CELEX: C2003/083/13
Language: en
Date: 2003-04-05 00:00:00
Title: Case C-41/03 P: Appeal brought on 4 February 2003 by Rica Foods (Free Zone) NV against the judgment delivered on 14 November 2002 by the Court of First Instance (Third Chamber) in Joined Cases T-94/00, T-110/00 and T-159/00 Rica Foods (Free Zone) NV, Free Trade Foods NV and Suproco NV, supported by the Kingdom of the Netherlands, v Commission of the European Communities, supported by the Kingdom of Spain and the French Republic

5.4.2003                EN                        Official Journal of the European Union                                           C 83/7
Reference for a preliminary ruling by the High Court                      Appeal brought on 4 February 2003 by Rica Foods (Free
of Justice (England & Wales), Queen’s Bench Division                      Zone) NV against the judgment delivered on 14 Novem-
(Administrative Court) by order of that court dated                       ber 2002 by the Court of First Instance (Third Chamber)
23 December 2002, in the case of The Queen on the                         in Joined Cases T-94/00, T-110/00 and T-159/00 Rica
application of Approved Prescription Services Ltd against                 Foods (Free Zone) NV, Free Trade Foods NV and Suproco
the Licensing Authority (acting by the Medicines Control                  NV, supported by the Kingdom of the Netherlands, v
         Agency), Interested party: Eli Lilly & Co. Ltd                   Commission of the European Communities, supported by
                                                                                the Kingdom of Spain and the French Republic
                           (Case C-36/03)
                                                                                                   (Case C-41/03 P)
                          (2003/C 83/12)                                                            (2003/C 83/13)
                                                                          An appeal has been brought before the Court of Justice of the
Reference has been made to the Court of Justice of the                    European Communities on 4 February 2003 by Rica Foods
European Communities by an order of the High Court of                     (Free Zone) NV, represented by G. van der Wal, advocaat
Justice (England & Wales), Queen’s Bench Division (Adminis-               before the Hoge Raad der Nederlanden, against the judgment
trative Court) dated 23 December 2002, which was received                 delivered on 14 November 2002 by the Court of First Instance
at the Court Registry on 3 February 2003, for a preliminary               (Third Chamber) in Joined Cases T-94/00, T-110/00 and
ruling in the case of The Queen on the application of Approved            T-159/00 Rica Foods (Free Zone) NV, Free Trade Foods NV and
Prescription Services Ltd against the Licensing Authority                 Suproco NV, supported by the Kingdom of the Netherlands, v
(acting by the Medicines Control Agency), Interested party: Eli           Commission of the European Communities, supported by the
Lilly & Co. Ltd, on the following questions:                              Kingdom of Spain.
Can an application for a marketing authorisation for a                    The appellant claims that the Court should:
medicinal Product C validly be made under the first paragraph
of Article 10.1(a)(iii) of Directive 2001/83/EC (1), where the            (1) declare admissible the appeal lodged by the appellant
application seeks to demonstrate that Product C is essentially                 against the judgment delivered on 14 November 2002 by
similar to another product, Product B, in circumstances where:                 the Court of First Instance of the European Communities
                                                                               in Joined Cases T-94/00, T-110/00 and T-159/00;
(1) Product B is related to an original medicinal Product A,
       in that Product B has been authorised as a ‘line extension’        (2) set aside the judgment delivered on 14 November 2002
       of Product A, but has a different pharmaceutical form                   by the Court of First Instance of the European Communi-
       from Product A or is otherwise not ‘essentially similar’ to             ties in Joined Cases T-94/00, T-110/00 and T-159/00
       Product A within the meaning of Article 10.1(a)(iii); and               and, ruling afresh pursuant to the application at first
                                                                               instance lodged by the present appellant on 18 April
                                                                               2000:
(2) Product A has been authorised for marketing in the
       Community for more than the six/ten year period stipu-
       lated in Article 10.1(a)(iii); and                                      —     annul Regulation No 465/2000/EC (1);
                                                                               —     declare that the Community is liable for the damage
(3) Product B has been authorised for marketing for less than                        suffered by the appellant by reason of the fact that
       the six/ten year period stipulated in Article 10.1(a)(iii).                   imports of the products referred to in Regulation
                                                                                     (EC) No 465/2000 have, since 1 March 2000, been
                                                                                     prevented or restricted as a consequence of that
                                                                                     regulation, and order the parties to reach agreement
( 1) Directive 2001/83/EC of the European Parliament and of the                      on the extent of the damage suffered by the appel-
     Council of 6 November 2001 on the Community code relating to                    lant, and, if no agreement is reached on that matter,
     medicinal products for human use (OJ L 311, 28.11.2001, p. 67).                 order that proceedings be continued within a period
                                                                                     to be laid down by the Court of Justice for the
                                                                                     purpose of determining the extent of the damage, or
                                                                                     at any rate order the Community to pay compen-
                                                                                     sation for the provisionally estimated damage and
 ---pagebreak--- C 83/8                  EN                          Official Journal of the European Union                                             5.4.2003
            that still to be assessed; in the further alternative,          —      Infringement of the preferential status of the OCT: the
            order the Community to pay compensation to be                          Court of First Instance erred in its determination of the
            determined on an equitable basis by the Court of                       relevant facts to such an extent that its appraisal in the
            Justice, plus annual interest of 8 % from the date of                  grounds of its judgment here referred to is, in the light of
            the application at first instance to the date of full                  the procedural documents, incomprehensible.
