ORDER OF THE PRESIDENT OF THE GENERAL COURT
23 May 2016 (*)
(Application for interim measures — Access to documents — Regulation (EC) No 1049/2001 — Documents held by the EMA concerning information submitted by an undertaking as part of its application for authorisation to place a medicinal product on the market — Order granting suspension of operation of the decision to grant a third party access to the documents — Application for cancellation — No change in circumstances — Article 159 of the Rules of Procedure of the General Court)
In Case T‑235/15 R,
Pari Pharma GmbH, established in Starnberg (Germany), represented by M. Epping and W. Rehmann, lawyers,
applicant,
v
European Medicines Agency (EMA), represented by T. Jabłoński, N. Rampal Olmedo, A. Spina, A. Rusanov and S. Marino, acting as Agents,
defendant,
supported by
Novartis Europharm Ltd, established in Camberley (United Kingdom), represented by C. Schoonderbeek, lawyer,
intervener,
APPLICATION based on Article 159 of the Rules of Procedure of the General Court seeking the cancellation of the order of 1 September 2015 in Pari Pharma v EMA (T‑235/15 R, EU:T:2015:587), by which it granted the suspension of operation of Decision EMA/271043/2015 of the EMA of 24 April 2015, granting to a third party, pursuant to Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43), access to certain documents containing information submitted in the context of an application for marketing authorisation for the medicinal product Vantobra,
THE PRESIDENT OF THE GENERAL COURT
makes the following
Order
Background to the dispute, procedure and forms of order sought by the parties
1 Pursuant to 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), certain categories of medicinal products must be approved under the centralised procedure pursuant to that regulation. That procedure entails the submission, by the pharmaceutical company concerned, of an application for marketing authorisation (‘MA application’), which is examined by the European Medicines Agency (EMA), and a decision by the European Commission on the MA application. Exclusive responsibility for preparing the EMA’s opinions on all questions concerning medicinal products for human use is to be vested in a Committee for Medicinal Products for Human Use (‘CHMP’).
2 The intervener, Novartis Europharm Ltd, is the holder of a marketing authorisation (‘MA’) granted by the Commission, on 20 July 2011, under Regulation No 726/2004, for the medicinal product TOBI Podhaler.
3 TOBI Podhaler was classified 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), that is to say, medicinal products intended for the diagnosis, prevention or treatment of rare conditions. In order to promote the development of effective treatments for patients affected by rare conditions, that regulation introduces a system of incentives to encourage pharmaceutical companies to invest in orphan medicinal products. To that end, Article 8 of Regulation No 141/2000 provides that orphan medicinal products for which an MA has been granted are to benefit from market exclusivity for 10 years during which no other MA will be granted for the same therapeutic indication or similar medicinal product. That exclusivity may be lifted by way of derogation if another undertaking can establish that its medicinal product, although similar, is safer, more effective or otherwise clinically superior.
4 It was on the basis of that provision that the applicant, Pari Pharma GmbH, requested an MA in respect of its medicinal product Vantobra.
5 The Commission granted that request on 18 March 2015. On the basis of the additional compilation of clinical trial data and related calculations provided by the applicant, the CHMP concluded, on 22 January 2015, that the applicant’s claim that Vantobra was clinically superior to TOBI Podhaler by reason of its greater safety for a significant part of the target population had been substantiated by sufficient evidence and that an MA should therefore be granted for Vantobra. That favourable opinion is based on two CHMP reports issued on the same day, namely the Assessment Report EMA/CHMP/702525/2014 for Vantobra on similarity with Cayston and TOBI Podhaler, and Assessment Report EMA/CHMP/778270/2014 on clinical superiority to TOBI Podhaler (together ‘the reports at issue’).
6 On 13 April 2015 the EMA informed the applicant that it had received a request for access to the reports at issue, submitted on the basis of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43). It emerged in the course of the procedure that the person requesting access was the intervener. The EMA informed the applicant of its intention to disclose those documents with a few redactions concerning personal data, while setting it a deadline for requesting additional redactions. On 20 April 2015 the applicant asked the EMA not to disclose the reports at issue.
