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.
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.
This content includes guidance on marketing authorisations, orphan and paediatric medicines, pharmacovigilance, manufacturing, unlicensed and off-label medicines.
Covering key areas of medical devices regulation including classification, conformity assessments, clinical and performance evaluation as well as post-market surveillance.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on plans to streamline the assessment of some substantial...
Law360, London: The Unified Patent Court (UPC) said 20 August 2025 that it cannot refer questions of its framework or procedures to the EU's top...
The Swiss Agency for Therapeutic Products (Swissmedic) has published its 12th annual benchmarking study, comparing its drug authorisation times with...
The Competition and Markets Authority's Subsidy Advice Unit (SAU) has accepted a request from the Office for Life Sciences (OLS) to review its...
This week's edition of Life Sciences weekly highlights includes analysis by Browne Jacobson of the Court of Appeal’s decision in Accord v Astellas...
Managing a breach of confidentiality or information securityMany companies and government bodies (such as HMRC) have been exposed to or suffered loss...
Pharmaceutical patentsThis Practice Note discusses pharmaceutical patents, and the effect of regulations associated with the approval of new medicinal...
Patents for new chemical entities and small moleculesThis Practice Note discusses issues specific to patents for small molecules or ‘new chemical...
Sub-licensing intellectual property rightsAn IP owner may choose to license its IP to a third party. This can be an effective route to generating...
Patent invalidity—obviousnessPatents may be revoked (ie removed from the register of patents) if they are held to be invalid in some respect. If a...
Grounds of invalidity—patent infringement claimClaim No: [insert claim number]IN THE HIGH COURT OF JUSTICEBUSINESS AND PROPERTY COURTS OF ENGLAND &...
Confidentiality agreement—one-way—pro-discloserThis Agreement is made on [date]Parties1[Insert name of party][ of [insert details] OR a company...
Sustainability glossary terms (The Chancery Lane Project)These Precedent sustainability definitions, produced by The Chancery Lane Project (TCLP) as...
Medicinal products due diligence questionnaireIntroductionThis medicinal products regulatory due diligence questionnaire relates to the proposed...
Patent licence—pro-licensorThis Agreement is dated [insert date]Parties1[insert name] [of OR a company incorporated in [insert jurisdiction, eg...
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 UKThis Practice Note provides an overview of the UK regulatory framework for cosmetics. It sets out the legal...
Intellectual property protection for medical devicesChanges to intellectual property (IP) law from 1 January 2021Before discussing how intellectual...
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 infringementPatent systems are intended to foster innovation, not to impede it. For this...
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 agreementDATA PROTECTION NOTICE: Please note that the drafting of clause 7 (Data Protection), in...
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 questionnaireIntroductionThis medical devices regulatory due diligence questionnaire relates to the proposed purchase by...
Biotechnology patentsPatenting biotechnological inventionsBiotechnological inventions are, in principle, patentable. While there is no general...
Unlicensed medicinal products and off-label use of medicinal productsThis Practice Note explores unlicensed medicinal products and the various ways...
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 UKThis Practice Note provides an overview of the UK regulatory regime for medical devices. It explains the...
The National Archives has published the judgment in British Standards Institution v RRR Manufacturing Pty Ltd, R (on the application of) [2024] EWCA...
The Competition and Markets Authority (CMA) has announced a Phase 1 merger inquiry into Roche Diagnostics Ltd's acquisition of point-of-care testing...
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 productsThe development of medicine, biomicrobiology and biotechnology has led to the emergence of a...
Generally, active devices refer to medical devices powered by electricity or any source of power other than that generated by the human body or gravity. Examples are examination lights, surgical microscopes, gas pressure regulators or blood pumps for heart-lung machines or devices for viewing diagnostic images such as ultrasound images. Under Regulation (EU) 2017/745 (EU MDR), ‘active device means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device’. UK legislation compounds the definition of an ‘active’ device with implantable devices.
Also referred to as a ‘drug substance’, this term refers to any substance or mixture of substances intended to be the biologically active ingredient (or ‘active substance’) contained in a final medicinal product and intended to provide pharmacological activity or other direct effects. It is internationally defined as: ‘…any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.’ Medicinal products are usually composed of several components: the primary biologically active ingredient(s) which form the active pharmaceutical ingredient (API) plus other non-active ingredients known as ‘excipients’. The procedure for optimising and compositing this mixture of components, often producing ‘pharmaceutical intermediate’ byproducts as synthesising the API, and excipients into a final medicinal product is referred to as drug ‘formulation’. APIs are legally required to be registered with drug regulatory authorities (eg MHRA, FDA, EMA) and manufactured in compliance with good manufacturing practice (GMP) regulations and licensed facilities.
Mandatory conformity marking for certain products sold within the EEA, including medical devices. It shows that the manufacturer has checked that these products meet EU safety, health or environmental requirements, is an indicator of a product’s compliance with EU legislation and allows the free movement of products within the EEA.