The Court of Justice of the European Union (CJEU) upheld decisions by the European Medicines Agency in two identical rulings on January 22, 2020. In the cases of PT Therapeutics International v. EMA (C-175/18 P) and MSD Animal Health Innovation and Intervet International v EMA (C-178/18 P), the decision was upheld to grant access to documents containing information submitted as part of medicinal product marketing authorisations (MA) applications. This decision could be of concern to those in the biotech or pharmaceutical industries. Competitors may gain an advantage by having the right to access documents and critical information contained in the MA file, especially in patent litigation. Companies should consider this carefully when submitting future applications and decide whether it may benefit them to withhold some of the most confidential information contained in the MAs. For a more in-depth review, please visit reedsmith.com.
Home International Life Sciences Court of Justice of the European Union delivers rulings on market authorisation applications