7 On 24 April 2015 the EMA decided to disclose the reports at issue (‘the contested decision’).
8 By application lodged at the Court Registry on 15 May 2015, the applicant brought an action seeking annulment of the contested decision.
9 By separate document, lodged at the Court Registry on the same day, the applicant submitted an application for interim relief, in which it asked the President of the Court, in essence, to suspend the operation of the contested decision and order the EMA not to disclose the reports at issue.
10 In its observations on that application, the EMA asked the President of the Court to dismiss the application.
11 After having been granted leave to intervene in the interim relief proceedings in support of the form of order sought by the EMA, the intervener requested the President of the Court to dismiss the application for interim relief.
12 By order of 1 September 2015 in Pari Pharma v EMA (T‑235/15 R, ‘the first General Court order’, EU:T:2015:587), the President of the Court suspended the operation of the contested decision and ordered the EMA not to disclose the reports at issue.
13 In parallel to the applicant’s action as mentioned in paragraph 8 above, on 28 May 2015 the intervener brought an action before the Court seeking annulment of the decision of 18 March 2015 by which the Commission had granted the MA for Vantobra, on the ground that that decision infringed the market exclusivity which it enjoyed, pursuant to Regulation No 141/2000, in respect of its medicinal product TOBI Podhaler. That action was registered as Case T‑269/15.
14 By application lodged at the Registry of the Court of Justice on 23 October 2015, the EMA brought an appeal against the first General Court order. Supported by the intervener, it claimed that the Court of Justice should set aside that order, dismiss the request for interim measures seeking suspension of operation of the contested decision and order the applicant to pay the costs incurred in the proceedings at first instance and on appeal.
15 In relation to the proceedings before the Court of Justice, in its response lodged on 23 November 2015, the applicant contended that the Court of Justice should dismiss the appeal. The reports at issue were included in the annexes to that response.
16 On 24 November 2015 the response lodged by the applicant and the annexes thereto were notified to the other parties to the appeal proceedings.
17 On 25 November 2015 the applicant submitted a request for confidential treatment in order that the reports at issue not be notified to the intervener. However, because that request for confidential treatment was submitted out of time, those reports had already been notified as they stood.
18 Subsequently, the applicant informed the Court of Justice that it had succeeded in concluding an agreement with the intervener under which the latter company had undertaken to keep the reports at issue confidential and not to communicate them to third parties. The intervener would not be authorised to use those documents except in connection with the case pending between it and the Commission, registered with the General Court as Case T‑269/15.
19 By letter of 3 December 2015, the Court of Justice asked the EMA to clarify whether, given the circumstances, it considered that there was still any need to adjudicate on its appeal. The EMA replied in the affirmative, stating that its interest in bringing proceedings in the present appeal proceedings was based, first, on the fact that, despite the agreement in principle concluded between the applicant and the intervener, the intervener had not withdrawn its request for access to the reports at issue submitted pursuant to Regulation No 1049/2001 and, second, on the fact that a decision granting access to documents has an erga omnes effect, with the result that any person requesting access is entitled to obtain those reports. According to the EMA, several other requests for access to those reports had already been submitted, on which it had to rule. Last, the first General Court order was contrary to the case-law of the Court of Justice and raised a question of principle as regards the effective application of Regulation No 1049/2001.
20 By order of 17 March 2016 in EMA v Pari Pharma (C‑550/15 P(R), not published, ‘the order on the appeal’, EU:C:2016:196), the Vice-President of the Court of Justice found that there was no need to adjudicate on the EMA’s appeal. According to the wording of the order on the appeal, the EMA did not have an interest in bringing proceedings, the appeal not being capable, if successful, of procuring an advantage for it. The reasoning underlying the operative part of that order is as follows:
‘38 Indeed, the fact that [the intervener] now has access to the reports at issue clearly deprives the interim measures obtained by [the applicant] through the order under appeal of all effect.
