Sepracor Pharmaceuticals (Ireland) Ltd v European Commission [2011] EUECJ T-275/09

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(Action for annulment - Medicinal products for human use - Active substance eszopiclone - Marketing authorisation - Refusal of recognition as a new active substance - Act not amenable to review - Inadmissibility)

Sepracor Pharmaceuticals (Ireland) Ltd, established in Dublin (Ireland), represented by I. Dodds-Smith, Solicitor, D. Anderson QC, and J. Stratford, Barrister,

European Commission, represented initially by A. Sipos, and subsequently by M. Wilderspin and M. Šimerdová, acting as Agents,

ACTION for annulment of the decision in the letter of the Commission addressed to the applicant on 6 May 2009 in the context of the procedure for authorising the placing on the market of Lunivia, inasmuch as it concerns classification of the active substance eszopiclone,

composed of I. Pelikánová, President, K. Jürimäe (Rapporteur) and M. van der Woude, Judges,

1 On 20 July 2007, the applicant, Sepracor Pharmaceuticals (Ireland) Ltd, filed an application for marketing authorisation with the European Medicines Agency (EMA) for tablets of 2mg and 3mg of Lunivia, a medicinal product used in the treatment of insomnia. The active substance in Lunivia is eszopiclone.

2 On 23 October 2008, the Committee for Medicinal Products for Human Use (‘the Committee’) of EMA gave its opinion on the application for marketing authorisation for Lunivia (‘the initial opinion’), in accordance with Article 9(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1), as amended. In that opinion, the Committee recommended that the applicant be granted marketing authorisation for Lunivia. However, it took the view that the active substance eszopiclone could not be regarded as a new active substance within the meaning of Article 3(2) of Regulation No 726/2004.

3 On 4 November 2008, in accordance with Article 62(1) of Regulation No 726/2004, the applicant requested EMA to re-examine the initial opinion, inasmuch as the Committee had stated that eszopiclone could not be regarded as a new active substance.

4 On 19 February 2009, the Committee gave its final opinion on the application for marketing authorisation for Lunivia. It confirmed therein the recommendation made in the initial opinion. The final opinion was served on the applicant on 20 February 2009.

5 By letters sent to the Commission of the European Communities on 10 and 20 February 2009 and 9 and 24 March 2009, the applicant stated, inter alia, that the grant of marketing authorisation without treating eszopiclone as a new active substance would compromise the commercial viability of the launch of Lunivia in the European Union to such an extent that it was prepared to withdraw its application for marketing authorisation. It explained that refusal to treat it as a new active substance would allow producers of generic medicinal products to use the pre-clinical or clinical data obtained by it during its research and development work with a view to obtaining marketing authorisation, whether or not it or its contractual partners exploit the authorisation themselves. The applicant requested that the Commission discuss that question with it. A meeting between the applicant and the Commission services took place on 2 April 2009.

6 By letter of 6 May 2009 (‘the contested measure’), the Commission informed the applicant, in particular, that, after an in-depth examination of the arguments put forward by the applicant, it saw no reason to depart from the scientific conclusions of the Committee with regard to the refusal to regard eszopiclone as a new active substance.

7 By letter of 13 May 2009, the applicant informed EMA that it withdrew its application for marketing authorisation for tablets of 2mg and 3mg of Lunivia.

8 By application lodged at the Registry of the Court on 16 July 2009, the applicant brought the present action.

9 By separate document lodged at the Registry of the Court on 12 October 2009, the Commission raised a plea of inadmissibility, pursuant to Article 114(1) of the Rules of Procedure of the General Court. The applicant lodged its observations on the plea of inadmissibility on 27 November 2009.

- declare the application admissible or, in the alternative, reserve its decision on admissibility until it has ruled on the substance;

12 Under Article 114(1) of the Rules of Procedure, if a party so requests, the Court may make a decision on admissibility without considering the substance. Under Article 114(3), unless the Court otherwise decides, the remainder of the proceedings is to be oral.

13 In this case, the Court considers that it has sufficient information from the documents before it and decides to give judgment without opening the oral procedure.

