CJEU confirms 10 years of independent orphan market exclusivity for independently authorised similar orphan medicinal product

On 3 March 2016, the Court of Justice of the European Union (CJEU) issued its judgment in the appeal case between Teva and the European Medicines Agency (EMA) and the European Commission concerning orphan market exclusivity (Case C-138/15 P). The CJEU confirmed the previous judgment from the EU General Court of 22 January 2015 (for further background to the case and the EU regulatory framework, see our earlier newsletter).

In the EU, orphan medicinal products enjoy a period of 10 years of market exclusivity. During that period, no marketing authorisation applications may be accepted and no marketing authorisations may be granted to similar medicinal products for the same therapeutic indication. The EU Orphan Regulation No 141/2000 provides for derogations to this exclusivity, for example if the marketing authorisation holder for the first orphan medicinal product provides consent to the authorisation of a similar medicinal product or if the second applicant demonstrates that the second product is safer, more effective or otherwise clinically superior. The CJEU confirms that if such a similar medicinal product is an orphan medicinal product, it enjoys market exclusivity, which is independent of the market exclusivity of the first orphan product. The CJEU confirms that market exclusivity "must be granted in all cases in which an orphan product has been given marketing authorisation".