Case T-123/03: Action brought on 10 April 2003 by Pfizer Limited against the Commission of the European Communities
Date: 2003-07-19
Institutions: Court of First Instance
Subjects: European Commission, action for annulment (EU), approximation of laws, market approval, pharmaceutical legislation, pharmaceutical product, product quality, product safety

19.7.2003

EN

Official Journal of the European Union

C 171/31

Action brought on 10 April 2003 by Pfizer Limited
against the Commission of the European Communities

(Case T-123/03)

(2003/C 171/53)

(Language of the case: English)

An action against the Commission of the European Communi-
ties was brought before the Court of First Instance of the
European Communities on 10 April 2003 by Pfizer Limited,
Sandwich, United Kingdom, represented by D. Anderson QC,
Mr K. Bacon, Barrister, Mr I. Dodds-Smith and Mr T. Fox,
Solicitors.

The applicant claims that the Court should:

— annul the Decision of 6 January 2003 of the Commission
initiating a referral ‘Lopid’ to the Committee for Pro-
prietary Medicinal Products (‘CPMP’) under article 30 of
the Community Code on human medicines.

— 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
Authorisation Holders (‘MAH’) for ‘Lopid’ throughout the EU
and Iceland. The authorisations in the EU were obtained under
national marketing procedures. As a result, there are some
differences between the EU authorisations. Due to the diver-
the Commission notified the
gence of national decisions,
European Agency for the Evaluation of Medicinal Products
(‘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
(‘SPC’). The EMEA notified this Decision of the Commission to
the applicant by letter dated 27 January 2003.

invokes a lack of
In support of its claim,
competence, infringement of an essential procedural require-
ment and/or misuse of powers.

the applicant

in the sense intended in Article 30. Second, the applicant
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
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
include generic versions of ‘Lopid’ in the referral to the CPMP.

the issues raised. Third,

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
Instance of the European Communities in Case Artegodan et
al v Commission (1), the applicant submits that an Article 30
referral can not lead to a binding Commission decision.
Furthermore, the applicant submits that it is extremely unlikely
that all of the national competent authorities would abandon
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
breach of the principle of good administration. Further or
alternatively, the approach of the Commission amounts to
misuse of powers.

(1) Case T-74/00; Currently under appeal by the Commission: Case

C-39/03 P.

Action brought on 18 April 2003 by SUCCESS-MARKET-
ING Unternehmensberatungsgesellschaft m.b.H. against
the Office for Harmonisation in the Internal Market
(Trade Marks and Design) (OHIM)

(Case T-128/03)

(2003/C 171/54)

(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)

According to the applicant, the contested Decision should be
annulled on the grounds of lack of competence of the EMEA/
CPMP and the Commission. The applicant argues that none of
the three preconditions for a valid Article 30 referral by the
Commission have been met. First, the applicant submits that
the divergent decisions concerning the terms of the SPCs are
not divergent decisions concerning the authorisation of ‘Lopid’

An action against the Office for Harmonisation in the Internal
Market (Trade Marks and Design) (OHIM) was brought before
the Court of First Instance of the European Communities on
18 April 2003 by SUCCESS-MARKETING Unternehmensbera-
tungsgesellschaft m.b.H., Linz (Austria),
represented by
G. Secklehner, lawyer, with an address for service in Luxem-
bourg. Chipita International S.A., Athens, was also a party to
the proceedings before the Board of Appeal.