant invokes a lack of
competence, infringement of an essential procedural require-
ment and/or misuse of powers.
                                                                          An action against the Office for Harmonisation in the Internal
According to the applicant, the contested Decision should be              Market (Trade Marks and Design) (OHIM) was brought before
annulled on the grounds of lack of competence of the EMEA/                the Court of First Instance of the European Communities on
CPMP and the Commission. The applicant argues that none of                18 April 2003 by SUCCESS-MARKETING Unternehmensbera-
the three preconditions for a valid Article 30 referral by the            tungsgesellschaft m.b.H., Linz (Austria), represented by
Commission have been met. First, the applicant submits that               G. Secklehner, lawyer, with an address for service in Luxem-
the divergent decisions concerning the terms of the SPCs are              bourg. Chipita International S.A., Athens, was also a party to
not divergent decisions concerning the authorisation of ‘Lopid’           the proceedings before the Board of Appeal.
 ---pagebreak--- 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