On 22 January 2015, the Sixth Chamber of the General Court of the Court of Justice of the European Union (“General Court”) issued its judgment in Case T‑140/12 Teva Pharma and Teva Pharmaceuticals Europe v EMA concerning market exclusivity for orphan medicinal products.

As part of the General Court’s judgment, the Court examined the possibility for the Applicant, Teva Pharmaceuticals, to introduce an additional ground for annulment of the European Medicines Agency (“EMA”) Decision (“Contested Decision”) to reject an application by the Applicant for authorisation of a generic of an authorised orphan medicinal product.

The General Court rejected the admissibility of a second plea by the Applicant on the grounds of Article 48(2) of the Rules of Procedure of the General Court (“Rules of Procedure”). The Court concluded that certain documents, which the Applicant argued only came to light during the course of the proceedings, were publically available prior to the submission of the application for annulment.

Applicant’s second plea

In its reply to the EMA Defence, the Applicant submitted a new additional ground for annulment of the Contested Decision based on alleged infringement of certain provisions of the Orphan Medicinal Products Regulation.

The Applicant submitted that the additional ground for annulment was admissible because it was raised in response to information that came to light only during the course of the procedure before the Court. The Applicant argued that it only became aware of the opinion and the summary report of the Committee for Orphan Medicinal Products (“COMP”), which is the EMA committee responsible for reviewing applications for orphan medicinal product designation, when the EMA produced these documents as part of its Defence. As such, the Applicant submitted that it was permitted to introduce a new plea in law on the basis of the information arising from the new documents.