Action brought on 28 March 2012 - Teva Pharma and Teva Pharmaceuticals Europe v EMA

(Case T-140/12)

Language of the case: English

Parties

Applicants: Teva Pharma BV (Utrecht, Netherlands) and Teva Pharmaceuticals Europe BV (Utrecht, Netherlands) (represented by: D. Anderson, QC (Queen's Counsel), K. Bacon, Barrister, G. Morgan and C. Drew, Solicitors)

Defendant: European Medicines Agency

Form of order sought

Annul the decision of the European Medicines Agency, contained in its letter of 24 January 2012, refusing to validate the applicants' application for a marketing authorisation;

Order the Commission to pay the applicants' costs.

Pleas in law and main arguments

In support of the action, the applicants rely on one plea in law, alleging that the refusal to validate their application for the authorisation of a generic version of an orphan medicinal product is contrary to Article 8 of Regulation (EC) No 141/2000 properly interpreted. In particular, it is contrary to the wording and effect of Article 8, as well as the policy underlying the said regulation and its travaux préparatoires, to exclude a generic version of an orphan medicinal product from the market for more than the ten year period stipulated in Article 8(1) of the said regulation. The applicants further allege that Article 8(3) permits an authorisation for a similar product to be granted during that 10 year period, by way of derogation from Article 8(1), in certain specified circumstances. Such authorisation should not, however, have the effect of extending the 10 year market exclusivity for the first orphan product.

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¹ - Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1)