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Corte di giustizia UEsentenza

Corte di giustizia UE n. 1049/2016

ECLI:EU:C:2016:775
Testo integrale del provvedimento

Testo integrale del provvedimento

[OSCURATO:PERSONA]-[OSCURATO:PERSONA]

18 October 2016 ( * ) (Appeal — [OSCURATO:PERSONA] for interim measures — Suspension of operation of a measure challenged before the [OSCURATO:PERSONA] — Change in circumstances — [OSCURATO:PERSONA] to documents — [OSCURATO:PERSONA] (EC) No 1049/2001 — Documents held by the [OSCURATO:PERSONA] (EMA) submitted as part of an application for authorisation to place a medicinal product on the market — [OSCURATO:PERSONA] to grant a third party access to the documents)

[OSCURATO:PERSONA] C‑406/16 P(R),

APPEAL under the second paragraph of [OSCURATO:PERSONA] 57 of the Statute of the [OSCURATO:PERSONA] of Justice of the [OSCURATO:PERSONA], brought on 19 July 2016,

[OSCURATO:PERSONA] (EMA),

represented by S. Marino, A. Spina, A. Rusanov, T. Jabłoński and N. [OSCURATO:PERSONA], acting as Agents, appellant, the other parties to the proceedings being: [OSCURATO:PERSONA] GmbH, established in Starnberg (Germany), represented by M. Epping and W. Rehmann, Rechtsanwälte, applicant at first instance,

[OSCURATO:PERSONA],

established in Camberley ([OSCURATO:PERSONA]), represented by C. Schoonderbeek, avocate, intervener at first instance,

[OSCURATO:PERSONA]-[OSCURATO:PERSONA],

after hearing the [OSCURATO:PERSONA], M. Wathelet, makes the following

[OSCURATO:PERSONA]

1 By its appeal, the [OSCURATO:PERSONA] (EMA) seeks to have set aside the order of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 23 May 2016,

[OSCURATO:PERSONA]

v EMA (T‑235/15 R, not published, ‘the order under appeal’, EU:T:2016:309), by which that court rejected its application for cancellation of the order of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 1 September 2015,

[OSCURATO:PERSONA]

v EMA (T‑235/15 R, ‘the first [OSCURATO:PERSONA] order’, EU:T:2015:587).

Background to the dispute, procedure before the [OSCURATO:PERSONA] and the order under appeal 2 [OSCURATO:PERSONA] (EC) No 726/2004 of the [OSCURATO:PERSONA] and of the [OSCURATO:PERSONA] of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a [OSCURATO:PERSONA] (OJ 2004 L 136, p. 1), certain categories of medicinal products must be approved under a centralised procedure established by that regulation.

That procedure requires the submission of an application for marketing authorisation (‘MA application’), which, following an examination and an opinion of the EMA, results in a decision of the [OSCURATO:PERSONA].

A committee of the EMA, namely the Committee for [OSCURATO:PERSONA] for [OSCURATO:PERSONA] (‘CHMP’), is responsible for preparing the opinions of the EMA on any question relating to medicinal products for human use. 3 [OSCURATO:PERSONA] is the holder of a marketing authorisation (‘MA’) granted by the [OSCURATO:PERSONA], on 20 July 2011, under [OSCURATO:PERSONA] 726/2004, for the medicinal product ‘TOBI Podhaler’. 4 TOBI Podhaler was classified as an ‘orphan medicinal product’, within the meaning of [OSCURATO:PERSONA] (EC) No 141/2000 of the [OSCURATO:PERSONA] and of the [OSCURATO:PERSONA] 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 undertakings to invest in orphan medicinal products.

To that end, [OSCURATO:PERSONA] 8(1) of [OSCURATO:PERSONA] 141/2000 provides that, where an MA has been granted in respect of an orphan medicinal product, no other MA is to be granted for a period of 10 years for the same therapeutic indication in respect of a similar medicinal product.

However, under [OSCURATO:PERSONA] 8(3), a similar medicinal product may be granted an MA for the same therapeutic indication if the second applicant [for an MA] can establish that its medicinal product, although similar to the orphan medicinal product already authorised, is safer, more effective or otherwise clinically superior. 5 It was on the basis of that derogating provision that [OSCURATO:PERSONA] GmbH applied for an MA in respect of its medicinal product ‘Vantobra’. 6 [OSCURATO:PERSONA] granted that application on 18 March 2015, following the favourable opinion of the CHMP of 22 January 2015.

That opinion is based on two CHMP reports issued on the same day, namely [OSCURATO:PERSONA] EMA/CHMP/702525/2014 for Vantobra on similarity with Cayston and TOBI Podhaler, and [OSCURATO:PERSONA] EMA/CHMP/778270/2014 on clinical superiority to TOBI Podhaler (together ‘the reports at issue’). 7 On 13 April 2015, the EMA informed [OSCURATO:PERSONA] that it had received a request for access to the reports at issue, submitted on the basis of [OSCURATO:PERSONA] (EC) No 1049/2001 of the [OSCURATO:PERSONA] and of the [OSCURATO:PERSONA] of 30 May 2001 regarding public access to [OSCURATO:PERSONA], [OSCURATO:PERSONA] and [OSCURATO:PERSONA] documents (OJ 2001 L 145, p. 43).

It emerged in the course of the procedure that the person requesting access was [OSCURATO:PERSONA].

The EMA informed [OSCURATO:PERSONA] of its intention to disclose those reports with a few redactions concerning personal data, while setting it a deadline for requesting additional redactions.

On 20 April 2015, [OSCURATO:PERSONA] requested that the EMA not disclose the reports at issue. 8 [OSCURATO:PERSONA] EMA/271043/2015 of the EMA of 24 April 2015 (‘the decision at issue’), the EMA decided to disclose the reports at issue to [OSCURATO:PERSONA] pursuant to [OSCURATO:PERSONA] 1049/2001. 9 On 15 May 2015, [OSCURATO:PERSONA] brought an action before the [OSCURATO:PERSONA] seeking annulment of that decision ([OSCURATO:PERSONA] T‑235/15). 10 By separate document, lodged at the [OSCURATO:PERSONA] on the same day, [OSCURATO:PERSONA] submitted an application for interim relief, in which it asked the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA], in essence, to suspend operation of the decision at issue and order the EMA not to disclose the reports at issue. 11 The EMA asked the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] to dismiss that application. 12 By order of 22 June 2015, [OSCURATO:PERSONA] was granted leave to intervene in the interim relief proceedings in support of the form of order sought by the EMA. 13 In parallel to [OSCURATO:PERSONA] action, on 28 May 2015, [OSCURATO:PERSONA] brought an action before the [OSCURATO:PERSONA] seeking annulment of the decision of 18 March 2015 by which the [OSCURATO:PERSONA] had granted the MA for Vantobra, on the ground that that decision infringed the market exclusivity which it enjoyed, under [OSCURATO:PERSONA] 8(1) of [OSCURATO:PERSONA] 141/2000, in respect of TOBI Podhaler.

That action was registered as [OSCURATO:PERSONA] T‑269/15. 14 By the first [OSCURATO:PERSONA] order, it was decided, first, to suspend operation of the decision at issue in so far as that decision granted a third party access to the reports at issue, pursuant to [OSCURATO:PERSONA] 1049/2001, and, second, to order the EMA not to disclose those reports. 15 By application lodged at the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of Justice on 23 October 2015, the EMA brought an appeal against that order. 16 In the proceedings before the [OSCURATO:PERSONA] of Justice, in its response lodged on 23 November 2015, [OSCURATO:PERSONA] contended that the [OSCURATO:PERSONA] of Justice should dismiss the appeal.

