About Life Sciences Law
Lexis®+ Life Sciences is an online practical guidance product for contentious and non-contentious lawyers providing advice to and supporting the UK’s Life Sciences sector.
Research and development
Highly regulated, with strict compliance rules, work can be in-house or in collaboration with another entity. Guidance includes practice notes on UK and EU regime for clinical trials and various precedents.
Intellectual property
Patents and supplementary protection certificates are significant to many life sciences businesses. We have practice notes on pharmaceutical patents, biotechnology patents, IP protection for medical devices and more.
Medicinal products
This content includes guidance on marketing authorisations, orphan and paediatric medicines, pharmacovigilance, manufacturing, unlicensed and off-label medicines.
Medical devices
Covering key areas of medical devices regulation including classification, conformity assessments, clinical and performance evaluation as well as post-market surveillance.
Topics We Cover
Latest Life Sciences News
This week's edition of Life Sciences weekly highlights includes news analysis of Patent Court’s decision in an inventor’s long-running patent dispute...
The Advertising Standards Authority (ASA) has upheld two complaints against AirDoctor LLC and health.detective Garstang Health Food Store Ltd...
The Advisory Council on the Misuse of Drugs (ACMD) has produced a report that includes recommendations on classification and scheduling following a...
One complaint was received by the Advertising Standards Authority (ASA) regarding a broadcast ad for Huusk knives shown immediately after a children’s...
The Competition and Markets Authority (CMA) has accepted final commitments from Vifor Pharma on 23 May 2025, addressing concerns about its abuse of...
Latest Life Sciences Practice Notes
Contractual set-offA set-off is the right of one party, Party A, who is owed money by another party, Party B, to ensure payment by setting off the...
Life sciences cases tracker—EUThis Practice Note is intended to be used to track the progress of EU cases relevant to the life sciences sector.Jump...
Confidentiality agreement playbook—one—way (pro-discloser)This playbook provides guidance for drafting and negotiating a confidentiality agreement...
Comparing arbitration and ADRThis Practice Note compares and contrasts, at a high level and in table form, the key differences between arbitration and...
Arbitration—an introduction to the key features of arbitrationThis Practice Note has been updated in light of the new Arbitration Act 2025 and...
Latest Life Sciences Precedents
Data protection schedule—Life SciencesParties1[Insert the company name (the name of the sponsor)] with a registered office at [insert address]...
Hardship clauseHardship•means[, subject to clause [1.6 OR 1.7],] a [fundamental OR material] change in the balance of a party’s benefits and...
Clinical Research Organisation (CRO) master services agreementThis Agreement is made on [date]Parties1[Insert the company name] a company registered...
Letter of claim—patent infringementLetter of claim—patent infringement[Alleged infringer’s name and address][Date]Dear [insert organisation...
Declaration of a director’s interests in a proposed transaction or arrangement—general noticeThe directors[Insert name of company] ([Company])[Insert...
Latest Life Sciences Q&As
Featured Life Sciences content
Introduction to technology transfer agreements in the Life Sciences industry
Introduction to technology transfer agreements in the Life Sciences industryWhat is a technology transfer agreement?The term ‘technology transfer...
Regulation of cosmetic products in the UK
Regulation of cosmetic products in the UKThis Practice Note provides an overview of the UK regulatory framework for cosmetics. It sets out the legal...
Intellectual property protection for medical devices
Intellectual property protection for medical devicesChanges to intellectual property (IP) law from 1 January 2021Before discussing how intellectual...
Second and subsequent medical use patent claims
Second and subsequent medical use patent claimsBackground to medical use claimsSecond (and subsequent) medical use patent claims are specific to the...
The experimental use and Bolar-type exemptions to patent infringement
The experimental use and Bolar-type exemptions to patent infringementPatent systems are intended to foster innovation, not to impede it. For this...
The 2024 ABPI Code of Practice—what are the key proposed changes?
...
Clinical Research Organisation (CRO) master services agreement
Clinical Research Organisation (CRO) master services agreementDATA PROTECTION NOTICE: Please note that the drafting of clause 7 (Data Protection), in...
The EU Clinical Trials Regulation
The EU Clinical Trials RegulationThis Practice Note looks at Regulation (EU) 536/2014, the EU Clinical Trials Regulation (CTR), which governs clinical...
Medical devices due diligence questionnaire
Medical devices due diligence questionnaireIntroductionThis medical devices regulatory due diligence questionnaire relates to the proposed purchase by...
Biotechnology patents
Biotechnology patentsPatenting biotechnological inventionsBiotechnological inventions are, in principle, patentable. While there is no general...
Unlicensed medicinal products and off-label use of medicinal products
Unlicensed medicinal products and off-label use of medicinal productsThis Practice Note explores unlicensed medicinal products and the various ways...
MHRA releases guidance on pharmacovigilance following Windsor Framework agreement
...
The regulation of medical devices in the UK
The regulation of medical devices in the UKThis Practice Note provides an overview of the UK regulatory regime for medical devices. It explains the...
Court of Appeal allows appeal in British Standards v RRR Manufacturing
...
CMA announces Phase 1 merger inquiry into Roche Diagnostics
...
DSIT publishes international scientific report on advanced AI safety
...
The regulation of advanced therapy medicinal products
The regulation of advanced therapy medicinal productsThe development of medicine, biomicrobiology and biotechnology has led to the emergence of a...
Associated legal terms
Biosimilar
A medicinal product that is similar to a biological medicinal product (the originator or ‘reference’ product) that has already been granted a authorisation'>marketing authorisation in the EEA, but which does not meet the definition of a generic medicinal product owing, in particular, to differences in raw materials or manufacturing processes.
Marketing Authorisation
The approval needed to place a medicinal product on the market. It sets out the medical conditions (known as indications), patient population and dosage for which the product is authorised as well as any conditions imposed on the holder of the marketing authorisation.
Orphan medicinal product
A medicinal product that is used to prevent, diagnose or treat a rare medical condition or disease. In the EU, according to Regulation (EC) 141/2000, a disease is defined as rare if it affects fewer than 5 in 10,000 people across the EU.
CONTACT US
