CELEX: C2003/083/55
Language: en
Date: 2003-04-05 00:00:00
Title: 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")

5.4.2003               EN                        Official Journal of the European Union                                           C 83/25
The applicant claims that the Court should:                              The applicant furthermore invokes a violation of Rule 52(2) of
                                                                         Regulation 2868/95 ( 1) and an infringement of the right to
—     cancel the decision of the Third Board of Appeal of                good administration and the right to an effective remedy and
      20 November 2002;                                                  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).
—     reassign the application No 1131739 for the figurative
      mark ‘W@P’ to the original filing date of 8 April 1999;
                                                                         The applicant finally submits that the defendant made a
—     as an auxiliary request it is asked for that the application       statement and not a decision so that the time-limit of two
      No 1131739, the figurative mark ‘W@P’, be reassigned               months indicated in Rule 52(2) of Regulation 2868/95 is not
      the application date of 13 October 1999, the date given            applicable.
      to the application for the word mark ‘WAP FORUM’ with
      the No 1131705 which was also filed for on 8 April
      1999;
                                                                         (1 ) Commission Regulation (EC) No 2868/95 of 13 December
                                                                              1995 implementing Council Regulation (EC) No 40/94 on the
—     as an auxiliary request it is asked for that the application            Community trade mark (OJ L 303, p. 1).
      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                                          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
The applicant applied on 8 April 1999 for the registration of
                                                                                                      (‘EMEA’)
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                                    (Case T-41/03)
their deposit account.
                                                                                                   (2003/C 83/55)
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                                (Language of the case: English)
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.
                                                                         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
The defendant informed the applicant on 5 September 2000                 Instance of the European Communities on 4 February 2003 by
that the application would have 17 March 2000 as its filing              Merck Sharp & Dohme Limited, Hoddeston, United Kingdom,
date because this was the date actual payment by cheque was              Merck Sharp & Dohme BV, Haarlem, Netherlands, Laboratoires
received. The applicant was furthermore informed that the                Merck Sharp & Dohme-Chibret, Paris, France, MSD Sharp &
deposit account did not have sufficient funds to debit the fee.          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.,
The applicant contested this decision before the board of                Madrid, Spain, Merck Sharp & Dohme Ges.m.b.H., Wien,
appeal on 23 January 2001. The Board of Appeal decided that              Austria, Merck & Co. Inc., Whitehouse Station, USA, Dieck-
the appeal was out of time and declared it inadmissible.                 mann Arzneimittel GmbH, Haar, Germany, Neopharmed SpA,
                                                                         Rome, Italy, Istituto Gentili SpA., Pisa, Italy, Laboratórios
                                                                         Químico-Farmacêuticos Chibret, LDA., Paço de Arcos, Portu-
In support of its present application, the applicant submits             gal, Laboratoires Sanofi, Synthelabo France, Paris, France,
that the defendant has breached an obligation it has as a public         Boehringer Ingelheim Pharma GmbH & Co.KG, Ingelheim,
authority to keep track of its bookkeeping and an infringement           Germany, VIANEX S.A., Nea Erythrea, Greece, Sigma-Tau
of Article 41 of the Charter of Fundamental Rights, namely               Industrie Farmaceutiche Riunite SpA., Rome, Italy, Mediola-
the right to good administration. According to the applicant,            num SpA., Milano, Italy, BIOHORM S.A. (Groupo Uriach),
the defendant has the responsibility to notify within a reason-          Barcelona, Spain, and LACER S.A., Barcelona, Spain, represent-
able period of time any inconsistencies.                                 ed by Dr Georg M. Berrisch and Mr Peter Bogaert, Lawyers.
 ---pagebreak--- C 83/26                EN                         Official Journal of the European Union                                        5.4.2003
The applicant claims that the Court should:                               —      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
—     annul the Contested Decision                                               question’, according to Article 30, second indent, of the
                                                                                 Directive.
—     order the Commission to pay the applicants’ costs                   —      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.
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         Action brought on 10 February 2003 by Lurgi AG and
medicine reducing levels of toal cholesterol, LDL-C (low                  Lurgi S.p.A. against the Commission of the European
density lipoprotein cholesterol), Apo B (Apolipoprotein B) and                                       Communities
triglycerides in the blood It also increases the amount of HDL-
C (High density lipoprotein cholesterol) in the blood.                                              (Case T-42/03)
                                                                                                    (2003/C 83/56)
They challenge the decision of the European Agency for the
Evaluation of Medicinal Products to initiate a referral procedure                             (Language of the case: English)
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               An action against the Commission of the European Communi-
product.                                                                  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-
The Applicants sumit that the contested Decision violates                 teli, Lawyers with an address for service in Luxembourg.
Article 30 of the Directive on the following grounds:
                                                                          The applicant claims that the Court should:
—     There are no divergent decisions following decisions in
      accordance with Article 8, 10(1) and 11 of the Directive.           —      annul the notice terminating the THERMIE Contract,
                                                                                 notified by the Commission’s letter of 26 November
                                                                                 2002;
—     The contested Decision is a decision to harmonise the
      summary of product characteristics (SPC) for ZOCORD                 —      declare that the Commission is not entitled to claim
      and associated trade names, and the single proposal of                     reimbursement of the funds paid to the contractors under
      the referral procedure for ZOCORD is to develop and                        the THERMIE contract BM/1007/94;
      impose the EU-wide harmonised SPC. The Article 30
      procedure, however, does not allow for the adoption of a            —      order the Commission to bear the costs of these proceed-
      harmonised SPC.                                                            ings.
—     Before the mutual recognition procedure took effect,
      pharmaceutical companies were under no obligation to                Pleas in law and main arguments
      submit identical marketing authorisation applications to
      different Member States. Applicants could, for example,
      request approval of different therapeutic uses or presen-           The applicants, together with several other contractors, con-
      tations, often to take account of differences in national           cluded a contract (THERMIE contract) on 12 December 1994
      medical practices and customs. Such differences in appli-           with the Commission for activities relating to the promotion
      cations unavoidably result in differences in the approvals,         of energy technology in Europe. The contract was concluded
      but do not qualify as ‘divergent decisions’ for the purposes        under number BM 1007/1994 IT/DE/UK and its object was
      of Article 30. Hence, differences between national                  the funding and implementation of the project ‘Energy farm:
      approvals resulting from different applications are not             an IGCC plant for the production of electricity and heat trough
      covered by Article 30.                                              gasification of SFR biomass’