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

ORDER OF THE PRESIDENT OF THE FIFTH CHAMBER OF THE GENERAL COURT

26 March 2010 (*)

(Confidentiality)

In Case T-52/09,

Nycomed Danmark ApS, established in Roskilde (Denmark), represented by C. Schoonderbeek and M.H. Speyart van Woerden, lawyers,

applicant,

v

European Medicines Agency (EMEA), represented by V. Salvatore and N. Rampal Olmedo, acting as Agents,

defendant,

supported by

French Republic, represented by G. de Bergues, A. Adam and R. Loosli-Surrans, acting as Agents,

Portuguese Republic, represented by L. Inez Fernandes and A.P. Antunes, acting as Agents,

Kingdom of Belgium, represented by T. Materne and C. Pochet, acting as Agents,

United Kingdom of Great Britain and Northern Ireland, represented by S. Ossowski, acting as Agent, and J.L. Stratford, Barrister,

European Commission, represented by P. Oliver and M. Šimerdová, acting as Agents,

interveners,

APPLICATION for annulment of the EMEA-™s decision of 28 November 2008 rejecting the application by the applicant for a product-specific waiver in respect of the ultrasound echocardiographic imaging agent Imagify which it developed,

THE PRESIDENT OF THE FIFTH CHAMBER OF THE GENERAL COURT

makes the following

Order

1 By application lodged at the Registry of the Court on 11 February 2009, the applicant, Nycomed Danmark ApS, sought annulment of the EMEA-™s decision of 28 November 2008 rejecting the application for a waiver under Article 11(1)(b) and Article 13(1) of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ 2006 L 378, p. 1), submitted by the applicant on 3 March 2008, in respect of the ultrasound echocardiographic imaging agent Imagify which it developed.

The applications to intervene

2 By document lodged at the Registry of the Court on 13 May 2009, the Portuguese Republic sought leave to intervene in the present case in support of the form of order sought by the EMEA.

3 By documents lodged at the Registry of the Court on 15 May 2009, the Kingdom of Belgium and the United Kingdom of Great Britain and Northern Ireland sought leave to intervene in the present case in support of the form of order sought by the EMEA.

4 By documents lodged at the Registry of the Court on 19 and 20 May 2009 respectively, the French Republic and the Commission of the European Communities sought leave to intervene in the present case in support of the form of order sought by the EMEA.

5 The applications to intervene were served on the parties in accordance with Article 116(1) of the Rules of Procedure of the Court.

6 By order of 9 July 2009, the President of the Fifth Chamber of the Court granted the Portuguese Republic leave to intervene in support of the form of order sought by the EMEA.

7 By order of 2 September 2009, the President of the Fifth Chamber of the Court granted the Kingdom of Belgium, the United Kingdom of Great Britain and Northern Ireland, the French Republic and the Commission leave to intervene in support of the form of order sought by the EMEA.

The applications for confidential treatment

8 By separate letters, lodged at the Registry of the Court on 22 June and 22 July 2009, the applicant applied for confidential treatment vis-à-vis all the interveners, in particular, of information concerning, first, the active substance used in Imagify and, second, the exact wording of the therapeutic indication in respect of which it intends to apply for marketing authorisation for Imagify, contained in the originating application, the defence and the reply and, more specifically, in the following parts of those pleadings:

- application: cover page and points 2 to 5, 8, 58, 59, 61, 67, 78 and 79, 88, 91, 93, 112, 123, 124 and 127;

- defence: points 1, 14, 17 and 18, 24 and 25, 38, 49, 59 and 61;

- reply: points 9, 121 and 134.

9 In support of its applications for confidential treatment summarised above, the applicant claims that both the name of the active substance used in Imagify and the therapeutic indication in respect of which it intends to apply for marketing authorisation for Imagify constitute business secrets.

10 By letter lodged at the Registry of the Court on 25 September 2009, the United Kingdom objected to the abovementioned applications for confidential treatment.

11 It submits, essentially, that neither the name of the active substance used in Imagify nor the exact wording of the intended indication of the product is confidential in nature. The active substance used in Imagify can be easily identified using information which is freely available and easily accessible through, for example, a simple internet search.

12 Regarding the exact wording of the intended indication, the United Kingdom observes that the therapeutic indication which will be the subject of the application for marketing authorisation for Imagify which the applicant intends to submit is already stated in paragraph 16 of the order of the President of 24 April 2009 in Case T-52/09 R Nycomed Danmark v EMEA, not published in the ECR.

13 The United Kingdom submits in the alternative that, even if the therapeutic indication referred to in the order of 24 April 2009 in Nycomed Danmark v EMEA does not correspond exactly to the wording of the indication used in the obscured parts of the documents covered by the applicant-™s application for confidential treatment, it must have access to the exact wording of the indication in question, in order to be able to defend its rights as intervener.

