CELEX: C2003/251/27
Language: en
Date: 2003-10-18 00:00:00
Title: Case T-273/03: Action brought on 1 August 2003 by Merck Sharp & Dohme Limited and 8 others against the Commission of the European Communities

C 251/14              EN                        Official Journal of the European Union                                          18.10.2003
The applicant further alleges: breach of the duty to give                contested Decision. The opening of the procedure was not
reasons for decisions, the duty to have regard for the welfare           properly based on public health considerations. Furthermore,
of officials and of the principle of sound administration;               the referral and the opening of the procedure covered the
manifest error of assessment; breach of the principle of                 entire content of the SPC. This goes beyond the permissible
legitimate expectations; and, finally, misuse of powers.                 scope of an Article 30 referral, and such a procedure does not
                                                                         allow for the adoption of a harmonised SPC. Moreover, the
                                                                         opening of the procedure lacked proper reasoning.
                                                                         Furthermore, the applicants submit that the harmonisation of
                                                                         the SPCs in the contested Decision was illegal, since the
                                                                         Commission did not have the power to adopt the Decision.
                                                                         In the alternative, the applicants argue that even if the
Action brought on 1 August 2003 by Merck Sharp &                         Commission could, in principle, have harmonised the SPCs
Dohme Limited and 8 others against the Commission of                     for RENITEC, the Commission has failed to identify any public
                 the European Communities                                health reasons justifying the harmonisation of the SPCs.
                        (Case T-273/03)
                        (2003/C 251/27)                                  The applicants finally claim that the contested Decision is
                                                                         illegal because binding time-limits of the Directive were not
                  (Language of the case: English)                        observed and because the Commission and the Committee for
                                                                         Proprietary Medicinal Products failed to provide sufficient rea-
                                                                         soning.
An action against the Commission of the European
Communities was brought before the Court of First Instance
of the European Communities on 1 August 2003 by Merck
Sharp & Dohme Limited, Hoddesdon, (United Kingdom),                      (1) Directive 2001/83/EC of the European Parliament and of the
Merck Sharp & Dohme B.V., Haalem, (Netherlands),                             Council on the Community code relating to medicinal products
Laboratoires Merck Sharp & Dohme-Chibret, Paris, (France),                   for human use (OJ L 311 of 28.11.2001, p. 67).
MSD Sharp & Dohme GmbH, Haar, (Germany), Merck Sharp
& Dohme (Italia) SpA., Rome, (Italy), Merck Sharp & Dohme,
LDA, Paço de Arcos, (Portugal), Merck Sharp & Dohme de
Espana S.A., Madrid, (Spain), Merck Sharp & Dohme Ges.m.b.
H., Vienna, (Austria), and VIANEX S.A., Nea Erythrea, (Greece),
represented by Mr G. Berrisch and Mr P. Bogaert, lawyers.
                                                                         Action brought on 4 August 2003 by Focus Magazin
The applicants claim that the Court should:                              Verlag GmbH against the Office for Harmonisation in
                                                                                the Internal Market (Trade Marks and Designs)
—     annul the contested Decision;                                                                (Case T-275/03)
                                                                                                   (2003/C 251/28)
—     order the Commission to pay the applicant's costs.
                                                                         (Language of the case to be determined pursuant to Article 131(2) of
Pleas in law and main arguments                                          the Rules of Procedure — language in which the application was
                                                                                                  submitted: German)
The applicants are Marketing Authorization Holders of the
medicinal product RENITEC and associated trade names.
RENITEC contains the active ingredient ‘enalapril’ and is used           An action against the Office for Harmonisation in the Internal
in treatment of hypertension and heart failure.                          Market (Trade Marks and Designs) was brought before the
                                                                         Court of First Instance of the European Communities on
The applicants challenge the Commission Decision C(2003)                 4 August 2003 by Focus Magazin Verlag GmbH, Munich
1752 of 21 May 2003 concerning the placing on the market                 (Germany), represented by U. Gürtler, lawyer. ECI Telecom
of medicinal products for human use containing the substance             Ltd., Petach Tikva (Israel) was also a party to the proceedings
‘enalapril’ by which the Commission harmonised the Summary               before the Board of Appeal.
of Product Characteristics (‘SPC’) for RENITEC and associated
trade names. The contested Decision was adopted as a result of
a referral procedure under Article 30 of Directive 2001/83/EC            The applicant claims that the Court should:
of the European Parliament and the Council (1).
                                                                         —     annul Decision No 2055/2001 of the Opposition
The applicants argue that the initiation of the Article 30                     Division of the defendant of 27 August 2001 in opposi-
procedure was illegal and that that entails the illegality of the              tion proceedings B 288680;