ORDER OF THE PRESIDENT OF THE SECOND CHAMBER OF THE GENERAL COURT
28 January 2014 (*)
(Confidentiality – Challenge by the intervener)
In Case T‑67/13,
Novartis Europharm Ltd, established in Horsham (United Kingdom), represented by C. Schoonderbeek, lawyer,
applicant,
v
European Commission, represented by K. Mifsud-Bonnici and M. Šimerdová, acting as Agents,
defendant,
supported by
Hospira UK Ltd, established in Royal Leamington Spa (United Kingdom), represented by N. Stoate, H. Austin, Solicitors, and J. Stratford QC,
intervener,
APPLICATION for annulment of Commission Implementing Decision C(2012) 8605 (final) of 19 November 2012 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 for ‘Zoledronic acid Hospira – zoledronic acid’, a medicinal product for human use,
THE PRESIDENT OF THE SECOND CHAMBER OF THE GENERAL COURT
makes the following
Order
Procedure
1 By originating application lodged at the Court Registry on 1 February 2013, the applicant, Novartis Europharm Ltd, brought an action seeking annulment of Commission Decision C(2012) 8605 (final) of 19 November 2012 granting marketing authorisation for ‘Zoledronic acid Hospira – zoledronic acid’, a medicinal product for human use (‘the contested decision’). That decision was adopted under Article 3 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1).
2 By document lodged at the Court Registry on 17 May 2013, the intervener, Hospira UK Ltd, applied for leave to intervene in support of the form of order sought by the European Commission.
3 By document lodged at the Court Registry on 17 June 2013, the applicant submitted an application for confidential treatment, with regard to Hospira UK, in respect of Annexes A13 and A15 and the two letters attached to Annex A17 to the originating application.
4 By order of the President of the Eighth Chamber of the General Court of 12 July 2013, Hospira UK was granted leave to intervene in support of the form of order sought by the Commission. The decision on the merits of the application for confidential treatment was reserved.
5 A non-confidential version of the pleadings, prepared by the applicant, was sent to Hospira UK.
6 By document lodged at the Court Registry on 30 July 2013, Hospira UK claimed that the Court should, first, place no reliance on Annexes A13 and A15 or, second and in the alternative, order the applicant to provide a properly redacted version of Annexes A13 and A15 to Hospira, third, order the disclosure of the two letters attached to Annex A17 or, fourth and in the alternative, place no reliance on the two letters attached to Annex A17 or, fifth and in the alternative, order the applicant to provide a properly redacted version of them to Hospira.
The requests for confidential treatment
Subject-matter of the requests
7 The applicant submitted an application for confidential treatment concerning Annexes A13 and A15 and the two letters attached to Annex A17.
8 Annexes A13 and A15 form part of the correspondence between the applicant and the European Medicines Agency (EMA) during the authorisation procedure for Aclasta, a product which was used as a reference product in the procedure which led to the adoption of the contested decision.
9 Annex A13 is a letter from the applicant addressed to the EMA on 4 November 2003 requesting that zoledronic acid for non-oncology indications, in particular as a treatment for Paget’s disease, which would become Aclasta, be declared eligible for the centralised authorisation procedure.
10 Annex A15 is a letter from the EMA addressed to the applicant on 12 May 2004, following the latter’s submission of the application for authorisation of Aclasta, in which the EMA provides a list of various items of information which had to be provided before the authorisation procedure could begin.
11 Annex A17 is a letter from the applicant addressed to the Commission on 28 March 2012, designed to explain its position concerning the application for authorisation of another generic version of Aclasta, ‘Zoledronic acid Teva Pharma’. That letter is accompanied by a legal analysis prepared by the applicant and by two letters from the Commission addressed to the applicant’s lawyer on 8 August 2002 and 28 December 2004; the applicant requests confidentiality in respect of those two letters.
The merits of the requests for confidential treatment
Preliminary observations
12 The requests for confidential treatment have been submitted on the basis of Article 116(2) of the Rules of Procedure of the General Court, which provides that ‘[t]he intervener shall receive a copy of every document served on the parties’, but that ‘[t]he President may, however, on application by one of the parties, omit secret or confidential documents’.
