Case C-528/07 P: Appeal brought on 29 November 2007 by Association de la presse internationale ASBL (API) against the judgment of the Court of First Instance (Grand Chamber) delivered on 12 September 2007 in Case T-36/04: Association de la presse internationale ASBL (API) v Commission of the European Communities
Date: 2007-11-29
Institutions: Court of Justice
Subjects: European Commission, General Court (EU), access to EU information, action for annulment (EU), association, communications profession

C 22/36

EN

Official Journal of the European Union

26.1.2008

Reference for a preliminary ruling from High Court of
Justice (England & Wales), Queen's Bench Division (Admin-
istrative Court) (United Kingdom) made on 28 November
2007 — Generics (UK) Ltd, Regina v Licensing Authority
and Healthcare products
(acting via

the Medicines

Regulatory Agency)

(Case C-527/07)

(2008/C 22/64)

Language of the case: English

Referring court

High Court of Justice (England & Wales), Queen's Bench Divi-
sion (Administrative Court)

(e) a product containing the same active ingredient has
subsequently been authorised under Article 6 of Direc-
tive 2001/83 and placed on the market in the EC;

is the medicinal product to be considered to be ‘a reference
medicinal product which is or has been authorised under
Article 6 … in a Member State’ within the meaning of
Article 10(1) of Directive 2001/83, and if so which of the
above conditions is/are decisive in this respect?

(2) In circumstances where the competent authority of a refer-
ence Member State erroneously refuses an application for a
marketing authorisation made under Article 10(1) of Direc-
tive 2001/83 in the context of the decentralised procedure
provided for in that Directive, on the ground that the medic-
inal product referred to in Question 1 above was not a
‘reference medicinal product’ within the meaning of Article
10(1), what guidance, if any, does the Court of Justice think
it appropriate to provide as to which circumstances the
national court ought to take into consideration when it
comes to determine whether the breach of Community law
is a sufficiently serious breach within the meaning of the
judgment in Brasserie du Pecheur and Factortame?

Parties to the main proceedings

Applicant: Generics (UK) Ltd, Regina

(1) OJ L 214 p. 1.
(2) OJ L 311 p. 67.

Defendant: Licensing Authority (acting via the Medicines and
Healthcare products Regulatory Agency)

Questions referred

(1) Where a medicinal product falling outside the scope of the
Annex to Regulation 2309/93 (1) has been placed on the
(Austria) under its national
market
authorisation procedure prior
that
Member State to the EEA or the EC and:

to the accession of

in a Member State,

(a) that Member State has subsequently acceded to the EEA
and then the EC, and as part of the conditions of its
accession it has transposed into its national
law the
authorisation provisions of Directive 65/65 (now Direc-
tive 2001/83 (2)), no transitional provisions applying in
this respect;

(b) the product in question has remained on the market in
that Member State for some years after its accession to
the EEA and the EC;

(c) following the accession of that Member State to the EEA
and the EE, the marketing authorisation for the product
in question has been varied by adding a new indication,
and the variation was considered by the authorities of
that Member State to be consistent with the require-
ments of Community law;

(d) the dossier of the product in question was not updated
in accordance with Directive 65/65 (now Directive
2001/83) after that Member State's accession to the
EEA and the EC; and

Appeal brought on 29 November 2007 by Association de
la presse internationale ASBL (API) against the judgment of
the Court of First Instance (Grand Chamber) delivered on
12 September 2007 in Case T-36/04: Association de la
presse internationale ASBL (API) v Commission of the
European Communities

(Case C-528/07 P)

(2008/C 22/65)

Language of the case: English

Parties

Appellant: Association de la presse internationale ASBL (API)
(represented by: S. Völcker, Rechtsanwalt, F. Louis, avocat and C.
O'Daly, Solicitor)

Other parties to the proceedings: Commission of the European
Communities

26.1.2008

EN

Official Journal of the European Union

C 22/37

Form of order sought

The appellant claims that the Court should:

Appeal brought on 29 November 2007 by Commission of
the European Communities against the judgment of the
Court of First Instance (Grand Chamber) delivered on
12 September 2007 in Case T-36/04: Association de la
presse internationale ASBL v Commission of the European
Communities

— set aside the judgment of the Court of First Instance of the
European Communities in Case T-36/04, API v Commission,
of 12 September 2007 in so far as the Court of First
Instance upheld the Commission's right not to disclose the
Commission's pleadings in cases where an oral hearing was
yet to be held;

(Case C-532/07 P)

(2008/C 22/66)

Language of the case: English

— annul the parts of Commission Decision D(2003) 30621 of
20 November 2003 not previously annulled by the Court of
First Instance in Case T-36/04, or in the alternative refer the
case back to the Court of First Instance for further adjudica-
tion in the light of the judgment of the Court of Justice; and

Parties

— order the Commission to pay costs.

Appellant: Commission of the European Communities (repre-
sented by: C. Docksey and P. Aalto, Agents)

Other party to the proceedings: Association de la presse internatio-
nale ASBL (API)

Pleas in law and main arguments

Form of order sought

The Appellant submits that the contested judgment should be
set aside on the following grounds:

1. First,

the Court of First

Instance erroneously interpreted
Article 4(2) 2nd indent of the Regulation (the ‘court proceed-
ings exception’) when it held that the Commission need not
carry out a concrete assessment as to whether to give access
to its written pleadings before the oral hearing. This interpre-
tation (i) is contrary to well-established principles for inter-
preting the court proceedings exception that are recognised
elsewhere in the Judgment; (ii) is premised on a non-existent
right by the Commission to defend its interests ‘free from all
external influences’; (iii) relies on manifestly incorrect legal
arguments when invoking the ‘equality of arms principle’;
(iv) erroneously dismisses the significance of other jurisdic-
tions' rules that allow access to pleadings before the hearing;
and (v) wrongly relies on the need to protect the effet utile of
the Community courts' in camera procedures.

2. Second, the Court of First Instance misinterpreted the term
‘overriding public interest’ in Article 4(2) in fine of the Regu-
lation by holding that, when written pleadings submitted to
the courts are in issue, the general public interest in the
content of proceedings before the Community courts is not
capable of overriding any interest protected by the court
proceedings exception.

The appellant claims that the Court should:

— quash the contested judgment in part insofar as it annulled
the decision of the Commission refusing access to docu-
ments requested by API as from the date of the hearing
concerning all actions save infringement proceedings;

— give final judgment in the matters that are the subject of this

appeal;

— order the Applicant in Case T-36/04 to pay the costs of the
Commission arising from that case and from the present
appeal.

Pleas in law and main arguments

that

The Commission respectfully submits that, first, the Court of
First Instance has erred in law by interpreting court proceedings
the institutions must consider
exception to the effect
requests for access to written pleadings in non-infringement
actions on a case by case basis as from the date of the hearing.
In this respect the Commission respectfully submits that the
conclusions of the Court of First Instance are inconsistent with
its reasoning, that the CFI did not take into account the interest
in the proper administration of justice or the interest of other
persons mentioned in the procedure, and that the CFI only
considered the rights and obligations of one of the parties.
Whilst court documents submitted by the institutions are not
excluded from the scope of Regulation 1049/2001 (1),
the
conclusion reached by the CFI has no basis in Community legis-
lation or in the case law of the Court of Justice.