14 The Commission contends that the application is inadmissible. In essence, it submits that the contested measure may not be the subject of an action for annulment under the fourth paragraph of Article 230 EC but that it is, instead, a document of a purely informative nature, without legal effects. Firstly, the contested measure does not contain the definitive position of the Commission, which would have had to be formalised in a decision adopted in accordance with Article 10(2) of Regulation No 726/2004. The Commission had no power to take a legally binding decision on the status of eszopiclone as a new active substance independently of the procedure established by that regulation. Secondly, the contested measure was drafted in the context of informal contacts in which the Commission’s services merely answered the applicant’s questions. Thirdly, the contested measure explains in general terms the notion of a new active substance without examining the specific case of eszopiclone.

15 It must be borne in mind that, according to settled case-law, the only decisions which may be the subject of an action for annulment within the meaning of Article 230 EC are measures the legal effects of which are binding on, and capable of affecting the interests of, the applicant by bringing about a distinct change in his legal position. In order to determine whether an act or decision produces such effects, it is necessary to look to its substance. The form in which such acts or decisions are cast is, in principle, immaterial as regards the question whether they are open to challenge by an action for annulment (Case 60/81 IBM v Commission [1981] ECR 2639, paragraph 9; Case C-147/96 Netherlands v Commission [2000] ECR I-4723, paragraph 27; and Case C-76/01 P Eurocoton and Others v Council [2003] ECR I-10091, paragraph 54).

16 In the present case, the contested measure is a letter sent by the Commission’s services to the applicant. In order to ascertain whether that measure can produce legal effects as regards the applicant, pursuant to the case-law set out in paragraph 15 above, it is necessary to analyse both its content and the context in which it was adopted.

17 In the first place, it is apparent from the context of the contested measure that it merely sets out the opinion of the competent services of the Commission on the effect of the Committee’s final opinion, without, however, constituting the decision which the Commission has to adopt following that opinion.

18 In that regard, firstly, it must be noted that the procedure for examining applications for marketing authorisation is set out in detail in Regulation No 726/2004. That regulation states without ambiguity that, after receiving the final opinion of the Committee, the Commission must adopt a proper and valid decision in accordance with one of the procedures provided for in Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ 1999 L 184, p. 23).

19 More precisely, the procedure referred to in Regulation No 726/2004 is as follows. Under Article 5(2) of that regulation, the Committee is to be responsible for drawing up the opinion of EMA, inter alia, on any matter concerning the granting of an authorisation to place a medicinal product for human use on the market. Under Article 6(3) of that regulation, EMA is to ensure that the opinion of the Committee is given within 210 days after receipt of a valid application for marketing authorisation. Pursuant to Article 9(3) thereof, EMA is, within 15 days after its adoption, to send the final opinion of the Committee to the Commission, to the Member States and to the applicants. Under Article 62(1) of Regulation No 726/2004, an applicant for marketing authorisation may request re-examination of the Committee’s opinion. Article 10(1) of that regulation provides that, within 15 days after receipt of the Committee’s opinion, the Commission is to prepare a draft of the decision to be taken in respect of the application for marketing authorisation. That paragraph states that, where the draft decision is not in accordance with the Committee’s opinion, the Commission is to explain the reasons which led it to depart from that opinion. In addition, Article 10(2) of Regulation No 726/2004 states that the Commission is to take a final decision in accordance with, and within 15 days after the end of, the procedure referred to in Article 87(3) thereof. Article 87(3) of that regulation refers to Decision 1999/468.

20 In the light of the foregoing, it must be held that a simple letter from the Commission’s services expressing their position as to the action to be taken following the Committee’s opinion cannot be regarded as a decision producing legal effects as regards the applicant. Firstly, since the Commission was required, under Article 10(1) of Regulation No 726/2004, to formalise its position in a decision adopted in accordance with Decision 1999/468, only such a decision is capable of bringing about a distinct change in the legal position of the applicant for marketing authorisation. Secondly, it is apparent from Article 10(1) of that regulation that the Commission may depart from the Committee’s opinion. Accordingly, even though the Commission has, in a letter, expressed its intention not to depart from the Committee’s opinion, it cannot be assumed that the final decision, adopted pursuant to Article 10(2) of the regulation, will necessarily accord with that intention.

