Research and development is key to innovation in the life sciences sector. A highly regulated sector with stringent compliance rules, work can be done in-house, or in collaboration with another entity. Key guidance includes practice notes on The EU Clinical Trials Regulation and precedents on material transfer agreements.
IP rights are extremely important in the innovative life sciences sector, with patents and supplementary protection certificates being of particular significance to many life sciences businesses. We provide practice notes on pharmaceutical patents, biotechnology patents, intellectual property protection for medical devices and more.
Brexit is of huge significance for life sciences lawyers and businesses. The life sciences sector is one of the most highly regulated and harmonised industry sectors at EU level. Trackers monitor key cases, legislation and consultations of interest to the sector .
Our content is written and structured to cover each stage in the life-cycle of a Life Sciences product from research and development to manufacturing, marketing and sale, including analyses of sector specific IP and data protection issues.
Our practice notes set out key principles supported by relevant authority and links through to in-depth commentary and underlying sources in Lexis®Library, all of which are designed to speed up the task of advising in this fast-moving and innovative sector.
LexisPSL Life Sciences is supported by an in-house legal team with extensive experience in practice and dedicated to producing content specifically for busy practitioners. This experience, combined with extensive customer research, has shaped our practical guidance on issues affecting the UK’s Life Sciences sector. We have built and continue to develop our product with the assistance of leading experts in the field.
This week's edition of Life Sciences weekly highlights includes news that the MHRA has launched a consultation on proposals to update the current UK...
MLex: A controversial proposal to cut protections for users affected by machine-made decisions as part of the UK’s data reform agenda is unlikely to...
Arbitration analysis: Is the introduction of international sanctions against a person sufficient to justify a move of the agreed dispute resolution...
IP analysis: The Court of Appeal held that the UK Patents Court was correct in finding that four DNA sequencing patents owned by Illumina were valid...
This week's edition of Life Sciences weekly highlights includes an update on ensuring all new applicants for Clinical Trials of Investigational...
Unitary patents and the Unified Patent Court—historical background and developmentThe unitary patent (UP)/Unified Patent Court (UPC) system entered...
Brexit legislation trackerThis Practice Note tracks the progress of UK legislation introduced as part of the legislative project associated with the...
Unified Patent Court—procedureIP COMPLETION DAY: The Brexit transition period ended at 11pm on 31 December 2020. At this time (referred to in UK law...
Anti-counterfeiting in the UKThis Practice Note summarises the main types of legal action that can be taken against the UK trade in counterfeit goods,...
Brexit timelineOn 23 June 2016, the UK held a referendum on its membership of the EU, with a majority voting in favour of the UK leaving the EU. On 29...
Confidentiality letter—private M&A—asset purchase—corporate sellerStrictly private and confidentialTo: [insert buyer name][insert buyer address]Date:...
Personal data processing schedule—short form—pro-controllerThis Precedent is drafted in contemplation of arrangements where the parties wish to insert...
Briefing for directors—general duties under the Companies Act 2006Every director of a company owes a number of duties to the company they are...
Confidentiality letter—private M&A—share purchase—corporate sellerStrictly private and confidentialTo: [insert buyer name][insert buyer address]Date:...
Confidentiality agreement—corporate joint ventureThis Agreement is made on [insert day and month] 20[insert year]Parties1[insert name of first...
Joint, several, and joint and several liabilityContractWhere a contract is made by two or more parties it may contain a promise or obligation made by...
The regulation of medical devices in the UKThis Practice Note provides an overview of the UK regulatory regime for medical devices. It explains the...
1 Definitions 1.1 In this clause: Background Intellectual Property means any and all Intellectual Property...
Medicines and Medical Devices Act 2021This Practice Note provides an overview of the Medicines and Medical Devices Act 2021 (MMDA 2021) which, in...
Key definitions under data protection lawOn 31 January 2020, the UK ceased to be a member of the EU and EEA. Given the extensive data flows between...
The Vertical Restraints Block ExemptionThe Vertical Restraints Block Exemption Regulation (VRBE, Regulation No 330/2010) defines a category of...
Joint ownership of intellectual property rightsWhen parties collaborate on creative projects or research and development, complex questions arise...
Introduction to borderline productsThis Practice Note provides an introduction to the concept of borderline products, how the regulatory status of...
Background Intellectual Property ...
Data portabilityUK and EU data protection laws each include a right to data portability. This right allows individuals to obtain from a controller a...
Powers of attorney in commercial transactionsCommercial lawyers will regularly come across situations where third parties are executing documents as...
1 No partnership or agency—short form Nothing in this agreement constitutes, or will be deemed to constitute, a partnership...
IP Rights and abuse of dominanceIntellectual Property Rights (‘IPRs’) enable their owner to exclude third parties from use of the relevant protected...
Exceptions and defences to patent infringementA ‘patent’ is a document conferring so-called monopoly rights to an inventor. A patent protects new...
Case T- 691/14 Servier v Commission et al (pay–for–delay) [Archived]ARCHIVED—this achieved case hub reflects the position at the date of the decision...
Declaration of a director's interests—articles of associationA director who is in any way, directly or indirectly, interested in:•a proposed...
Material transfer agreementThis Agreement is made on [date]Parties1[Insert the company name] a company registered in [England and Wales] under company...
A divorce petition (in Form D8) is the initial court document by which an application is made for spouses to divorce and is also known as an application for a matrimonial order. There is one ground for a divorce, which is that the marriage has broken down irretrievably. A petition for divorce cannot be presented to the court before the expiration of one year from the date of marriage.
Overage (or clawback) is a seller’s right to recover additional payment(s) from a buyer at some point in the future, usually after completion of a sale, often triggered by the occurrence of an event which increases the value of the land (eg the grant of planning or completion of development).
An express indication by insurers stating that rights are reserved or there is a reservation of rights under the policy, means that indemnity under the insurance policy has not been confirmed. Any continued assistance provided by insurers is not to be deemed as waiving the position on insurance coverage.
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