Court of Justice of the European Communities (including Court of First Instance Decisions)

ORDER OF THE COURT (Eighth Chamber)

14 May 2012 (*)

(Appeals - Regulation (EC) No 726/2004 - Medicinal products for human use - Active substance ‘eszopiclone’ - Marketing authorisation - Procedure - Statement of position by the Commission - Status of ‘new active substance’ - Concept of ‘actionable measure’)

In Case C-477/11 P,

APPEAL under Article 56 of the Statute of the Court of Justice, brought on 16 September 2011,

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

appellant,

the other party to the proceedings being:

European Commission, represented by M. Wilderspin and M. Šimerdová, acting as Agents, with an address for service in Luxembourg,

defendant at first instance,

THE COURT (Eighth Chamber),

composed of A. Prechal, President of the Chamber, C. Toader (Rapporteur) and E. Jarašiūnas, Judges,

Registrar: A. Calot Escobar,

Advocate General: V. Trstenjak,

after hearing the Advocate General,

makes the following

Order

1        By its appeal, Sepracor Pharmaceuticals (Ireland) Ltd (‘Sepracor Pharmaceuticals’) asks the Court of Justice to set aside the order of the General Court of the European Union of 4 July 2011 in Case T-275/09 Sepracor Pharmaceuticals v Commission (‘the contested order’) by which the latter dismissed as inadmissible its application seeking annulment of the decision allegedly constituted by the letter of 6 May 2009 (‘the letter at issue’) which the European Commission sent to it and in which that institution did not recognise the status of ‘new active substance’ for the active substance eszopiclone contained in the medicinal product Lunivia, in respect of which Sepracor Pharmaceuticals had brought and then withdrawn an application for marketing authorisation.

 Legal context

 Regulation (EC) No 726/2004

2        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) defines the conditions in which marketing authorisation can be granted in the European Union for a medicinal product.

3        Recital 11 in the preamble to that regulation reads as follows:

‘For medicinal products for human use, the period for protection of data relating to pre-clinical tests and clinical trials should be the same as that provided for in Directive 2001/83/EC [of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311 p. 67)]. …’

4        Article 3(2) of Regulation No 726/2004 provides:

‘Any medicinal product not appearing in the Annex may be granted marketing authorisation by the Community in accordance with the provisions of this Regulation, if:

(a)       the medicinal product contains a new active substance which, on the date of entry into force of this Regulation, was not authorised in the Community; or

(b)       the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorisation in accordance with this Regulation is in the interests of patients or animal health at Community level.

…’

5        Article 4 of that regulation provides:

‘1.       Applications for the marketing authorisation referred to in Article 3 shall be submitted to the [European Medicines Agency, (“EMA”)].

2.       The Community shall grant and supervise marketing authorisations for medicinal products for human use in accordance with Title II.

…’

6        Under Article 5(1) of that regulation, a Committee for Medicinal Products for Human Use (‘the Committee’) is established as part of the EMA. Under Article 5(2) thereof, the Committee is to be responsible for drawing up the opinion of the EMA on any matter concerning the admissibility of the files submitted in accordance with the centralised procedure, the granting, variation, suspension or revocation of an authorisation to place a medicinal product for human use on the market in accordance with the provisions of Chapter 1 of Title II of the regulation, entitled ‘Submission and examination of applications - Authorisations’, as well as pharmacovigilance.

7        Article 6(3) of that regulation provides that, once an application has been made, the EMA must ensure that the opinion of the Committee is given within 210 days after receipt of a valid application.

8        In that regard, under Article 7(a) of Regulation No 726/2004, the Committee is to verify specifically, in order to prepare its opinion, that the particulars and documents submitted in accordance with Article 6 of that regulation comply with the requirements of Directive 2001/83/EC, and is to examine whether the conditions specified in that regulation for granting marketing authorisation are satisfied.

