Life Sciences Sector Update – Q4 2019

As part of our sector-focused series, we have curated the key resources and points you need to know from the last quarter’s legal updates. Understand the key news stories, practice notes, trackers and upcoming webinars specific to the Life Sciences industry.

5 key news stories

1.  Supreme Court—Unilever involved in dispute with inventor and fined £2m

Mark Daniels, partner and head of patents at Browne Jacobson LLP, examines the Supreme Court’s decision in Shanks v Unilever plc [2019] UKSC 45, [2019] All ER (D) 139 (Oct) that, under section 40 of the Patents Act 1977, the appellant inventor (Professor Shanks) was entitled to compensation of £2m from the group of companies of which his employer was part. The court held that £2m would give him a fair share of the outstanding benefit that the group had derived from the invention and various patents relating to it.

See News Analysis: Supreme Court—inventor entitled to fair share from employer of £2m (Shanks v Unilever Plc and others).

2.  Human Medicines and Medical Devices Regulations 2019

The Human Medicines and Medical Devices (Amendment etc) (EU Exit) Regulations 2019, SI 2019/1385: this enactment is made in exercise of legislative powers under the European Union (Withdrawal) Act 2018 in preparation for Brexit. This enactment amends UK subordinate legislation in relation to the regulation of human medicines and medical devices in order to ensure that the published policy in the event that no deal is reached on the UK’s withdrawal from the EU is properly reflected in those legislation. It comes into force immediately before exit day. (Updated from draft on 28 October 2019.)

See: LNB News 25/07/2019 9.

3.  European Commission sets out good practice to assess GMO for gene therapy products

The European Commission has updated its advanced therapies website to include a document on good practice on the assessment of genetically modified organisms (GMO)-related aspects in the context of clinical trials with Adeno-associated virus (AAV) clinical vectors as part of its GMO section dealing with GMO requirements for investigational products.

See: