Shire Pharmaceutical Contracts v Commission (Order of the Court of First instance) [2014] EUECJ T-583/13

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(Action for annulment — Medicinal products for paediatric use — Regulation (EC) No 1901/2006 — Article 37 — Extension of the duration of the market exclusivity of non-patented orphan medicinal products — Non-actionable measure — Inadmissibility)

Shire Pharmaceutical Contracts Ltd, established in Hampshire (United Kingdom), represented by K. Bacon, Barrister, M. Utges Manley and M. Vickers, Solicitors,

European Commission, represented by A. Sipos and V. Walsh, acting as Agents,

APPLICATION for the annulment of the decision purportedly contained in the letter which the Commission sent to the applicant on 2 September 2013, as subsequently confirmed by the letter of 18 October 2013, concerning whether the medicinal product Xagrid was eligible for the reward provided for in Article 37 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ 2006 L 378, p. 1),

composed of D. Gratsias, President, M. Kancheva (Rapporteur) and C. Wetter, Judges,

1 The applicant, Shire Pharmaceutical Contracts Ltd, is a biopharmaceutical company which provides treatments in the field of rare genetic diseases. It is the holder of a marketing authorisation for Xagrid, a medicinal product whose active ingredient is anagrelide hydrochloride and which is used for the treatment of essential thrombocythaemia. Xagrid has been recognised by the European Commission as an orphan medicinal product within the meaning of Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1) and will enjoy a ten-year period of market exclusivity up to 18 November 2014 in accordance with Article 8 of that regulation.

2 On 1 August 2013, the applicant sent a letter to the Commission headed ‘Applicability of Article 37 of the Paediatric Regulation to non-patented orphan medicinal products; Paediatric Investigation Plan: EMEA-000720-PIP01-09; Name of product: Xagrid ® 0.5mg hard capsules (anagrelide hydrochloride); Indication: essential thrombocythaemia’. In that letter, the applicant indicated to the Commission that it would like to arrange a meeting to discuss recital 29 and Article 37 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ 2006 L 378, p. 1), on the basis of which, in the applicant’s view, it was possible to conclude that non-patented orphan medicinal products were eligible for an extension of the market exclusivity period from ten to twelve years, on condition, inter alia, that studies were conducted in compliance with a paediatric investigation plan approved by the European Medicines Agency (EMA) and that the results of all such studies were submitted in the summary of the characteristics of the medicinal product. Moreover, the applicant stated that the context in which it was submitting its request was essentially one in which Xagrid was a non-patented orphan medicinal product in respect of which a paediatric investigation plan had already been approved by the EMA. Lastly, the applicant informed the Commission that when the results of the studies to be conducted in accordance with that plan were available, it intended to seek an extension of the marketing authorisation for Xagrid in order to include a paediatric indication.

3 The Commission replied to the applicant’s letter by letter of 2 September 2013. First, the Commission indicated to the applicant that it did not share its interpretation of Article 37 of Regulation No 1901/2006 and gave its opinion in that respect, in particular as regards the Commission’s view that that provision did not confer on non-patented orphan medicinal products entitlement to any extension of the market exclusivity period. Second, the Commission indicated to the applicant that the meeting which it had requested did not appear to be necessary.

4 By letter of 11 October 2013, the applicant sent a further letter to the Commission, stating that it was seeking further clarification on the Commission’s position concerning Article 37 of Regulation No 1901/2006. The applicant submitted additional observations as to the correct interpretation to be given, in its view, to that provision and its application to non-patented orphan medicinal products. The applicant also requested the Commission to confirm that Xagrid would be eligible for the two-year market exclusivity extension under Article 37 of Regulation No 1901/2006 once the requirements laid down by that provision were satisfied.

5 By letter of 18 October 2013, the Commission informed the applicant that it could only maintain the position set out in its letter of 2 September 2013 and that it did not, in any event, share the interpretation of Article 37 of Regulation No 1901/2006 proposes by the applicant.

6 By application lodged at the Registry of the General Court on 8 November 2013, the applicant brought the present action.

7 By separate document lodged at the Court Registry on the same day, the applicant submitted an application for the case to be decided under an expedited procedure, in accordance with Article 76a of the Rules of Procedure of the General Court.

8 The Commission submitted its observations on the applicant’s request for the case to be decided under an expedited procedure on 26 November 2013.

9 On 9 December 2013, the General Court rejected the applicant’s request that the case be decided under an expedited procedure.

10 By document lodged at the Court Registry on 19 December 2013, the Commission raised an objection of inadmissibility under Article 114(1) of the Rules of Procedure.