9        Article 9 of that regulation provides::

‘1. [The EMA] shall forthwith inform the applicant if the opinion of the Committee … is that:

(a)      the application does not satisfy the criteria for authorisation set out in this Regulation;

(b)      the summary of the product characteristics proposed by the applicant needs to be amended;

(c)      the labelling or package leaflet of the product is not in compliance with Title V of Directive 2001/83/EC;

(d)      the authorisation needs to be granted subject to the conditions provided for in Article 14(7) and (8).

2. Within 15 days of receipt of the opinion, the applicant may provide written notice to [the EMA] that he wishes to request a re-examination of the opinion. In that case, he shall forward to [the EMA] the detailed grounds for the request within 60 days after receipt of the opinion.

Within 60 days following receipt of the grounds for the request, the said Committee shall re-examine its opinion in accordance with the conditions laid down in the fourth subparagraph of Article 62(1). The reasons for the conclusion reached shall be annexed to the final opinion.

3. Within 15 days after its adoption, [the EMA] shall send the final opinion of the said Committee to the Commission, to the Member States and to the applicant, together with a report describing the assessment of the medicinal product by the Committee and stating the reasons for its conclusions.

4. If an opinion is favourable to the granting of the relevant authorisation to place the medicinal product concerned on the market, the following documents shall be annexed to the opinion:

(a)      a draft summary of the product characteristics, as referred to in Article 11 of Directive 2001/83/EC;

(b)      details of any conditions or restrictions which should be imposed on the supply or use of the medicinal product concerned, including the conditions under which the medicinal product may be made available to patients, in accordance with the criteria laid down in Title VI of Directive 2001/83/EC;

(c)      details of any recommended conditions or restrictions with regard to the safe and effective use of the medicinal product;

(d)      the draft text of the labelling and package leaflet proposed by the applicant, presented in accordance with Title V of Directive 2001/83/EC;

(e)      the assessment report.’

10      Article 10 of Regulation No 726/2004 provides:

‘1.       Within 15 days after receipt of the opinion referred to in Article 5(2), the Commission shall prepare a draft of the decision to be taken in respect of the application.

Where a draft decision envisages the granting of marketing authorisation, it shall include or make reference to the documents mentioned in Article 9(4)(a), (b), (c) and (d).

Where the draft decision is not in accordance with the opinion of [EMA], the Commission shall annex a detailed explanation of the reasons for the differences.

The draft decision shall be forwarded to the Member States and the applicant.

2.      The Commission shall take a final decision in accordance with, and within 15 days after the end of, the procedure referred to in Article 87(3).

3.      The Standing Committee on Medicinal Products for Human Use referred to in Article 87(1) shall adjust its rules of procedure so as to take account of the tasks incumbent upon it under this Regulation.

…

6.      The [EMA] shall disseminate the documents referred to in Article 9(4)(a), (b), (c) and (d).’

11      Under Article 11 of Regulation No 726/2004, if an applicant withdraws an application for marketing authorisation submitted to the EMA before an opinion has been given on the application, the applicant shall communicate its reasons for doing so to the EMA. The EMA then makes this information publicly accessible and publishes the assessment report, if available, after deletion of all information of a commercially confidential nature.

12      Article 13(1) and (3) of that regulation is worded as follows:

‘1.       Without prejudice to Article 4(4) of Directive 2001/83/EC, marketing authorisation which has been granted in accordance with this Regulation shall be valid throughout the Community. It shall confer the same rights and obligations in each of the Member States as marketing authorisation granted by that Member State in accordance with Article 6 of Directive 2001/83/EC.

…

3.       The [EMA] shall immediately publish the assessment report on the medicinal product for human use drawn up by the Committee … and the reasons for its opinion in favour of granting authorisation, after deletion of any information of a commercially confidential nature.

The European Public Assessment Report (EPAR) shall include a summary written in a manner that is understandable to the public. The summary shall contain in particular a section relating to the conditions of use of the medicinal product.’

13      Article 14 of that regulation provides:

‘1.       Without prejudice to paragraphs 4, 5 and 7 a marketing authorisation shall be valid for five years.

2.       The marketing authorisation may be renewed after five years on the basis of a re-evaluation by the [EMA] of the risk-benefit balance.