The reports at issue were included in the annexes to that response. 17 On 24 November 2015, the response lodged by [OSCURATO:PERSONA] and the annexes thereto were served on the other parties to the appeal proceedings, including [OSCURATO:PERSONA], the intervener at first instance. 18 On 25 November 2015, [OSCURATO:PERSONA] submitted a request for confidential treatment in order that the reports at issue not be served on [OSCURATO:PERSONA].

However, because that request for confidential treatment was submitted out of time, those reports had already been served as they stood. 19 [OSCURATO:PERSONA], [OSCURATO:PERSONA] informed the [OSCURATO:PERSONA] of Justice that it had succeeded in concluding an agreement with [OSCURATO:PERSONA], under which the latter had undertaken to keep the reports at issue confidential and not to disclose them to third parties. [OSCURATO:PERSONA] would be authorised to use those documents only for the purposes of the case pending between it and the [OSCURATO:PERSONA], registered with the [OSCURATO:PERSONA] as [OSCURATO:PERSONA] T‑269/15.

In addition, [OSCURATO:PERSONA] had agreed to make limited use of those documents; such use was in particular not to affect the proceedings in [OSCURATO:PERSONA] T‑235/15 which were pending before the [OSCURATO:PERSONA]. 20 Having asked the EMA, by letter of the Registrar of 3 December 2015, to clarify whether, given the circumstances, it considered that there was still a need to adjudicate on its appeal, the [OSCURATO:PERSONA]-[OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of Justice, by order of 17 March 2016, EMA v

[OSCURATO:PERSONA]

(C‑550/15 P(R), not published, ‘the order on the appeal’, EU:C:2016:196), held that there was no need to adjudicate on the EMA’s appeal, on the ground that the EMA no longer had an interest in bringing proceedings, since the appeal was no longer capable, if successful, of procuring an advantage for the EMA. 21 In particular, at paragraphs 38 to 41 of that order, the [OSCURATO:PERSONA]-[OSCURATO:PERSONA] of the [OSCURATO:PERSONA] held as follows: ‘38 … the fact that [OSCURATO:PERSONA] now has access to the reports at issue clearly deprives the interim measures obtained by [OSCURATO:PERSONA] 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 (see, in particular, order of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 27 February 2002, Reisebank v

[OSCURATO:PERSONA]

, C‑477/01 P(R), EU:C:2002:126, paragraphs 22 and 23 and the case-law cited). 40 Regardless of the assessments which could be carried out by the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] concerning the possibility of cancelling or modifying the order under appeal upon application by one of the parties to that effect pursuant to [OSCURATO:PERSONA] 159 of the Rules of Procedure of the [OSCURATO:PERSONA], 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 decision at issue, the sole effect thereof would be to enable the EMA to communicate to [OSCURATO:PERSONA] 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 [OSCURATO:PERSONA].

However, the fact that [OSCURATO:PERSONA] has in any event obtained access to those documents means that the EMA is deprived of any interest in the immediate implementation of the decision at issue.’ 22 In those circumstances, by document lodged at the [OSCURATO:PERSONA] on 31 March 2016, the EMA submitted an application based on [OSCURATO:PERSONA] 159 of the Rules of Procedure of the [OSCURATO:PERSONA], seeking cancellation of the first [OSCURATO:PERSONA] order following the change in circumstances that has arisen in the present case. 23 Having held, in paragraphs 29 to 35 of the order under appeal, in essence, that the order on the appeal had not called into question the assessments set out in the first [OSCURATO:PERSONA] order and that the relations between the EMA, [OSCURATO:PERSONA] and [OSCURATO:PERSONA] were in essence taken into account therein, the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA], at paragraphs 36 to 41 of the order under appeal, held as follows: ‘36 That being said, it is clear that the interim measures granted to [[OSCURATO:PERSONA]] in the first [OSCURATO:PERSONA] order have in fact become ineffective if the sole effect of the [decision at issue] is “to enable the EMA to communicate to [[OSCURATO:PERSONA]] the reports at issue which it already holds” and “if the fact that [[OSCURATO:PERSONA]] has in any event obtained access to those documents means that the EMA is deprived of any interest in the immediate implementation of the [decision at issue]”.

In other words, if [[OSCURATO:PERSONA]] were content to use the reports at issue solely for the purposes of protecting its interests in the context of [OSCURATO:PERSONA] T‑269/15, and the EMA regarded the [decision at issue] as having become devoid of purpose since [[OSCURATO:PERSONA]] already had those reports, [[OSCURATO:PERSONA]] 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 [OSCURATO:PERSONA]-[OSCURATO:PERSONA] [of the [OSCURATO:PERSONA]] to find that there was no need to adjudicate on the EMA’s appeal would not continue if the first [OSCURATO:PERSONA] order were cancelled. 38 In response to the questions asked by the judge hearing the application for interim relief, first, [[OSCURATO:PERSONA]] stated that it was maintaining its request based on [OSCURATO:PERSONA] 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 [[OSCURATO:PERSONA]].

Second, according to the EMA, the fact that [[OSCURATO:PERSONA]] obtained access to the reports at issue has no influence on the [decision at issue], since the request for access was specifically not withdrawn. 39 It follows that, in the event that the first [OSCURATO:PERSONA] order were cancelled, with the result that [[OSCURATO:PERSONA]] would be deprived of the protective effect of the interim measures granted, the EMA would proceed to implement the [decision at issue] and grant [[OSCURATO:PERSONA]] access to the reports at issue pursuant to [OSCURATO:PERSONA] 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,

[OSCURATO:PERSONA]

v [OSCURATO:PERSONA] and EACEA , T‑439/08, not published, EU:T:2010:442, paragraph 116).

Furthermore, [[OSCURATO:PERSONA]] would be in a position to use them for its pharmaceutical activities and, therefore, as a competitor of [[OSCURATO:PERSONA]]. 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 [OSCURATO:PERSONA] order, that it would place [[OSCURATO:PERSONA]] 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 [OSCURATO:PERSONA] order was subject, with the result that the condition relating to a change in circumstances, as referred to in [OSCURATO:PERSONA] 159 of the Rules of Procedure, is not satisfied.’ 24 On the basis of those considerations, the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] rejected the EMA’s request.

Forms of order sought and procedure before the [OSCURATO:PERSONA] of Justice 25 By its appeal, the EMA asks the [OSCURATO:PERSONA] to set aside the order under appeal and cancel the first [OSCURATO:PERSONA] order, and order [OSCURATO:PERSONA] to pay all the costs of the proceedings, including the costs before the [OSCURATO:PERSONA]. 26 [OSCURATO:PERSONA] asks the [OSCURATO:PERSONA] to dismiss the appeal and the application for cancellation of the first [OSCURATO:PERSONA] order, and order the EMA to pay the costs of the proceedings, including the costs of the proceedings before the [OSCURATO:PERSONA]. 27 At the request of the [OSCURATO:PERSONA] of 24 August 2016, [OSCURATO:PERSONA] lodged a copy of the confidentiality agreement that it had concluded with [OSCURATO:PERSONA], referred to in paragraph 19 of the present order, at the [OSCURATO:PERSONA] on 25 August 2016.