13 That provision lays down the principle that interveners are to receive a copy of every pleading served on the parties and permits only by way of derogation that certain secret or confidential documents or information not be sent to them (order of 4 April 1990 in Case T‑30/89 Hilti v Commission, not published in the ECR, paragraph 10; order in Case T‑383/03 Hynix Semiconductor v Council [2005] ECR II‑621, paragraph 18; order of the President of the Eighth Chamber of the Court of 2 March 2010 in Case T‑336/07 Telefónica and Telefónica de España v Commission, not published in the ECR, paragraph 26; and order of the President of the Third Chamber of the Court of 4 July 2013 in Case T‑151/11 Telefónica de España and Telefónica Móviles España, not published in the ECR, paragraph 11).
14 First, the party who makes an application for confidentiality has the task of specifying the documents or information covered and of duly stating the reasons for which they are confidential (orders in Hynix Semiconductor v Council, cited in paragraph 13 above, paragraph 31; Telefónica and Telefónica de España v Commission, cited in paragraph 13 above, paragraph 27; and Telefónica de España and Telefónica Móviles España, cited in paragraph 13 above, paragraph 12).
15 The Practice Directions to Parties before the General Court (OJ 2012 L 68, p. 23) set out these requirements in their point 89, which provides that ‘[a]n application for confidential treatment must accurately identify the particulars or passages to be excluded and state very briefly the reasons for which each of those particulars or passages is regarded as secret or confidential’ and that ‘[f]ailure to provide such information may result in the application being rejected by the Court’. According to point 88 of those practice directions, ‘an application [for confidential treatment] must … be limited to what is strictly necessary and may not in any event cover the entirety of a procedural document; only exceptionally may it extend to the entirety of an annexed document’, because it is considered that ‘it should usually be possible to furnish a non-confidential version of a document in which passages, words or figures have been deleted without affecting the interests it is sought to protect’.
16 It should be recalled, in this regard, that the first subparagraph of Article 6(2) of the Instructions to the Registrar of the General Court adopted on 5 July 2007, as amended by the decision of the General Court of 24 January 2012 (OJ 2012 L 68, p. 20), provides that an application for confidential treatment must be presented in accordance with, inter alia, points 88 and 89 of the Practice Directions to Parties before the General Court.
17 Second, where a party makes an application under the second sentence of Article 116(2) of the Rules of Procedure of the General Court, the President is to give a decision solely on the documents and information the confidentiality of which is disputed (orders in Hynix Semiconductor v Council, cited in paragraph 13 above, paragraph 36; Telefónica and Telefónica de España v Commission, cited in paragraph 13 above, paragraph 30; and Telefónica de España and Telefónica Móviles España, cited in paragraph 13 above, paragraph 13).
18 The intervener’s opposition to the confidentiality sought must relate to specific matters which have been obscured in the procedural documents and must state the reasons for which confidentiality with regard to those matters should be refused. Consequently, an application for confidential treatment must be upheld in so far as it concerns matters which have not been disputed by the intervener, or which have not been disputed expressly and in detail (order in Telefónica and Telefónica de España v Commission, cited in paragraph 13 above, paragraph 31; order of the President of the Seventh Chamber of the Court of 14 October 2009 in Case T‑353/08 vwd Vereinigte Wirtschaftsdienste v Commission, not published in the ECR, paragraph 10; and order in Telefónica de España and Telefónica Móviles España, cited in paragraph 13 above, paragraph 14).
19 Third, in so far as the application presented under the second sentence of Article 116(2) of the Rules of Procedure is in dispute, it is for the President, in the first place, to examine whether each document and item of information, the confidentiality of which is in dispute and in relation to which a request for confidential treatment has been submitted, is secret or confidential in nature (orders in Telefónica and Telefónica de España v Commission, cited in paragraph 13 above, paragraph 32; vwd Vereinigte Wirtschaftsdienste v Commission, cited in paragraph 18 above, paragraph 15; and Telefónica de España and Telefónica Móviles España, cited in paragraph 13 above, paragraph 15).
20 The requirement to state reasons for the application for confidentiality to which the applicant is subject must be assessed in the light of the secret or confidential nature of each document and item of information covered. A distinction must be drawn between, on the one hand, information which is inherently secret, such as business secrets of a commercial, competition-related, financial or accounting nature, or confidential, such as purely internal information, and, on the other hand, documents or information which may be secret or confidential for a reason that the applicant must provide (orders in Telefónica and Telefónica de España v Commission, cited in paragraph 13 above, paragraph 33; vwd Vereinigte Wirtschaftsdienste v Commission, cited in paragraph 18 above, paragraph 16; and Telefónica de España and Telefónica Móviles España, cited in paragraph 13 above, paragraph 16).