21 Secondly, it is apparent from the exchanges between the applicant and the Commission, leading to the adoption of the contested measure, that it was not in dispute, when those exchanges - instigated by the applicant - took place, that they were informal and took place alongside the formal procedure laid down in Regulation No 726/2004; that the Commission was required, pursuant to that regulation, to formalise its position in a decision adopted in accordance with the procedures prescribed in Decision 1999/468 and that the question of the status of eszopiclone as a new active substance would be determined finally by that decision.

22 In that regard, it is appropriate to note, first, that, by the letters of 10 and 20 February 2009, the applicant did not attempt to convince the Commission that eszopiclone should be regarded as a new active substance. However, it did seek, in essence, to obtain the Commission’s confirmation that the relevant legislation could be interpreted as meaning that its clinical and pre-clinical data would be protected even if the Commission’s decision authorising the marketing of Lunivia followed the Committee’s opinion and refused to treat eszopiclone as a new active substance. In addition, in the letter of 9 March 2009, apart from confirming its attendance at the meeting of 2 April 2009, the applicant stated that it did not wish the Commission to grant marketing authorisation for Lunivia so long as the question of protection of the clinical and pre-clinical data had not been clarified. Finally, in the letter of 24 March 2009, the applicant disputed the validity of the test applied by the Committee in order to determine the status of the active substance eszopiclone and requested the Commission to discuss that question with the applicant before adopting its decision.

23 Since the applicant was aware that, in addition to the answer it obtained in the informal exchanges, a decision within the meaning of the fourth paragraph of Article 230 EC would be adopted and, in the contested measure, the Commission merely answered the questions put by the applicant alongside the formal procedure laid down in Regulation No 726/2004, the applicant cannot validly claim that the position expressed by the Commission in a mere letter was able to bring about a change in the applicant’s legal position.

24 Thirdly, it must be noted that the applicant withdrew its application for marketing authorisation on 13 May 2009 in order to avoid, in its view, its clinical and pre-clinical data becoming immediately available to manufacturers of generic medicinal products on adoption by the Commission of a decision authorising the marketing of Lunivia. That means that the contested measure constitutes mere information as to the probable content of the future Commission decision and that it was understood as such by the applicant. It does not therefore produce any legal effects as regards the applicant, unlike the decision which the Commission would have been required to adopt, under Regulation No 726/2004 and in accordance with the procedures prescribed in Decision 1999/468, following the final opinion of the Committee, if the application for marketing authorisation had not been withdrawn.

25 In the second place, as regards the content of the contested measure, it must be noted that, with regard to the question of the classification of the active substance eszopiclone, the terms used by the Commission in the contested measure clearly indicate its intention to give the applicant a simple piece of information as to the probable content of a future decision. There is nothing in the terms of the contested measure to suggest that the Commission thereby adopted a final decision on the classification of that substance.

26 The question of the status of the active substance eszopiclone is dealt with by the Commission, in the contested measure, in two stages. Firstly, the Commission set out its theoretical view of the notion of a new active substance and of the assessment which the Committee must carry out in order to determine the presence of such an active substance in a medicinal product for which an application for marketing authorisation has been filed. Secondly, the Commission advised the applicant that, ‘on the basis of the above, I would like to inform you that, after careful consideration of your arguments, we see no reason to depart from the scientific conclusions of the [Committee] on this matter’. It is apparent from the terms of that finding that the Commission did not intend to adopt a final decision but merely informed the applicant of the position which it intended, in principle, to take in a future decision.

27 Accordingly, it cannot be deduced from the substance and wording of the contested measure that it is such as to alter the applicant’s legal position.

29 Firstly, the applicant submits that a decision to grant or refuse marketing authorisation would not have contained a decision about whether eszopiclone is or is not a new active substance. That implies that the Commission’s position as regards the notion of new active substance and the legal test applied by the Committee to determine whether an active substance may be regarded as new could not be subject to review by the Court.

30 In that regard, the Commission does not dispute that, if the decision to grant marketing authorisation had been adopted in favour of the applicant, the operative part of that decision would have been limited to the grant of that authorisation and would not have dealt with the question whether eszopiclone is or is not a new active substance. According to the Commission, the operative part of the decision would have contained a simple reference to the Committee’s opinion.