39 In that regard, it should be noted that the assessment of an applicant’s interest in obtaining the measures sought takes on particular importance in proceedings on an application for interim relief.
The judge hearing an application for interim relief may order suspension of operation of an act or other interim measures only if it is established, inter alia, that such an order is urgent inasmuch as, in order to prevent serious and irreparable harm to the applicant’s interests, it must be made and produce its effects before a decision is reached in the main action. Interim measures which would no longer serve to prevent the serious and irreparable harm feared by the applicant cannot, a fortiori, be necessary for that purpose ...
40 Regardless of the assessments which could be carried out by the President of the General Court concerning the possibility of cancelling or modifying [the first General Court order] upon application by one of the parties to that effect pursuant to Article 159 of the Rules of Procedure of the General Court, it must be held that the fact that those interim measures serve no purpose also deprives the EMA of any interest in bringing proceedings in the present appeal proceedings.
41 Indeed, whatever the outcome of the present proceedings, no advantage will be procured for the EMA. In particular, if the appeal were to be upheld and the EMA could therefore implement the [contested decision], the sole effect thereof would be to enable the EMA to communicate to [the intervener] the reports at issue which it already holds. If, by contrast, the appeal were to be dismissed, the EMA would, admittedly, not be entitled to communicate those reports to [the intervener]. However, the fact that [the intervener] has in any event obtained access to those documents means that the EMA is deprived of any interest in the immediate implementation of the [contested decision].
42 That assessment is not called in question by the EMA’s arguments seeking to establish that it has an interest in bringing proceedings in the present appeal proceedings.
43 First, the fact that [the intervener] has maintained its request for access has no effect on the need to adjudicate on the present appeal. Although the withdrawal of that request is in fact capable of affecting [the applicant’s] interest in bringing proceedings at first instance, the fact that the request has been maintained does not in itself require, in view of the circumstances of the present case, a ruling on the present appeal.
44 Next, it is true that the EMA’s interest as regards the outcome of the processing of other requests for access is legitimate and well founded, but it does not concern the resolution of the present dispute and is not connected to the form of order sought in its appeal.
45 Lastly, regarding the answer to the question of principle raised by the present appeal, it must be held that it can no longer procure an advantage for the EMA in the present case, and may only be raised in the future, in cases similar to that which gave rise to the present appeal. That cannot suffice to justify the appeal proceeding to judgment ...
46 In those circumstances, given that the [EMA] has, in the course of the proceedings, lost its interest in pursuing the proceedings for interim relief, there is no longer any need to adjudicate on its appeal ...’
21 With regard to the costs, the Vice-President held that, in the appeal proceedings, because the fact that there was no need to adjudicate in the present case was the result of the applicant’s submitting its request for confidential treatment out of time, the applicant had to be ordered to bear its own costs and to pay those incurred by the EMA and by the intervener.
22 In those circumstances, the EMA, by document lodged at the Registry of the General Court on 31 March 2016, lodged an application, on the basis of Article 159 of the Rules of Procedure of the General Court, requesting the President of the Court to:
– cancel the first General Court order following the change in circumstances in the case;
– order the applicant to pay the costs.
23 In support of that application, the EMA refers to paragraphs 38 to 40 of the order on the appeal, highlighting the fact that the Vice-President found that the interim measures granted to the applicant by the President of the General Court were redundant.
24 In its observations on that request lodged at the Registry of the General Court on 21 April 2016, the applicant objects to the cancellation of the first General Court order and claims that the EMA should pay the costs.
25 Recalling that the intervener had obtained access to the reports at issue, the President of the Court asked, first, the intervener to explain why it was maintaining its request for access to those reports and second, the EMA to indicate why it was of the view that the contested decision, in so far as it granted that access, had not become devoid of purpose. The EMA and the intervener responded to those questions within the prescribed period.