21 Thus, the secret or confidential nature of the documents or information for which no statement of reasons is provided other than that consisting of the description of their content will be accepted only in so far as that information may be considered to be inherently secret or confidential (orders in Telefónica and Telefónica de España v Commission, cited in paragraph 13 above, paragraph 34; vwd Vereinigte Wirtschaftsdienste v Commission, cited in paragraph 18 above, paragraph 17; and Telefónica de España and Telefónica Móviles España, cited in paragraph 13 above, paragraph 17). Account will be taken of the succinct nature of the statement of reasons provided in support of an application for confidential treatment in the event that it is not sufficiently clear from an examination of the particulars covered by that application that those particulars are confidential in nature (see order in Telefónica and Telefónica de España v Commission, cited in paragraph 13 above, paragraph 59 and the case-law cited).
22 Fourth, where his examination leads him to conclude that some of the documents and information the confidentiality of which is disputed are secret or confidential, it is then for the President to assess and weigh up the competing interests for each document and item of information (orders in Hynix Semiconductor v Council, cited in paragraph 13 above, paragraph 42; Telefónica and Telefónica de España v Commission, cited in paragraph 13 above, paragraph 35; and Telefónica de España and Telefónica Móviles España, cited in paragraph 13 above, paragraph 18).
23 Where confidential treatment is requested in the interests of the applicant, the President is required, when carrying out such an assessment, to weigh in the balance, for each document or item of information, the applicant’s legitimate concern to prevent serious harm from being caused to its interests and the equally legitimate concern of the intervener that it should have the information necessary for exercising its procedural rights (orders in Hynix Semiconductor v Council, cited in paragraph 13 above, paragraph 44; Telefónica and Telefónica de España v Commission, cited in paragraph 13 above, paragraph 36; and Telefónica de España and Telefónica Móviles España, cited in paragraph 13 above, paragraph 19).
24 In any event, an applicant for confidential treatment must, in view of the adversarial and public nature of judicial proceedings, envisage the possibility that some of the secret or confidential documents or information which it has decided to place on the file may appear necessary for the exercise of the intervener’s procedural rights and, consequently, must be disclosed to the latter (orders in Hynix Semiconductor v Council, cited in paragraph 13 above, paragraph 46; Telefónica and Telefónica de España v Commission, cited in paragraph 13 above, paragraph 37; and Telefónica de España and Telefónica Móviles España, cited in paragraph 13 above, paragraph 20).
25 In the present case the requests for confidential treatment must be examined in the light of those principles.
The requests for confidentiality in respect of Annexes A13 and A15 and of the two letters attached to Annex A17
26 The intervener raises objections in respect of all the particulars for which the applicant requests confidential treatment. Those particulars must therefore be examined in their entirety, in accordance with the principles referred to in paragraphs 17 and 18 above.
– Arguments of the parties
27 First, as regards Annexes A13 and A15, the applicant claims, first of all, that it submitted confidential information to the EMA and to the Committee for Medicinal Products for Human Use (CHMP) in the course of the authorisation procedure for Aclasta in the expectation, given the obligation of confidentiality binding the members of those bodies, that that correspondence would not be disclosed to third parties.
28 That correspondence, it argues, thus contains detailed and sensitive information on the development of the product Aclasta and on the applicant’s strategies for the placing on the market of medicinal products for human use, in relation not only to Aclasta but also to future products and even to pending authorisation procedures. That information is therefore of a competitive nature and its disclosure would cause serious harm to the legitimate interests of the applicant.
29 Next, the applicant submits that there is no public or other interest in disclosing the information at issue because all relevant information relating to the centralised authorisation procedure for medicinal products is contained in the assessment report accessible on the EMA’s website.
30 Finally, the applicant contends that the originating application contains, in paragraphs 64 and 66, a description of the documents at issue and an explanation of their relevance to the present case.
31 Second, as regards the two letters attached to Annex A17, the applicant claims that the documents in question form part of the confidential correspondence between its lawyer, acting as the representative of a separate client in another case, and the Commission. The applicant’s lawyer is consequently under a legal obligation not to disclose that correspondence, or any other information pertaining to the representation of that other client, to third parties such as Hospira UK. In addition, a description of the two letters and of their relevance to the case is provided in the Novartis letter of 28 March 2012 (Annex A17), which forms part of the non-confidential documents.
