CELEX: C1997/040/15
Language: en
Date: 1997-02-08 00:00:00
Title: Reference for a preliminary ruling by the High Court of Justice, Queen's Bench Division, by order of that Court of 10 October 1996, in the case of the Queen against Medicines Control Agency, Ex parte: Generics (UK) Limited, E. R. Squibb & Sons, Intervener (Case C-368/96)

8 . 2 . 97             I r,N                   Official Journal of the European Communities                                     No C 40 7
on 17 September 1996 by Giorgio Bernardi , represented                    2 . If the reply to Question 1 is in the negative, if, that is,
by Giancarlo Lattanzi, of the Massa-Carrara Bar, with an                       the Court of Justice reserves such competence for
address for service in Luxembourg at 22 Rue Godchaux.                          itself, for reasons relating, for instance, to the uniform
                                                                               application of Community provisions, may the specific
The appellant claims that the Court should :                                   circumstances as formulated by the defendant­
                                                                               respondent State as an objection, which constituted
— find and declare the present appeal (') admissible and                       the issue of proof in Judgment No 5943/ 1994 of this
      well-founded,
                                                                               Court, and which were set out succinctly in the
— set aside the judgment appealed against,                                     previous paragraph of this Judgment, or certain of
                                                                               them and if so which, prevent an action founded on
— dispose of the case and allow the claims made therein,                       infringement of Article 25 ( 1 ) of the Second Council
                                                                               Directive 77/91 /EEC (') from succeeding ?
— refer the case back, as appropriate .
                                                                          (') OJ No L26 , 30 . 1 . 1977, p . 1 .
Pleas in law and main arguments adduced in support:
— lack of jurisdiction of the Court of First Instance to
       consider the action on the basis of Article 173 of the
       EC Treaty: In the present case, the action concerns the            Reference for a preliminary ruling by the High Court of
       procedure for appointing the European Ombudsman,                   Justice, Queen's Bench Division, by order of that Court of
       and is therefore a new subject matter, hence the                   10 October 1996, in the case of the Queen against
       application either of Article 43 of the ECSC Treaty                Medicines Control Agency, Ex parte: Generics ( UK )
       ( according to which 'the Court shall have jurisdiction                          Limited, E. R. Squibb & Sons, Intervener
       in any other case provided for by a provision
                                                                                                      Case C-368/96
       supplementing this Treaty'), or of a general principle
       of jurisdiction 'according to subject matter' ( since the                                       ( 97/C 40/ 15 )
       oath was taken by the European Ombudsman before
       the Court of Justice ),                                            Reference has been made to the Court of Justice of the
— ( In the alternative ) breach of Community law.                         European Communities by an order of the High Court of
                                                                          Justice, Queen 's Bench Division, of 10 October 1996 ,
                                                                          which was received at the Court Registry on 22 November
(') Appeal directed against the judgment published in OJ No
     C 247, 24 . 8 . 1996 , p. 15 .
                                                                          1996 , for a preliminary ruling in the case of the Queen
                                                                          against Medicines Control Agency, Ex parte : Generics
                                                                          ( UK ) Limited, E. R. Squibb & Sons, Intervener, on the
                                                                          following questions:
Reference for a preliminary ruling by the First Chamber of                1 . ( a ) What is meant by 'essentially similar' for the
the Efetio Athinon ( Court of Appeal, Athens ), by a                                   purposes of Article 4.8 ( a ) ( iii ) of Council
judgment of that court of 6 June 1996 in the case of                                   Directive 65/65/EEC (^ of 26 January 1965 on the
Alexandros Kefalas            and Others v.     Greek State     and                    approximation of provisions laid down by law,
Organismos Ikonomikis Anasinkrotisis Epikhirseon AE                                    regulation or administrative action relating to
and Others — Interveners: Athinaiki Khartopiia AE and                                  proprietary medicinal products ( as amended )? In
                                    Others                                             particular, when seeking to establish for that
                                                                                       purpose that a medicinal product (product B ) is
                            ( Case C-367/96 )                                          essentially similar to a medicinal product which
                               ( 97/C 40/ 14 )                                         has been authorized within the Community for
                                                                                       6/ 10 years in accordance with the Community
Reference has been made to the Court of Justice of the                                 provisions in force ( product A ), by reference to
European Communities by a judgment of the First                                        which physical or other characteristics or
Chamber of the Court of Appeal, Athens, of 6 June 1996 ,                               attributes of the medicinal products in question
                                                                                       should this be determined ?
which was received at the Court Registry on 21 November
 1996 , for a preliminary ruling in the case of Alexandros                      ( b) Does the competent authority of a Member State
Kefalas and Others v. Greek State and Organismos                                       have a margin of discretion in determining the
 Ikonomikis Anasinkrotisis Epikhiriseon AE — Interveners :                             criteria in accordance with which the question of
 Athinaiki Khartopiia AE and Others — on the following                                 whether product B is essentially similar to
 questions:                                                                            product A is to be judged, and if so to what
                                                                                       extent ?
