Source: EURLEX
Language: en
Format: md

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 Communities 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 Proprietary 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 divergence of national decisions, the Commission notified the
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.

In support of its claim, the applicant invokes a lack of
competence, infringement of an essential procedural requirement and/or misuse of powers.

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’

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 issues raised. Third, 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.

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)_

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 Unternehmensberatungsgesellschaft m.b.H., Linz (Austria), represented by
G. Secklehner, lawyer, with an address for service in Luxembourg. Chipita International S.A., Athens, was also a party to
the proceedings before the Board of Appeal.

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 Communities 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
medicinal product ‘Allex 5 mg oral lyophilisate’ into
‘Allex Reditabs 5 mg oral lyophilisate’.

—
order the Defendants to pay the Applicant’s costs

_Pleas in law and main arguments_

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

approved underthe name ‘Allex’. ThisMarketing 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
name of the oral lyophilisate form from ‘Allex 5 mg 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-discrimination. 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 applicant, 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)_

An action against the Commission of the European Communities was brought before the Court of First Instance of the