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
Date: 2003-10-18
Institutions: Court of First Instance
Subjects: European Commission, action for annulment (EU), approximation of laws, market approval, medicinal product, pharmaceutical industry

C 251/14

EN

Official Journal of the European Union

18.10.2003

further alleges: breach of

the duty to give
The applicant
reasons for decisions, the duty to have regard for the welfare
the principle of sound administration;
of officials and of
manifest error of assessment; breach of
the principle of
legitimate expectations; and, finally, misuse of powers.

contested Decision. The opening of the procedure was not
properly based on public health considerations. Furthermore,
the referral and the opening of the procedure covered the
entire content of the SPC. This goes beyond the permissible
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
Commission could, in principle, have harmonised the SPCs
for RENITEC, the Commission has failed to identify any public
health reasons justifying the harmonisation of the SPCs.

the applicants argue that even if

The applicants finally claim that the contested Decision is
illegal because binding time-limits of the Directive were not
observed and because the Commission and the Committee for
Proprietary Medicinal Products failed to provide sufficient rea-
soning.

(1) Directive 2001/83/EC of the European Parliament and of the
Council on the Community code relating to medicinal products
for human use (OJ L 311 of 28.11.2001, p. 67).

Action brought on 1 August 2003 by Merck Sharp &
Dohme Limited and 8 others against the Commission of
the European Communities

(Case T-273/03)

(2003/C 251/27)

(Language of the case: English)

the Commission of

Sharp & Dohme B.V., Haalem,

An action against
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),
(Netherlands),
Merck
Laboratoires Merck Sharp & Dohme-Chibret, Paris, (France),
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.

The applicants claim that the Court should:

— annul the contested Decision;

— order the Commission to pay the applicant's costs.

Pleas in law and main arguments

The applicants are Marketing Authorization Holders of the
medicinal product RENITEC and associated trade names.
RENITEC contains the active ingredient ‘enalapril’ and is used
in treatment of hypertension and heart failure.

The applicants challenge the Commission Decision C(2003)
1752 of 21 May 2003 concerning the placing on the market
of medicinal products for human use containing the substance
‘enalapril’ by which the Commission harmonised the Summary
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
of the European Parliament and the Council (1).

The applicants argue that the initiation of the Article 30
procedure was illegal and that that entails the illegality of the

Action brought on 4 August 2003 by Focus Magazin
Verlag GmbH against the Office for Harmonisation in
the Internal Market (Trade Marks and Designs)

(Case T-275/03)

(2003/C 251/28)

(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)

An action against the Office for Harmonisation in the Internal
Market (Trade Marks and Designs) was brought before the
Court of First Instance of
the European Communities on
4 August 2003 by Focus Magazin Verlag GmbH, Munich
(Germany), represented by U. Gürtler,
lawyer. ECI Telecom
Ltd., Petach Tikva (Israel) was also a party to the proceedings
before the Board of Appeal.

The applicant claims that the Court should:

— annul Decision No 2055/2001 of

the Opposition
Division of the defendant of 27 August 2001 in opposi-
tion proceedings B 288680;