11 On 14 March 2014, the applicant submitted its observations on the Commission’s plea of inadmissibility.

– annul the decision purportedly contained in the letters of 2 September 2013 and 18 October 2013 (‘the letters at issue’), by which the Commission refused to concede that the medicinal product Xagrid was eligible for the reward provided for in Article 37 of Regulation No 1901/2006;

14 In its observations on the objection of inadmissibility, the applicant contends that the Court should:

15 Pursuant to Article 114(1) of the Rules of Procedure, the Court may, if a party so requests, rule on the question of admissibility without considering the merits of the case. Under Article 114(3) of those rules, unless the Court decides otherwise, the remainder of the proceedings is to be oral. In the present case, the Court considers that it has sufficient information from the documents before it and has decided to give its decision without opening the oral procedure.

16 The Commission claims that the action is inadmissible on the ground that, in its view, the letters at issue are not acts open to challenge for the purpose of Article 263 TFEU, but are, on the contrary, documents of a purely informative nature, lacking any legal effect.

18 First of all, it should be observed that it is settled case-law that only a measure which produces binding legal effects such as to affect the interests of an applicant by bringing about a distinct change in his legal position is an act or decision which may be the subject of an action for annulment under Article 263 TFEU (see judgment of 26 September 2013 in Polyelectrolyte Producers Group and SNF v ECHA, C-626/11 P, ECR, EU:C:2013:395, paragraph 37 and the case-law cited).

19 Next, in order to ascertain whether or not a measure which has been challenged produces such effects, it is necessary to look to its substance. The form in which acts or decisions are cast is, in principle, immaterial as regards the question whether they are open to challenge by an action for annulment (see the judgment of 11 November 1981 in IBM v Commission, 60/81, ECR, EU:C:1981:264, paragraph 9, and the order of 22 February 2008 in Base v Commission, T-295/06, EU:T:2008:48, paragraph 56 and the case-law cited).

20 Lastly, the opinions and recommendations of the institutions of the European Union are expressly excluded from the scope of Article 263 TFEU and cannot therefore be the subject of an action for annulment (see the order of 14 May 2012 in Sepracor Pharmaceuticals (Ireland) v Commission, C-477/11 P, EU:C:2012:292, paragraph 52 and the case-law cited).

21 In the present case, it should be noted at the outset that, while the reason why the applicant has brought these proceedings before the General Court is to ascertain whether it is possible to conclude, on the basis of Article 37 of Regulation No 1901/2006, that non-patented orphan medicinal products such as Xagrid may be eligible for a two-year extension of their market exclusivity, the fact nevertheless remains that the assessment which the Court is required to carry out in connection with the Commission’s objection of inadmissibility must be confined to determining whether the letters at issue contain a decision that is open to challenge for the purpose of the case-law cited at paragraph 18 above, or whether, on the other hand, they merely constitute an opinion, which cannot, therefore, be the subject of an action for annulment in accordance with Article 263 TFEU and with the case-law cited at paragraph 20 above. It should also be recalled that, according to case-law, in order to answer the latter question, it is necessary to examine both the context in which the two letters at issue were adopted and the content of those letters (see, to that effect, the order of 4 July 2011 in Sepracor Pharmaceuticals (Ireland) v Commission, Case T-275/09, EU:T:2011:327, paragraph 16).

22 In the first place, with regard to the letter of 2 September 2013, the Court finds that, contrary to what is claimed by the applicant, that letter does not contain a decision on the part of the Commission refusing to concede the reward provided for in Article 37 of Regulation No 1901/2006 in the specific case of the medicinal product Xagrid, but simply the Commission’s reply to a request for a meeting made by the applicant and an informed opinion, formulated in general and hypothetical terms, as to whether that provision may be applicable to non-patented orphan medicinal products.

23 First, it should be noted that the letter of 2 September 2013 is a response to the applicant’s earlier letter to the Commission of 1 August 2013. In its letter, the applicant simply requested a meeting with the Commission in order to discuss the ‘applicability’ of recital 29 and Article 37 of Regulation No 1901/2006 to non-patented orphan medicinal products (‘Shire would like to request a meeting with the European Commission to discuss the applicability of the Paediatric Regulation to non-patented, orphan medicinal products’). Even though, as the applicant observes, the heading of that letter refers to the medicinal product Xagrid, it is not apparent at any point in that letter that the applicant was also asking the Commission to give a definitive opinion on the application of Regulation No 1901/2006 to that medicinal product. As regards the letter of 2 September 2013, it is apparent from the wording of that letter that the Commission specifically replied to the applicant that the meeting requested did not appear to be necessary and at the same time set out its own interpretation of Article 37 of Regulation No 1901/2006 to the effect that it did not permit an extension of market exclusivity for non-patented orphan medicinal products (‘I regret to inform you that we do not share the interpretation [of] Article 37’ and ‘[i]n view of the above explanations, a meeting with the Commission services does not seem to be necessary’). Accordingly, the words used by the Commission in that letter reflect unequivocally that institution’s intention not to agree to the meeting requested and to explain that it did not share the interpretation of Article 37 of Regulation No 1901/2006 proposed.

