CELEX: C1998/327/23
Language: en
Date: 1998-10-24 00:00:00
Title: Reference for a preliminary ruling by the Commissione dei Ricorsi contro i Provvedimenti dell'Ufficio Italiano Brevetti e Marchi by order of 16 December 1997 in the case of Merck & Co. Inc. v Ufficio Italiano Brevetti e Marchi (Case C-333/98)

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.