The appeal Arguments of the parties 28 The EMA puts forward, in essence, three grounds of appeal in support of its appeal. 29 By its first ground of appeal, the EMA claims that the order under appeal is at odds with the order on the appeal. 30 The second and third grounds of appeal, for their part, allege that the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] was in error in holding, at paragraph 37 of the order under appeal, that ‘the status quo which enabled the [OSCURATO:PERSONA]-[OSCURATO:PERSONA] [of the [OSCURATO:PERSONA]] to find that there was no need to adjudicate on the EMA’s appeal would not continue if the first [OSCURATO:PERSONA] order were cancelled’. 31 In the context of those latter two grounds of appeal, the EMA claims that the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] artificially restricted, within limits not present in the order on the appeal, his assessment of the change in circumstances in question.

It is submitted that the conclusion set out in paragraphs 38 to 41 of the order on the appeal is not conditional on the existence of any ‘status quo’. 32 In any event, the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA], it is claimed, did not take into consideration the new circumstances and, in particular, the fact that [OSCURATO:PERSONA] had agreed to make limited use of the documents in question. 33 As regards the allegedly erga omnes effect of the decision at issue, the EMA has, furthermore, stated in its appeal that, ‘in practice, and in line with … settled case-law, … any future request for access to the Documents will result in a notification of such request being sent by the EMA to [[OSCURATO:PERSONA]] and [[OSCURATO:PERSONA]] will be given again the opportunity to challenge the new release decision in the same manner the [decision at issue] was challenged, including by way of seeking interim relief’. 34 [OSCURATO:PERSONA] contends, by contrast, that, as long as the decision at issue has not been withdrawn, the first [OSCURATO:PERSONA] order is not devoid of purpose, since that decision would have an influence on the future decisions to grant access to the reports at issue to third parties which the EMA might adopt in respect of requests pending before it. [OSCURATO:PERSONA] states that the fact that [OSCURATO:PERSONA] has obtained access to those reports in the proceedings that gave rise to the order on the appeal, without [OSCURATO:PERSONA] consenting thereto, is not such as to call into question the reasons set out in that regard in the first [OSCURATO:PERSONA] order. 35 In the first place, it is submitted that [OSCURATO:PERSONA] has indicated that it has a continuing interest in obtaining unrestricted access to the reports at issue without obligations of confidentiality, which can be granted only by way of a decision taken on the basis of [OSCURATO:PERSONA] 1049/2001 and, therefore by maintaining its request for access which gave rise to the decision at issue. 36 In the second place, it is submitted that the EMA considered that it could not withdraw the decision at issue in the absence of a withdrawal by [OSCURATO:PERSONA] of its request for access to the reports at issue.

Furthermore, in the proceedings that gave rise to the order on the appeal, the EMA claimed that it still had an interest in bringing proceedings because of the erga omnes effect of decisions to grant access to documents under [OSCURATO:PERSONA] 1049/2001.

Similarly, it is submitted that, without expressly repeating the argument in its appeal in the present proceedings, the EMA has not excluded the erga omnes effect of the decision at issue. 37 In this connection, [OSCURATO:PERSONA] states that the erga omnes effect of a decision adopted under [OSCURATO:PERSONA] 1049/2001 is confirmed by [OSCURATO:PERSONA] 8(3) of the Rules for the implementation of [OSCURATO:PERSONA] 1049/2001 on access to EMEA documents of 19 December 2006 (‘the rules on access’), which states as follows: ‘The [EMA] shall grant the application without consulting the third-party author where the document requested has already been disclosed either by its author or under [OSCURATO:PERSONA] … No 1049/2001 or similar provisions’. 38 The EMA’s statement to the effect that, in the event of future requests for access to the reports at issue, [OSCURATO:PERSONA] would be given again the opportunity to challenge the new release decision therefore contradicts both the line of argument put forward by the EMA in the proceedings that gave rise to order on the appeal and the rules on access. 39 In the third place, [OSCURATO:PERSONA] contends that it still has a definite interest in the first [OSCURATO:PERSONA] order being maintained and in the EMA’s application for cancellation thereof being rejected inasmuch as that order deprives the decision at issue of its erga omnes effect.

Findings of the [OSCURATO:PERSONA] 40 In adjudicating on the second and third grounds of appeal, which it is appropriate to deal with first and together, it must be recalled that, in paragraph 36 of the order under appeal, the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] stated that if [OSCURATO:PERSONA] were content to use the reports at issue solely for the purposes of protecting its interests in the context of [OSCURATO:PERSONA] T‑269/15, and the EMA regarded the decision at issue as having become devoid of purpose since [OSCURATO:PERSONA] already had those reports, [OSCURATO:PERSONA] would no longer have need for the protection of interim measures. 41 However, at paragraph 37 of the order under appeal, the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] held that that was not the case given that the status quo, which enabled the [OSCURATO:PERSONA]-[OSCURATO:PERSONA] of the [OSCURATO:PERSONA] to find that there was no need to adjudicate on the EMA’s appeal, would not continue if the first [OSCURATO:PERSONA] order were cancelled. 42 In reaching that conclusion, the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] took into consideration, in paragraph 38 of the order under appeal, the responses that [OSCURATO:PERSONA] and the EMA gave to the questions, set out in paragraph 25 of that order, addressed to them by the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA]. 43 Thus, in that paragraph 38, the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] simply noted, first, that [OSCURATO:PERSONA] stated that it was maintaining its request based on [OSCURATO:PERSONA] 1049/2001 for 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 [OSCURATO:PERSONA], and, second, that according to the EMA, the fact that [OSCURATO:PERSONA] had access to the reports at issue has no influence on the decision at issue, since the request for access was not withdrawn. 44 However, it must be stated that both [OSCURATO:PERSONA] maintaining that request and the fact that the EMA has not withdrawn the decision at issue concern the substance of the action for annulment of that decision.

In that context, those factors are to be considered in particular in the light of the EMA’s potential liability following a possible annulment of that decision at the end of the procedure dealing with the substance of the case in that action. 45 On the other hand, those factors do not prove that the interim measures in question continue to serve a purpose, given the change in circumstances that has arisen in the present case and that consists, in particular, in [OSCURATO:PERSONA] having obtained access to the reports at issue and the conclusion of the confidentiality agreement between [OSCURATO:PERSONA] and

[OSCURATO:PERSONA].

46 That is a fortiori true since it is clear from paragraph 3 of that confidentiality agreement that [OSCURATO:PERSONA] may use the reports at issue only for the purposes of [OSCURATO:PERSONA] T‑269/15 and ‘without affecting the proceedings currently conducted before the [OSCURATO:PERSONA] in [OSCURATO:PERSONA] T‑235/15’.

It follows that [OSCURATO:PERSONA] is required to make limited use of those reports until such time as the [OSCURATO:PERSONA] has ruled on the action for annulment of the decision at issue that is the subject matter of the proceedings in [OSCURATO:PERSONA] T‑235/15. 47 Indeed, the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] ought to have taken those circumstances into consideration in adjudicating on the purpose served by the measure suspending operation of the decision at issue since that decision granted a third party, namely [OSCURATO:PERSONA], access to those reports. 48 Consequently, since the factors taken into consideration by the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] were not sufficient to exclude that the change in circumstances that arose subsequently to the first [OSCURATO:PERSONA] order might warrant its cancellation, the second and third grounds of appeal must be upheld and the order under appeal must be set aside, and it is not necessary to rule on the first ground of appeal.

