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 analyses by Venner Shipley LLP that the Patents Court has upheld uniQure’s patent...
The European Commission has confirmed that Directive (EU) 2024/2853 (the revised Product Liability Directive) entered into force on 8 December 2024....
IP analysis: The Patents Court rejected Pfizer’s revocation action against uniQure’s patent EP(UK) 3,581,650 (EP 650) which protects a ‘Factor IX...
The Association of the British Pharmaceutical Industry (ABPI) has released its annual report ‘the road to recovery for UK industry clinical trials’...
The Department for Science, Innovation and Technology (DSIT) has announced an update to the UK-Swiss science and research partnership, backed by £16m...
Latest Life Sciences Practice Notes
Profiling and automated decision-makingIn briefData protection law in the UK seeks to ensure information about living individuals (within the...
Vifor Pharma (abuse of dominance)CASE HUBSee further, timeline and commentary.Case factsOutlineCMA Chapter II CA98 investigation into Vifor for...
Execution of contracts—jurisdictional guideThis guide sets out the requirements for executing simple contracts in various international jurisdictions....
Trade secrets and confidential information—protection and enforcementThis Practice Note sets out the protection available for trade secrets and...
Hague Convention on Choice of Court Agreements (jurisdiction and enforcement)—Brexit considerationsThis Practice Note considers how the Hague...
Latest Life Sciences Precedents
Product recall clause1Product recall clause—pro-supplier1.1The Customer shall immediately notify the Supplier if it becomes aware of any complaint or...
Template agreement—mutualThis Agreement is made on [date]Parties1[insert name of Party A][ of OR a company incorporated in [England and Wales] under...
Manufacturing agreement—pro-customerThis Agreement is made on [insert date]parties1[insert name of customer ][of OR a company incorporated in [England...
Manufacturing agreement—pro-manufacturerThis Agreement is made on [insert date]parties1[insert name of manufacturer ][of OR a company incorporated in...
Distribution agreement—non-exclusive [Archived]ARCHIVED: This Precedent has been archived and is not maintained. This Precedent was suitable for use...
Latest Life Sciences Q&As
Featured Life Sciences content
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...
Regulation of e-cigarettes
Regulation of e-cigarettes31 December 2020 marked the end of the Brexit implementation period following the UK’s decision to withdraw from the EU. At...
Clinical evaluation and performance evaluation of medical devices in the EU
Clinical evaluation and performance evaluation of medical devices in the EUThis Practice Note describes key changes to the requisite clinical...
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...
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...
Post-market surveillance of medical devices in the EU
Post-market surveillance of medical devices in the EUPost-market surveillance is the monitoring by manufacturers of medical devices to ensure their...
Intellectual property protection for medical devices
Intellectual property protection for medical devicesChanges to intellectual property (IP) law from 1 January 2021Before discussing how intellectual...
Medicines and Medical Devices Act 2021
Medicines and Medical Devices Act 2021This Practice Note provides an overview of the Medicines and Medical Devices Act 2021 (MMDA 2021) which, in...
Introduction to borderline products
Introduction to borderline productsThis Practice Note provides an introduction to the concept of borderline products, how the regulatory status of...
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...
Pharmacovigilance
PharmacovigilancePharmacovigilance is the process of collecting and understanding information relating to the adverse effects of medicinal product...
The UK medical devices regime and the impact of the Northern Ireland Protocol
Life Sciences analysis: Peter Rudd-Clarke, partner, and Anna Lundy, associate director, at Osborne Clarke discuss how the medical device industry is...
Medical devices due diligence questionnaire
Medical devices due diligence questionnaireIntroductionThis medical devices regulatory due diligence questionnaire relates to the proposed purchase by...
Life Sciences weekly highlights—11 August 2022
This week's edition of Life Sciences weekly highlights includes analysis of the English court’s jurisdiction to decide COVID-related business...
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...
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...
Life Sciences weekly highlights—18 August 2022
This week's edition of Life Sciences weekly highlights includes consideration of the arguments put forward against DeepMind, Google’s subsidiary, for...
Pharma and medical device regulation—Colombia—Q&A guide
Pharma and medical device regulation—Colombia—Q&A guideThis Practice Note contains a jurisdiction-specific Q&A guide to pharma and medical device...
Associated legal terms
In-vitro diagnostic medical device
Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in-vitro for the examination of specimens derived from the human body.
Medical device
Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for a medical purpose, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body.
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.
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