UK’s exit from the UPC now final

On 20 July 2020, the UK officially withdrew its ratification of the Unified Patent Court Agreement. This was expected, following the announcement from the UK Prime Minister’s Office on 28 February 2020 – see our previous post here.  Details can be viewed here on the UPC website. In a written statement in the House of … Read more

Where is the balance now? Preliminary injunctions in pharmaceutical patent proceedings in 2020 and beyond

Recent decisions of the Federal Court of Australia have significantly changed the way in which parties to pharmaceutical patent litigation should analyse and approach preliminary injunction applications. While previously a patentee could generally expect to obtain a preliminary injunction if their product was facing a mandatory price drop as a result of generic or biosimilar … Read more

The CJEU’s decision in Santen confirms a restrictive interpretation of ‘product’ under article 1(b) and 3(d) of the SPC Regulation, and rejects the possibility of an SPC based on a Marketing Authorisation for a new use of a previously authorised product

On 9 July 2020, the Grand Chamber of the Court of Justice of the European Union (“CJEU”) handed down its decision in Santen SAS v Directeur général de l’Institut national de la propriété industrielle (C-673/18), a reference from the Paris Court of Appeal concerning the interpretation of Articles 1(b) and 3(d) of Regulation (EC) No … Read more

The High Court of England & Wales maintains the status quo for Edwards’ PASCAL Transcatheter Valve Repair System when considering a stay of a final injunction pending appeal

On 18 June 2020, Birss J gave a judgment (see here) setting out his reasoning for granting a stay of the final injunction in favour of Edwards Life Sciences Ltd (“Edwards”) pending appeal, on the condition that Edwards gave undertakings to limit its supply of PASCAL to no more than 2 hospitals for the purpose … Read more

Court of Appeal of England & Wales maintains no interim injunction for Neurim and Flynn against generic Circadin® – damages held to be an adequate remedy

On 19 June 2020, LJJ Floyd, Males and Arnold dismissed the appeal brought by Neurim Pharmaceuticals (1991) Limited (Neurim) and Flynn Pharma Limited (Flynn) that sought to overturn the High Court’s decision refusing an interim injunction against Generics UK Ltd (t/a Mylan) and Mylan UK Healthcare Limited (Mylan), concerning their generic prolonged release melatonin product. … Read more

CJEU rules that providing free samples of non-prescription drugs to pharmacists is permitted

CJEU rules that providing free samples of non-prescription drugs to pharmacists is permitted On 11 June, the Court of Justice of the European Union (“CJEU“) ruled on the question of whether free samples to pharmacists of medicines may be supplied by pharmaceutical companies to pharmacists. The German Federal Supreme Court (Bundesgerichtshof) had referred questions regarding … Read more