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R (Greyhound Board of Great Britain Ltd) v Welsh Ministers [2026] EWHC 670 (Admin) What are the practical implications of this case? The ruling reinforces the constitutional divide between the courts and the legislature. It explains that the scheme and framework of the Government of Wales Act 2006 (GWA 2006) embody that separation of powers, and that any judicial attempt to recognise and enforce a common law obligation on Welsh Ministers to consult prior to introducing legislation in the Senedd would trespass upon that boundary. This is not a departure from established principle; case law has already upheld comparable rules for lawmakers in Scotland and at Westminster. However, this is the first express confirmation of the position for Welsh lawmakers, and the first time this dimension of the GWA 2006 has been analysed in such depth. The court examined earlier
The solution arrived through the United Nations Compensation Commission (UNCC), a quasi‑judicial body handling mass claims, created under UN Security Council Resolution 687. By addressing environmental harm—most notably via its ‘F4’ claim class—the UNCC set a seminal benchmark shaping how international law and contemporary arbitral panels allocate financial responsibility for wartime ecological devastation. With present-day wars in areas such as Eastern Europe and the Middle East bringing dam breaches, strikes on chemical facilities, and the burning of farmland, the UNCC’s legacy endures as an essential reference point for states, global investors, and companies engaged in post‑conflict arbitration. The F4 claims: Quantifying the unquantifiable Prior to the 1990s, mechanisms in international law for war reparations overwhelmingly favoured property loss, foregone earnings, and bodily injury. The natural world was commonly treated as a mute, non-compensable victim of armed hostilities...
Understanding the farming business as a business Many farms still use long-standing structures that arose by habit, not strategy. Sole traders, informal partnerships and outdated partnership deeds are common. While once effective, such setups can cause major issues around succession, tax planning and involving the next generation. A corporate team can take a fresh, business-led view of the farm, asking: Who owns the land and other critical assets? Who manages daily operations? Who carries the risk and who enjoys the return? What is the enduring plan for succession? From this review, the team can confirm whether the current setup is fit for purpose or if an alternative — for example an updated partnership agreement, a company, a limited liability partnership, or a blended model — would better meet the family’s aims. Tax efficiency through joined-up advice Tax sits at the centre of most
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In this issue: Intellectual property Pharmaceutical—regulatory framework Research and development Competition in life sciences Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Intellectual property Haemophilia gene therapy patent valid and infringed ( Pfizer v uni Qure) The Patents Court rejected Pfizer’s attempt to revoke uni Qure’s EP( UK) 3,581,650 ( EP 650), which claims a “ Factor IX polypeptide mutant and a method for its production” and underpins uni Qure’s haemophilia therapy, Hemgenix. As a consequence, Pfizer cannot, for now, introduce its gene therapy Beqvez—approved by the EMA on 24 July 2024—in the UK, although it has indicated it will appeal. Pfizer accepted that, if EP 650 stood, it would infringe, but maintained the patent was invalid, alleging the particular amino acid substitution was obvious and devoid of...
Pfizer Inc v Uniqure Biopharma BV; Uniqure Biopharma BV and another company v CSL Behring Llc [2024] EWHC 2672 ( Pat) What are the practical implications of this case? This decision carries practical consequences for practitioners regarding, particularly: (i) how secondary material bears on inventive step; and (ii) the significance of expert testimony and the way the judge views those experts within proceedings. Secondary evidence The heart of Pfizer’s case was its ‘primary evidence’: that EP 650 lacked an inventive step over prior art— Stafford, a PCT application describing non‑naturally occurring FIX polypeptide mutants with assorted substitutions at position 338—when assessed by the notional skilled team (a gene therapist and a structural biologist). On that footing, they would deem it obvious to employ a modified FIX gene bearing leucine at position 338; on Pfizer’s telling, this followed...