To this end, the marketing authorisation holder shall provide the [EMA] with a consolidated version of the file in respect of quality, safety and efficacy, including all variations introduced since the marketing authorisation was granted, at least six months before the marketing authorisation ceases to be valid in accordance with paragraph 1.

…

11.       Without prejudice to the law on the protection of industrial and commercial property, medicinal products for human use which have been authorised in accordance with the provisions of this Regulation shall benefit from an eight-year period of data protection and a ten-year period of marketing protection, in which connection the latter period shall be extended to a maximum of 11 years if, during the first eight years of those ten years, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies.’

 Directive 2001/83

14      Article 6(1) of Directive 2001/83, as amended by Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 (OJ 2006 L 378, p. 1; ‘Directive 2001/83’), provides:

‘No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EC) No 726/2004 … .

When a medicinal product has been granted an initial marketing authorisation in accordance with the first subparagraph, any additional strengths, pharmaceutical forms, administration routes, presentations, as well as any variations and extensions shall also be granted an authorisation in accordance with the first subparagraph or be included in the initial marketing authorisation. All these marketing authorisations shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the application of Article 10(1).’

15      Article 10 of Directive 2001/83 provides:

‘1.      By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 6 for not less than eight years in a Member State or in the Community.

A generic medicinal product authorised pursuant to this provision shall not be placed on the market until ten years have elapsed from the initial authorisation of the reference product.

…

The ten-year period referred to in the second subparagraph shall be extended to a maximum of eleven years if, during the first eight years of those ten years, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies.

2.       For the purposes of this:

(a)      “reference medicinal product” shall mean a medicinal product authorised under Article 6, in accordance with the provisions of Article 8;

(b)      “generic medicinal product” shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information providing proof of the safety and/or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant. The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form. Bioavailability studies need not be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines.

3.       In cases where the medicinal product does not fall within the definition of a generic medicinal product as provided in paragraph 2(b) or where the bioequivalence cannot be demonstrated through bioavailability studies or in case of changes in the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration, vis-à-vis the reference medicinal product, the results of the appropriate pre-clinical tests or clinical trials shall be provided.

4.       Where a biological medicinal product which is similar to a reference biological product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or differences in manufacturing processes of the biological medicinal product and the reference biological medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The type and quantity of supplementary data to be provided must comply with the relevant criteria stated in Annex I and the related detailed guidelines. The results of other tests and trials from the reference medicinal product’s dossier shall not be provided.

5.       In addition to the provisions laid down in paragraph 1, where an application is made for a new indication for a well-established substance, a non-cumulative period of one year of data exclusivity shall be granted, provided that significant pre-clinical or clinical studies were carried out in relation to the new indication.

6.       Conducting the necessary studies and trials with a view to the application of paragraphs 1, 2, 3 and 4 and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products.’

16      Article 10a of Directive 2001/83 provides:

‘By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests or clinical trials if he can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Community for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex I. In that event, the test and trial results shall be replaced by appropriate scientific literature.’

 Background to the dispute

17      On 23 July 2007, Sepracor Pharmaceuticals filed an application with the EMA, under Article 3(2)(a) of Regulation No 726/2004 for marketing authorisation for tablets of 2 mg and 3 mg of Lunivia, a medicinal product used in the treatment of insomnia. The active substance in Lunivia is eszopiclone.

18      On 23 October 2008, the Committee gave its opinion on the application for marketing authorisation for Lunivia (‘the initial opinion’), in accordance with Article 9(3) of Regulation No 726/2004. In that opinion, the Committee recommended granting 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)(a) of Regulation No 726/2004, particularly when compared with the active substance zopiclone, which had first been put on the market as a medicinal product in the European Union in 1984 by the company Rhône-Poulenc Rorer and was then marketed by the Sanofi-Aventis group under the names ‘Imovane’ and ‘Zimovane’, medicinal products with a marketing authorisation and indicated, in particular, for the treatment of insomnia.

19      On 4 November 2008, Sepracor Pharmaceuticals requested the EMA to re-examine the initial opinion, inasmuch as the Committee had stated that eszopiclone could not be regarded as a new active substance.

20      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, namely that marketing authorisation should be issued for Lunivia, but that it should not be granted the status of a new active substance. The final opinion was sent to Sepracor Pharmaceuticals on 20 February 2009.

21      By letters sent to the Commission on 10 and 20 February 2009 and on 9 and 24 March 2009, Sepracor Pharmaceuticals 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 exploited the authorisation themselves. The appellant requested the Commission to discuss that question with it. A meeting between Sepracor Pharmaceuticals and the Commission services took place on 2 April 2009.

22      In the letter at issue, Sepracor Pharmaceuticals was informed in particular that, after an in-depth examination of its arguments, the Commission saw no reason to depart from the final opinion of the Committee with regard to the refusal to regard eszopiclone as a new active substance. Furthermore, with regard to the interpretation sought by Sepracor Pharmaceuticals of the concept of ‘global marketing authorisation’ within the meaning of the second subparagraph of Article 6(1) of Directive 2001/83, the Commission indicated, inter alia, whilst recalling that the Court had not yet ruled on the matter, that it considered that an authorisation of that type was appropriate where a medicine was put on the market for the first time after granting the original marketing authorisation and where, subsequently, a company belonging to the same group that had obtained the original marketing authorisation marketed a medicine containing the same active substance.

23      By letter of 13 May 2009, Sepracor Pharmaceuticals informed the EMA that it withdrew its application for marketing authorisation for tablets of 2 mg and 3 mg of Lunivia. The EMA took note of that withdrawal and, in a document published under the reference EMEA/307582/2009 addressed to the public, it explained, with regard to its recommendation to refuse the status of new active substance to the medicinal product Lunivia, that as a consequence of that recommendation, ‘Lunivia would not have been able to benefit from 10 years of “market exclusivity”. This is the period during which other companies would have been prevented from marketing “generic medicines” of Lunivia (medicines that contain the same active substance at the same dose as Lunivia and that are used for the same conditions)’.

 The proceedings before the General Court and the order under appeal

24      By application lodged at the Registry of the General Court on 16 July 2009, Sepracor Pharmaceuticals brought an action for annulment of the decision allegedly constituted by the letter at issue and by which the Commission allegedly took a definitive position as to whether it would grant the medicinal product Lunivia the status of new active substance.

25      By separate document lodged at the Registry of the General 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. Sepracor Pharmaceuticals lodged its observations on the plea of inadmissibility on 27 November 2009.

26      Sepracor Pharmaceuticals claimed that the General Court should:

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

-        annul the contested measure;

-        order the Commission to pay the costs.

27      In its plea of inadmissibility, the Commission claimed that the General Court should dismiss the action as inadmissible and order the appellant to pay the costs.

28      By the order under appeal, the General Court dismissed the action as inadmissible, finding that the letter at issue merely set 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 had to adopt following that opinion.

29      In particular, the General Court held that a simple letter from the Commission’s services expressing their position regarding that opinion could not be regarded as a decision producing legal effects as regards Sepracor Pharmaceuticals. Accordingly, even though the Commission had, in that letter, expressed its intention not to depart from the Committee’s opinion, it could not be assumed that the final decision that it would have adopted, pursuant to Article 10(2) of Regulation No 726/2004, concerning the application for marketing authorisation, would necessarily accord with that intention.

30      Furthermore, the General Court noted that the letter at issue had been sent to Sepracor Pharmaceuticals alongside the formal procedure for adopting the decision concerning the application for marketing authorisation, as laid down in Regulation No 726/2004.

31      Finally, the General Court noted that Sepracor Pharmaceuticals had itself withdrawn its application for marketing authorisation in order to avoid, in its view, its clinical and pre-clinical data becoming immediately available to producers of generic medicinal products on adoption by the Commission of a decision authorising the marketing of Lunivia. Accordingly, the letter at issue constituted mere information as to the probable content of the future Commission decision and, unlike the final decision which it would have been required to adopt under the provisions of Regulation No 726/2004, that letter did not produce any legal effects as regards the appellant.

