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 analysis by Gill Jennings & Every LLP of the impact of the UK Intellectual Property...
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has released new research revealing that while EU pharmaceutical R&D...
Life sciences analysis: This case concerned the messenger RNA (mRNA) technology used to develop BioNTech and Pfizer’s Cominarty coronavirus (COVID-19)...
The European Commission's Artificial Intelligence (AI) Office has initiated a targeted stakeholder consultation process to gather input on the future...
MedTech Europe has welcomed the Budapest Declaration, which commits to strengthen Europe's competitiveness, prosperity, sovereignty, and global...
Latest Life Sciences Practice Notes
Supplementary protection certificates and paediatric extensions—UKThis Practice Note provides an introduction to supplementary protection certificates...
Legal professional privilege in civil proceedingsThis Practice Note considers legal professional privilege (LPP), which is made up of legal advice...
Privilege—loss or waiver of privilegeThis Practice Note looks at loss of privilege in civil litigation in the context of legal professional privilege...
Privilege—general principlesThis Practice Note considers the general principles, meaning and rationale behind privilege. It identifies the different...
Teva (Copaxone) (AT.40588) [Archived]CASE HUBARCHIVED–this archived case hub reflects the position at the date of the final decision of 31 October...
Latest Life Sciences Precedents
Executing documents—training materialsThese Training Materials provide an introduction to execution and cover the principal areas of executing simple...
Board minutes—declaration of interests paragraph1Declaration of interests1.1[The Chair drew the attention of the Meeting to:1.1.1[a declaration of...
Personal data sharing clause—controller to controller—pro-receiving partyDefined terms: This Precedent clause uses the additional defined terms...
Particulars of Claim—patent infringement claimCLAIM No: [insert claim number]IN THE HIGH COURT OF JUSTICEBUSINESS AND PROPERTY COURTS OF ENGLAND &...
Letter of claim—patent infringementLetter of claim—patent infringement[Alleged infringer’s name and address][Date]Dear [insert organisation...
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
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.
Notified body
An organisation that has been appointed by the authorities'>competent authorities of a Member State to conduct conformity assessment procedures in respect of medical devices and verify the conformity of the manufacturer with the requirements of the medical devices legislation. The Notified Bodies are listed on the Commission website.
Specials
Unlicensed medicinal products for human use which have been specially manufactured or imported to the order of a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber for the treatment of individual patients in order to fulfil the special needs of an individual patient.
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