In this issue: Research and development Medical devices Pharmaceuticals—regulatory framework Commercialisation Advertising of medicines Lex Talk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Research and development Navigating decentralised clinical trials with FDA’s guidance Law360: On 18 September 2024, the US Food and Drug Administration ( FDA) issued final guidance, ‘ Conducting Clinical Trials With Decentralised Elements’, for sponsors, investigators and other stakeholders to advance further development of drugs, biologics and medical devices. See: Navigating decentralised clinical trials with FDA’s guidance. HRA proposes simplified consent process for low-risk clinical trials The Health Research Authority ( HRA) has proposed streamlining informed consent for low-risk clinical trials in the UK. These trials, as defined by the HRA, compare pre-approved medicines and involve no additional therapeutic or diagnostic procedures. Under the plan, consent would be entered in patients’ medical records rather than written forms, while retaining the legal...
Decentralised clinical trials ( DCTs) Traditional clinical research is being reimagined through approaches that shift part or all trial activities from fixed sites to remote settings—participants’ homes, nearby healthcare facilities or mobile units—rather than standard trial centres. The goal is to expand access, boost participant diversity and drive operational efficiency. Yet the distance-based nature of DCTs brings distinct legal and regulatory challenges that sponsors must manage with care. The FDA’s final guidance, while not legally binding, outlines the agency’s current views and offers a practical road map for sponsors, investigators and other stakeholders to protect trial integrity and participant safety. For sponsors, adopting the DCT model entails devising strategies that align decentralised protocols with established regulatory requirements, while addressing risks such as cybersecurity threats, data integrity issues and telehealth privacy laws. As many DCTs operate...
In this issue: Medical devices Competition in life sciences Research and development Medical devices Commercialisation Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Medical devices Medical devices and the EU AI Act—how will two sets of regulations work together? Alison Dennis, partner and joint head of Taylor Wessing’s international life sciences group, examines how the EU AI Act slots into the existing regulatory regime for medical devices. See News Analysis: Medical devices and the EU AI Act—how will two sets of regulations work together? Competition in life sciences CMA: CAT fines Pfizer and Flynn £69m for excessive epilepsy drug pricing In 2022, the CMA imposed penalties of £63m on Pfizer and £6,704,422 on Flynn, amounting to £69.7m overall. The CAT reimposed virtually the same fines, concluding that Pfizer and Flynn had deliberately exploited their dominant market positions. The tribunal described their pricing as...
When is a medical device including AI subject to the EU AI Act? Any medical device that is, or incorporates, an AI system as defined by the EU AI Act, and is intended for the EU market, must comply with the Act’s rules. The term ‘ AI system’ is interpreted broadly and can encompass solutions that leverage big data to generate, for example, reasonably accurate predictions of an indication, even if they are not strictly what many would regard as artificial intelligence. As a consequence, many medical devices already available are captured within the Act’s scope... Medical devices and high- or limited-risk AI systems under the EU AI Act Medical devices may fall into high-risk or otherwise limited-risk categories. High-risk devices are subject to a more demanding regulatory framework that, in addition to medical device regulation obligations, requires Notified Body...
My Contracts Ltd v 74 Hamilton Terrace Freehold Ltd [2024] EWHC 2896 ( TCC) What are the practical implications of this case? This decision offers a timely reminder of the way time periods are to be construed within construction contracts, and acts as a useful sequel to the judgment in Elements ( Europe) Ltd v FK Building Ltd, which likewise involved a JCT form of contract. At bottom, though, it principally reiterates that the courts will give effect to the contractual text as agreed, and will decline to interpolate wording into a clause that the parties neither drafted nor intended. What was the background? My Contracts Ltd ( MCL) and 74 Hamilton Terrace Freehold Ltd (74HTF) entered into a contract based on the JCT Design and Build Contract 2016 edition, incorporating extensive bespoke amendments and dated 2 March 2023 (the Contract), for the execution of works...