The application for cancellation of the first [OSCURATO:PERSONA] order 49 [OSCURATO:PERSONA] the first paragraph of [OSCURATO:PERSONA] 61 of the Statute of the [OSCURATO:PERSONA] of Justice of the [OSCURATO:PERSONA], the [OSCURATO:PERSONA] may, where the decision of the [OSCURATO:PERSONA] has been set aside, either itself give final judgment in the matter, where the state of the proceedings so permits, or refer the case back to the [OSCURATO:PERSONA] for judgment.

That provision also applies to appeals brought under the second paragraph of [OSCURATO:PERSONA] 57 of the Statute of the [OSCURATO:PERSONA] (orders of the [OSCURATO:PERSONA]-[OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 7 March 2013, EDF v

[OSCURATO:PERSONA]

, C‑551/12 P(R), EU:C:2013:157, paragraphs 36 and 37, and 23 April 2015,

[OSCURATO:PERSONA]

v [OSCURATO:PERSONA] & Benefits , C‑35/15 P(R), EU:C:2015:275, paragraph 59). 50 Since the state of the proceedings so permits, it is appropriate to adjudicate on the EMA’s application for cancellation of the first [OSCURATO:PERSONA] order. 51 In this connection, it should be recalled that it was found, in that first order, that it was urgent to grant the interim measures applied for in order to prevent [OSCURATO:PERSONA] suffering serious and irreparable damage.

According to paragraphs 93 to 101 of that order, that damage might occur if, first, [OSCURATO:PERSONA] had access to the reports at issue, and, second, if those reports were disclosed to other third parties. 52 However, since [OSCURATO:PERSONA] has the reports at issue in its possession, the interim measures in question are no longer capable of preventing the occurrence of harm resulting from possession thereof.

Furthermore, as the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] stated in paragraph 36 of the order under appeal, [OSCURATO:PERSONA] would no longer have need for the protection of interim measures if [OSCURATO:PERSONA] were content to use those reports solely for the purposes of protecting its interests in the context of [OSCURATO:PERSONA] T‑269/15. 53 In that regard, as stated in paragraph 19 of the present order, it is clear from the confidentiality agreement concluded between [OSCURATO:PERSONA] and [OSCURATO:PERSONA] that [OSCURATO:PERSONA] is required to make limited use of the reports at issue, such use being limited to the protection of its interests in the context of [OSCURATO:PERSONA] T‑269/15 until such time as the [OSCURATO:PERSONA] has ruled on the substance of the action in [OSCURATO:PERSONA] T‑235/15.

Against that background, and given the circumstances of the present case, that agreement suffices to protect the interests of [OSCURATO:PERSONA] against any detrimental use of the reports at issue, other than for the purposes of [OSCURATO:PERSONA] T‑269/15, by [OSCURATO:PERSONA]. 54 As regards the claimed erga omnes effect of the decision at issue, it should be pointed out that, even if it is true that the EMA has claimed, in the context of the present proceedings, that such an effect attaches to decisions adopted on the basis of [OSCURATO:PERSONA] 1049/2001 in order to maintain that there is still a need to adjudicate on its appeal, the fact remains that, in its appeal, it has expressly stated that, ‘in practice, and in line with … settled case-law, … any future request for access to the Documents will result in a notification of such request being sent by the EMA to [[OSCURATO:PERSONA]] and [[OSCURATO:PERSONA]] will be given again the opportunity to challenge the new release decision in the same manner the [decision at issue] was challenged, including by way of seeking interim relief’. 55 Indeed, even if decisions adopted on the basis of [OSCURATO:PERSONA] 1049/2001 enable access to documents to be granted to third parties — other than the initial applicants to whom those decisions apply — who wish to have access to them, that does not mean that any third party automatically has a right of access to those documents.

In other words, the institution in question is still required to carry out a specific and individual examination of any request for access to documents, irrespective of whether those documents have already been disclosed and must, should the case arise, provide the reasons justifying a different decision for the purpose of protecting one of the interests referred to in [OSCURATO:PERSONA] 4 of that regulation. 56 Since the examination required for the purpose of processing a request for access to documents must be specific in nature, if the institution concerned decides to refuse access to a document which it has been asked to disclose, it must, in principle, explain how disclosure of that document could specifically and actually undermine the interest protected by the exception — among those provided for in [OSCURATO:PERSONA] 4 of [OSCURATO:PERSONA] 1049/2001 — upon which it is relying.

Moreover, the risk of the interest being undermined must be reasonably foreseeable and must not be purely hypothetical (judgment of 17 October 2013,

[OSCURATO:PERSONA]

v

[OSCURATO:PERSONA]

, C‑280/11 P, EU:C:2013:671, paragraph 31 and the case-law cited). 57 Consequently, the fact that the reports at issue have already been disclosed in the present case cannot prevent the EMA from examining any other request for access concerning the same reports by subjecting that request to the procedure laid down in [OSCURATO:PERSONA] 1049/2001 and thereby enabling [OSCURATO:PERSONA] to oppose any disclosure under one of the grounds provided for in [OSCURATO:PERSONA] 4 of that regulation. 58 Moreover, it cannot be claimed that the rules on access prohibit the EMA from proceeding in that manner, since, in the present case, access to the reports at issue was provided without the consent of the author of those documents and outside of that regulation or of any similar provision. 59 Regardless of what the EMA claimed in the context of the proceedings that gave rise to the order on the appeal or to the order under appeal, the fact remains that, as noted in paragraph 54 of the present order, in its appeal, the EMA expressly stated before the [OSCURATO:PERSONA] that it intended to subject any request for access to the reports at issue to the procedure laid down in

[OSCURATO:PERSONA] 1049/2001.

60 It follows that, even in the absence of the interim measures in question, first, [OSCURATO:PERSONA] may use the reports at issue only within the limits agreed in the confidentiality agreement concluded with [OSCURATO:PERSONA], and only until the end of the proceedings on the substance.

Second, since the EMA has undertaken before the [OSCURATO:PERSONA] to subject any request for access to the reports at issue to the procedure laid down in [OSCURATO:PERSONA] 1049/2001, no erga omnes effect can be attached to the decision at issue. 61 In the light of those circumstances, the interim measures in question no longer serve their purpose and the first [OSCURATO:PERSONA] order must be cancelled.

Costs 62 [OSCURATO:PERSONA] 184(2) of the Rules of Procedure of the [OSCURATO:PERSONA] of Justice, where the appeal is well founded and the [OSCURATO:PERSONA] itself gives final judgment in the case, the [OSCURATO:PERSONA] is to make a decision as to costs. [OSCURATO:PERSONA] 138(1) of those rules, which applies to the procedure on appeal by virtue of [OSCURATO:PERSONA] 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. 63 In the present case, since [OSCURATO:PERSONA] has been unsuccessful in its contentions and the EMA has applied for costs, [OSCURATO:PERSONA] must be ordered to pay the costs incurred in the appeal proceedings and at first instance.

On those grounds, the [OSCURATO:PERSONA]-[OSCURATO:PERSONA] of the [OSCURATO:PERSONA] hereby orders:

1. The order of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 23 May 2016,

[OSCURATO:PERSONA]

v EMA (T‑235/15 R, not published, EU:T:2016:309), is set aside. 2. The order of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 1 September 2015,

[OSCURATO:PERSONA]

v EMA (T‑235/15 R, EU:T:2015:587), is cancelled. 3. [OSCURATO:PERSONA] GmbH is to pay the costs incurred in the appeal proceedings and in the proceedings at first instance. [Signatures] * Language of the case: English.

