Case T-15/04: Action brought on 14 January 2004 by Sandoz GmbH against the Commission of the European Communities
Date: 2004-03-20
Institutions: Court of First Instance
Subjects: European Commission, action for annulment (EU), market approval, pharmaceutical product

20.3.2004

EN

Official Journal of the European Union

C 71/35

Action brought on 14 January 2004 by Alto de Casablanca,
S.A. against the Office for Harmonisation in the Internal
Market (Trade Marks and Designs) (OHIM)

Decision of the Board of
Appeal:

Appeal rejected

Pleas in law:

(Case T-14/04)

(2004/C 71/62)

on

that,

claims

The applicant is represented by a
registered patent agent and trade
mark attorney, authorised to prac-
tice both in the United Kingdom
and at a European level. The appli-
cant
these
grounds, its representative is also
authorised to represent it before
Instance of
the Court of First
the European Communities.
In
support of the substantive part
of
its application the applicant
submits that the mark applied for
did
contravene
Article 8 (1) (b), of Regulation 40/
94 (1) and the Office was mistaken
to refuse registration.

not

(1) Council Regulation (EC) No 40/94 of 20 December 1993 on the

Community trade mark (OJ 11, p. 1).

(Case T-15/04)

(2004/C 71/63)

(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 14 January 2004 by Sandoz
(Austria), represented by C. Thomas and
GmbH, Kundl,
N. Dagg, Solicitors, and B. Oosting, lawyer.

The applicant claims that the Court should:

(Language of the case to be determined pursuant to Article 131(2)
of the Rules of Procedure-language in which the application was
submitted: English)

An action against the Office for Harmonisation in the Internal
Market (Trade Marks and Designs) (OHIM) was brought before
the Court of First Instance of the European Communities on
14 January 2004 by Alto de Casablanca, S.A., Casablance,
(Chile), represented by A. W. Pluckrose, Chartered Patent
Attorney. Bodegas Julián Chivite, S.L. was also a party to the
proceedings before the Board of Appeal.

The applicant claims that the Court should:

— annul the decision of the Second Board of Appeals of the
Office for Harmonisation in the Internal Market of
4 November 2003;

— order payment of the Applicant’s costs.

Pleas in law and main arguments

Applicant for the Com-
munity trade mark:

ALTO DE CASABLANCA S.A.

Community trade mark Word mark ‘VERAMONTE’
sought:

goods in class 33 (wine)

for

BODEGAS JULIAN CHIVITE S.L.

Proprietor of the right to
the trade mark or sign
asserted by way of oppo-
sition in the opposition
proceedings:

Trade mark or
sign
asserted by way of oppo-
sition in the opposition
proceedings:

BEAMONTE’

National marks ‘BEAMONTE’ and
‘BODEGAS
for
goods in class 33 (wines, spirits,
liquors) and services in class 39
(goods transportation services)

— annul the Commission decision, notified to the applicant
by letter dated 14 November 2003, not to proceed with
the decision for a marketing authorisation of Omnitrop
under Article 10(1)(a)(ii) of Directive 2001/83 and to
send the CPMP opinion of 26 June 2003 back to the
EMEA;

Decision of the Oppo-
sition Division:

Registration refused

— order the Commission to pay the applicants costs.

— direct the Office for Harmonisation in the Internal Market
to proceed to register Community Mark Application
number 568337;

Action brought on 14 January 2004 by Sandoz GmbH
against the Commission of the European Communities

C 71/36

EN

Official Journal of the European Union

20.3.2004

Pleas in law and main arguments

The context of the contested Decision was an application for
marketing authorisation made to the European Agency for the
Evaluation of Medicinal Products in 2001, in accordance with
scientific advice from the Committee for Proprietary Medicinal
Products (CPMP), which issued a favourable Opinion in June
2003. However, the Commission decided not to proceed with
a decision on the authorisation of the medicinal product in
question, OMNITROP, under Article 10(1)(a)(ii) and Annex I
of the Directive 2001/83 of the European Parliament and
Council of 6 November 2001, on the Community Code
relating to medicinal products for human use (1), on the basis
that the performance of ‘comparability studies’ implied that
the legal conditions for the application of the procedure were
not met. Hence, the dispute between the applicant and the
Commission relates to the interpretation of Article 10(1)(a)(ii)
and Annex I of this Directive, which govern ‘bibliographical
applications’ based on the well-established medicinal use of
the product concerned.

— The scientific rigour of comparability exercises is clear
from the CPMP’s 2001 Note for Guidance and from the
CPMP’s review of OMNITROP.

— The use of comparability studies is therefore fully consist-
ent with the objective of safeguarding public health, and
certainly does not represent any relaxation of health
protection standards.

— The CPMP consistently opposed the use of the essential

similarity route.

(1) OJ L 311 of 28.11.2001, p. 67.
(2) Case C-440/93 [1995] ECR I-2851.

The applicant considers in this respect that the defendant’s
position conflicts with the clear wording of the applicable
legislation. It would also conflict with the scientific view of the
body established to provide the Community with expertise in
these matters, the CPMP.

Action brought on 15 January 2004 by Arcelor S.A.
against the European Parliament and the Council of the
European Union

the applicant submits, as a single plea,

Accordingly,
the
infringement of Article 10(1)(a)(ii) and Annex I, mainly
indent d) of Sections I of its Parts 3 and 4, for the following
grounds:

— Annex I to Directive 2001/83 expressly requires the
CPMP to make a judgment on whether two products are
similar, and this necessarily requires the applicant to
support its explanations with comparability studies.

— The rules established by the Scotia judgment (2), as
invoked, in the Commission’s Decision, have previously
been reversed by the Commission’s own legislation.

— The Commission has publicly rejected the ‘extremely
rigid’ approach of the Scotia judgment and called for a
‘flexible’ approach to Article 10(1)(a)(ii) of the Directive
2001/83.

— The principles governing comparability exercises have
been established by the Communty’s centre of expertise
on biotechnology-derived products (the EMEA) and the
exercise will always be carried out under the EMEA’s
supervision.

(Case T-16/04)

(2004/C 71/64)

(Language of the case: English)

An action against the European Parliament and the Council of
the European Union was brought before the Court of First
Instance of the European Communities on 15 January 2004
by Arcelor S.A., Luxembourg, represented by Dr W. Deselaers,
Dr Bernd Meyring and Dr B. Schmitt-Rady, lawyers.

The applicant claims that the Court should:

— Declare Articles 4, 12(3) and 6(2e), 9, 16(2), (3) and (4),
in conjunction with Article 2, Annex I and Annex III,
No. 1, of Directive 2003/87/EC of the European Parlia-
ment and of the Council of 13 October 2003 establishing
a scheme for greenhouse gas emission allowance trading
within the Community and amending Council Directive
96/61 EC void to the extent that these provisions apply
to installations for the production of pig iron or steel
(primary or secondary fusion) including continuous cast-
ing, with a capacity exceeding 2,5 tonnes per hour;