12.12.2022

EN

Official Journal of the European Union

C 472/41

(Case T-574/22)

(2022/C 472/48)

Language of the case: English

Parties

Applicant: ViiV Healthcare BV (Amersfoort, Netherlands) (represented by: G. Castle, M. Doyle-Rossi, E. Handy, Solicitors, and D. Scannell, Barrister-at-Law)

Defendant: European Medicines Agency

Form of order sought

The applicant claims that the Court should:

—annul the decision communicated by the European Medicines Agency to the applicant on 7 July 2022 to suspend the applicant’s marketing authorisation application in respect of APRETUDE made under Article 8(3) of the Directive 2001/83/EC of the European Parliament and of the Council, (1) and

order the EMA to pay the applicant’s costs.

Pleas in law and main arguments

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

1.First plea in law, alleging that the contested Decision is premised upon a manifest error of assessment. The applicant holds a marketing authorisation for a separate medicinal product, VOCABRIA, which the European Commission granted to the applicant on 17 December 2020. The basis for the European Medicines Agency’s (hereafter the ‘EMA’) contested Decision is the EMA’s view that APRETUDE is the same medicinal product as VOCABRIA. The EMA therefore considers that a request for authorisation must be made to the Commission under Article 82(2) of Regulation (EC) No. 726/2004 of the European Parliament and of the Council, (2) before a marketing authorisation application may be made in respect of APRETUDE. The EMA committed a manifest error of assessment by concluding that APRETUDE is the same medicinal product as VOCABRIA. The differences between APRETUDE and VOCABRIA’s indications (and thus the two products’ safety and efficacy profiles), their strengths, and presentations mean they cannot be regarded in law as the same medicinal product. Accordingly, the contested Decision is premised upon a manifest error and must be annulled.

2.Second plea in law, alleging that the contested Decision is contrary to the principle of the protection of legitimate expectations. On 30 June 2021, the EMA stated to the applicant that it did not consider that APRETUDE and VOCABRIA are the same medicinal product. The EMA therefore advised the applicant that it would be unnecessary to make a request for authorisation from the Commission under Article 82(2) of Regulation (EC) No. 726/2004. In reliance on the EMA’s advice, the applicant submitted its marketing authorisation application for APRETUDE on 24 June 2022 without making any such request from the Commission. The applicant submits that by adopting the contested Decision the EMA has resiled from its precise and unconditional assurances as to the proper legal basis for the Applicant’s marketing authorisation application for APRETUDE. The applicant thus contends that the contested Decision infringes the principle of the protection of legitimate expectations and falls to be annulled.

(1) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67).

(2) 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).