Case T-133/03: Action brought on 18 April 2003 by Shering-Plough Ltd. against the Commission of the European Communities and the European Agency for the Evaluation of Medicinal Products ("EMEA")
Date: 2003-07-19
Institutions: Court of First Instance
Subjects: European Commission, European Medicines Agency, action for annulment (EU), market approval, medicinal product, product designation

C 171/32

EN

Official Journal of the European Union

19.7.2003

The applicant claims that the Court should:

— annul the decision of the Board of Appeal of 13 February
2003 and/or the corrigendum of the decision of the First
Board of Appeal of 13 March 2003;

— order the defendant to pay all the costs associated with

these proceedings.

Pleas in law and main arguments

The origin of the action is the same as in Case T-380/02
(SUCCESS-MARKETING Unternehmensberatungsgesellschaft
v OHIM, (OJ C 101 of 26.4.2003, p. 35)), and the pleas in law
and arguments correspond to those submitted in that case.

Action brought on 18 April 2003 by Shering-Plough Ltd.
against the Commission of the European Communities
and the European Agency for the Evaluation of Medicinal
Products (‘EMEA’)

(Case T-133/03)

(2003/C 171/55)

(Language of the case: English)

An action against the Commission of the European Communi-
ties and the European Agency for the Evaluation of Medicinal
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:

— annul the Decision of 14 February 2003 of the EMEA
rejecting a so-called type I variation for the name of the
into
medicinal product ‘Allex 5 mg oral
‘Allex Reditabs 5 mg oral lyophilisate’.

lyophilisate’

— order the Defendants to pay the Applicant’s costs

Pleas in law and main arguments

approved under the name ‘Allex’. This Marketing Authorisation
(‘MA’) covers three pharmaceutical forms: film-coated tablets,
syrup and an oral lyophilisate.

On 2 October 2002, the applicant submitted to the EMEA an
application for a type I variation of the MA to change the
lyophilisate form from ‘Allex 5 mg oral
name of the 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.

In support of its claim, the applicant invokes violations of the
applicable legislation and of the principle of non-discrimi-
nation. Furthermore, the applicant submits that its rights of
defence have been violated and that the EMEA has violated the
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
same medicinal product but the question of whether different
names can be used for different medicinal products covered by
the same MA. As a consequence, the applicant submits that
the Judgment in Case T-123/00 does not apply nor can it be
extended to apply in the present case.

The applicant claims furthermore that the EMEA has violated
the principle of non-discrimination. According to the appli-
cant, there is no objective justification to treat the Marketing
Authorisation Holders whose two pharmaceutical forms are
covered by the same MA and those whose two pharmaceutical
forms are covered by two MA differently.

(1) Judgement of 10.12.2002, Case T-123/00 Dr. Karl Thomae

GmbH v Commission (not published yet).

Action brought on 14 April 2003 by Sniace, S.A. against
the Commission of the European Communities

(Case T-141/03)

(2003/C 171/56)

(Language of the case: Spanish)

The applicant is active in the field of medicinal products and
is the Marketing Authorisation Holder for medicinal products

An action against the Commission of the European Communi-
ties was brought before the Court of First Instance of the