Anonimizzato ex art. 52 D.Lgs. 196/2003
[OSCURATO:PERSONA]-[OSCURATO:PERSONA] 18 October 2016 ( * ) (Appeal — [OSCURATO:PERSONA] for interim measures — Suspension of operation of a measure challenged before the [OSCURATO:PERSONA] — Change in circumstances — [OSCURATO:PERSONA] to documents — [OSCURATO:PERSONA] (EC) No 1049/2001 — Documents held by the [OSCURATO:PERSONA] (EMA) submitted as part of an application for authorisation to place a medicinal product on the market — [OSCURATO:PERSONA] to grant a third party access to the documents) [OSCURATO:PERSONA] C‑406/16 P(R), APPEAL under the second paragraph of [OSCURATO:PERSONA] 57 of the Statute of the [OSCURATO:PERSONA] of Justice of the [OSCURATO:PERSONA], brought on 19 July 2016, [OSCURATO:PERSONA] (EMA), represented by S. Marino, A. Spina, A. Rusanov, T. Jabłoński and N. [OSCURATO:PERSONA], acting as Agents, appellant, the other parties to the proceedings being: [OSCURATO:PERSONA] GmbH, established in Starnberg (Germany), represented by M. Epping and W. Rehmann, Rechtsanwälte, applicant at first instance, [OSCURATO:PERSONA], established in Camberley ([OSCURATO:PERSONA]), represented by C. Schoonderbeek, avocate, intervener at first instance, [OSCURATO:PERSONA]-[OSCURATO:PERSONA], after hearing the [OSCURATO:PERSONA], M. Wathelet, makes the following [OSCURATO:PERSONA] 1 By its appeal, the [OSCURATO:PERSONA] (EMA) seeks to have set aside the order of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 23 May 2016, [OSCURATO:PERSONA] v EMA (T‑235/15 R, not published, ‘the order under appeal’, EU:T:2016:309), by which that court rejected its application for cancellation of the order of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 1 September 2015, [OSCURATO:PERSONA] v EMA (T‑235/15 R, ‘the first [OSCURATO:PERSONA] order’, EU:T:2015:587). Background to the dispute, procedure before the [OSCURATO:PERSONA] and the order under appeal 2 [OSCURATO:PERSONA] (EC) No 726/2004 of the [OSCURATO:PERSONA] and of the [OSCURATO:PERSONA] of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a [OSCURATO:PERSONA] (OJ 2004 L 136, p. 1), certain categories of medicinal products must be approved under a centralised procedure established by that regulation. That procedure requires the submission of an application for marketing authorisation (‘MA application’), which, following an examination and an opinion of the EMA, results in a decision of the [OSCURATO:PERSONA]. A committee of the EMA, namely the Committee for [OSCURATO:PERSONA] for [OSCURATO:PERSONA] (‘CHMP’), is responsible for preparing the opinions of the EMA on any question relating to medicinal products for human use. 3 [OSCURATO:PERSONA] is the holder of a marketing authorisation (‘MA’) granted by the [OSCURATO:PERSONA], on 20 July 2011, under [OSCURATO:PERSONA] 726/2004, for the medicinal product ‘TOBI Podhaler’. 4 TOBI Podhaler was classified as an ‘orphan medicinal product’, within the meaning of [OSCURATO:PERSONA] (EC) No 141/2000 of the [OSCURATO:PERSONA] and of the [OSCURATO:PERSONA] 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 undertakings to invest in orphan medicinal products. To that end, [OSCURATO:PERSONA] 8(1) of [OSCURATO:PERSONA] 141/2000 provides that, where an MA has been granted in respect of an orphan medicinal product, no other MA is to be granted for a period of 10 years for the same therapeutic indication in respect of a similar medicinal product. However, under [OSCURATO:PERSONA] 8(3), a similar medicinal product may be granted an MA for the same therapeutic indication if the second applicant [for an MA] can establish that its medicinal product, although similar to the orphan medicinal product already authorised, is safer, more effective or otherwise clinically superior. 5 It was on the basis of that derogating provision that [OSCURATO:PERSONA] GmbH applied for an MA in respect of its medicinal product ‘Vantobra’. 6 [OSCURATO:PERSONA] granted that application on 18 March 2015, following the favourable opinion of the CHMP of 22 January 2015. That opinion is based on two CHMP reports issued on the same day, namely [OSCURATO:PERSONA] EMA/CHMP/702525/2014 for Vantobra on similarity with Cayston and TOBI Podhaler, and [OSCURATO:PERSONA] EMA/CHMP/778270/2014 on clinical superiority to TOBI Podhaler (together ‘the reports at issue’). 7 On 13 April 2015, the EMA informed [OSCURATO:PERSONA] that it had received a request for access to the reports at issue, submitted on the basis of [OSCURATO:PERSONA] (EC) No 1049/2001 of the [OSCURATO:PERSONA] and of the [OSCURATO:PERSONA] of 30 May 2001 regarding public access to [OSCURATO:PERSONA], [OSCURATO:PERSONA] and [OSCURATO:PERSONA] documents (OJ 2001 L 145, p. 43). It emerged in the course of the procedure that the person requesting access was [OSCURATO:PERSONA]. The EMA informed [OSCURATO:PERSONA] of its intention to disclose those reports with a few redactions concerning personal data, while setting it a deadline for requesting additional redactions. On 20 April 2015, [OSCURATO:PERSONA] requested that the EMA not disclose the reports at issue. 8 [OSCURATO:PERSONA] EMA/271043/2015 of the EMA of 24 April 2015 (‘the decision at issue’), the EMA decided to disclose the reports at issue to [OSCURATO:PERSONA] pursuant to [OSCURATO:PERSONA] 1049/2001. 9 On 15 May 2015, [OSCURATO:PERSONA] brought an action before the [OSCURATO:PERSONA] seeking annulment of that decision ([OSCURATO:PERSONA] T‑235/15). 10 By separate document, lodged at the [OSCURATO:PERSONA] on the same day, [OSCURATO:PERSONA] submitted an application for interim relief, in which it asked the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA], in essence, to suspend operation of the decision at issue and order the EMA not to disclose the reports at issue. 11 The EMA asked the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] to dismiss that application. 12 By order of 22 June 2015, [OSCURATO:PERSONA] was granted leave to intervene in the interim relief proceedings in support of the form of order sought by the EMA. 13 In parallel to [OSCURATO:PERSONA] action, on 28 May 2015, [OSCURATO:PERSONA] brought an action before the [OSCURATO:PERSONA] seeking annulment of the decision of 18 March 2015 by which the [OSCURATO:PERSONA] had granted the MA for Vantobra, on the ground that that decision infringed the market exclusivity which it enjoyed, under [OSCURATO:PERSONA] 8(1) of [OSCURATO:PERSONA] 141/2000, in respect of TOBI Podhaler. That action was registered as [OSCURATO:PERSONA] T‑269/15. 14 By the first [OSCURATO:PERSONA] order, it was decided, first, to suspend operation of the decision at issue in so far as that decision granted a third party access to the reports at issue, pursuant to [OSCURATO:PERSONA] 1049/2001, and, second, to order the EMA not to disclose those reports. 15 By application lodged at the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of Justice on 23 October 2015, the EMA brought an appeal against that order. 16 In the proceedings before the [OSCURATO:PERSONA] of Justice, in its response lodged on 23 November 2015, [OSCURATO:PERSONA] contended that the [OSCURATO:PERSONA] of Justice should dismiss the appeal. The reports at issue were included in the annexes to that response. 17 On 24 November 2015, the response lodged by [OSCURATO:PERSONA] and the annexes thereto were served on the other parties to the appeal proceedings, including [OSCURATO:PERSONA], the intervener at first instance. 18 On 25 November 2015, [OSCURATO:PERSONA] submitted a request for confidential treatment in order that the reports at issue not be served on [OSCURATO:PERSONA]. However, because that request for confidential treatment was submitted out of time, those reports had already been served as they stood. 