26 Having regard to the material in the case file, the President considers that he has all the information needed to rule on the present application for interim measures without there being any need first to hear oral argument from the parties.
Law
27 According to Article 159 of the Rules of Procedure, on application by a party, an order for interim measures may at any time be varied or cancelled on account of a change in circumstances.
28 That provision covers the occurrence of any factual or legal matter such as to call into question the assessment by the judge who heard the application with regard to the conditions which are to be met if the operation of an act is to be suspended or other interim relief is to be granted (order of 14 February 2002 in Commission v Artegodan, C‑440/01 P(R), EU:C:2002:95, paragraph 63).
29 It is therefore necessary for the judge who heard the application for interim relief to ascertain whether there exists, in the present case, a matter ‘such as to call into question’ the assessment which led the judge to suspend, in the first General Court order, the operation of the contested decision and direct the EMA not to disclose the reports at issue.
30 In that regard, it should be pointed out that the Vice-President did not rule, in the order on the appeal, on the merits of the assessments acknowledging, in the first General Court order, the existence of a prima facie case and of urgency. Thus, the Vice-President inter alia called into question neither the existence of a prima facie case since the information in question was obviously not confidential (see, to that effect, order of 2 March 2016 in Evonik Degussa v Commission, C‑162/15 P-R, EU:C:2016:142, paragraph 29) nor the serious and irreparable harm the applicant risked suffering in the event of disclosure of the reports at issue. Nor did he invalidate the reasoning according to which the weighing-up of interests favoured the applicant, owing to the intrinsically ancillary and provisional nature of the proceedings for interim relief by comparison with the main action, as well as the need to avoid prejudging, at the stage of the proceedings for interim relief, the outcome of the main action.
31 It must be stated that the reason for the order on the appeal finding that there was no need to adjudicate was the mere fact that the EMA had ‘in the course of the proceedings’ lost its interest in pursuing the proceedings for interim relief. In doing so, the Vice-President took into account the fact that ‘[the intervener] now [had] access to the reports at issue’, after they had been communicated to it during the appeal proceedings, and took into consideration the particularities of the triangular procedural situation, involving the applicant, the EMA and the intervener, that was presented to him.
32 Far from declaring that the request for access addressed to the EMA under Regulation No 1049/2001 emanated from an anonymous third party, the Vice-President made a point of stating, in paragraph 15 of the order on the appeal, that it was the intervener, ‘Novartis Europharm’ in this case, which, by the contested decision, had ‘obtained disclosure of the documents in question’. Moreover, in paragraph 29 of that order, the Vice-President stated that ‘[the applicant had] informed the Court [of Justice] that it had succeeded in concluding an agreement in principle with [the intervener] under which the latter company had undertaken, in any event, to keep the documents in question confidential and not to communicate them to third parties, [the intervener not being] authorised to use those documents except in connection with the case pending between it and the Commission, registered with the General Court as Case T‑269/15’.
33 It is in view of that specific situation that the Vice-President considered, in paragraphs 38 and 41 of the order on the appeal, that the fact that the intervener by then had access to the reports at issue clearly deprived the interim measures obtained by the applicant through the first General Court order of all effect, which meant simultaneously that, whatever the outcome of the appeal proceedings, no advantage would be procured for the EMA. The Vice-President concluded that, if the appeal were to be upheld and the EMA could therefore implement the contested decision, ‘the sole effect thereof would be to enable the EMA to communicate to [the intervener] the reports at issue which it already [held]’, whereas, if the appeal were to be dismissed, ‘the EMA would, admittedly, not be entitled to communicate those reports to [the intervener]’, but that ‘the fact that [the intervener had] in any event obtained access to those documents [meant] that the EMA [was] deprived of any interest in the immediate implementation of the [contested decision]’.
