Case T-52/09: Action brought on 11 February 2009 — Nycomed Danmark v EMEA
Date: 2009-02-11
Institutions: Court of First Instance
Subjects: European Medicines Agency, action for annulment (EU), derogation from EU law, medical diagnosis, medicinal product

4.4.2009

EN

Official Journal of the European Union

C 82/33

— In the alternative, order the defendant to repay the principal
sum of EUR 479 332,40, together with the interest accrued
at the Italian statutory rate from 4 January 2004 until the
date of final settlement, less the sum of EUR 461 979 called
on and paid on 25 January 2005;

— In any event, order Antiche Terre Società Agricola Coopera-

tiva to pay the costs.

Action brought on 11 February 2009 — Nycomed
Danmark v EMEA

(Case T-52/09)

(2009/C 82/58)

Language of the case: English

Pleas in law and main arguments

Parties

By the present action, brought under Article 238 EC,
the
Commission seeks the repayment of the sums advanced to the
limited liability cooperative Antiche Terre scarl Società Agricola
Cooperativa (‘Antiche Terre’),
in the context of the THERMIE
programme, for the creation of an installation producing electri-
city (10 MWe)
through an innovative biomass combustion
process. The reference contract (No BM/188/96) was drawn up
between the Commission, Antiche Terre (as coordinator) and
two other companies having their seats in Finland and Spain
respectively.

Antiche Terre built up a number of significant delays in
commencing its own task, and it requested several extensions so
as to be able to complete its work, which it obtained. It also
proposed a substantial change to the installation, which would
have meant abandoning the innovative biomass combustion
process and producing energy in substantially smaller quantities
than had been estimated.

The Commission was unable to authorise such a fundamental
change to the project, which would have had no chance of
funding under the THERMIE programme.

Consequently, since it was found that Antiche Terre would not
have completed the installation in accordance with the terms of
the project originally submitted, the Commission was forced to
withdraw from contract BM/188/96, making it clear moreover
that the failure to complete the original project could have
entailed the repayment in whole or in part of the advance paid
to Antiche Terre.

The Commission therefore asked Antiche Terre on a number of
occasions to repay the sums advanced,
in the amount of
EUR 479 332,40, but it did not receive any payment. After
calling on the guarantee, and after further requests for repay-
ment of
the Commission therefore brings the
present action before the Court of First Instance.

the balance,

Applicant: Nycomed Danmark ApS (Roskilde, Denmark) (repre-
sented by: C. Schoonderbeek, H. Speyart van Woerden, lawyers)

Defendant: European Medicines Agency

Form of order sought

— annul the contested decision;

— order the EMEA to pay its own costs and those of Nycomed.

Pleas in law and main arguments

By means of the present application, the applicant seeks the
annulment, pursuant to Article 230 EC and to Article 73a of
Regulation (EC) No 726/2004 (1), as amended by Regulation
(EC) No 1901/2006 (2) of the European Parliament and of the
Council,
of
28 November 2008 of the European Medicines Agency (‘EMEA’)
rejecting its application for a product specific waiver provided
for in Article 11(1)(b) of the aforementioned regulation.

‘EMEA-000194-IPI01-07’

decision

the

of

The applicant applied for such a waiver in respect of an ultra-
sound echocardiographic imaging agent to be marketed under
the brand name Imagify, intended to diagnose coronary artery
disease (‘CAD’)
in adults. Through its contested decision, the
EMEA denied that waiver to the applicants on the grounds that
the disease or condition for which the medicinal product is
intended is not CAD but myocardial perfusion defects, which
also occur in children.

The applicant claims that the contested decision is unlawful in
that it is based on an interpretation and application of the
concept of
‘disease or condition for which the medicinal
product is intended’ within the meaning of Article 11(1)(b) of
Regulation (EC) No 1901/2006 which according to the appli-
cant is incorrect in that it does not take into account the thera-
peutic indication applied for in the concomitant Community
market authorisation application and that myocardial perfusion
defects are not a disease or condition, but a sign of various
diseases.

C 82/34

EN

Official Journal of the European Union

4.4.2009

The applicant further submits that the contested decision is
unlawful
in that it is an attempt by the EMEA to misuse its
powers pursuant to Articles 11(1)(b) and 25 of Regulation (EC)
No 1901/2006 in order to attain the aim which is not contem-
plated by those provisions, namely, the obligation to propose a
paediatric investigation plan for
indications which are not
covered by the concomitant Community market authorisation
application.