19 [OSCURATO:PERSONA], [OSCURATO:PERSONA] informed the [OSCURATO:PERSONA] of Justice that it had succeeded in concluding an agreement with [OSCURATO:PERSONA], under which the latter had undertaken to keep the reports at issue confidential and not to disclose them to third parties. [OSCURATO:PERSONA] would be authorised to use those documents only for the purposes of the case pending between it and the [OSCURATO:PERSONA], registered with the [OSCURATO:PERSONA] as [OSCURATO:PERSONA] T‑269/15. In addition, [OSCURATO:PERSONA] had agreed to make limited use of those documents; such use was in particular not to affect the proceedings in [OSCURATO:PERSONA] T‑235/15 which were pending before the [OSCURATO:PERSONA]. 20 Having asked the EMA, by letter of the Registrar of 3 December 2015, to clarify whether, given the circumstances, it considered that there was still a need to adjudicate on its appeal, the [OSCURATO:PERSONA]-[OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of Justice, by order of 17 March 2016, EMA v [OSCURATO:PERSONA] (C‑550/15 P(R), not published, ‘the order on the appeal’, EU:C:2016:196), held that there was no need to adjudicate on the EMA’s appeal, on the ground that the EMA no longer had an interest in bringing proceedings, since the appeal was no longer capable, if successful, of procuring an advantage for the EMA. 21 In particular, at paragraphs 38 to 41 of that order, the [OSCURATO:PERSONA]-[OSCURATO:PERSONA] of the [OSCURATO:PERSONA] held as follows: ‘38      … the fact that [OSCURATO:PERSONA] now has access to the reports at issue clearly deprives the interim measures obtained by [OSCURATO:PERSONA] 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 (see, in particular, order of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 27 February 2002, Reisebank v [OSCURATO:PERSONA] , C‑477/01 P(R), EU:C:2002:126, paragraphs 22 and 23 and the case-law cited). 40      Regardless of the assessments which could be carried out by the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] concerning the possibility of cancelling or modifying the order under appeal upon application by one of the parties to that effect pursuant to [OSCURATO:PERSONA] 159 of the Rules of Procedure of the [OSCURATO:PERSONA], 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 decision at issue, the sole effect thereof would be to enable the EMA to communicate to [OSCURATO:PERSONA] 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 [OSCURATO:PERSONA]. However, the fact that [OSCURATO:PERSONA] has in any event obtained access to those documents means that the EMA is deprived of any interest in the immediate implementation of the decision at issue.’ 22 In those circumstances, by document lodged at the [OSCURATO:PERSONA] on 31 March 2016, the EMA submitted an application based on [OSCURATO:PERSONA] 159 of the Rules of Procedure of the [OSCURATO:PERSONA], seeking cancellation of the first [OSCURATO:PERSONA] order following the change in circumstances that has arisen in the present case. 23 Having held, in paragraphs 29 to 35 of the order under appeal, in essence, that the order on the appeal had not called into question the assessments set out in the first [OSCURATO:PERSONA] order and that the relations between the EMA, [OSCURATO:PERSONA] and [OSCURATO:PERSONA] were in essence taken into account therein, the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA], at paragraphs 36 to 41 of the order under appeal, held as follows: ‘36      That being said, it is clear that the interim measures granted to [[OSCURATO:PERSONA]] in the first [OSCURATO:PERSONA] order have in fact become ineffective if the sole effect of the [decision at issue] is “to enable the EMA to communicate to [[OSCURATO:PERSONA]] the reports at issue which it already holds” and “if the fact that [[OSCURATO:PERSONA]] has in any event obtained access to those documents means that the EMA is deprived of any interest in the immediate implementation of the [decision at issue]”. In other words, if [[OSCURATO:PERSONA]] were content to use the reports at issue solely for the purposes of protecting its interests in the context of [OSCURATO:PERSONA] T‑269/15, and the EMA regarded the [decision at issue] as having become devoid of purpose since [[OSCURATO:PERSONA]] already had those reports, [[OSCURATO:PERSONA]] 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 [OSCURATO:PERSONA]-[OSCURATO:PERSONA] [of the [OSCURATO:PERSONA]] to find that there was no need to adjudicate on the EMA’s appeal would not continue if the first [OSCURATO:PERSONA] order were cancelled. 38      In response to the questions asked by the judge hearing the application for interim relief, first, [[OSCURATO:PERSONA]] stated that it was maintaining its request based on [OSCURATO:PERSONA] 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 [[OSCURATO:PERSONA]]. Second, according to the EMA, the fact that [[OSCURATO:PERSONA]] obtained access to the reports at issue has no influence on the [decision at issue], since the request for access was specifically not withdrawn. 39      It follows that, in the event that the first [OSCURATO:PERSONA] order were cancelled, with the result that [[OSCURATO:PERSONA]] would be deprived of the protective effect of the interim measures granted, the EMA would proceed to implement the [decision at issue] and grant [[OSCURATO:PERSONA]] access to the reports at issue pursuant to [OSCURATO:PERSONA] 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, [OSCURATO:PERSONA] v [OSCURATO:PERSONA] and EACEA , T‑439/08, not published, EU:T:2010:442, paragraph 116). Furthermore, [[OSCURATO:PERSONA]] would be in a position to use them for its pharmaceutical activities and, therefore, as a competitor of [[OSCURATO:PERSONA]]. 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 [OSCURATO:PERSONA] order, that it would place [[OSCURATO:PERSONA]] 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 [OSCURATO:PERSONA] order was subject, with the result that the condition relating to a change in circumstances, as referred to in [OSCURATO:PERSONA] 159 of the Rules of Procedure, is not satisfied.’ 24 On the basis of those considerations, the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] rejected the EMA’s request. Forms of order sought and procedure before the [OSCURATO:PERSONA] of Justice 25 By its appeal, the EMA asks the [OSCURATO:PERSONA] to set aside the order under appeal and cancel the first [OSCURATO:PERSONA] order, and order [OSCURATO:PERSONA] to pay all the costs of the proceedings, including the costs before the [OSCURATO:PERSONA]. 26 [OSCURATO:PERSONA] asks the [OSCURATO:PERSONA] to dismiss the appeal and the application for cancellation of the first [OSCURATO:PERSONA] order, and order the EMA to pay the costs of the proceedings, including the costs of the proceedings before the [OSCURATO:PERSONA]. 27 At the request of the [OSCURATO:PERSONA] of 24 August 2016, [OSCURATO:PERSONA] lodged a copy of the confidentiality agreement that it had concluded with [OSCURATO:PERSONA], referred to in paragraph 19 of the present order, at the [OSCURATO:PERSONA] on 25 August 2016. The appeal Arguments of the parties 28 The EMA puts forward, in essence, three grounds of appeal in support of its appeal. 29 By its first ground of appeal, the EMA claims that the order under appeal is at odds with the order on the appeal. 30 The second and third grounds of appeal, for their part, allege that the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] was in error in holding, at paragraph 37 of the order under appeal, that ‘the status quo which enabled the [OSCURATO:PERSONA]-[OSCURATO:PERSONA] [of the [OSCURATO:PERSONA]] to find that there was no need to adjudicate on the EMA’s appeal would not continue if the first [OSCURATO:PERSONA] order were cancelled’. 31 In the context of those latter two grounds of appeal, the EMA claims that the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] artificially restricted, within limits not present in the order on the appeal, his assessment of the change in circumstances in question. It is submitted that the conclusion set out in paragraphs 38 to 41 of the order on the appeal is not conditional on the existence of any ‘status quo’. 32 In any event, the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA], it is claimed, did not take into consideration the new circumstances and, in particular, the fact that [OSCURATO:PERSONA] had agreed to make limited use of the documents in question. 33 As regards the allegedly erga omnes effect of the decision at issue, the EMA has, furthermore, stated in its appeal that, ‘in practice, and in line with … settled case-law, … any future request for access to the Documents will result in a notification of such request being sent by the EMA to [[OSCURATO:PERSONA]] and [[OSCURATO:PERSONA]] will be given again the opportunity to challenge the new release decision in the same manner the [decision at issue] was challenged, including by way of seeking interim relief’. 34 [OSCURATO:PERSONA] contends, by contrast, that, as long as the decision at issue has not been withdrawn, the first [OSCURATO:PERSONA] order is not devoid of purpose, since that decision would have an influence on the future decisions to grant access to the reports at issue to third parties which the EMA might adopt in respect of requests pending before it. [OSCURATO:PERSONA] states that the fact that [OSCURATO:PERSONA] has obtained access to those reports in the proceedings that gave rise to the order on the appeal, without [OSCURATO:PERSONA] consenting thereto, is not such as to call into question the reasons set out in that regard in the first [OSCURATO:PERSONA] order. 35 In the first place, it is submitted that [OSCURATO:PERSONA] has indicated that it has a continuing interest in obtaining unrestricted access to the reports at issue without obligations of confidentiality, which can be granted only by way of a decision taken on the basis of [OSCURATO:PERSONA] 1049/2001 and, therefore by maintaining its request for access which gave rise to the decision at issue. 36 In the second place, it is submitted that the EMA considered that it could not withdraw the decision at issue in the absence of a withdrawal by [OSCURATO:PERSONA] of its request for access to the reports at issue. Furthermore, in the proceedings that gave rise to the order on the appeal, the EMA claimed that it still had an interest in bringing proceedings because of the erga omnes effect of decisions to grant access to documents under [OSCURATO:PERSONA] 1049/2001. Similarly, it is submitted that, without expressly repeating the argument in its appeal in the present proceedings, the EMA has not excluded the erga omnes effect of the decision at issue. 37 In this connection, [OSCURATO:PERSONA] states that the erga omnes effect of a decision adopted under [OSCURATO:PERSONA] 1049/2001 is confirmed by [OSCURATO:PERSONA] 8(3) of the Rules for the implementation of [OSCURATO:PERSONA] 1049/2001 on access to EMEA documents of 19 December 2006 (‘the rules on access’), which states as follows: ‘The [EMA] shall grant the application without consulting the third-party author where the document requested has already been disclosed either by its author or under [OSCURATO:PERSONA] … No 1049/2001 or similar provisions’. 38 The EMA’s statement to the effect that, in the event of future requests for access to the reports at issue, [OSCURATO:PERSONA] would be given again the opportunity to challenge the new release decision therefore contradicts both the line of argument put forward by the EMA in the proceedings that gave rise to order on the appeal and the rules on access. 39 In the third place, [OSCURATO:PERSONA] contends that it still has a definite interest in the first [OSCURATO:PERSONA] order being maintained and in the EMA’s application for cancellation thereof being rejected inasmuch as that order deprives the decision at issue of its erga omnes effect. Findings of the [OSCURATO:PERSONA] 40 In adjudicating on the second and third grounds of appeal, which it is appropriate to deal with first and together, it must be recalled that, in paragraph 36 of the order under appeal, the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] stated that if [OSCURATO:PERSONA] were content to use the reports at issue solely for the purposes of protecting its interests in the context of [OSCURATO:PERSONA] T‑269/15, and the EMA regarded the decision at issue as having become devoid of purpose since [OSCURATO:PERSONA] already had those reports, [OSCURATO:PERSONA] would no longer have need for the protection of interim measures. 41 However, at paragraph 37 of the order under appeal, the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] held that that was not the case given that the status quo, which enabled the [OSCURATO:PERSONA]-[OSCURATO:PERSONA] of the [OSCURATO:PERSONA] to find that there was no need to adjudicate on the EMA’s appeal, would not continue if the first [OSCURATO:PERSONA] order were cancelled. 42 In reaching that conclusion, the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] took into consideration, in paragraph 38 of the order under appeal, the responses that [OSCURATO:PERSONA] and the EMA gave to the questions, set out in paragraph 25 of that order, addressed to them by the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA]. 43 Thus, in that paragraph 38, the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] simply noted, first, that [OSCURATO:PERSONA] stated that it was maintaining its request based on [OSCURATO:PERSONA] 1049/2001 for 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 [OSCURATO:PERSONA], and, second, that according to the EMA, the fact that [OSCURATO:PERSONA] had access to the reports at issue has no influence on the decision at issue, since the request for access was not withdrawn. 44 However, it must be stated that both [OSCURATO:PERSONA] maintaining that request and the fact that the EMA has not withdrawn the decision at issue concern the substance of the action for annulment of that decision. In that context, those factors are to be considered in particular in the light of the EMA’s potential liability following a possible annulment of that decision at the end of the procedure dealing with the substance of the case in that action. 45 On the other hand, those factors do not prove that the interim measures in question continue to serve a purpose, given the change in circumstances that has arisen in the present case and that consists, in particular, in [OSCURATO:PERSONA] having obtained access to the reports at issue and the conclusion of the confidentiality agreement between [OSCURATO:PERSONA] and [OSCURATO:PERSONA]. 46 That is a fortiori true since it is clear from paragraph 3 of that confidentiality agreement that [OSCURATO:PERSONA] may use the reports at issue only for the purposes of [OSCURATO:PERSONA] T‑269/15 and ‘without affecting the proceedings currently conducted before the [OSCURATO:PERSONA] in [OSCURATO:PERSONA] T‑235/15’. It follows that [OSCURATO:PERSONA] is required to make limited use of those reports until such time as the [OSCURATO:PERSONA] has ruled on the action for annulment of the decision at issue that is the subject matter of the proceedings in [OSCURATO:PERSONA] T‑235/15. 47 Indeed, the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] ought to have taken those circumstances into consideration in adjudicating on the purpose served by the measure suspending operation of the decision at issue since that decision granted a third party, namely [OSCURATO:PERSONA], access to those reports. 48 Consequently, since the factors taken into consideration by the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] were not sufficient to exclude that the change in circumstances that arose subsequently to the first [OSCURATO:PERSONA] order might warrant its cancellation, the second and third grounds of appeal must be upheld and the order under appeal must be set aside, and it is not necessary to rule on the first ground of appeal. The application for cancellation of the first [OSCURATO:PERSONA] order 49 [OSCURATO:PERSONA] the first paragraph of [OSCURATO:PERSONA] 61 of the Statute of the [OSCURATO:PERSONA] of Justice of the [OSCURATO:PERSONA], the [OSCURATO:PERSONA] may, where the decision of the [OSCURATO:PERSONA] has been set aside, either itself give final judgment in the matter, where the state of the proceedings so permits, or refer the case back to the [OSCURATO:PERSONA] for judgment. That provision also applies to appeals brought under the second paragraph of [OSCURATO:PERSONA] 57 of the Statute of the [OSCURATO:PERSONA] (orders of the [OSCURATO:PERSONA]-[OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 7 March 2013, EDF v [OSCURATO:PERSONA] , C‑551/12 P(R), EU:C:2013:157, paragraphs 36 and 37, and 23 April 2015, [OSCURATO:PERSONA] v [OSCURATO:PERSONA] & Benefits , C‑35/15 P(R), EU:C:2015:275, paragraph 59). 50 Since the state of the proceedings so permits, it is appropriate to adjudicate on the EMA’s application for cancellation of the first [OSCURATO:PERSONA] order. 51 In this connection, it should be recalled that it was found, in that first order, that it was urgent to grant the interim measures applied for in order to prevent [OSCURATO:PERSONA] suffering serious and irreparable damage. According to paragraphs 93 to 101 of that order, that damage might occur if, first, [OSCURATO:PERSONA] had access to the reports at issue, and, second, if those reports were disclosed to other third parties. 52 However, since [OSCURATO:PERSONA] has the reports at issue in its possession, the interim measures in question are no longer capable of preventing the occurrence of harm resulting from possession thereof. Furthermore, as the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] stated in paragraph 36 of the order under appeal, [OSCURATO:PERSONA] would no longer have need for the protection of interim measures if [OSCURATO:PERSONA] were content to use those reports solely for the purposes of protecting its interests in the context of [OSCURATO:PERSONA] T‑269/15. 53 In that regard, as stated in paragraph 19 of the present order, it is clear from the confidentiality agreement concluded between [OSCURATO:PERSONA] and [OSCURATO:PERSONA] that [OSCURATO:PERSONA] is required to make limited use of the reports at issue, such use being limited to the protection of its interests in the context of [OSCURATO:PERSONA] T‑269/15 until such time as the [OSCURATO:PERSONA] has ruled on the substance of the action in [OSCURATO:PERSONA] T‑235/15. Against that background, and given the circumstances of the present case, that agreement suffices to protect the interests of [OSCURATO:PERSONA] against any detrimental use of the reports at issue, other than for the purposes of [OSCURATO:PERSONA] T‑269/15, by [OSCURATO:PERSONA]. 54 As regards the claimed erga omnes effect of the decision at issue, it should be pointed out that, even if it is true that the EMA has claimed, in the context of the present proceedings, that such an effect attaches to decisions adopted on the basis of [OSCURATO:PERSONA] 1049/2001 in order to maintain that there is still a need to adjudicate on its appeal, the fact remains that, in its appeal, it has expressly stated that, ‘in practice, and in line with … settled case-law, … any future request for access to the Documents will result in a notification of such request being sent by the EMA to [[OSCURATO:PERSONA]] and [[OSCURATO:PERSONA]] will be given again the opportunity to challenge the new release decision in the same manner the [decision at issue] was challenged, including by way of seeking interim relief’. 55 Indeed, even if decisions adopted on the basis of [OSCURATO:PERSONA] 1049/2001 enable access to documents to be granted to third parties — other than the initial applicants to whom those decisions apply — who wish to have access to them, that does not mean that any third party automatically has a right of access to those documents. In other words, the institution in question is still required to carry out a specific and individual examination of any request for access to documents, irrespective of whether those documents have already been disclosed and must, should the case arise, provide the reasons justifying a different decision for the purpose of protecting one of the interests referred to in [OSCURATO:PERSONA] 4 of that regulation. 56 Since the examination required for the purpose of processing a request for access to documents must be specific in nature, if the institution concerned decides to refuse access to a document which it has been asked to disclose, it must, in principle, explain how disclosure of that document could specifically and actually undermine the interest protected by the exception — among those provided for in [OSCURATO:PERSONA] 4 of [OSCURATO:PERSONA] 1049/2001 — upon which it is relying. Moreover, the risk of the interest being undermined must be reasonably foreseeable and must not be purely hypothetical (judgment of 17 October 2013, [OSCURATO:PERSONA] v [OSCURATO:PERSONA] , C‑280/11 P, EU:C:2013:671, paragraph 31 and the case-law cited). 57 Consequently, the fact that the reports at issue have already been disclosed in the present case cannot prevent the EMA from examining any other request for access concerning the same reports by subjecting that request to the procedure laid down in [OSCURATO:PERSONA] 1049/2001 and thereby enabling [OSCURATO:PERSONA] to oppose any disclosure under one of the grounds provided for in [OSCURATO:PERSONA] 4 of that regulation. 58 Moreover, it cannot be claimed that the rules on access prohibit the EMA from proceeding in that manner, since, in the present case, access to the reports at issue was provided without the consent of the author of those documents and outside of that regulation or of any similar provision. 59 Regardless of what the EMA claimed in the context of the proceedings that gave rise to the order on the appeal or to the order under appeal, the fact remains that, as noted in paragraph 54 of the present order, in its appeal, the EMA expressly stated before the [OSCURATO:PERSONA] that it intended to subject any request for access to the reports at issue to the procedure laid down in [OSCURATO:PERSONA] 1049/2001. 60 It follows that, even in the absence of the interim measures in question, first, [OSCURATO:PERSONA] may use the reports at issue only within the limits agreed in the confidentiality agreement concluded with [OSCURATO:PERSONA], and only until the end of the proceedings on the substance. Second, since the EMA has undertaken before the [OSCURATO:PERSONA] to subject any request for access to the reports at issue to the procedure laid down in [OSCURATO:PERSONA] 1049/2001, no erga omnes effect can be attached to the decision at issue. 61 In the light of those circumstances, the interim measures in question no longer serve their purpose and the first [OSCURATO:PERSONA] order must be cancelled. Costs 62 [OSCURATO:PERSONA] 184(2) of the Rules of Procedure of the [OSCURATO:PERSONA] of Justice, where the appeal is well founded and the [OSCURATO:PERSONA] itself gives final judgment in the case, the [OSCURATO:PERSONA] is to make a decision as to costs. [OSCURATO:PERSONA] 138(1) of those rules, which applies to the procedure on appeal by virtue of [OSCURATO:PERSONA] 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. 63 In the present case, since [OSCURATO:PERSONA] has been unsuccessful in its contentions and the EMA has applied for costs, [OSCURATO:PERSONA] must be ordered to pay the costs incurred in the appeal proceedings and at first instance. On those grounds, the [OSCURATO:PERSONA]-[OSCURATO:PERSONA] of the [OSCURATO:PERSONA] hereby orders: 1. The order of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 23 May 2016, [OSCURATO:PERSONA] v EMA (T‑235/15 R, not published, EU:T:2016:309), is set aside. 2. The order of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 1 September 2015, [OSCURATO:PERSONA] v EMA (T‑235/15 R, EU:T:2015:587), is cancelled. 3. [OSCURATO:PERSONA] GmbH is to pay the costs incurred in the appeal proceedings and in the proceedings at first instance. [Signatures] * Language of the case: English.
Sentenza Corte di giustizia UE n. 1049/2016 — Fons Iuris — Fons Iuris