Action brought on 18 December 2012 - Teva Pharma and Teva Pharmaceuticals Europe v EMA
(Case T-547/12)
Language of the case: English
Parties
Applicants: Teva Pharma BV (Utrecht, Netherlands); and Teva Pharmaceuticals Europe BV (Utrecht) (represented by: K. Bacon and D. Piccinin, Barristers, G. Morgan and C. Drew, Solicitors)
Defendant: European Medicines Agency
Form of order sought
The applicants claim that the Court should:
Annul the decision of the European Medicines Agency, contained in its letter of 26 November 2012, refusing to validate the applicants' application for a marketing authorisation for its generic version of abacavir / lamivudine; and
Order the European Medicines Agency 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 a fixed dose combination medicinal product, on the basis that the product was protected by a ten year period of exclusivity is contrary to Regulation (EC) No 726/2004
2 and Directive No 2001/83/EC properly interpreted. In particular, the applicants contend that the marketing authorisation holder for the product is not entitled to enjoy a ten year period of data exclusivity, as the product is a fixed dose combination combining two active substances which have been supplied and used within the EU as components of a number of different medicinal products for some years. The applicants therefore contend that the product falls within the same global marketing authorisation as the earlier marketing authorisations for its component parts within the meaning of the second sub-paragraph of Article 6(1) of Directive No 2001/83. Accordingly, the applicants state that it did not enjoy any further period of data exclusivity after the expiry of the data exclusivity relating to these authorisations.