34 It necessarily follows that, taking into account the specific circumstances of the present case for the purposes of the appeal proceedings, the Vice-President considered decisive the fact — justifying the lack of need to adjudicate — that the intervener, which had requested the EMA to grant it access to the reports at issue so as to be in a position to defend itself effectively in court, in fact had those reports communicated to it in the course of the proceedings, enabling it to use them specifically for the protection of its interests in the context of Case T‑269/15, which is between the applicant and the Commission, but without being authorised to use them for non-judicial purposes or to transmit them to third parties.
35 In contrast to the submissions of the EMA, which had put forward considerations of general interest going beyond the limits of the triangular procedural situation (see paragraph 19 above), the Vice-President adopted an approach focused on the individual interests, inter alia, of the intervener and the applicant. In other words, according to the Vice-President, on the one hand, the intervener had obtained all that it could legitimately expect to obtain from the EMA following its request on the basis of Regulation No 1049/2001 and, on the other hand, the applicant enjoyed sufficient confidentiality of its pharmaceutical and commercial data, the procedural situation taken into consideration thus being characterised by a particular balance between the specific interests of the parties involved.
36 That being said, it is clear that the interim measures granted to the applicant in the first General Court order have in fact become ineffective if the sole effect of the contested decision is ‘to enable the EMA to communicate to [the intervener] the reports at issue which it already holds’ and if ‘the fact that [the intervener] has in any event obtained access to those documents means that the EMA is deprived of any interest in the immediate implementation of the [contested decision]’. In other words, if the intervener were content to use the reports at issue solely for the purposes of protecting its interests in the context of Case T‑269/15, and the EMA regarded the contested decision as having become devoid of purpose since the intervener already had those reports, the applicant would no longer have need for the protection of interim measures.
37 That is not the case, however, given that the status quo which enabled the Vice-President to find that there was no need to adjudicate on the EMA’s appeal would not continue if the first General Court order were cancelled.
38 In response to the questions asked by the judge hearing the application for interim relief, first, the intervener stated that it was maintaining its request based on Regulation No 1049/2001 seeking to obtain access to the reports at issue, on the ground that such access granted pursuant to that regulation would allow it to use those reports without the restrictions on it under the confidentiality agreement concluded with the applicant. Second, according to the EMA, the fact that the intervener obtained access to the reports at issue has no influence on the contested decision, since the request for access was specifically not withdrawn.
39 It follows that, in the event that the first General Court order were cancelled, with the result that the applicant would be deprived of the protective effect of the interim measures granted, the EMA would proceed to implement the contested decision and grant the intervener access to the reports at issue pursuant to Regulation No 1049/2001, which would have an erga omnes effect in the sense that those documents could be communicated to other persons requesting access and that any person would have the right to access them (see, to that effect, judgment of 21 October 2010 in Agapiou Joséphidès v Commission and EACEA, T‑439/08, not published, EU:T:2010:442, paragraph 116). Furthermore, the intervener would be in a position to use them for its pharmaceutical activities and, therefore, as a competitor of the applicant.
40 It should be recalled that it is precisely in consideration of the erga omnes effect, in view of which the judge who heard the application for interim relief found, in paragraphs 95 to 97 of the first General Court order, that it would place the applicant in a vulnerable situation capable of causing it serious and irreparable damage, that the condition relating to urgency was regarded as having been met.
41 It follows from all the foregoing that there is nothing in the order on the appeal such as to call into question the assessment of the judge who heard the application for interim relief as to the conditions to which the grant of the interim measures adopted in the first General Court order was subject, with the result that the condition relating to a change in circumstances, as referred to in Article 159 of the Rules of Procedure, is not satisfied.
42 Accordingly, the request based on Article 159 of the Rules of Procedure seeking to obtain the cancellation of the first General Court order must be rejected.
On those grounds,
THE PRESIDENT OF THE GENERAL COURT
hereby orders:
1. The request seeking the cancellation of the order of 1 September 2015 in Pari Pharma v EMA (T‑235/15 R, EU:T:2015:587) is rejected.
2. The costs are reserved.
Luxembourg, 23 May 2016.