Case T-41/03: Action brought on 4 February 2003 by Merck Sharp & Dohme Limited and 19 other applicants against the Commission of the European Communities and the European Agency for the Evaluation of Medicinal Products ("EMEA")
Date: 2003-04-05
Institutions: Court of First Instance
Subjects: European Commission, European Medicines Agency, action for annulment (EU), marketing, medicinal product, pharmaceutical legislation

5.4.2003

EN

Official Journal of the European Union

C 83/25

The applicant claims that the Court should:

— cancel the decision of the Third Board of Appeal of

20 November 2002;

— reassign the application No 1131739 for the figurative

mark ‘W@P’ to the original filing date of 8 April 1999;

— as an auxiliary request it is asked for that the application
No 1131739, the figurative mark ‘W@P’, be reassigned
the application date of 13 October 1999, the date given
to the application for the word mark ‘WAP FORUM’ with
the No 1131705 which was also filed for on 8 April
1999;

— as an auxiliary request it is asked for that the application
No 1131739, the figurative mark ‘W@P’, be reassigned
the application date of 21 December 1999;

— as an auxiliary request it

is asked for reinstatement

according to article 78 of Council Regulation 40/94;

Pleas in law and main arguments

The applicant applied on 8 April 1999 for the registration of
the figurative mark ‘W@P’ for goods and services in classes 35,
41 and 42 (application No 1131739). The then representatives
of the applicant requested that the filing fee be deducted from
their deposit account.

The defendant informed the applicant that the filing fee had to
be paid within a time-limit of one month. Later, the defendant
informed the applicant that since the application fee had not
been paid, the application would have, as its filing date,
the date on which all flaws had been remedied. The then
representatives of the applicant requested again that the fee be
deducted from their deposit account.

The defendant informed the applicant on 5 September 2000
that the application would have 17 March 2000 as its filing
date because this was the date actual payment by cheque was
received. The applicant was furthermore informed that the
deposit account did not have sufficient funds to debit the fee.

The applicant contested this decision before the board of
appeal on 23 January 2001. The Board of Appeal decided that
the appeal was out of time and declared it inadmissible.

In support of its present application, the applicant submits
that the defendant has breached an obligation it has as a public
authority to keep track of its bookkeeping and an infringement
of Article 41 of the Charter of Fundamental Rights, namely
the right to good administration. According to the applicant,
the defendant has the responsibility to notify within a reason-
able period of time any inconsistencies.

The applicant furthermore invokes a violation of Rule 52(2) of
Regulation 2868/95 (1) and an infringement of the right to
good administration and the right to an effective remedy and
a fair trial as incorporated in articles 41 and 47 of the Charter
of Fundamental Rights. The applicant states that no written
communication was attached as required by Rule 52(2).

The applicant
finally submits that the defendant made a
statement and not a decision so that the time-limit of two
months indicated in Rule 52(2) of Regulation 2868/95 is not
applicable.

(1) Commission Regulation (EC) No 2868/95 of 13 December
1995 implementing Council Regulation (EC) No 40/94 on the
Community trade mark (OJ L 303, p. 1).

Action brought on 4 February 2003 by Merck Sharp &
Dohme Limited and 19 other applicants against
the
Commission of the European Communities and the Euro-
pean Agency for the Evaluation of Medicinal Products
(‘EMEA’)

(Case T-41/03)

(2003/C 83/55)

(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 4 February 2003 by
Merck Sharp & Dohme Limited, Hoddeston, United Kingdom,
Merck Sharp & Dohme BV, Haarlem, Netherlands, 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., Wien,
Austria, Merck & Co. Inc., Whitehouse Station, USA, Dieck-
mann Arzneimittel GmbH, Haar, Germany, Neopharmed SpA,
Rome,
Italy, Istituto Gentili SpA., Pisa, Italy, Laboratórios
Químico-Farmacêuticos Chibret, LDA., Paço de Arcos, Portu-
gal, Laboratoires Sanofi, Synthelabo France, Paris, France,
Boehringer Ingelheim Pharma GmbH & Co.KG, Ingelheim,
Germany, VIANEX S.A., Nea Erythrea, Greece, Sigma-Tau
Industrie Farmaceutiche Riunite SpA., Rome, Italy, Mediola-
num SpA., Milano, Italy, BIOHORM S.A. (Groupo Uriach),
Barcelona, Spain, and LACER S.A., Barcelona, Spain, represent-
ed by Dr Georg M. Berrisch and Mr Peter Bogaert, Lawyers.