32 The intervener objects, first, that it does not understand why the applicant relies on the documents for which confidentiality is sought if all the relevant information is published on the EMA’s website, and, second, that it is not in a position either to understand why the applicant relies on Annex A13 or to evaluate whether the conclusions drawn from one sentence in Annex A15 are justified.
33 Consequently, the intervener requests the Court not to place any reliance on Annexes A13 and A15 or, in the alternative, that the applicant be directed to provide a properly redacted version of those documents.
34 The intervener further notes that the principle of equality of arms is a well-established principle of European Union law, now enshrined in Article 47 of the Charter of Fundamental Rights, and that basic fairness dictates that the Court should not rely on matters set out in redacted documents on which the intervener has not had an opportunity to comment.
35 As regards the two letters attached to Annex A17, the intervener claims, first of all, that those letters have been extensively referred to in the pleadings and that its ability properly to fulfil its role as intervener is materially restricted by the non-disclosure of those letters. The intervener further expresses doubt as to whether those letters are properly confidential, since they contain statements of the Commission’s views on the legal position at a particular date.
36 Finally, the intervener contends that the applicant cannot claim confidentiality for the letters in question by arguing that they relate to another client in another case, even though they have, as a matter of course, already been disclosed to a third party, namely the applicant itself. Alternatively, the intervener submits that it is not open to the applicant to claim confidentiality in respect of letters which were sent by a third party to the Commission. Accordingly, if the Court is minded not to order disclosure of those letters, the intervener requests, in the alternative, that no reliance be placed on those letters, or, in the further alternative, that the applicant be ordered to provide a properly redacted version of those letters.
– Assessment of the President
37 In the first place, it is clear from an appraisal of Annexes A13 and A15 and of the two letters attached to Annex A17 that those documents are not so inherently secret or confidential as to warrant their being treated as confidential in their entirety.
38 As regards, first, Annexes A13 and A15, those documents cannot be regarded as confidential by reason of the fact that they form part of the correspondence between the applicant and the EMA in the course of the authorisation procedure for Aclasta (see, to that effect and by analogy, the order of the President of the First Chamber of the Court of 18 April 2013 in Case T‑191/10 Greenwood Houseware (Zhuhai) and Others v Council, not published in the ECR, paragraph 45). Furthermore, even if those documents had been accorded confidential treatment during the administrative procedure, they would not automatically be regarded as confidential in the proceedings before the Court (see, to that effect and by analogy, orders in Hynix Semiconductor v Council, cited in paragraph 13 above, paragraph 40; Telefónica and Telefónica de España v Commission, cited in paragraph 13 above, paragraph 72; and order of the President of the Eighth Chamber of the Court of 5 October 2012 in Case T‑258/10 France Télécom v Commission, not published in the ECR, paragraphs 41 and 42).
39 Second, as regards the two letters attached to Annex A17, it should be noted that the fact, relied on by the applicant, that those letters form part of the correspondence of the applicant’s lawyer in a separate case does not, as such, confer confidentiality on those letters. Although the Court has recognised that, when examining requests for confidentiality, account must be taken of the essential principle that correspondence between lawyers and clients should be protected (order in Hilti v Commission, cited in paragraph 13 above, paragraph 11), the two letters attached to Annex A17 were not exchanged between the applicant’s lawyer and her client in another case, but between the applicant’s lawyer and the Commission, which wrote the two letters in question.
40 In the second place, in accordance with the case-law cited in paragraphs 19 to 21 above, it is necessary to examine whether granting comprehensive confidential treatment to the documents at issue is justified in the light of the reasons provided by the applicant. In this regard, it is clear that the applicant requests that confidentiality be accorded to the documents in their entirety, without any appropriate supporting reasons being provided to justify the granting of such comprehensive confidential treatment, rather than providing a non-confidential version of those annexes in which data and information would be redacted without jeopardising the commercial interests of either the applicant (see, to that effect, orders in Case T‑336/04 SBS TV and SBS Danish Television v Commission [2007] ECR II‑491, paragraph 58, and in Telefónica and Telefónica de España v Commission, cited in paragraph 13 above, paragraph 71) or any potential third parties, as the applicant alleges in the present case.
