The Italian medicines agency AIFA opens a public consultation on the draft guidelines for the preparation of the dossier supporting a price and reimbursement application

The Italian Medicines Agency (AIFA) has launched a one week public consultation, closing 30 September 2020, on the draft "Guidelines for the preparation of the Dossier supporting the price and reimbursement application", i.e. draft guidelines that set out, in practice, the information and documentation that pharmaceutical companies will now be required to submit before AIFA to support their price and reimbursement applications. This is the last step before the implementation of the new procedure for the price and reimbursement negotiation set out in the Decree on price and reimbursement negotiation of 2 August 2019. Read more

Glaxo’s purple inhalers fail to get trade mark protection

Like Cadbury before them, Glaxo’s hard-fought attempts to register a trade mark for a shade of purple have been rejected. In this case, Glaxo had sought to register the colour of its seretide inhalers and asthma treatments as a trade mark, by providing the description “Purple – Pantone: 2787C” and this sign: The General Court … Read more

The Unified Patent Court – on the move again?

The UPC Preparatory Committee met yesterday (10.9.20) to discuss UK withdrawal and German ratification. It agreed that, on a temporary basis (in order not to delay the start of the UPC system further), Munich and Paris would split the workload London would have taken as the life sciences seat of the central division of the UPC.  Milan looks to be a lead candidate for the location of this seat of the central division in the longer term. Read more

Patent and Pharma Update, August 2020

Key recent developments in the United Kingdom and Europe relating to patents and the pharmaceutical sector In this edition we cover landmark judgments from the UK and German Supreme Courts, on sufficiency in the UK and FRAND obligations in Germany. We also cover a significant decision of the CJEU in relation to SPCs in the … Read more

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 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