May 7, 2013

Interim relief granted in challenge to EMA's decision to disclose pre-clinical and clinical information from an application for a centralised marketing authorisation

Arnold & Porter Advisory

InterMune has challenged a decision of the European Medicines Agency (EMA) to disclose to a third party competitor, under EU transparency rules, confidential information concerning pre-clinical and clinical research contained in the application for an EU marketing authorisation for its product Esbriet (pirfenidone). On 25 April 2013, the President of the General Court of the European Union granted InterMune's application for an interim injunction preventing the EMA from releasing the contested information pending the Court's decision on the substantive issues. A similar order was made in relation to separate proceedings brought independently by AbbVie relating to disclosure of research data concerning one of its products.

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