# C_2015221EN.01002601.xml

| 6.7.2015 | EN | Official Journal of the European Union | C 221/26 |
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6.7.2015

EN

Official Journal of the European Union

C 221/26

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Action brought on 15 May 2015 — Pari Pharma/EMA

(Case T-235/15)

(2015/C 221/35)

Language of the case: English

Parties

Parties

Applicant: Pari Pharma GmbH (Starnberg, Germany) (represented by: M. Epping, and W. Rehmann, lawyers)

Applicant:

Defendant: European Medicines Agency

Defendant:

Form of order sought

Form of order sought

The applicant claims that the Court should:

| — | annul the decision ASK-11351 (Vantobra) of the European Medicines Agency (‘EMA’) of 24 April 2015, insofar as it grants a third party access to the CHMP Assessment Report for VANTOBRA on similarity with Cayston and TOBI Podhaler (EMA/CHMP/702525/2014), and the CHMP Assessment Report on clinical superiority to TOBI Podhaler (EMA/CHMP/778270/2014), pursuant to Regulation (EC) No 1049/2001 (1); |
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annul the decision ASK-11351 (Vantobra) of the European Medicines Agency (‘EMA’) of 24 April 2015, insofar as it grants a third party access to the CHMP Assessment Report for VANTOBRA on similarity with Cayston and TOBI Podhaler (EMA/CHMP/702525/2014), and the CHMP Assessment Report on clinical superiority to TOBI Podhaler (EMA/CHMP/778270/2014), pursuant to Regulation (EC) No 1049/2001 (1);

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| — | order the EMA not to disclose the documents referred to in the first head of claim; |
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order the EMA not to disclose the documents referred to in the first head of claim;

| — | in the alternative, annul the decision ASK-11351 (Vantobra) of the EMA of 24 April 2015, insofar as it grants a third party access to (i) the CHMP Assessment Report on clinical superiority to TOBI Podhaler, (EMA/CHMP/778270/2014), without additional redactions on pages 9 (Superior Respiratory Tolerability of Vantobra over Tobi Podhaler), pages 11 to 12 and 14 (Extrapolation of tolerability from TOBI to Vantobra), pages 17 to 19 (Claimant’s position Q.1 and assessment of the response) and pages 19 to 23 (Claimant’s position Q.2, Assessment of the response, 3. Conclusion and Recommendation), as set out in Exhibit A 1, and (ii) the CHMP Assessment Report for VANTOBRA on similarity with Cayston and TOBI Podhaler, (EMA/CHMP/702525/2014), without additional redactions on pages 9 to 10, Section 2.3 (Therapeutic indication, 1) Data from field survey) and pages 11 to 12, Section 2.3 (Therapeutic indication, 2) Interview of physicians in CF centers), as set out in Exhibit A 2, and order the EMA not to disclose the aforementioned documents without the redactions arising from Exhibit A 1 and Exhibit A2; and |
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in the alternative, annul the decision ASK-11351 (Vantobra) of the EMA of 24 April 2015, insofar as it grants a third party access to (i) the CHMP Assessment Report on clinical superiority to TOBI Podhaler, (EMA/CHMP/778270/2014), without additional redactions on pages 9 (Superior Respiratory Tolerability of Vantobra over Tobi Podhaler), pages 11 to 12 and 14 (Extrapolation of tolerability from TOBI to Vantobra), pages 17 to 19 (Claimant’s position Q.1 and assessment of the response) and pages 19 to 23 (Claimant’s position Q.2, Assessment of the response, 3. Conclusion and Recommendation), as set out in Exhibit A 1, and (ii) the CHMP Assessment Report for VANTOBRA on similarity with Cayston and TOBI Podhaler, (EMA/CHMP/702525/2014), without additional redactions on pages 9 to 10, Section 2.3 (Therapeutic indication, 1) Data from field survey) and pages 11 to 12, Section 2.3 (Therapeutic indication, 2) Interview of physicians in CF centers), as set out in Exhibit A 2, and order the EMA not to disclose the aforementioned documents without the redactions arising from Exhibit A 1 and Exhibit A2; and

| — | order the EMA to pay the costs of the proceedings. |
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order the EMA to pay the costs of the proceedings.

Pleas in law and main arguments

Pleas in law and main arguments

In support of the action, the applicant relies on one plea in law.

The applicant submits that the decision of the EMA violates Regulation (EC) No 1049/2001, and that it thus violates the applicant’s fundamental rights and freedoms as regards private life and confidentiality under article 7 of the Charter of Fundamental Rights of the European Union (the ‘Charter’), article 8 of the Convention for the protection of Human Rights and Fundamental Freedoms of 4 November 1950 and article 339 TFEU, its freedom to conduct a business under article 16 of the Charter and its property right with regard to intellectual property, article 17(2) of the Charter. The applicant submits that (i) disclosure would allow any competitor to simply use the data and information provided by the applicant for the purpose of obtaining marketing authorisation for its own tobramycin product without any additional investment, thereby undermining the applicant’s commercial interest, and (ii) there is no overriding public interest in the disclosure of these documents.

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(1)  Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43).

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