32      As regards the content of the letter at issue, the General Court noted that the terms used by the Commission clearly indicated its intention to give the appellant a simple piece of information as to the probable content of a future decision and, consequently, there was nothing in the letter at issue to suggest that the Commission intended to take a definitive position as to whether eszopiclone constituted a new active substance.

33      It follows from this, in the view of the General Court, that the letter at issue was not able to bring about a change in the legal position of Sepracor Pharmaceuticals.

34      With regard to the appellant’s argument concerning the risk that producers of generic medicinal products would use pre-clinical and clinical data in the marketing authorisation application dossier in the event of adoption of a decision granting marketing authorisation, the General Court noted that, in fact, Sepracor Pharmaceuticals was relying on the future legal effects of the Commission’s decision ruling on that application, whereas the Commission had not yet adopted such a decision and could not do so since the appellant had withdrawn its application for marketing authorisation. In that regard, the Court of Justice had held in Case 114/86 United Kingdom v Commission [1988] ECR 5289, paragraph 13, that it was not the announcement of the intention to adopt a decision but the actual adoption of the decision which was capable of having legal effects as regards an applicant such as Sepracor Pharmaceuticals.

 Forms of order sought by the parties

35      By its appeal, Sepracor Pharmaceuticals claims that the Court should:

-        set aside the order under appeal;

-        declare its action for annulment admissible and determine the case in its favour (on the essential procedural requirement point) and/or refer the case back to the General Court so that it may examine the substance of the action for annulment;

-        order the Commission to pay Sepracor Pharmaceuticals’ costs of the present proceedings and those arising at the first instance relating to the plea of inadmissibility; and

-        reserve the costs as to the remainder.

36      The Commission for its part contends that the Court should dismiss the appeal and order Sepracor Pharmaceuticals to pay the costs.

 The appeal

37      Under Article 119 of the Rules of Procedure, where the appeal is clearly inadmissible or clearly unfounded, the Court may at any time, acting on a report from the Judge-Rapporteur and after hearing the Advocate General, by reasoned order dismiss the appeal. The Court considers that to be the case in the present proceedings.

38      In support of its appeal, Sepracor Pharmaceuticals puts forward two grounds of appeal alleging, respectively, an infringement of the right to an effective legal remedy and ‘infringement of an essential procedural requirement’.

 The first ground of appeal

 Arguments of the parties

39      By its ground of appeal, Sepracor Pharmaceuticals argues, in essence, that by dismissing its action as inadmissible, the General Court infringed its right to an effective remedy within the meaning of Article 47 of the Charter of Fundamental Rights of the European Union as well as Articles 6 and 13 of the European Convention for the Protection of Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950.

40      As the European Union is a community based on the rule of law with a complete system of remedies designed to enable the Court of Justice to review the legality of acts of the institutions, the General Court should have declared admissible its action for annulment of the letter at issue, as it held in Case T-437/05 Brink’s Security Luxembourg v Commission [2009] ECR II-3233.

41      Sepracor Pharmaceuticals criticises in particular the fact that, by refusing to afford it an opportunity to challenge the position taken by the Commission on the issue of whether or not Lunivia should be granted the status of new active substance, as that position was adopted in the contested decision, the approach of the General Court obliged it to maintain its application for marketing authorisation until the Commission adopts a formal and final decision against which it could bring an action for annulment on the basis of Article 263 TFEU and, in the context of such an action, rely on the illegality of the opinion of the EMA in so far as it recommended not to recognise the status of new active substance for the medicinal product in question.

42      In practice, such an approach would oblige Sepracor Pharmaceuticals to expose itself against its wishes to a risk in order to be able to bring its action for annulment since, after adopting such an actionable final decision, the competitors of that company could have relied on the absence of recognition of the status of new active substance to gain access to the pre-clinical tests and clinical data of the appellant and, subsequently, to place generic medicinal products on the market.

43      Referring, by analogy, to Case C-243/09 Fuß [2010] ECR I-0000, paragraphs 66 and 67, Sepracor Pharmaceuticals considers that such an approach deprived it of its right to effective judicial protection and that this approach is not in line with the approaches concerning admissibility adopted in national law in the United Kingdom and France.

44      Thus, even if the letter at issue should be considered as a preparatory act, it should have been considered as definitively establishing the position of the Commission at the culmination of a special and distinct procedure, as was held in Case 60/81 IBM v Commission [1981] ECR 2639, in Joined Cases T-377/00, T-379/00, T-380/00, T-260/01 and T-272/01 Philip Morris International and Others v Commission [2003] ECR II-1 and in Case T-326/99 Olivieri v Commission and EMEA [2003] ECR II-6053, paragraph 81.

45      In any event, the appellant claims that the General Court did not take into account sufficiently the fact that, in the letter at issue, the Commission indicated that it was after an ‘in-depth examination’ that it had come to the decision not to ‘depart from the opinion’ of the Committee. By making such a declaration, the Commission fixed its position so that the General Court was wrong, having regard in particular to the principle of legitimate expectations, to find that, even having thus expressed itself, the Commission could, if it wanted to, depart from that position when adopting the final decision on whether to grant marketing authorisation.

46      Furthermore, Sepracor Pharmaceuticals adds that the letter at issue had the practical effect of removing the need for the Commission to make a final decision as that institution thereby obliged that company to withdraw its application for marketing authorisation in order to avoid the consequences of a marketing authorisation that did not include the status of a new active substance. That letter, it is claimed, also had the legal effect of automatically depriving Sepracor Pharmaceuticals of the opportunity to pursue the marketing authorisation application while preserving the commercial viability of such an application.

47      Moreover, the letter at issue could be viewed as a procedural decision within the meaning of the case-law resulting from the judgment in Case C-131/03 P Reynolds Tobacco and Others v Commission [2006] ECR I-7795. It could also, applying by analogy the reasoning of the Court in Case 53/85 AKZO Chemie and AKZO Chemie UK v Commission [1986] ECR 1965, paragraphs 17 and 18, be considered as a decision immediately authorising third parties to use information, specifically pre-clinical and clinical data, supplied by Sepracor Pharmaceuticals in the context of the procedure for granting marketing authorisation. From that perspective, the General Court was wrong to find that Sepracor Pharmaceuticals was relying on the future legal effects of a marketing authorisation decision.

48      The Commission contests the merits of the appellant’s arguments. It considers in particular that, as the General Court held, the letter at issue sent to Sepracor Pharmaceuticals in the context of informal exchanges that took place alongside the procedure set out in Regulation No 726/2004 only provided information in response to a question raised by the appellant. Consequently, the Commission did not have any intention to adopt a decision that could affect the legal situation of the appellant and, furthermore, that letter was in no way the culmination of a distinct and special procedure to decide on granting the status of new active substance or on the eligibility of Sepracor Pharmaceuticals’ application to the centralised authorisation procedure for medicinal products.

49      Furthermore, even if the letter at issue could have created a legitimate expectation on the part of Sepracor Pharmaceuticals, the Commission argues that this aspect could have been raised by the appellant in an action for annulment against a final decision of the Commission concerning the granting of marketing authorisation. By withdrawing its application for marketing authorisation, the appellant prevented the Commission from adopting such a decision ruling definitively on the application for marketing authorisation, even though the adoption of that decision would have given Sepracor Pharmaceuticals the opportunity of having the legality of that decision, and of the opinion of the Committee, reviewed.

 Findings of the Court

50      In order to determine whether the contested act constitutes a decision against which an action may be brought pursuant to Article 263 TFEU, it should be recalled that the Court has consistently held that it is necessary to look at the substance of the act in question (order in Case C-50/90 Sunzest v Commission [1991] ECR I-2917, paragraph 12).

51      In that regard, it is also settled case-law that only 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 its legal position are acts or decisions which may be the subject of an action for annulment (see, inter alia, IBM v Commission, paragraph 9; order in Case C-117/91 Bosman v Commission [1991] ECR I-4837, paragraph 13, and Reynolds Tobacco and Others v Commission, paragraph 54).