            and final payment;
                                                                            (1 ) Commission Regulation (EC) No 465/2000 of 29 February 2000
                                                                                 introducing safeguard measures for imports from the overseas
(3) order the respondent to pay the costs of both sets of                        countries and territories of sugar sector products with EC/OCT
      proceedings, in accordance with Article 69(2) of the Rules                 cumulation of origin (OJ 2000 L 56, p. 39).
      of Procedure.                                                         (2 ) — Council Decision 91/482/EEC of 25 July 1991 on the
                                                                                 association of the overseas countries and territories with the
                                                                                 European Economic Community (OJ 1991 L 263, p. 1).
Pleas in law and main arguments
                                                                            Reference for a preliminary ruling by the Tribunale di
—     Breach of Article 109(1) of the OCT Decision ( 2): the                Catania — Prima Sezione Civile, by order of that Court of
      Court of First Instance failed to take into account the fact          19 January 2003 in the case of Catania Commissary
      that Article 109(1) of the OCT Decision constitutes a                         General of Police against Oxana Dem’Yanenko
      derogation from the prohibition in Article 101 of the
      OCT Decision of import duties and measures having
      equivalent effect. As in the case of every derogation which                                       (Case C-45/03)
      departs from the principal rule, and in this case from the
      objective of the successive OCT Decisions, this derogation
      must be narrowly construed and applied. The ‘wide                                                (2003/C 83/14)
      discretion’ of the Commission and the limited appraisal
      of the Community judicature on which the Court of
      First Instance based itself are incompatible with such a
      possibility of applying Article 109(1) of the OCT Decision            Reference has been made to the Court of Justice of the
      that is limited to exceptional cases (Article 109(1) of the           European Communities by order of the Tribunale di Catania
      OCT Decision as an ‘emergency brake’);                                — Prima Sezione Civile (Catania District Court, First Civil
                                                                            Chamber) of 19 January 2003, received at the Court Registry
                                                                            on 7 February 2003, for a preliminary ruling in the case
—     Failure to provide reasons: it was wrong in law and also, in          of Catania Commissary General of Police against Oxana
      light of the documents on the case-file, incomprehensible             Dem’Yanenko on the following questions:
      and/or indicative of inadequate reasoning that the Court
      of First Instance should hold (i) that any additional                 1.     Are the Community rules set out above — Articles 7, 8
      imports of OCT sugar under the EC/OCT cumulation of                          and 9 of Council Directive 64/221/EEC ( 1) of 25 February
      origin regime would increase the amount of surplus sugar                     1964 and Articles 2, 5, 6, 13 and 14 of the Convention
      on the Community market, and (ii) that ‘additional                           for the Protection of Human Rights and Fundamental
      imports’ within the meaning of (i) impose an extra burden                    Freedoms, signed in Rome on 4 November 1950 — and
      on the Community budget;                                                     the general, fundamental principles of Community law to
                                                                                   be interpreted as meaning that any foreigner deported
                                                                                   from a Member State of the European Community is
                                                                                   entitled to have his deportation order reviewed before it
—     Breach of Article 109(1) of the OCT Decision: the Court                      is enforced by an impartial authority different from that
      of First Instance erred in law in its construction of the                    which adopted the order?
      terms ‘difficulties’ and ‘deterioration’ and consequently
      erred in law in its application of those terms. The
      appellant refers to its application at first instance;                2.     Are the Community rules set out above — Articles 7, 8
                                                                                   and 9 of Council Directive 64/221/EEC of 25 February
                                                                                   1964 and Articles 2, 5, 6, 13 and 14 of the Convention
                                                                                   for the Protection of Human Rights and Fundamental
—     Breach of Article 109(2) of the OCT Decision: there is no                    Freedoms, signed in Rome on 4 November 1950 — and
      quantitative correlation between the quota in Regulation                     the general, fundamental principles of Community law to
      No 465/2000 and ‘difficulties’ and/or ‘deterioration’. In                    be interpreted as meaning that it is unacceptable and
      the light of the historical quantities, the measure is also                  unlawful for the police of a Member State of the European
      entirely arbitrary and inequitable;                                          Community, without prior review by any other authority,