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.
Article 48(2) of the Rules of Procedure
Article 48(2) of the Rules of Procedure provides that no new plea in law may be introduced in the course of proceedings before the General Court, including applications for annulment, unless this plea is based on matters of law or of fact which come to light in the course of the procedure.
In the present judgement the General Court recalled a number of general requirements that must be fulfilled to support introduction of a new plea in law during the course of a procedure by examining settled case-law. The Court held that the mere fact that a party becomes aware of a factual matter during the course of the procedure before the General Court does not infer that such fact only came to light in the course of the procedure. The Court also held that any party that wishes to introduce a new plea in law by relying on Article 48(2) of the Rules of Procedure must not have previously been in a position to become aware of the facts.
As such, if, in the present case, the Applicant were in a position to become aware of both documents by virtue of its own investigation, then the Applicant would not be permitted to introduce a new plea in law on the basis of information arising from the documents.
The EMA had published a number of relevant documents on its website in relation to the COMP’s assessment of the medicinal product in question, including a summary of the COMP’s opinion and a related scientific discussion. The General Court concluded that, by virtue of the fact that such documents were in the public domain, the Applicant had been in a position to be aware of the matters that the COMP had taken into account when considering its opinion.
The General Court concluded that even if the Applicant had not been aware of the documents in question at the time of submitting the application for annulment, it must be considered as having been in a position to learn of the documents in question.
Article 277 TFEU
The Applicant also invoked Article 277 of the Treaty in the Functioning of the European Union (“TFEU”) to argue that the COMP opinion and related summary report were unlawful. Article 277 TFEU provides that any act of general application capable of producing legal effects adopted by an EU institution, body, office or agency may be challenged.
The General Court, however, rejected this argument. It concluded that the COMP opinion and related summary report did not constitute general acts, were not capable of forming the legal basis of the Contested Decision and did not have a direct link to the Contested Decision. The Court held that the legal basis for the Contested Decision was the European Commission Decision that authorised the orphan medicinal product and on the basis of which market exclusivity was granted to the product. The COMP opinion and related summary report are mere preparatory measures for such Commission Decision and as such, are not challengeable acts.
As such, the General Court dismissed the Applicants plea of illegality on the basis of Article 277 TFEU.