52      Accordingly, it is not only preparatory acts which fall outside the scope of the judicial review provided for in Article 263 TFEU but any act not producing legal effects which are binding on and capable of affecting the interests of the individual, such as confirmatory measures and implementing measures, mere recommendations and opinions and, in principle, internal instructions (see Reynolds Tobacco and Others v Commission, paragraph 55 and the case-law cited).

53      It is true that, by means of Articles 263 TFEU and 277 TFEU, on the one hand, and Article 267 TFEU, on the other, the Treaty establishes a complete system of legal remedies and procedures designed to ensure review of the legality of acts of the institutions and has entrusted such review to the EU judicature (see Case 294/83 Les Verts v Parliament [1986] ECR 1339, paragraph 23, and Reynolds Tobacco and Others v Commission, paragraph 80).

54      However, the fact remains that, although the requirement as to legal effects which are binding on, and capable of affecting the interests of, the applicant by bringing about a distinct change in his legal position must be interpreted in the light of the principle of effective judicial protection, such an interpretation cannot have the effect of setting aside that condition without going beyond the jurisdiction conferred by the Treaty on the EU judicature (Reynolds Tobacco and Others v Commission, paragraph 81).

55      In that regard, it should be recalled that provisional measures intended to pave the way for the final decision do not, in principle, constitute acts which may form the subject-matter of an action for annulment. Such provisional acts include, in particular, acts which express a provisional opinion of the institution (see IBM v Commission, paragraph 10 and Joined Cases C-463/10 P and C-475/10 P Deutsche Post and Germany v Commission [2011] ECR I-0000, paragraph 50 and the case-law cited).

56      An action for annulment of measures expressing a provisional opinion of the Commission might make it necessary for the EU judicature to arrive at a decision on questions on which the institution concerned has not yet had an opportunity to definitively state its position and would as a result anticipate the arguments on the substance of the case, confusing the different stages of the administrative and judicial procedures. To allow such an action would thus be incompatible with the system of the division of powers between the Commission and the EU judicature and of the remedies laid down by the Treaty, as well as with the requirements of the sound administration of justice and the proper course of the Commission’s administrative procedure (see, to that effect, IBM v Commission, paragraph 20, and Deutsche Post and Germany v Commission, paragraph 51).

57      Next, the case-law shows that an intermediate measure is not capable of forming the subject-matter of an action if it is established that the illegality attaching to that measure can be relied on in support of an action against the final decision for which it represents a preparatory step. In such circumstances, the action brought against the decision terminating the procedure will provide sufficient judicial protection (see IBM v Commission, paragraph 12; AKZO Chemie BV and AKZO Chemie UK Ltd v Commission, paragraph 19; Case C-400/99 Italy v Commission [2001] ECR I-7303, paragraph 63, and Deutsche Post and Germany v Commission, paragraph 53).

58      It is only if that latter condition is not satisfied that it will be considered that the intermediate measure, independently of whether the latter expresses a provisional opinion of the institution concerned, produces independent legal effects and must therefore be capable of forming the subject-matter of an action for annulment (see AKZO Chemie and AKZO Chemie UK v Commission, paragraph 20; Case C-170/89 BEUC v Commission [1991] ECR I-5709, paragraphs 9 to 11; Case C-39/93 P SFEI and Others v Commission [1994] ECR I-2681, paragraph 28; Italy v Commission, paragraphs 57 to 68; Case C-521/06 P Athinaïki Techniki v Commission [2008] ECR I-5829, paragraph 54, and Deutsche Post and Germany v Commission, paragraph 54).

59      In that regard, it must be observed, first, that by the letter at issue the Commission did not adopt a preparatory act with a view to adopting the final decision concerning the granting of marketing authorisation sought by Sepracor Pharmaceuticals, nor did it draft such a letter in the context of a special procedure distinct from that formally provided for by Regulation No 726/2004. In that letter the Commission confined itself to responding to the questions raised by the appellant.

