Action brought on 20 January 2017 – Amicus Therapeutics UK and Amicus Therapeutics v EMA

(Case T-33/17)

Language of the case: English

Parties

Applicants: Amicus Therapeutics UK Ltd (Gerrards Cross, United Kingdom) and Amicus Therapeutics, Inc. (Cranbury, New Jersey, United States) (represented by: L. Tsang, J. Mulryne, Solicitors, and F. Campbell, Barrister)

Defendant: European Medicines Agency (EMA)

Form of order sought

The applicants claim that the Court should:

annul the decision, communicated by the defendant to the applicants on 14 December 2016, to release Clinical Study Report AT1001-011 under Regulation 1049/2001/EC;

in the alternative, remit the decision to the defendant in order to reconsider it, following an opportunity for the applicants to make specific submissions on particular parts of the clinical study report that should be redacted prior to release; and

order the defendant to pay the applicants’ legal and other costs and expenses in relation to this matter.

Pleas in law and main arguments

In support of the action, the applicant relies on two pleas in law.

First plea in law, alleging that the clinical study report in question attracts a general presumption of confidentiality for the purposes of Article 4(2) of Regulation 1049/2001, in light of: (i) the scheme and terms of the relevant EU sectoral legislation; (ii) the obligation on EU institutions to give effect to obligations under Article 39(3) of the Trade-Related Aspects of Intellectual Property Rights Agreement; and (iii) the importance to be attached to the applicants’ fundamental rights to privacy and to property.

Second plea in law, alleging, in the alternative, that the only legally permissible outcome of a proper balancing exercise, under Article 4(2) of Regulation 1049/2001, would have been a decision not to release the clinical study report in question, in light of: (i) the compelling weight of the applicants’ private interest in avoiding disclosure, given the destructive effect such disclosure would have upon fundamental property and business rights; and (ii) the merely vague and generic public interest in disclosure, there being no sufficiently pressing public need for disclosure.

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