41 As regards Annexes A13 and A15, the applicant merely claims that those documents contain detailed and sensitive information on the development of the product Aclasta and on the applicant’s commercial strategies, disclosure of which would cause serious harm to its interests, without specifying the particulars which it has in mind and why disclosure of those particulars would harm it. Similarly, as regards the two letters attached to Annex A17, the applicant merely states that those documents form part of the confidential correspondence between its lawyer and the Commission in relation to another case, with the result that the lawyer is bound by a legal obligation not to disclose that correspondence to third parties, without specifying the particulars at issue or explaining why disclosure of those particulars could cause harm to the applicant’s interests in the case in question.
42 Even though it cannot be discounted at this stage that the documents for which confidentiality is sought include information which may be regarded as secret or confidential, such confidentiality cannot be accorded to the documents at issue in their entirety on the basis of general and generic reasoning relating to their nature (see, to that effect, order in Telefónica and Telefónica de España v Commission, cited in paragraph 13 above, paragraph 73, and order of the President of the Third Chamber of the Court of 3 May 2011 in Case T‑384/09 SKW Stahl-Metallurgie Holding and SKW Stahl-Metallurgie v Commission, not published in the ECR, paragraphs 44 and 45).
43 Furthermore, the applicant’s argument that there is no interest in disclosing the information at issue because all relevant information on the centralised procedure for authorisation of medicinal products is contained in the assessment report accessible on the EMA’s website and because the originating application contains a description of the documents at issue and their relevance to the present case, is, first, ineffective because, at this stage of the procedure, the relevance of any such information cannot be assessed by the President. Second, where it is established that the intervener has a direct and present interest in the granting of the form of order sought by the Commission, the view must necessarily be taken that the intervener has every interest in submitting its observations on the questions forming the subject‑matter of the pleas put forward by the applicant (see, to that effect, orders in vwd Vereinigte Wirtschaftsdienste v Commission, cited in paragraph 18 above, paragraph 21; Telefónica and Telefónica de España v Commission, cited in paragraph 13 above, paragraph 74; and order of the President of the Seventh Chamber of the Court of 8 September 2010 in Case T‑421/08 Performing Right Society v Commission, not published in the ECR, paragraph 37).
44 In those circumstances, thirdly, it is necessary to rule on the application for confidential treatment of the documents at issue while taking account of the imprecise nature of the request relating to those documents and of the global and brief nature of the reasons given for it (see, to that effect, orders in Hynix Semiconductor v Council, cited in paragraph 13 above, paragraph 33, and in Greenwood Houseware (Zhuhai) and Others v Council, cited in paragraph 38 above, paragraph 46).
45 Where confidential treatment cannot be accorded to the documents at issue in their entirety, it is, none the less, necessary to examine whether certain particulars or passages of those documents are confidential or secret such that it would be appropriate to omit them in a redacted version. The Court may restrict confidential treatment to certain parts of documents, notwithstanding the fact that the application was directed at the document in its entirety (see, to that effect, order of the President of the First Chamber of the Court of 25 November 1998 in Case T‑258/97 Eridania and Others v Council, not published in the ECR, paragraphs 12 and 16, and order of the President of the Third Chamber (Extended Composition) of the Court of 13 January 2005 in Case T‑266/02 Deutsche Post v Commission, not published in the ECR, paragraph 85).
46 In this regard, it must be pointed out that it is settled case-law that, when the same information is reproduced a number of times in the pleadings and a party neglects to request that each of the passages in which it appears be treated confidentially, with the result that that information will in any event be disclosed to the interveners, the request relating to that information must, as a matter of course, be rejected, given that it is pointless (orders in Hynix Semiconductor v Council, cited in paragraph 13 above, paragraph 49, and in Telefónica and Telefónica de España v Commission, cited in paragraph 13 above, paragraph 39; see, to that effect, order of the President of the Second Chamber of the Court of 9 November 1994 in Case T‑9/93 Schöller Lebensmittel v Commission, not published in the ECR, paragraph 11).
47 It should also be recalled that, according to the case-law of the Court, information may lose its secret or confidential character where the general public or certain specialist circles have access to it (orders in Case T‑89/96 British Steel v Commission [1997] ECR II‑835, paragraph 26; Hynix Semiconductor v Council, cited in paragraph 13 above, paragraph 56; and Telefónica and Telefónica de España v Commission, cited in paragraph 13 above, paragraph 63).
48 In the first place, it is necessary to examine Annex A13, which consists of the letter sent by the applicant to the EMA on 4 November 2003 and the two attachments thereto. First, as regards the body of the letter itself, the following must be stated.
