CELEX: C2003/083/12
Language: en
Date: 2003-04-05 00:00:00
Title: Case C-36/03: Reference for a preliminary ruling by the High Court of Justice (England & Wales), Queen's Bench Division (Administrative Court) by order of that court dated 23 December 2002, in the case of The Queen on the application of Approved Prescription Services Ltd against the Licensing Authority (acting by the Medicines Control Agency), Interested party: Eli Lilly & Co. Ltd

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