60      Second, the General Court was able to find, without committing any error of law in that regard, that the intention not to depart from the opinion of the Committee, expressed by the Commission in the letter at issue, was not such as to prejudge the definitive decision to be given under Article 10(2) of Regulation No 726/2004, as that letter could at most constitute a provisional indication of the intentions of the Commission regarding the draft decision that it might have submitted to the Member States in the context of the comitology procedure normally provided for the purposes of adopting that definitive decision under Article 10(2) of Regulation No 726/2004.

61      In that regard, even if it were accepted that the principle of legitimate expectation could possibly have been raised, under certain conditions, in order to call into question the legality of the final decision of the Commission if it had departed from such an indication, that would not be such as to show that the alleged element generating such legitimate expectation, in this case the content of the letter at issue, itself constituted an act producing legal effects with regard to Sepracor Pharmaceuticals in that it definitively decided the Commission’s position in place of the final decision that the Commission was supposed to adopt at the end of the marketing authorisation procedure set out in Regulation No 726/204.

62      Third, the letter at issue did not have the effect of authorising competitors of Sepracor Pharmaceuticals to have access to the pre-clinical and clinical data supplied by it in the context of the marketing authorisation request.

63      Fourth, it must be noted that, by bringing its action against the letter at issue, Sepracor Pharmaceuticals sought, in essence, to call into question the position taken by the Committee which, in its final opinion, recommended granting marketing authorisation but did not consider that the substance in question could be granted the status of a new active substance. For that purpose, Sepracor Pharmaceuticals could have called that final opinion into question in the context of an action for annulment of the final decision that might have been adopted by the Commission under Article 10(2) of Regulation No 726/2004 if Sepracor Pharmaceuticals had not withdrawn its application for marketing authorisation.

64      Fifth, with regard to the risks to which the appellant would have been exposed if, in order to benefit from a useful legal remedy, it had maintained its application for marketing authorisation, which could have led to granting such authorisation without the benefit of the status of a new active substance, it should be noted that, in the context of an action for annulment brought under Article 263 TFEU against the final decision that could have been adopted in that regard by the Commission, Sepracor Pharmaceuticals could have requested, under Article 279 TFEU, the granting of provisional measures to prevent the irreparable damage that it claims it would have suffered due to the adoption of such a final decision.

65      In this respect, the General Court’s finding that Sepracor Pharmaceuticals’ action for annulment is inadmissible does not infringe the right to an effective judicial remedy.

66      Furthermore, it should also be recalled that an action for non-contractual liability under Article 268 TFEU and the second paragraph of Article 340 TFEU is available if the conduct in question is of such a nature as to entail liability on the part of the European Union (Reynolds Tobacco and Others v Commission, paragraph 82).

67      In the light of all those considerations, the first ground of appeal must be rejected as being clearly unfounded.

 Second ground of appeal

68      By its second ground of appeal, Sepracor Pharmaceuticals criticises the General Court for not examining its plea alleging an infringement by the EMA of its essential procedural rights in so far as the Committee received and took account of, for the purposes of drawing up its report, observations submitted by an interested third party without informing Sepracor Pharmaceuticals of their existence or granting it the opportunity to take a position regarding those observations. Given that the Commission had not raised any objection of inadmissibility against that part of its application, the General Court should, in any event, have examined that plea.

69      In that regard, it is sufficient to note that, since the General Court held, without committing any error of law, that it had to dismiss the action brought on the basis of Article 263 TFEU as being inadmissible in its entirety, it was in no way necessary, therefore, to rule on the substance of the second plea raised by Sepracor Pharmaceuticals.

70      It follows that the second ground of appeal is clearly unfounded.

71      In the light of all the foregoing considerations, the present appeal must be dismissed as clearly unfounded.

 Costs

72      Under Article 69(2) of the Rules of Procedure, which is applicable to the procedure on appeal pursuant to Article 118 of those rules, 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 Commission has applied for costs and Sepracor Pharmaceuticals has been unsuccessful, the latter must be ordered to pay the costs.

On those grounds, the Court (Eighth Chamber) hereby orders:

1.      The appeal is dismissed.

2.      Sepracor Pharmaceuticals Ltd is to pay the costs.

[Signatures]

* Language of the case: English.