CELEX: C1998/327/24
Language: en
Date: 1998-10-24 00:00:00
Title: Action brought on 11 September 1998 by Commission of the European Communities against Italian Republic (Case C-334/98)

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.
 ---pagebreak--- 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.