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
The Data (Use and Access) Bill (DUA) is set to receive Royal Assent and become an Act of Parliament on Thursday 19 June 2025. This follows its...
The Chartered Trading Standards Institute (CTSI) has issued a warning about unregulated aesthetic procedures and called for immediate regulatory...
The Department of Health and Social Care, alongside Health and Social Care Secretary Wes Streeting MP, has unveiled the government’s 10 Year Health...
The Medicines and Healthcare products Regulatory Agency (MHRA) has brought into force the Medical Devices (Post-market Surveillance Requirements)...
The Medical Device Coordination Group (MDCG) has published guidance clarifying the regulatory responsibilities of app platform providers facilitating...
Latest Life Sciences Practice Notes
Life sciences—new starter guideThis new starter guide provides an introduction to the Life Sciences practice area, the legislative and regulatory...
Life Sciences News Analysis—Brexit collection [Archived 2017–2022]ARCHIVED: This Practice Note has been archived and is not maintained.11 pm (GMT) on...
What does IP completion day mean for intellectual property? [Archived]ARCHIVED: This Practice Note has been archived and is not maintained.IP law is...
Intellectual property (IP)—new starter guideThis new starter guide provides an introduction to IP law. It is aimed at trainee solicitors and those who...
Brexit post implementation period—considerations for dispute resolution practitioners [Archived]ARCHIVED: This archived Practice Note addressed the...
Latest Life Sciences Precedents
Reply and defence to counterclaim—patent infringement claimClaim No.: [insert claim number]IN THE HIGH COURT OF JUSTICEBUSINESS AND PROPERTY COURTS OF...
Defence and counterclaim—patent infringement claimClaim No. [insert claim number]IN THE HIGH COURT OF JUSTICEBUSINESS AND PROPERTY COURTS OF ENGLAND &...
Particulars of Claim—patent infringement claimCLAIM No: [insert claim number]IN THE HIGH COURT OF JUSTICEBUSINESS AND PROPERTY COURTS OF ENGLAND &...
Grounds of invalidity—patent infringement claimClaim No: [insert claim number]IN THE HIGH COURT OF JUSTICEBUSINESS AND PROPERTY COURTS OF ENGLAND &...
Particulars of Infringement—patent infringement claimCLAIM No: [insert claim number]IN THE HIGH COURT OF JUSTICEBUSINESS AND PROPERTY COURTS OF...
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?
The PMCPA has recently launched a consultation to update:•the 2021 ABPI Code of Practice•the Constitution and Procedure which sets out how the PMCPA...
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 Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the implementation of changes to pharmacovigilance for...
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
The National Archives has published the judgment in British Standards Institution v RRR Manufacturing Pty Ltd, R (on the application of) [2024] EWCA...
CMA announces Phase 1 merger inquiry into Roche Diagnostics
The Competition and Markets Authority (CMA) has announced a Phase 1 merger inquiry into Roche Diagnostics Ltd's acquisition of point-of-care testing...
DSIT publishes international scientific report on advanced AI safety
The Department for Science, Innovation and Technology (DSIT) has released the interim International Scientific Report on the Safety of Advanced...
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
Advanced therapy medicinal product
Also known as an ATMP, a medicinal product for human use that is based on genes, tissues or cells. There are three types of ATMP: - gene therapy medicines - somatic cell therapy medicines - tissue engineered medicines.
Bioequivalence
Two medicinal products containing the same active substance are considered bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and their bioavailabilities (rate and extent) after administration in the same molar dose lie within acceptable predefined limits.
Off label
The intentional use of an authorised medicinal product outside the terms of its authorisation'>marketing authorisation (e.g. for a different indication, different dose or in a different patient population). It is considered off-label use of a medical device if the device is used differently from how the manufacturer has instructed.
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