What is the background that has led to the proposed legislation? The existing legal framework in Great Britain ( GB) – the Medical Devices Regulations 2002, SI 2002/618 (the UK MDR) – sets out only high-level, limited rules on post-market surveillance ( PMS). The practical detail on how manufacturers must carry out PMS and meet vigilance duties is instead provided through guidance. This has resulted in variations in how different manufacturers undertake PMS for devices in GB. The draft PMS Regulations are intended to curb these differences by codifying, in legislation, PMS obligations that are more stringent, prescriptive, and proportionate to risk for medical devices placed on the market or put into service in GB. PMS denotes the mandatory system requiring manufacturers to monitor and document the real-world use of medical devices by patients, safeguarding ongoing health and safety once regulatory...
In this issue: Medical devices Intellectual property Research and development Pharmaceuticals—regulatory framework Commercialisation Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Medical devices Impact of the draft Medical Devices ( Post-market Surveillance Requirements) ( Amendment) ( Great Britain) Regulations 2024 Alison Dennis, partner, and Alice Matthews, associate, at Taylor Wessing examine the draft Medical Devices ( Post‑market Surveillance Requirements) ( Amendment) ( Great Britain) Regulations 2024, which were laid before Parliament on 21 October 2024. See News Analysis: Impact of the draft Medical Devices ( Post‑market Surveillance Requirements) ( Amendment) ( Great Britain) Regulations 2024. MHRA launches consultation on pre-market medical device regulations The Medicines and Healthcare products Regulatory Agency ( MHRA) has opened a consultation on proposed revisions to pre‑market regulatory requirements for medical devices in Great Britain,...
Background to the appeal The question on this appeal concerns when a trade union may litigate, as a third party, for breach of an employment contract between employer and worker. Sections 1(1)(b) and 1(3) of the Contracts ( Rights of Third Parties) Act 1999 ( C( RTP) A 1999) create a default rule: where a contractual term grants a benefit to a third party who is expressly identified in the instrument, that third party can enforce the term in its own name. It applies only where the beneficiary is expressly identified within the contract and thereby conferred a benefit. The appeal turns on the proper reading of section 1(2) C( RTP) A 1999, which states that the default position is displaced if, construing the contract correctly, it appears the parties did not intend the term to be actionable by the third party. The...
General Court backs Glenmark over COPD inhaler trade mark The General Court has backed the UK based Glenmark Pharmaceuticals Europe Ltd in its successful opposition to the trade mark owned by Boehringer Ingelheim Pharma Gmb H & Co. KG concerning an inhaler for chronic obstructive pulmonary disease, a disorder that leads to breathing difficulties. According to the judgment, the German company’s sign is composed solely of elements required to achieve a technical outcome. As a result, it cannot function as a valid trade mark under the EU’s intellectual property framework, the court noted. An earlier European Union Intellectual Property Office......
In this issue: Intellectual property Medicines advertising Medical devices Data protection in life sciences Pharmaceuticals—regulatory framework Research and development Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Intellectual property Ian Jones, partner at Gill Jennings & Every LLP, reviews upcoming changes to UK marketing authorisations ( MAs) and supplementary protection certificates ( SPCs) following the UK Intellectual Property Office’s statutory guidance on SPCs for medicines, set to apply from 1 January 2025. On 31 October 2024, the UK IPO issued guidance detailing significant updates to MAs for medicines in the UK, grounded in the Windsor Framework, which will come into force on 1 January 2025. These reforms will influence existing and prospective SPCs, as well as the types of authorisation used to support SPC applications. See News Analysis: Changes to marketing authorisations and SPCs in the UK. The Patents Court has revoked two m RNA patents related to vaccine...
What are the practical implications of this case? The judgment offers insight into how the UK Patents Court currently treats plausibility. Applying the approach articulated by Lord Sumption in Warner‑ Lambert v Actavis [2018] UKSC 56, and restated by Mr Justice Meade, the touchstone is that there must be a substantive basis to consider the claimed effect credible, not mere conjecture. Absent such a reason, plausibility fails. On that test, the judge held the Patents were not plausible. Nonetheless, he accepted that, in some instances, the necessary “positive reason” might flow solely from the skilled person’s common general knowledge ( CGK). He cautioned, however, that this is more likely in mechanical arts than within the life sciences, and particularly not in the context of second medical use claims—the very scenario considered by the Supreme Court in Warner‑ Lambert. In any case, an example of that kind would be a...