49 The particulars set out in the subject line and in the first paragraph of the letter cannot be considered confidential since they concern uncontested data in the case-file before the Court, referred to in particular in paragraph 60 et seq. of the originating application and in Annex A2, namely, first, information relating to the product at issue – being a product containing the same active substance as Zometa, zoledronic acid, for non-oncology indications and, in particular, for the treatment of Paget’s disease – and, second, the declaration of the applicant’s intention to submit a dossier for the evaluation of that product under Part B of the Annex to Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (OJ 1993 L 214, p. 1), through the centralised procedure.
50 Regarding the first sentence of the second paragraph of the letter, even though it certainly appears to express a choice which could reveal the applicant’s commercial strategy, the fact remains that its content is substantially identical to that found in the last sentence of the first numbered point of the third paragraph of Annex B1 to the defence, the content of which is also reproduced in paragraph 62 of the defence, confidentiality for which is not sought. As regards the second sentence of the second paragraph of that letter, it reproduces the first sentence of the third paragraph of the letter sent by the EMA to the applicant on 26 April 2001 (Annex B2 to the defence), confidentiality for which is also not sought. Confidentiality cannot therefore be accorded to those particulars.
51 The same also applies with regard to the third paragraph of the letter and the matters set out in the three bullet points of that paragraph, since they are almost identical to those set out in paragraph 64 of the originating application.
52 The fourth and fifth paragraphs of the letter concern the entry into force of the new pharmaceutical legislation, expected at the time, and the applicant’s preoccupations as to whether the product at issue would be eligible for the centralised authorisation procedure after the entry into force of that new legislation. Those particulars cannot be regarded as confidential for two reasons. First, the fact that the applicant expressed its preoccupations concerning the eligibility of Aclasta under the new legislation in the letter at issue is apparent from the first sentence of the third paragraph of the EMA’s reply to that letter (Annex A14 to the originating application), confidentiality for which is not sought.
53 Second, the applicant’s speculations as to the reasons for Aclasta’s eligibility for the centralised authorisation under the new legislation are obsolete in so far as Aclasta was, ultimately, granted authorisation under the old legislation. It is, however, settled case-law that confidential treatment can be granted only exceptionally to data relating to facts going back five years or more if it is shown that, notwithstanding their historical nature, they still constitute, in the case in hand, essential elements of the commercial position of the undertaking concerned (see, to that effect, order of the President of the First Chamber of the Court of 5 August 2003 in Case T‑168/01 Glaxo Wellcome v Commission, not published in the ECR, paragraph 39; order of the President of the Fifth Chamber of the Court in Case T‑271/03 Deutsche Telekom v Commission [2006] ECR II‑1747, paragraph 45; and Telefónica and Telefónica de España v Commission, cited in paragraph 13 above, paragraphs 68 to 70). Accordingly, given the absence of any specific reasons from the applicant showing that disclosure of the passages at issue to the intervener, notwithstanding their historical nature, would be liable to harm the applicant’s commercial interests, confidential treatment cannot be accorded to those passages (see, to that effect, order in Telefónica and Telefónica de España v Commission, cited in paragraph 13 above, paragraph 70, and order of the President of the Fifth Chamber of the Court of 12 July 2011 in Case T‑198/09 UOP v Commission, not published in the ECR, paragraph 37).
54 Second, as regards Attachment 1 to Annex A13, it must be noted that part of that document is illegible and that the legible parts do not contain any information which is secret or confidential or which the applicant has shown to be confidential in this case.
55 Third, Attachment 2 to Annex A13 cannot be regarded as being confidential, since its content, in this instance the justifications for zoledronic acid’s eligibility, as a treatment for Paget’s disease, for evaluation with a view to authorisation under the centralised procedure, is either identical, at least in substance, to that found in the case-file – without there being anything to suggest that the particulars which may not appear in the case-file could be considered confidential – or refers to information which is public or, at the very least, accessible to specialised circles: the subject line and the first paragraph state that the document contains the justifications and arguments in favour of zoledronic acid’s eligibility as a treatment for Paget’s disease; the contents of the second paragraph are to be found in paragraph 63 of the originating application and in paragraph 18 of the reply; the information contained in the first five sentences of the third paragraph, relating to the advantages of intravenous treatment in comparison with oral therapy, is to be found in paragraphs 18 and 26 and in footnote 2 of the reply; the last two sentences of the third paragraph dwell on the advantages of intravenous treatment by highlighting certain negative effects found in oral therapy; the fourth paragraph states that zoledronic acid could be the only therapeutic option for patients who are unresponsive to other therapies, citing two studies on that subject published in scientific publications; finally, in the fifth and last paragraph, Novartis reiterates its belief that zoledronic acid offers a truly innovative solution compared with current treatments and that it could be the only therapeutic option for patients suffering from Paget’s disease who are resistant to other treatments.