(1) Regulation (EC) No 726/2004 of the European Parliament and of the
Council of 31 March 2004 laying down Community procedures for
the authorisation and supervision of medicinal products for human
and veterinary use and establishing a European Medicines Agency
(OJ 2004 L 136, p. 1).

(2) Regulation (EC) No 1901/2006 of the European Parliament and of
the Council of 12 December 2006 on medicinal products for paedia-
tric use and amending Regulation (EEC) No 1768/92, Directive
(EC)
2001/83/EC
2001/20/EC, Directive
No 726/2004 (OJ 2006 L 378, p. 1).

Regulation

and

Action brought on 11 February 2009 — Schemaventotto v
Commission

(Case T-58/09)

(2009/C 82/59)

Language of the case: Italian

Parties

Applicant: Schemaventotto SpA (Milan, Italy) (represented by: M.
Siragusa, G. Scassellati Sforzolini, G.C. Rizza, M. Piergiovanni,
lawyers)

Defendant: Commission of the European Communities

Forms of order sought

— Annul the decision(s) contained in the letter of 13 August
2008, File No C(2008) 4494, from Commissioner Kroes, for
and on behalf of the European Commission, to the Italian
authorities, and relating to a proceeding under Article 21 of
[Regulation No 139/2004] on the control of concentrations
between undertakings (Case COMP/M.4388 — Abertis v
Autostrade); and

— Order the Commission to pay the costs incurred by the

applicant in the present proceedings.

Pleas in law and main arguments

The present action contests the decision contained in Commis-
sioner Kroes' letter of 13 August 2008, by which — according
to the applicant — the Commission notified the Italian authori-
ties of its intention not to pursue Case COMP/M.4388 Abertis v
Autostrade under Article 21 of Council Regulation (EC)

Indeed,

(‘the Regulation’).

No 139/2004 of 20 January 2004 on the control of concentra-
tions between undertakings
the
Commission approves the regulatory measures relating to the
authorisation procedures for the ‘transfer’ of motorway conces-
sions (Ministerial Directive of 2007 and Decree of 2008).
However,
the Commission
reserves its position as to whether the Italian regulatory frame-
work relating to the authorisation procedure for the transfer of
motorway concessions is compatible with the rules governing
the internal market.

in the above-mentioned letter,

In support of its claims, the applicant alleges infringement of
Article 21 of the regulation on concentrations, on the following
grounds:

the Commission's powers of

— The Commission may in no circumstances refer to amend-
ments made to the relevant regulatory framework after
31 January 2007, the date of the preliminary assessment.
Since
assessment under
Article 21(4) of the Regulation are closely linked to the
context of the assessment of a specific concentration with a
Community dimension, with which the national measures at
issue are concerned, subsequent amendments to the regula-
tions could not have any effects on the earlier conduct of
the Italian authorities, which led the parties to abandon the
transaction in December 2006, three months after it was
authorised under Article 6(1)(b) of the Regulation.

— The applicant alleges that the Commission acted ultra vires or
misused its powers, in so far as the legal basis chosen for
the contents of the specific Decision ‘not to pursue’ the
Italian measures at issue is inadequate. It is submitted in that
connection that, by deciding that the amendments which
had meanwhile been made to the regulatory framework
would ensure that there would be no grounds in future for
the misgivings expressed in its preliminary assessment of
31 January 2007,
the Commission has adopted under
Article 21 of the Regulation a type of decision which that
provision does not envisage. In fact, the Commission has
used the powers conferred upon it under Article 21 to
declare compatible with Community law certain measures of
general application adopted by a Member State, which have
nothing to do with the specific concentration which Italy's
adoption of the national measures at issue was intended to
block.

— By considering that

the Italian regulatory framework, as
amended, has been made compatible with Community law,
the Commission has failed to take into account the fresh
uncertainties which have arisen in the Italian legal system as
a result of those national measures, which have certainly not
helped to establish a favourable environment for any future
concentrations concerning the Italian market in motorway
concessions.
the regulations adopted by the
Italian Administration in 2007 and 2008 must in any event
also be said to be contrary to Article 21 [of the Regulation]
in so far as they impose more extensive obligations for a
‘transfer’ of a motorway concession than those to which the
interested parties would otherwise be subject.

In addition,