In this issue: Research and development Medical devices Pharmaceutical regulation Data protection and life sciences Commercialisation Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Research and development Autumn Budget 2024—key Life Sciences announcements On 30 October 2024, within the Autumn Budget 2024, the Chancellor of the Exchequer, the Rt Hon Rachel Reeves MP, set out a £520m long‑term pledge for the Life Sciences Innovative Manufacturing Fund and an increase to the National Institute for Health and Care Research budget. These sit within more than £2bn of R& D backing to bolster life sciences and medtech research and to enhance the UK clinical trials ecosystem, alongside over £2bn earmarked for NHS technology and digital transformation. In total, £20.4bn of R& D investment was outlined for 2025–26. The government also confirmed renewal of the Tobacco Duty escalator and the introduction of a Vaping Product Duty from 1 October 2026. Miranda Cass,...
In this issue: Medical devices Pharmaceuticals—regulatory framework Borderline products Research and development Data protection and life sciences Competition in life sciences Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Medical devices Parliament lays draft SI to enhance patient and medical devices safety The UK Parliament has laid a draft statutory instrument ( SI) to implement the Medical Devices ( Post-market Surveillance Requirements) ( Amendment) ( Great Britain) Regulations 2024, aimed at strengthening patient safety. The reforms will boost traceability of incidents and trend reporting, set out clearer, risk‑proportionate obligations to improve device safety, and introduce a new risk‑based classification model. This will enable patients to access a wider range of medical devices already approved for use in other countries. The SI proposes a six‑month lead‑in period once parliamentary procedures have finished. The regulation is expected to take effect in 2025. See: LNB News 23/10/2024...
Most of the revisions mirror the CMA’s expanded powers under the UK Digital Markets, Competition and Consumer Act 2024 ( DMCCA), which received Royal Assent on 24 May 2024 and is now law. The government has indicated it intends to commence the competition and merger control provisions in December 2024 or January 2025. The DMCCA represents the most far‑reaching overhaul of UK competition rules since the Enterprise Act 2002 reshaped the merger control regime more than two decades ago. Merger control While the DMCCA establishes a bespoke reporting regime for designated tech firms, the bulk of the new rules cut across all sectors, not just technology. It: recalibrates the UK’s jurisdictional thresholds; introduces the UK’s first hybrid, no‑increment share of supply test to catch so‑called killer acquisitions as well as vertical and conglomerate mergers; and creates a safe harbour for smaller...
Illiquidx Ltd v Altana Wealth Ltd and others [2024] EWHC 2191 ( Ch) What are the practical implications of this case? This ruling underscores for all practitioners the need to pin down, with accuracy, the precise scope of the 'confidential information' their client wishes to shield. It contains takeaways for both transactional and disputes lawyers: from settling the language of a non-disclosure agreement ( NDA) to setting out, with particularity, the confidential material in issue and the ways said material is alleged to have been misused. Pitching an over expansive tranche of information as 'confidential' risks a strike-out for abuse of process. By contrast, failing to identify the relevant categories of 'confidential' information at the start, then attempting to widen those categories mid-proceedings, will almost certainly attract robust opposition from a defendant. Here, the claimant was criticised for a succession of amendments since...
In this issue: Intellectual property Competition in life sciences Pharmaceuticals—regulatory framework Medical devices Research and development Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Intellectual property Pfizer/ Bio NTech COVID-19 vaccine infringes a valid Moderna m RNA patent ( Moderna v Pfizer/ Bio NTech) Ian Turner, senior associate, and Sarah Taylor, senior practice development lawyer at Pinsent Masons LLP, provide commentary on the m RNA coronavirus vaccine patent clash initiated by Moderna against Pfizer and Bio NTech. The Patents Court ruled that one Moderna patent, EP ( UK) 3 718 565 ( EP565), was invalid for obviousness and added matter, while a second, EP ( UK) 3 590 949 ( EP949), remained valid and, by admission, Pfizer/ Bio NTech’s Comirnaty sat within its claim scope. Mr Justice Meade also...
