life science @en

Liability for damages caused by defective medical devices: the ECJ in the Boston Scientific case

(An Italian version of this post is published on Diritto 24 – Il Sole 24 Ore)

By decision of 5 March in joint cases C-503/13 and C-504/13, the European Court of Justice (“ECJ”) provided a preliminary ruling on the liability for damages caused by defective medical devices. The national proceedings […]

The ECJ in Actavis v. Boehringer on supplementary protection certificates

On 12 March, the Court of Justice of the European Union (“ECJ”) ruled on the possibility of issuing a valid supplementary protection certificate (“SPC”) for a combination of two active ingredients, one the object of the basic patent (and already covered by an SPC) and the other one in […]

The Court of Milan on territorial jurisdiction and unfair competition in a case concerning pharmaceutical products

By judgment no. 9086/2014 of 26 June 2014, Business Chamber “A” of the Court of Milan addressed some interesting issues regarding territorial jurisdiction and unfair competition.

The dispute arose from a hypothesis of interference between trademarks: the plaintiff, a pharmaceutical company and owner of the trademark “Inofert” had brought proceedings against […]

The court of Milan on interim non-infringement proceedings in Novartis v. Mylan: the applicant’s interest in the action and the danger in delay

(Original Italian version is published also on Diritto24 – Il Sole 24 Ore)

By order of 19 June the Business Court of Milan pointed out the difference between interest in an action and the danger in delay in interim declaratory judgment actions for the ascertainment of non-infringement (already discussed here […]

Pharmaceutical patent litigation: the Balduzzi Decree put to the test

In recent years a large number of patent infringement proceedings have started between originator pharmaceutical companies manufacturing patented drugs, and companies commercialising the corresponding generic medicinal products. These proceedings are particularly linked to the entry onto the market of the generic product before the expiry date of the patent […]

General Court annuls the Commission’s decision refusing to grant a marketing authorisation for Orphacol

On 4 July the General Court of the European Union (“GC”) ruled in case T-301/12 as regards the grant of the Marketing Authorisation (“MA”) of Orphacol, a cholic acid-based orphan medicinal product which is used to treat two rare but very serious liver disorders (the “Medicinal Product”). Specifically, the […]