31 However, that does not mean that that question cannot be subject to review by the Court. The Committee’s opinion that eszopiclone cannot be regarded as a new active substance must be regarded as a preparatory act to the decision to grant the marketing authorisation which the Commission is to adopt under Regulation No 726/2004. In accordance with the case-law, whilst measures of a purely preparatory character may not themselves be the subject of an action for annulment, any legal defects therein may be relied upon in an action directed against the definitive act for which they represent a preparatory step (IBM v Commission, paragraph 15 above, paragraph 12).

32 Accordingly, if the applicant had not withdrawn its application for marketing authorisation, it would have been able to challenge, by an action against the Commission’s decision granting marketing authorisation, both the Committee’s refusal to recognise eszopiclone as a new active substance and the legal test applied by that Committee to reach that conclusion. Accordingly, it cannot rightfully be claimed that the refusal to recognise eszopiclone as a new active substance, as decided upon by the Committee and confirmed by the Commission, could not be subject to any review in the event of an action against the decision to grant the marketing authorisation, adopted by virtue of Regulation No 726/2004.

33 Secondly, the applicant submits that its rights were not adequately or effectively protected by the possibility of challenging the decision granting marketing authorisation. Such a decision would have had grave and immediate effects, immediately enabling producers of generic medicinal products to use all the pre-clinical and clinical data on the applicant’s dossier for the purpose of obtaining their own marketing authorisations. The contested measure would have allowed producers of generic medicinal products access to those data and would thus have caused irreversible damage to its protection. The contested measure is therefore similar to a decision to communicate confidential information to a third party, such as those which are the subject-matter of the judgments of the Court of Justice in Case 53/85 AKZO Chemie and AKZO Chemie UK v Commission [1986] ECR 1965 and Case C-170/89 BEUC v Commission [1991] ECR I-5709.

34 It must be noted that, by that argument, the applicant in essence relies on the future legal effects of a decision to grant the marketing authorisation - effects originating, according to the applicant, in the contested measure - and anticipates the damage which that decision might cause to it.

35 The case-law does not recognise any right of an applicant to rely on future legal effects. The Court of Justice has thus held that it is not the announcement of the intention to adopt a decision but the actual adoption of the decision which is capable of having legal effects as regards the applicant (see, to that effect, Case 114/86 United Kingdom v Commission [1988] ECR 5289, paragraph 13).

36 Moreover, the judgments referred to by the applicant do not support its arguments.

37 The case which gave rise to the judgment in AKZO Chemie and AKZO Chemie UK v Commission, paragraph 33 above, concerned a proceeding opened by the Commission in respect of AKZO Chemie under Article 82 EC. In that proceeding, the Commission had agreed to send confidential documents to a competitor of AKZO Chemie. That undertaking therefore brought an action against the decision of the Commission to send those documents to the competitor. The Court of Justice considered that the action was admissible since the contested act was final, it being possible, pursuant to that act, to send the confidential documents to the competitor, and independent of the decision to be adopted concerning the existence of an infringement of Article 82 EC. Although, in the case which gave rise to the judgment in AKZO Chemie and AKZO Chemie UK v Commission, the contested act immedicately and definitively altered the position of AKZO Chemie, that is not the situation in the present case. In the contested measure, the Commission merely announced its intention to adopt a decision the effects of which would be immediate and irreversible. That judgment does not, therefore, support the applicant’s arguments.

38 The same is true of the judgment in BEUC v Commission, paragraph 33 above, since the Court of Justice held in that judgment that the contested act refused the European Bureau of Consumers’ Unions (BEUC) access to a non-confidential file in an anti-dumping proceeding, which harmed its interests. There is therefore no question in that judgment of a contested act which produces its effects in the future.

39 In the light of all the above considerations, the action must be dismissed as inadmissible.

40 Under Article 87(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the applicant has been unsuccessful it must be ordered to pay the costs, as applied for by the Commission.

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You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> Sepracor Pharmaceuticals (Ireland) Ltd v European Commission [2011] EUECJ T-275/09_CO (4 July 2011) URL: http://www.bailii.org/eu/cases/EUECJ/2011/T27509_CO.html Cite as: ECLI:EU:T:2011:327, [2011] EUECJ T-275/9_CO, EU:T:2011:327, [2011] EUECJ T-275/09_CO

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