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 of treating no more than 10 patients during the period that appeal was pending. The terms of these undertakings were similar to those given to the late Henry Carr J following an application by Abbott Cardiovascular Systems Inc., and Abbott Medical UK Ltd. ( together, “Abbott”), and Evalve ..read more

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. While the Court of Appeal (CoA) heavily criticised the approach taken by Marcus Smith J in his High Court decision, the CoA ultimately agreed with his conclusion and core finding – that damages would be an adequate remedy f ..read more

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 the German provisions which do not provide for supply to pharmacists. According to the judgement, free samples of non-prescription drugs may be supplied to pharmacists whereas prescription drugs may only be supplied to pers ..read more

The Supreme Court has handed down today its judgment in Regeneron Pharmaceuticals Inc v Kymab Ltd [2020] UKSC 27, allowing Kymab’s appeal and holding Regeneron’s patents invalid for insufficiency by a majority of 4:1. The judgment emphasises the fundamental principle of the patent bargain, which envisages that the patentee makes full disclosure of the invention in return for a time-limited monopoly. Sufficiency is, amongst other tools like novelty, inventive step and industrial application, one of the ways to ensure such patent bargain is struck in the right place, such that the protection aff ..read more

Teva UK Ltd v Chiesi Farmaceutici SpA [2020] EWHC 1311 (Pat), 2 June 2020 Summary After having been pressed by the defendant pharmaceutical company, Chiesi Farmaceutici SpA (“Chiesi”), to disclose a product description in a patent revocation action brought by Teva UK Ltd (“Teva”), Teva applied to strike out Chiesi’s counterclaim for quia timet infringement. Teva argued that the legal test for such a claim had not been met and, in the alternative, that the disclosure of the product description required for the infringement claim would violate competition law. Mr Justice Birss refused to strike ..read more

Neurim Pharmaceuticals (1991) Limited (Neurim) and Flynn Pharma Limited (Flynn) sought interim injunctive relief against Generics UK Ltd (t/a Mylan) and Mylan UK Healthcare Limited (Mylan), concerning their prolonged release melatonin pharmaceutical formulation sold under the brand names Circadin® and Slenyto®. The global market for melatonin is estimated to be around US$700 million in 2019 and is expected to reach more than US$2 billion in the next five years. Despite this case being portrayed as a David and Goliath battle, with Mylan far eclipsing the size of the claimants, the UK High Court ..read more

Responding to a question referred to it by the EPO’s President, the  Enlarged Board of Appeal of the European Patent Office has issued its opinion in relation to what was perhaps the most controversial referral of 2019. In a complete reversal of its opinion of just five years ago, the EPO has held that plants and animal products produced by essentially biological (natural) processes are not patentable. Background In 2015, the Enlarged Board of Appeal of the EPO held that although non-microbiological processes for the production of plants which are “essentially biological” cannot be patent ..read more

In this article we review the impact of the COVID-19 pandemic on the procedure of, and approach taken by the judiciary in, the patent courts of England & Wales, Germany, France, Italy, and at the EPO. Courts of England and Wales In response to the health emergency caused by COVID-19, the courts of England and Wales have put in place new measures to ensure that court work continues as much as possible. Overall, the judiciary is committed to continuing the work of the courts as a vital public service, although the message is to do what can be done safely. Guidance from Lord Chief Justice Th ..read more

Key recent developments in the United Kingdom and Europe relating to patents and the pharmaceutical sector In this update we welcome our new IP partner in Germany. We have a number of interesting updates from the UK Court of Appeal, including a decision on Arrow declarations, a competition decision, an appeal relating to the lapse of an SPC and a decision on off-label prescription of medical treatments. We cover the German Constitutional Court decision on the UPC and the UK government’s comments on participation in the UPC. We have updates from France on SPCs and a FRAND related inju ..read more

Two important pieces of medicines and medical devices regulation are currently pending in the UK and the European Union: in the UK, the Medicines and Medical Devices Bill (the UK Bill), and in the EU, the Medical Devices Regulation (the EU Regulation on Medical Devices). COVID-19 has also had an impact, with the EU Regulation on Medical Devices, which was due to start to apply to medical devices on 26 May 2020, having its date of application postponed by the EU for one year, until 26 May 2021, so as to avoid any extra burden on manufacturers during the current pandemic. The UK Bill The UK is c ..read more