 1 . Is the national court recognized as having the
        possibility of applying a provision of national law ( in           2 . May product B be authorized in accordance with
        this case Article 281 of the Greek Civil Code ) in order                Article 4.8 ( a ) ( iii ) of Directive 65/65/EEC ( as
        to assess whether a right granted by the Community                      amended ) in respect of:
        provisions at issue is being exercised by the party
        possessing the right in abuse of rights, or are there                    ( a ) all indications for which product A is currently
        other Community law principles, and if so which , to                           authorized in the relevant Member State at the
         be found in legislation or settled case-law, on which                          date of the application made in relation to
        the national court may, if need be, base itself?                               product B; or
 ---pagebreak--- No c 40/8                  ΓΕΝ ]                      Official Journal of the European Communities                                                8 . 2 . 97
    ( b) only those indications for which product A has                          4 . Does it make any difference to the answer to
              been authorized in the EU in accordance with                               Questions 2 and/or 3 whether the original or abridged
              Community provisions in force for 6/10 years; or                           applications for marketing authorizations were made
                                                                                         before     16 March            1995 , the date upon which
    ( c ) only :                                                                         Regulation ( EC ) No 541 /95 entered into forece ?
              1 . those indications for which product A has been
                   authorized       in   the   EU in     accordance   with
                   Community provisions in force for 6/ 10 years;                5 . In the light of the answers to Questions 1 —4 above, is
                   and                                                                   Article 4.8 ( a ) ( iii ) invalid as contrary to the principles
                                                                                         of protection of innovation and/or non-discrimination
              2 . those indications for which product A has been                         and/or proportionality and/or respect for property ?
                   authorized for a shorter period, and which did
                   not require an application for the grant of a
                   new marketing authorization under the                         (') Official Journal English Special Edition 1995— 1996 , p. 20 .
                   provisions of Annex II of Commission                          ( 2 ) OJ No E 55 , IE 3 . 1995 , p. 7 .
                   Regulation ( EC ) No 541 /95 or ( as the case
                   may be ) would not have required such an
                   application had the said Regulation been in
                   force at the time the indication in question was
                   added       by        variation     to    an    existing
                   authorization ; or
     ( d ) some other category of indications, and if so                         References for a preliminary ruling by the Tribunale di
              which ?                                                            Trento by orders of that Court of 24 October 1996 in the
                                                                                 cases of 1 . Ministero delle Finanze against Cotonificio del
                                                                                 Trention SpA ( C-371/96 ) and 2 . Ministero delle Finanze
3 . May product B be authorized in accordance with
                                                                                               against Merkur Chemical Sri ( C-373/96 )
     Article 4.8           (a)   ( iii ) of Directive 65/65/EEC ( as
     amended) in respect of:                                                                         ( Cases C-371 /96 and C-373/96 )
      ( a ) all dosage forms and/or doses and/or dosage                                                             ( 97/C 40/ 16 )
              schedules for which product A is currently
              authorized in the relevant Member State at the
              date of the application made in relation to
              product B; or                                                       Reference has been made to the Court of Justice of the
                                                                                  European Communities by orders of the Tribunale di
      ( b ) only those dosage forms and/or doses and/or                           Trento ( Trento District Court ) of 24 October 1996 ,
              dosage schedules for which product A has been                       received at the Court Registry on 25 November 1996 , for
              authorized       in      the   EU    in    accordance    with       a preliminary ruling in the cases of 1 . Ministero delle
               Community provisions in force for 6/ 1 0 years; or                 Finanze against Cotonificio del Trention SpA ( C-371 /96 )
                                                                                  and 2 . Ministero delle Finanze against Merkur Chemical
       ( c) only:                                                                  Sri ( C-373/96 ) on the following question:
               1 . those dosage forms and/or doses and/or dosage
                    schedules for which product A has been
                    authorized in the EU in               accordance with          'Does Community law, as interpreted by the Court of
                    Community provisions in force for 6/10 years;                 Justice in its judgment in Case C-208/90 Emmott v.
                    and                                                            Minister for Social Welfare and the Attorney General
                                                                                   ( 1991 ) ('), preclude the Italian State, in an action brought
               2 . those dosage forms and/or doses and/or dosage                   against it by a company for reimbursement of sums paid
                    schedules for which product A has been                         by way of taxes which were prohibited by Article 10 of
                    authorized for a shorter period, and which did                 Council Directive 69/335/EEC (2 ), from pleading a
                    not require an application for the grant of a                  national       time-limit       for   submission  of  reimbursement
                    new marketing authorization under the                          claims where, as is provided in Article 13 ( 2 ) of
                    provisions of Annex II of Commission                           Presidential Decree No 641 /72 of 26 October 1972 , time
                    Regulation ( EC ) No 541 /95 ( 2 ) of 10 March                  begins to run from the date of the undue payment of the
                     1995 concerning the examination of variations                 above sums, rather than from the point in time at which,
                    to the terms of a marketing authorization                      with the subsequent abolition of the tax falling within the
                    granted by a competent authority of a Member                    prohibition of Article 10 of the above Directive, the
                     State or ( as the case may be ) would not have                 Italian State abolished the measure which conflicted with
                    required such an application had the said                       that Directive ?'
                     Regulation been in force at the time the dosage
                     form and/or dose and/or dosage schedule in
                     question was added by variation to an existing                 (') ECR 1-4269 , 1991 .
                     authorization; or                                              (2 ) Official Journal English Special Edition 1969 ( II ) p. 412.
         ( d ) some other category of dosage forms and/or doses
                and/or dosage schedules, and if so which ?