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: LNB News 30/10/2019 65.

4.  World Health Organisation’s Digital Health Technical Advisory Group sets agenda for next two years

World Health Organisation has called upon experts from across the digital health industries to discuss and advance the access to and the use of digital health technologies worldwide. The Digital Health and Technical Advisory Group met for its first session to establish its priorities over the next two years.

See: LNB News 29/10/2019 80

5.  European federation seeks views on multi-sector health innovation partnership

The European Federation of Pharmaceutical Industries and Associations has released a questionnaire and seeks comment on a Health Public-Private Partnership (PPP) Strategic Research & Innovation Agenda. This agenda includes the inauguration of institutionalised PPPs by Horizon Europe, as well as the creation of a European multi-sector partnership for health innovation. To learn more about this proposed European Health PPP, a dedicated webinar will take place on 4 November 2019, 2 pm CET. The online questionnaire closes 24 November 2019.

See: LNB News 24/10/2019 25.

Brexit focus - Commercial and practical help

To help you cut through the noise, here are a couple of resources giving you the need-to-know information:

1.  Practice notes

Brexit – General implications for the life sciences sector

Brexit – the regulation of medicinal products

Brexit – medical devices

Life sciences – Brexit tracker

2.  Continental Shift: No-deal Brexit and the law

We have published a report on the repercussions of a no-deal Brexit, drawing from interviews with legal professionals:

Continental Shift: No-deal Brexit and the law

3.  Brexit toolkits

Our Brexit toolkit draws together Brexit content for the practice areas that are relevant for you.

Brexit toolkit

Brexit Contract Management Toolkit

Brexit legislation tracker

Keeping up to date

Trackers

Trackers are practice notes intended to be used to track the progress of legislative proposals, relevant cases, current consultations and key news and guidance relevant to the Life Sciences sector.

Click to view individual trackers in the following topic areas:

Life sciences tracker

Life sciences—Brexit tracker

Patents tracker

Practice notes

Practice notes give you practical guidance on specific case law and legislation across Life Sciences, helping you conduct your work efficiently and easily:

M&A in the Life Sciences sector

Unlicensed medicinal products and off-label use of medical products

An introduction to the regulation of medical devices

An introduction to the regulation of medicinal products

Clinical trials

Marketing authorisations—regulatory procedures for approval of medicinal products

Advertising and promotion of medicinal products

Pharmaceutical pricing and reimbursement

Pharmaceutical patents

Pharmaceutical pricing and reimbursement

The General Data Protection Regulation—application in the life sciences sector

Webinars

Sign-up to upcoming and view on demand:

Brexit - Implications for the Life Sciences sector

27^th November 2019 12:30pm GMT

Get connected…

LexTalk®Life Sciences: a Lexis®PSL community. Collaborate and network with a community of expert lawyers.

LexTalk® is a new online community forum which gives Lexis®PSL subscribers the opportunity to post questions, hold conversations, participate in discussions and share best practice. It has been designed to provide a secure place for legal professionals to discuss legal developments, offer and receive peer support, and gain a sense of up to date market practice and advances in real-time. You can access and post questions on all of the dedicated practice area forums, including a dedicated community for Lexis®PSL Life Sciences.

Click here to sign up and meet like-minded community members, create a profile, connect, share, and start participating today! Alternatively, you can access LexTalk® on the key resources tab on your Practice Area home page.