Related insights: Life Sciences and Pharmaceuticals


UK Supreme Court gives a strict interpretation on the rules of sufficiency

13 Jul 2020
The UK's Supreme Court ("UKSC") has handed down its eagerly awaited judgment in the dispute between Regeneron Pharmaceuticals Inc ("Regeneron") and Kymab Limited ("Kymab").  The invention by Regeneron related to the creation of a type of transgenic mouse (the "VelocImmune") that is more effective in its receipt of human antibody genes, for the production of human antibodies. As such, this genetically modified mouse has been regarded as a major breakthrough in the field of bio pharmaceuticals. Nevertheless, despite such an advancement, the UKSC has held that the patents upon which Regeneron based its innovative platform are invalid for lack of sufficiency because the claims, as construed, would include a range of modified mice, some of which it would not have been possible to produce as at the priority date of February 2001.

COVID-19 impacts go-live date of EU medical device regulation

07 Apr 2020
Following the European Commission's March press release on the suggested postponement of the effective date of the Medical Device Regulation (the MDR), given the impact of the Coronavirus pandemic, it's formal Proposal was published on Friday 3 April. This Preparatory Act, which amends the date of application of various provisions in the MDR from 26 May 2020 to 26 May 2021, has still to be approved by both the European Parliament and the Council.

MHRA guidance on the specification for rapidly manufactured ventilators

24 Mar 2020
The MHRA has published its guidance for manufacturers wishing to assist the UK by turning their capabilities to the urgent manufacture of ventilators during the Coronavirus outbreak. The guidance includes information on the minimum specification for clinically acceptable ventilators to be used in UK hospitals during the COVID-19 outbreak. These clinical requirements are based on the consensus of opinion on what is ‘minimally acceptable’ performance by anaesthesia and intensive care medicine professionals and medical device regulators.