# C_2016059EN.01004102.xml

| 15.2.2016 | EN | Official Journal of the European Union | C 59/41 |
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15.2.2016

EN

Official Journal of the European Union

C 59/41

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Action brought on 17 December 2015 — MSD Animal Health Innovation and Intervet international v EMA

(Case T-729/15)

(2016/C 059/48)

Language of the case: English

Parties

Parties

Applicants: MSD Animal Health Innovation GmbH (Schwabenheim, Germany) and Intervet international BV (Boxmeer, Netherlands) (represented by: J. Stratford, QC, C. Thomas, Barrister, P. Bogaert, lawyer, B. Kelly and H. Billson, Solicitors)

Applicants:

Defendant: European Medicines Agency (EMA)

Defendant:

Form of order sought

Form of order sought

The applicants claim that the Court should:

| — | annul the decision of EMA of 25 November 2015, communicated to the applicants the 3 December 2015, to grant a third party access to the information about a veterinary medicinal product, pursuant to Regulation (EC) No 1049/2001 (OJ 2001 L 145, p. 43), in so far as the decision concerns commercially confidential information the release of which will infringe the applicants' rights and in so far as the decision is prohibited by EU law; |
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annul the decision of EMA of 25 November 2015, communicated to the applicants the 3 December 2015, to grant a third party access to the information about a veterinary medicinal product, pursuant to Regulation (EC) No 1049/2001 (OJ 2001 L 145, p. 43), in so far as the decision concerns commercially confidential information the release of which will infringe the applicants' rights and in so far as the decision is prohibited by EU law;

| — | order the EMA to pay all costs in these proceedings. |
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order the EMA to pay all costs in these proceedings.

Pleas in law and main arguments

Pleas in law and main arguments

In support of the action, the applicants rely on five pleas in law.

| 1. | First plea in law, alleging that the documents at issue is protected by Article 4(2) and/or Article 4(3) of Regulation (EC) No 1049/2001 pursuant to a general presumption of confidentiality. |
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1.

First plea in law, alleging that the documents at issue is protected by Article 4(2) and/or Article 4(3) of Regulation (EC) No 1049/2001 pursuant to a general presumption of confidentiality.

| 2. | Second plea in law, alleging that the documents at issue in their entirety constitute commercially confidential information that is protected by Article 4(2) of said Regulation. |
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2.

Second plea in law, alleging that the documents at issue in their entirety constitute commercially confidential information that is protected by Article 4(2) of said Regulation.

| 3. | Third plea in law, alleging that the release of the documents would undermine the EMA's decision making process. |
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3.

Third plea in law, alleging that the release of the documents would undermine the EMA's decision making process.

| 4. | Fourth plea in law, alleging that the EMA failed to carry out a balancing exercise as required by law. |
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4.

Fourth plea in law, alleging that the EMA failed to carry out a balancing exercise as required by law.

| 5. | Fifth plea in law, alleging that the outcome of a proper balancing exercise, as required by law, would have been a decision not to release any part of the documents or at least a decision to accede to the redactions proposed by the applicants. |
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5.

Fifth plea in law, alleging that the outcome of a proper balancing exercise, as required by law, would have been a decision not to release any part of the documents or at least a decision to accede to the redactions proposed by the applicants.

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