Sie sind auf Seite 1von 2

24.10.

98 EN Official Journal of the European Communities C 327/15

administrative measure with the operation of services of not only to the product covered by the authorisation
general economic interest, but is sufficient that that to place the corresponding medicinal product on the
responsibility results from public-law contracts entered market' but also to the derivatives (salts and esters) of
into, as here, between the body in question and the public the product, bearing in mind that, under Article 1 of
authorities. Furthermore, it is not necessary, in order for Regulation (EEC) No 1768/92, product' must be
Article 90(2) of the Treaty to apply, for the body to hold a construed as meaning the active ingredient or
monopoly in the operation of the services in question. combination of active ingredients of a medicinal
product'?
(1) Not yet published in the OJ.

D. If the above extension to the derivatives of the active


ingredient is accepted, must Article 4 of Regulation
(EEC) No 1768/92 be construed as meaning that the
protection conferred by the SPC is not impaired by
the health authority measure granting marketing
authorisation and in particular by the active ingredient
Reference for a preliminary ruling by the Commissione indicated in that authorisation as corresponding to the
dei Ricorsi contro i Provvedimenti dell'Ufficio Italiano authorised medicinal product?
Brevetti e Marchi by order of 16 December 1997 in the
case of Merck & Co. Inc. v Ufficio Italiano Brevetti e
Marchi
E. On the assumption, once again, that the suggested
(Case C-333/98) extension of the protection conferred by the SPC to
the derivatives of the active ingredient is accepted,
(98/C 327/23) must the final phrase of Article 4 of Regulation (EEC)
No 1768/92 be construed as meaning that the
supplementary protection may be relied on for each of
the medicinal products in so far as they have been
Reference has been made to the Court of Justice of the
authorised by the health authority before the expiry of
European Communities by order of 16 December 1997
the certificate, or is the first authorisation of the
from the Commissione dei Ricorsi contro i Provvedimenti
medicinal product corresponding to the active
dell'Ufficio Italiano Brevetti e Marchi (Committee hearing
ingredient sufficient?
Appeals against measures of the Italian Patent and
Trademark Office), which was received at the Court
Registry on 9 September 1998, for a preliminary ruling in
the case of Merck & Co. Inc. v Ufficio Italiano Brevetti e F. Finally, if the active ingredient corresponding to the
Marchi (the Italian Patent and Trademark Office) on the medicinal product which was the subject of the first
following questions: marketing authorisation is a salt or an ester of the
patented substance, does the protection conferred by
the SPC also extend to that substance and to its other
derivatives?
A. May the recitals in the preamble to a Community
regulation (in this case, recitals 13 and 17 in the
preamble to Council Regulation (EC) No 1610/96) (1) (1) OJ L 198, 8.8.1996, p. 30.
be recognised as being prescriptive, and not solely as (2) OJ L 182, 2.7.1992, p. 1.
providing guidance for the interpretation of the
regulation which they introduce?

B. On the assumption that the rules of authentic


interpretation' are prescriptive and do not merely
have an interpretative function, may recital 17 in Action brought on 11 September 1998 by Commission of
the preamble to Regulation (EC) No 1610/96 be the European Communities against Italian Republic
recognised as having the status of a rule for the
authentic interpretation of the provisions of Council (Case C-334/98)
Regulation (EC) No 1768/92 (2) to which that recital
refers and, in particular, Article 4 of Regulation (EC) (98/C 327/24)
No 1768/92?

An action against Italian Republic was brought before


C. If it is accepted that recital 17 in the preamble to the Court of Justice of the European Communities on
Regulation (EC) No 1610/96 does have the suggested 11 September 1998 by Commission of the European
status as a rule of authentic interpretation, must Communities, represented by Paolo Stancanelli, of its
Article 4 of Regulation No 1768/92 be construed Legal Service, acting as Agent, with an address for service
as meaning that the protection conferred by a in Luxembourg at the office of Carlos Gómez de la Cruz,
supplementary protection certificate (SPC) extends Wagner Centre, Kirchberg.
C 327/16 EN Official Journal of the European Communities 24.10.98

The applicant claims that the Court should: provisions laid down by law, regulation or
administrative action necessary to comply with
Directive 94/47/EC (1) of the European Parliament and
Ð declare that, by failing to adopt or, in any event, the Council of 26 October 1994 on the protection of
by failing to communicate to the Commission purchasers in respect of certain aspects of contracts
the provisions laid down by law, regulation or relating to the purchase of the right to use immovable
administrative action necessary to comply with properties on a timeshare basis, the Italian Republic
has failed to fulfil its obligations under that directive;
Ð Commission Directive 95/12/EC of 23 May 1995
implementing Council Directive 92/75/EEC with
regard to energy labelling of household washing Ð order the Italian Republic to pay the costs.
machines (1),
Pleas in law and main arguments adduced in support:
Ð Commission Directive 95/13/EC of 23 May 1995
implementing Council Directive 92/75/EEC with
regard to energy labelling of household electric Article 189 of the EC Treaty, in accordance with which a
tumble driers (2), directive is binding, as to the result to be achieved, upon
each Member State to which it is addressed, obliges
Member States to respect the time-limits for
the Italian Republic has failed to fulfill its obligations
implementation prescribed by directives. When the time-
under those directives;
limit expired on 30 April 1997 the Italian Republic had
not adopted the provisions necessary to comply with the
Ð order the Italian Republic to pay the costs. directive referred to in the forms of order sought by the
Commission.

Pleas in law and main arguments adduced in support:


(1) OJ L 280, 29.10.1994, p. 83.

Article 189 of the EC Treaty, in accordance with which


a directive is binding, as to the result to be achieved,
upon each Member State to which it is addressed,
obliges Member States to respect the time-limits
for implementation prescribed by directives. When the
time-limit expired on 1 March 1996 the Italian Republic Action brought on 22 September 1998 by the Commission
had not adopted the provisions necessary to comply with of the European Communities against Ireland
the directives referred to in the forms of order sought by (Case C-345/98)
the Commission.
(98/C 327/26)
(1) OJ L 136, 21.6.1995, p. 1.
(2) OJ L 136, 21.6.1995, p. 28.
An action against Ireland was brought before the Court of
Justice of the European Communities on 22 September
1998 by the Commission of the European Communities,
represented by Hans Christian Stùvlbaek, a member of its
Legal Service, and Michael Shotter, a national official
seconded to the Commission under an arrangement for the
Action brought on 11 September 1998 by Commission of exchange of officials, acting as agents, with an address for
the European Communities against Italian Republic service in Luxembourg at the office of Carlos Gómez de la
(Case C-335/98) Cruz, a member of the Legal Service of the Commission,
Centre Wagner.
(98/C 327/25)

The applicant claims that the Court should:


An action against Italian Republic was brought before the
Court of Justice of the European Communities on
Ð declare that by failing to adopt and publish the laws,
11 September 1998 by Commission of the European
regulations or administrative provisions necessary to
Communities, represented by Paolo Stancanelli, of its
comply with Directive 94/9/EC (1) of the European
Legal Service, acting as Agent, with an address for service
Parliament and Council, of 23 March 1994, on the
in Luxembourg at the office of Carlos Gómez de la Cruz,
approximation of the laws of the Member States
Wagner Centre, Kirchberg.
concerning equipment and protective systems intended
for use in potentially explosive atmospheres, Ireland
The applicant claims that the Court should: has failed to fulfil its obligations under that Directive,
and

Ð declare that, by failing to adopt or, in any event, by


failing to communicate to the Commission the Ð order Ireland to pay the costs.