C 83/26

EN

Official Journal of the European Union

5.4.2003

The applicant claims that the Court should:

— annul the Contested Decision

— order the Commission to pay the applicants’ costs

Pleas in law and main arguments

The Applicants in the present case are all Marketing Authoris-
ation Holders (MAH)
for the product ZOCORD, which,
containing the active ingredient simvastatin, is a lipid-lowering
medicine reducing levels of toal cholesterol, LDL-C (low
density lipoprotein cholesterol), Apo B (Apolipoprotein B) and
triglycerides in the blood It also increases the amount of HDL-
C (High density lipoprotein cholesterol) in the blood.

They challenge the decision of the European Agency for the
Evaluation of Medicinal Products to initiate a referral procedure
under Article 30 of Directive 2001/83/EC of the European
Parliament and the Council, of 6 November 2001, of the
Community code relating to medicinal products for human
use (the Directive) (1),
in relation to the aforementioned
product.

The Applicants sumit that the contested Decision violates
Article 30 of the Directive on the following grounds:

— There are no divergent decisions following decisions in
accordance with Article 8, 10(1) and 11 of the Directive.

— The contested Decision is a decision to harmonise the
summary of product characteristics (SPC) for ZOCORD
and associated trade names, and the single proposal of
the referral procedure for ZOCORD is to develop and
impose the EU-wide harmonised SPC. The Article 30
procedure, however, does not allow for the adoption of a
harmonised SPC.

— Before the mutual recognition procedure took effect,
pharmaceutical companies were under no obligation to
submit identical marketing authorisation applications to
different Member States. Applicants could, for example,
request approval of different therapeutic uses or presen-
tations, often to take account of differences in national
medical practices and customs. Such differences in appli-
cations unavoidably result in differences in the approvals,
but do not qualify as ‘divergent decisions’ for the purposes
of Article 30. Hence, differences between national
approvals resulting from different applications are not
covered by Article 30.

— The referral covers the entire content of the SPC. This
goes beyond the permissible scope of an Article 30
referral, which must be limited to a ‘clearly identified
question’, according to Article 30, second indent, of the
Directive.

— It has not been demonstrated that the contested Decision

is based on public health grounds.

(1) OJ L 311, of 28.11.2001, p. 67.

Action brought on 10 February 2003 by Lurgi AG and
Lurgi S.p.A. against the Commission of the European
Communities

(Case T-42/03)

(2003/C 83/56)

(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 February 2003 by Lurgi AG,
Frankfurt am Main, Germany, and Lurgi S.p.A., Milan, Italy,
represented by Dr Michael Schütte and Prof Massimo Benedet-
teli, Lawyers with an address for service in Luxembourg.

The applicant claims that the Court should:

— annul the notice terminating the THERMIE Contract,
notified by the Commission’s letter of 26 November
2002;

— declare that the Commission is not entitled to claim
reimbursement of the funds paid to the contractors under
the THERMIE contract BM/1007/94;

— order the Commission to bear the costs of these proceed-

ings.

Pleas in law and main arguments

The applicants, together with several other contractors, con-
cluded a contract (THERMIE contract) on 12 December 1994
with the Commission for activities relating to the promotion
of energy technology in Europe. The contract was concluded
under number BM 1007/1994 IT/DE/UK and its object was
the funding and implementation of the project ‘Energy farm:
an IGCC plant for the production of electricity and heat trough
gasification of SFR biomass’