Illumina v Commission; Grail v Commission — Joined cases C-611/22 P and C-625/22 P What are the practical implications of this case? The Court of Justice has unequivocally dismissed the expansive reading of Article 22 that had permitted the Commission to examine transactions that were not notifiable at EU or Member State level. Transactions that do not satisfy the relevant jurisdictional thresholds can no longer be referred. Nevertheless, M& A parties should note that the Commission has reiterated its wish for legal instruments to intervene in ‘those few cases where a deal would have an impact in Europe but does not otherwise meet the EU notification thresholds’ ( Executive Vice- President, Margrethe Vestager). This remains in line with the Commission’s conclusions in its ‘2021 Evaluation on the procedural aspects of EU merger control’. The Commission is also still prepared to entertain Article 22...
Modernatx, Inc v Pfizer Ltd and other companies; Pfizer Inc and another company v Modernatx, Inc [2024] EWHC 1695 ( Pat) Note that the issues concerning Moderna’s undertaking not to enforce its patents were separated into their own proceedings at a case management conference. That question was determined in a distinct High Court judgment by Judge Jonathan Richards, also delivered on 2 July 2024, which found that Pfizer and Bio NTech cannot rely on Moderna’s pandemic-era non-enforcement pledge to avoid the consequences of any infringement. For additional detail on both matters and the background, see Practice Note: Life sciences cases tracker— UK. See also Law360 News Analysis: Pfizer, Bio NTech infringed Moderna’s m RNA vaccine patent. The connected case citation is Pfizer Inc v Modernatx, Inc; Modernatx, Inc v Pfizer Ltd [2024] EWHC 1648 ( Pat). What are the practical...
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This Practice Note This Practice Note reviews mechanisms used in settling litigation. A Tomlin order consists of a consent order paired with a schedule. It operates to stay proceedings on terms that have been agreed. The provisions contained in the schedule may remain confidential. This Practice Note describes the scope of confidentiality attaching to the schedule and sets out how it differs from a standard consent order. Sample wording for a Tomlin order is included, alongside links to precedents, as well as guidance on court approval. It also addresses varying, setting aside and enforcing a Tomlin order, including the considerations the court will take into account when handling applications for each. Further guidance is provided on interpreting and applying the relevant provisions of the CPR; however, some courts and divisions impose very specific requirements for both drafting and approval, and for approaching the schedule and confidentiality issues. Accordingly, you must consider the particular rules and court guide provisions in the forum where your claim is proceeding when drawing up the Tomlin order...
Date [ date ] Parties [ name of Landlord ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Landlord) [ name of Tenant ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Tenant) [ [ name of Guarantor ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Guarantor) ] [ [ name of Mortgagee ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Mortgagee) ] Definitions Within this Deed, the terms below shall be interpreted as follows: [ Annual Rent • the annual sum reserved under the Lease; ] [ Insurance Rent • the Tenant’s share of the Landlord’s costs of insuring the Property (as set out in the Lease); ] Lease • the lease of the Property dated [ date ], entered into between (1) [ the Landlord OR [ name ...
I, [ name ], of [ address ], solemnly and sincerely state that: [ Matters to be verified, set out in numbered paragraphs ] I make this solemn statement in good conscience, believing it to be true, and pursuant to the provisions of the Statutory Declarations Act 1835. DECLARED at [ details ] this [ day ] day of [ month and year ] Before me ................................................................................ [ signature of the person before whom the declaration is made ] A [ commissioner for oaths OR [ solicitor OR [ insert other qualification ] ] authorised to administer oaths ]...
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