31.5.2021

EN

Official Journal of the European Union

C 206/28

(Case T-138/21)

(2021/C 206/36)

Language of the case: French

Parties

Applicant: Virbac (Carros, France) (represented by: M. Thill-Tayara, S. Pelé and L. Bary, lawyers)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

—annul European Commission Implementing Decision C(2020) 7930 final of 10 November 2020 granting marketing authorisation for ‘Librela — bedinvetmab’, a veterinary medicinal product, published in the Official Journal of the European Union on 30 December 2020 (OJ 2020 C 453, p. 1), in so far as it was adopted in breach of Article 37 of 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;

—annul European Commission Implementing Decision C(2020) 7930 final of 10 November 2020 granting marketing authorisation for ‘Librela — bedinvetmab’, a veterinary medicinal product, published in the Official Journal of the European Union on 30 December 2020 (OJ 2020 C 453, p. 1), in so far as it was adopted in breach of Article 31 of 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;

—annul European Commission Implementing Decision C(2020) 7930 final of 10 November 2020 granting marketing authorisation for ‘Librela — bedinvetmab’, a veterinary medicinal product, published in the Official Journal of the European Union on 30 December 2020 (OJ 2020 C 453, p. 1), in so far as it results from a breach of Article 102 TFEU and thereby infringes the principles of effectiveness, legality and sound administration, which are binding on the European Commission;

—order the Commission to pay all the costs.

Pleas in law and main arguments

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

1.First plea in law, alleging breach of Article 37 of 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), in so far as the contested decision authorises the placing of Librela® on the European market, whereas the safety and effectiveness of that product have not been adequately and sufficiently demonstrated in the light of that provision.

2.Second plea in law, alleging breach of Article 31 of Regulation (EC) No 726/2004, in so far as the contested decision infringes the rules on the drafting of the summary of product characteristics, which should have led the European Commission to find that the special warning included for Librela® regarding the effect of anti-drug antibodies is too generic and imprecise.

3.Third plea in law, alleging infringement of the effectiveness of Article 102 TFEU and of the principles of legality and sound administration, in so far as the contested decision gives rise to an abuse of a dominant position by the Zoetis group in relation to the abandonment of the development of the product competing with Librela® and licensed to the applicant.