Case C-207/03: Reference for a preliminary ruling by the High Court of Justice (England and Wales), Chancery Division, Patents Court by order of that court dated 6 May 2003, in the case of 1) Novartis AG 2) University College London 3) Institute of Microbiology and Epidemiology against Comptroller General of Patents, Designs and Trade Marks for the United Kingdom
Date: 2003-07-05
Institutions: Court of Justice
Subjects: Liechtenstein, Switzerland, interpretation of the law, market approval, marketing, medicinal product

5.7.2003

EN

Official Journal of the European Union

C 158/17

Reference for a preliminary ruling by the High Court of
Justice (England and Wales), Chancery Division, Patents
Court by order of that court dated 6 May 2003, in the
case of 1) Novartis AG 2) University College London
3) Institute of Microbiology and Epidemiology against
Comptroller General of Patents, Designs and Trade Marks
for the United Kingdom

(Case C-207/03)

(2003/C 158/28)

Reference has been made to the Court of Justice of the
European Communities by an order of the High Court of
Justice (England and Wales), Chancery Division, Patents Court
dated 6 May 2003, which was received at the Court Registry
on 14 May 2003, for a preliminary ruling in the case of
1) Novartis AG 2) University College London 3) Institute of
Microbiology and Epidemiology and Comptroller General of
Patents, Designs and Trade Marks for the United Kingdom on
the following questions:

1)

Is the date of the granting of a marketing authorisation
in Switzerland, which is automatically recognised in
Liechtenstein, to be considered as the first authorisation
to place a medicinal product on the market,
for the
purpose of calculating the duration of a supplementary
protection certificate as provided in Article 13 of Regu-
lation 1768/92 (1) (as amended by the EEA Agreement)?

2)

Is a competent authority within the EEA obliged to rectify
any existing supplementary protection certificates, the
duration of which has been erroneously calculated?

( 1) Council Regulation (EEC) No 1768/92 of 18 June 1992 concern-
ing the creation of a supplementary protection certificate for
medicinal products OJ L 182, 02.07.1992, p. 1.

The Commission of the European Communities claims that
the Court should:

1.

2.

3.

declare that, by applying a prior authorisation procedure
to personal imports, not effected by personal transport,
of medicinal products lawfully prescribed in France,
amended Directive 65/65/EEC (1)
authorised under
(replaced by Directive 2001/83/EC) (2), both in France
and in the Member State of the European Community
where they are purchased, the French Republic has failed
to fulfil its obligations under Article 28 of the Treaty
establishing the European Community;

declare that, by applying a prior authorisation procedure
to personal imports, not effected by personal transport,
of homeopathic medicinal products lawfully prescribed
in France and registered in a Member State of the
to Directive 92/73/
European Community pursuant
EEC (3) (replaced by Directive 2001/83/EC), the French
Republic has failed to fulfil its obligations under Article 28
of the Treaty establishing the European Community;

declare that, by applying a disproportionate prior author-
isation procedure to personal imports, not effected by
personal transport, of medicinal products lawfully pre-
scribed in France, not authorised in that country but only
in the Member State of the European Community where
they are purchased, the French Republic has failed to
fulfil
the Treaty
establishing the European Community;

its obligations under Article 28 of

4.

order the French Republic to pay the costs.

Pleas in law and main arguments

Action brought on 15 May 2003 by the Commission of
the European Communities against the French Republic

(Case C-212/03)

(2003/C 158/29)

An action against the French Republic was brought before the
Court of Justice of the European Communities on 15 May
2003 by the Commission of the European Communities,
represented by H. Støvlbæk and B. Stromsky, acting as Agents,
with an address for service in Luxembourg.

The Commission alleges the existence of measures having an
effect equivalent to quantitative restrictions on imports of
medicinal products, consisting of the imposition of a prior
authorisation procedure relating to the personal importation
into France, not effected by personal transport, of lawfully
prescribed medicinal products, in breach of Article 28 EC.
Such authorisation is required by the articles of the French
Public Health Code relating to the importation into French
customs territory of medicinal products,
including those
having the status of Community goods. In many cases, that
prior authorisation procedure cannot be justified on the basis
of Article 30 EC.