24 Secondly, far from constituting the specific, concrete grounds of an act in the nature of a decision applying Article 37 of Regulation No 1901/2006 to the medicinal product Xagrid, the explanations given in the letter of 2 September 2013 merely amount to an opinion providing information on the Commission’s interpretation of that provision, subject to any future decision that may be delivered by the Court of Justice. It is clear that those explanations are formulated in purely general and hypothetical terms, which do not relate in any way to the specific case of the medicinal product Xagrid. Moreover, the hypothetical nature of the response given by the Commission is apparent from the fact that it expressly adopts as its starting point the general case in which a company voluntarily submits a paediatric investigation plan for the extension of the market exclusivity of an orphan medicinal product that is not protected by a patent (‘More specifically, you are referring to a situation where a company voluntary submitted a paediatric investigation plan for a planned extension of an already authorised orphan product, which is no longer patent protected’).

25 Thirdly, the Court shares the Commission’s view that the hypothetical nature of the explanations given in the letter of 2 September 2013 was especially clear in view of the fact that the Commission would not, in any event, have been in a position to adopt a decision producing legal effects vis-à-vis the applicant concerning the extension of the market exclusivity of the medicinal product Xagrid under Article 37 of Regulation No 1901/2006. It should be noted in that connection that that provision makes the grant of the reward of the two-year extension of the market exclusivity of an orphan medicinal product contingent on the requirement, inter alia, that studies are carried out in compliance with an EMA-approved paediatric investigation plan and that the results of all such studies are submitted in the summary of the characteristics of the medicinal product. However, it is apparent from the explanations given by the applicant in the letter of 1 August 2013 and also from the application that a request for the modification of the paediatric investigation plan for the medicinal product Xagrid was still being considered by the EMA and, what is more, that the compliance check in respect of the plan for Xagrid had not yet been completed. In those circumstances, even if the applicant had wanted the Commission to give a decision on the application of Article 37 of Regulation No 1901/2006 to the specific case of the medicinal product Xagrid, that institution could not have adopted any decision in that regard as the applicant had not even complied beforehand with the requirement laid down in that provision.

26 It is apparent from the foregoing that the letter of 2 September 2013 cannot be regarded as an act open to challenge for the purposes of Article 263 TFEU.

27 In the second place, as regards the letter of 18 October 2013, there is nothing in its wording to suggest that the Commission had adopted a decision relating to the application of Article 37 of Regulation No 1901/2006 to the specific case of the medicinal product Xagrid, thus altering the applicant’s legal position.

28 In that regard, first, it should be noted that that letter is a reply to the applicant’s letter of 11 October 2013, in which the applicant sought further clarification on the Commission’s position concerning Article 37 of Regulation No 1901/2006 and provided additional observations as the correct interpretation to be given, in its view, to that provision (‘We note that the Commission considers that Article 37 is not applicable to a “voluntary” paediatric investigation plan. We would like to seek further clarification on the Commission[’s] stated position, and its application to Shire’s product Xagrid’). In its letter of 18 October 2013, the Commission therefore simply informed the applicant that it could only confirm the opinion given in its letter of 2 September 2013 and that, in any event, it did not share the interpretation of Article 37 of Regulation No 1901/2006 proposed by the applicant.

29 Secondly, even though the applicant requested the Commission in its letter of 11 October 2013 to confirm that Xagrid was eligible for the extension provided for in Article 37 of Regulation No 1901/2006, it is clear that that request was made conditionally, contingent on the hypothetical situation in which the requirements laid down in that provision were satisfied in so far as concerns that medicinal product. Accordingly, the Court finds, first, that the letter of 18 October 2013 cannot be regarded as a decision and must be regarded as the provision of information by the Commission in response to a hypothetical request on the part of the applicant and, second, as indicated at paragraph 25 above, that, given the circumstances of the present case, the Commission would not, in any event, have been able to adopt an act in the nature of a decision with regard to the medicinal product Xagrid.

30 It is apparent from the foregoing that the letter of 18 October 2013 cannot be regarded as an act open to challenge for the purposes of Article 263 TFEU.

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

32 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.

33 Since the applicant has been unsuccessful, it must be ordered to bear its own costs and to pay those of the Commission, in accordance with the latter’s pleadings.

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