Articles for the ‘General’ Category

The Advocate General recently gave its opinion in the case No C-473/22 between Mylan AB (“Mylan”) and Gilead Sciences Finland Oy, Gilead Biopharmaceutics Ireland UC and Gilead Sciences Inc (“Gilead”).

The referral was made by the Finnish Market Court in proceedings concerning a claim for damages resulting from an unfounded preliminary injunction (“PI”) issued against Mylan. Under the Finnish system, the liability for such damages is deemed “strict”. In other words, the party that has enforced an unfounded PI is liable for any damages shown irrespective of other circumstances such as the level of care it has taken when evaluating the likelihood of infringement.

The case holds implications for all jurisdictions in the EU in which the same or similar strict liability regime is adopted into national law.

The European Commission published a draft proposal for a revised Product Liability Directive (the “PLD Proposal”) on 28 September 2022, which aims to bring the European Union’s product liability regime ‘up to speed’ with the digital age, circular economy business models and global value chains.This blog focuses on the main changes the PLD Proposal brings and its impact on life science companies.

The so-called Bolar provision is generally understood as the rule allowing generic and biosimilar manufacturers to get prepared for launching a drug by the time the relevant patent expires, thereby offering broader options to patients as early as possible.

A New Approach for Assessing Alleged Abuse of a Dominant Position under Article 102 TFEU? Many pharmaceutical companies risk facing acquisitions regarding abuse of a dominant

On 16 March 2023, in Joined Cases C‑438/21 P to C‑440/21 P, the Court of Justice of the European Union (CJEU) interpreted the concept of a global marketing authorisation.