CELEX: C2003/171/53
Language: en
Date: 2003-07-19 00:00:00
Title: Case T-123/03: Action brought on 10 April 2003 by Pfizer Limited against the Commission of the European Communities

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.