Related insights: Healthcare

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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: managing workplace safety – an update following 100 days in lockdown

13 Jul 2020
At the start of lockdown, the Health and Safety Executive's (HSE) general approach was to work with employers to ensure compliance and to issue enforcement notices to help secure improvements where appropriate. However, as the phased return to work has progressed, the general tone has changed. HSE is now making it plain that prosecution will be a consideration in appropriate cases. It has reported over 1,000 spot checks after it resumed inspections at the end of May.
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WBD advises Puma Private Equity on investment into Tictrac

05 Jun 2020
Womble Bond Dickinson (WBD) has advised Puma Private Equity which led a £6 million equity investment into Tictrac, a leading health engagement company. The corporate team was led by Partner Leon Miller, Managing Associate Alex Fergus and South African qualified lawyer Alice Millar who advised on the transaction.

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.

Keeping workers safe: COVID-19 health and safety FAQs

07 Apr 2020
We previously outlined some of the key questions that we had been asked by businesses in relation to managing the risks of COVID-19 from a health and safety perspective. This note provides an update of the position (as at 3 April 2020) to reflect recent developments which remain under constant review.
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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.