14 It should be noted as a preliminary point that an application for confidential treatment must be upheld in so far as it concerns items which have not been disputed by an intervener, or have not been disputed expressly and precisely (see order of the President of the Seventh Chamber of 14 October 2009 in Case T-353/08 vwd Vereinigthe Wirtschaftsdienste v Commission, not published in the ECR, paragraph 10 and case-law cited).

15 In the present case, given that the applicant, pursuant to Article 116(2) of the Rules of Procedure, requested that certain confidential items in the file be omitted from the copies of the documents to be provided to the interveners and produced, for that purpose, a non-confidential version of the pleadings or documents in question, the Court, in the orders referred to in paragraphs 6 and 7 above, ordered that a non-confidential version of each document served on the parties be provided to the interveners.

16 Apart from the applications for confidential treatment summarised in paragraph 8 above and contested by the United Kingdom, none of the applications for confidential treatment made by the applicant has been contested by any of the interveners.

17 Accordingly, in the present order, it is necessary to give a decision solely on the applications for confidential treatment summarised in paragraph 8 above.

18 In that regard, in so far as an application made pursuant to the second sentence of Article 116(2) of the Rules of Procedure is contested, it is for the President to examine whether each of the documents and pieces of information the confidentiality of which is disputed and in respect of which confidential treatment has been requested is secret or confidential in nature (order in vwd Vereinigthe Wirtschaftsdienste v Commission, paragraph 15 and case-law cited).

19 It should also be borne in mind that, under Article 18(3) of the Instructions to the Registrar of the Court of 5 July 2007 (OJ 2007 L 232, p. 1), the Registrar is to ensure that the case-law of the Court is made public. Under Article 18(4), however, where a party so requests, certain information may be omitted from the publications relating to a case if there is a legitimate interest in keeping that information confidential.

20 In the present case, since the applicant did not make an application to have confidential information omitted, within the meaning of Article 18(4) of the Instructions to the Registrar, the order of the President of 24 April 2009 in Nycomed Danmark v EMEA was published on the website of the Court, in accordance with standard practice, and is therefore available to the public.

21 A reading of that order reveals, first, that the active substance used in Imagify is perflubutane and, secondly, that the therapeutic indication in respect of which the applicant intends to apply for marketing authorisation for Imagify is the following: -˜[d]iagnosing coronary artery disease in patients with chest pain being evaluated for inducible ischemia-™ (see order of the President of 24 April 2009 in Nycomed Danmark v EMEA, paragraphs 27 and 16 respectively).

22 Moreover, a reading of the confidential versions of the application, defence and reply and a comparison of those documents with the non-confidential versions produced by the applicant show that the obscured parts of the various points of the non-confidential versions, referred to in paragraph 8 above, relate precisely to the two pieces of information referred to in the preceding paragraph.

23 Since that information was made public in the order of the President of 24 April 2009 in Nycomed Danmark v EMEA, without the applicant-™s having expressed any opposition, the conclusion must be that it is not confidential in nature. It follows that the applications for confidential treatment summarised in paragraph 8 above must be dismissed.

24 Lastly, as correctly observed by the United Kingdom, the non-confidential versions of the application and reply, produced by the applicant for the purposes of providing them to the interveners, also contain obscured parts in points 46 and 57 of the application and point 10 of the reply, even though those points are not formally covered by the various applications for confidential treatment made by the applicant. All those obscured parts relate to references to the intended therapeutic indication of Imagify, which, as just noted, is not confidential in nature.

25 Assuming that the mere fact of obscuring parts of the aforementioned points of the non-confidential versions of the application and the reply can be construed as constituting an application from the applicant for confidential treatment extending to those points of the pleadings in question, that application must also be dismissed as unfounded.

On those grounds,

THE PRESIDENT OF THE FIFTH CHAMBER OF THE GENERAL COURT

hereby orders:

1. The applicant-™s applications for confidential treatment, vis-à-vis the interveners, of the cover page and points 2 to 5, 8, 46, 57 to 59, 61, 67, 78 and 79, 88, 91, 93, 112, 123, 124 and 127 of the application, points 1, 14, 17 and 18, 24 and 25, 38, 49, 59 and 61 of the defence and points 9, 10, 121 and 134 of the reply are dismissed.

2. Costs are reserved.

Luxembourg, 26 March 2010.

* Language of the case: English.

The source of this judgment is the Europa web site. The information on this site is subject to a Disclaimer and a Copyright notice and rules related to Personal data protection. This electronic version is not authentic and is subject to amendment.