Judgment_paragraph 8 · Teva Pharma BV and Teva Pharmaceuticals Europe BV v European Medicines Agency (EMA) (T-140/12)

8Article 8 of Regulation No 141/2000 provides that orphan medicinal products for which a marketing authorisation has been granted are to benefit from market exclusivity:1. Where a marketing authorisation in respect of an orphan medicinal product is granted pursuant to Regulation (EEC) No 2309/93 or where all the Member States have granted marketing authorisations in accordance with the procedures for mutual recognition laid down in Articles 7 and 7a of Directive 65/65/EEC or Article 9(4) of Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, and without prejudice to intellectual property law or any other provision of Community law, the Community and the Member States shall not, for a period of 10 years, accept another application for a marketing authorisation, or grant a marketing authorisation or accept an application to extend an existing marketing authorisation, for the same therapeutic indication, in respect of a similar medicinal product.…3.By way of derogation from paragraph 1, and without prejudice to intellectual property law or any other provision of [European Union] law, a marketing authorisation may be granted, for the same therapeutic indication, to a similar medicinal product if:(a) the holder of the marketing authorisation for the original orphan medicinal product has given his consent to the second applicant, or(b) the holder of the marketing authorisation for the original orphan medicinal product is unable to supply sufficient quantities of the medicinal product, or(c) the second applicant can establish in the application that the second medicinal product, although similar to the orphan medicinal product already authorised, is safer, more effective or otherwise clinically superior.4. The Commission shall adopt definitions of “similar medicinal product” and “clinical superiority” in the form of an implementing Regulation in accordance with the procedure laid down in Article 72 of Regulation (EEC) No 2309/93.…’