56 It follows from the foregoing, without it being necessary to weigh the applicant’s interests against those of the intervener, that the request for confidential treatment relating to Annex A13 must be rejected.
57 In the second place, it is appropriate to examine Annex A15, which consists of a letter of 12 May 2004 sent by the EMA to the applicant following the latter’s submission of the application for authorisation of Aclasta, in which the EMA sets out a list of various items of information to be provided before the authorisation procedure could begin.
58 That letter clearly does not contain any particulars which could be regarded as secret or confidential in the absence of more detailed explanations from the applicant. While the EMA’s request for information does indeed form part of the authorisation procedure for Aclasta, it is not apparent how it might be liable to disclose secret or confidential information relating to that medicinal product’s development or to the applicant’s commercial strategies.
59 It follows that the request for confidentiality in respect of Annex A15 must be rejected, without it being necessary to weigh the applicant’s interests against those of the intervener.
60 In the third place, it is necessary to examine the two letters attached to Annex A17, sent by the Commission to the applicant’s lawyer and dated 8 August 2002 and 28 December 2004 respectively, in which the Commission sets out its position as regards the interpretation of the judgments of the Court of Justice in Case C‑368/96 Generics (UK) and Others [1998] ECR I‑7967 and in Case C‑106/01 Novartis Pharmaceuticals [2004] ECR I‑4403. The applicant claims in its application for confidential treatment that those letters were sent to its lawyer in her capacity as the representative of a separate client in another case.
61 In this regard, it should be borne in mind that it is only once an examination has been carried out to determine the confidentiality or otherwise of each document in respect of which an application for confidential treatment, duly supported by reasons, has been submitted and, as the case may be, once the interests of the third party and of the interveners have been weighed in the balance, that the President can rule on the merits of the application (order of the President of the Fifth Chamber (Extended Composition) of the Court in Case T‑102/96 Gencor v Commission [1997] ECR II‑879, paragraph 18).
62 Accordingly, it is necessary to verify whether or not the documents in respect of which confidential treatment has been sought contain confidential information relating to natural or legal persons other than the parties to the dispute. Third parties are, in principle, entitled to the protection of that information, except where they enter into commercial relationships with the interveners or where the information in question either is public, in the sense that any interested party could be aware of it, or concerns the interveners, in which case they are aware of it (order of 10 February 1995 in Case T‑154/94 CSF and CSME v Commission, not published in the ECR, paragraph 33).
63 It should be pointed out, however, that it is in no way apparent from the documents themselves that the two letters in question were sent in the context of another case involving a separate client of the lawyer, since no mention is made of any other client or of any other ongoing case therein. The Commission, in those letters, confines itself to developing legal arguments which, in themselves, cannot be regarded as secret or confidential (see, to that effect, order in SKW Stahl-Metallurgie Holding and SKW Stahl-Metallurgie v Commission, cited in paragraph 42 above, paragraph 36). Furthermore, the Commission reproduces its interpretation of those cases of the Court of Justice at a number of points in its written pleadings, namely in paragraphs 32, 49 to 52, 68 to 70 and 82 of the defence, and, in particular, in paragraph 10 of the rejoinder, where the Commission even summarises the essential import of the two letters at issue.
64 In those circumstances, and in the absence of any explanation from the applicant to demonstrate how disclosure of those purely legal arguments could harm the interests of a third party, the request for confidentiality in respect of those letters must be rejected, without it being necessary to weigh the applicant’s interests against those of the intervener.
65 It follows from all of the foregoing that the applicant’s requests for confidential treatment must be rejected.
On those grounds,
THE PRESIDENT OF THE SECOND CHAMBER OF THE GENERAL COURT
hereby orders:
1. The requests for confidential treatment are rejected.
2. The Registrar shall ensure that a complete version of the procedural documents is served on the intervener, Hospira UK Ltd.
3. A period shall be set for submission by the intervener, Hospira UK Ltd, of a statement in intervention.
4. The costs are reserved.
Luxembourg, 28 January 2014.
E. Coulon | | M.E. Martins Ribeiro |