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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 Sole traders, informal partnerships and outdated partnership deeds are common.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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Samsung Bioepis UK Ltd v Alexion Pharmaceuticals Inc [2025] EWHC 1240 ( Pat) What are the practical implications of this case? This decision delivers a clear warning to life sciences patent practitioners: exactitude in sequence‑defined claims is critical. Although the therapeutic product aligned with the invention’s aim, the presence of a non‑functional 22‑amino acid leader in the claimed light chain—absent from the mature eculizumab antibody—proved determinative. Alignment between product and concept could not cure the defect. The High Court refused a purposive reading that would excise the leader sequence, holding the claim wording unequivocal and the patent both invalid and not infringed. The ruling highlights the narrow scope for interpretative latitude. The court treated the language of the claim as pivotal, keeping its focus on the words actually chosen. It emphasised that “consisting of” expresses a closed definition, and that scientific...
In this issue: Post-market Intellectual property Pharmaceuticals—regulatory framework Medical devices Research and development Commercialisation Daily and weekly news alerts New and updated content Trackers Useful information Post-market UK product liability reform—new redress rules for AI systems? Andrew Austin, partner; Harriet Hanks, counsel; Rachel Duffy, senior associate and Alexandra Yang, trainee associate of Freshfields LLP, examine the UK Law Commission’s initiative to reassess the current regime on liability for defective products, with particular emphasis on emerging technologies such as AI, and set against the backdrop of notable, recent EU developments. See News Analysis: UK product liability reform—new redress rules for AI systems? Intellectual property When sequence precision backfires—invalidity and non-infringement of eculizumab patent with 22-amino acid leader ( Samsung v Alexion) IP analysis: The High Court found Alexion’s eculizumab patent, which specified a light chain sequence featuring a...
Changes on the horizon— AI to be in scope and hints of a more pro-consumer balance The UK Law Commission has unveiled a fresh project to reassess the framework for civil liability arising from defective products in the UK, a field presently set by the Consumer Protection Act 1987 ( CPA 1987). Long anticipated, this move follows sustained debate about the UK’s post- Brexit trajectory. In particular, attention has focused on the extensive, pro-consumer reform of the EU regime—on which the UK’s CPA 1987 is founded—first unveiled in September 2022 and now enshrined in Directive ( EU) 2024/2853, the Revised EU Product Liability Directive (the Revised EU PLD). Observers have expected such a step for some time, especially as the EU has pressed ahead with its revisions, prompting calls for clarity on the UK’s direction......
Justice Richard Arnold concluded that, at the material time, specialists would not have regarded it obvious to modify m RNA in the manner described in Moderna’s patent claims. He rejected arguments that the Moderna patent conferred protection on nothing beyond what was already common knowledge. Considering the issues as a whole, he stated that Pfizer/ Bio NTech’s obviousness attack fails—and it is not a close call—in a unanimous ruling. The dispute dates to 2022, when Moderna issued patent infringement proceedings against Pfizer and Bio NTech in the US and Germany, alleging that the rivals infringed two patents safeguarding its m RNA technology. Pfizer subsequently challenged the validity of the corresponding UK patents in the High Court. That court ultimately set aside one of the patents while leaving the other intact, with Arnold J explicitly recording these findings in the written...
In this issue: Pharmaceuticals—regulatory framework Research and development Medical devices Intellectual property Post-market Data protection and life sciences Advertising of medicines Lex Talk® Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Trackers Useful information Pharmaceuticals—regulatory framework NICE and MHRA to align under 10‑ Year Health Plan, speeding access to medicines The National Institute for Health and Care Excellence ( NICE) and the Medicines and Healthcare products Regulatory Agency ( MHRA) have established a joint information‑sharing arrangement to hasten NHS patients’ access to new medicines in England. As a component of the government’s 10‑ Year Health Plan for England, pharmaceutical companies are invited to engage early with both organisations to facilitate parallel decisions on licensing and value. The agencies indicate this joined‑up route should see medicines ready for NHS use at the point they obtain a UK licence, with access times expected to fall by three to six months. To access the...
In this issue: Disputes and regulatory enforcement Medical devices Pharmaceuticals—regulatory framework Research and development Data protection and life sciences Commercialisation Advertising of medicines Daily and weekly news alerts New and updated content Trackers Useful information Disputes and regulatory enforcement Astellas defeats bid by generics to overturn cancer drug patent protections. Law360 reports that, on 23 July 2025, producers of generic medicines were unable to persuade a London appeal judge to set aside the remaining protections for Astellas Pharma’s leading prostate cancer therapy, Xtandi, as the evidence was held to be ‘tainted with hindsight’. See: Astellas beats generics application to set aside cancer drug patent. Judgment Alert: General Pharmaceutical Council v Ahmed [2025] EWHC 1866 ( Admin). The Administrative Court allowed the General Pharmaceutical Council’s application, under Article 56(5) of the Pharmacy Order 2010, to prolong an interim suspension imposed on the respondent, a registered pharmacist, for a further nine months. The respondent neither attended nor obtained...
The Court of Appeal affirmed a decision dismissing assertions by Accord Healthcare, Sandoz and Teva that chemists would have deemed it 'immediately obvious' to create Astellas' patented cancer therapy, enzalutamide, because the expert evidence failed to explain why a particular atomic group would have been selected by chemists. The Xtandi patent is held by the University of California and is licensed on an exclusive basis to Astellas Pharma Inc. Writing for a panel of three justices in November 2024, Judge Richard Arnold said the judge was entitled to treat that omission as relevant when evaluating the expert’s evidence. The generics contended that a poster and presentation slides had disclosed a molecule akin to Astellas' claimed enzalutamide. According to the Court of Appeal judgment, they argued that the irresistible conclusion was that the patented invention was obvious. The claimed compound is...
The Commission has issued its ‘ Guidelines on the scope of obligations for general‑purpose AI models’. Though not legally binding, they explain how the Commission reads and applies Regulation ( EU) 2024/1689 (the EU AI Act), which will underpin its enforcement practice and thus offer significant practical clarity. They succeed a prior draft circulated in April 2025 for consultation (see: LNB News 18/07/2025 40 and LNB News 22/04/2025 37). The final text concentrates on four central and closely linked themes: defining GPAI models, what counts as a provider placing a GPAI model on the market, the open‑source exemptions to the obligations for GPAI models, and certain considerations on the enforcement of the GPAI model framework. What is a GPAI model? The guidelines set out three key elements about GPAI models: an indicative benchmark for when a model qualifies as a GPAI model, how the...
During an appearance with von der Leyen in Scotland, Trump hailed the pact as “the largest deal ever struck”, noting that 15% tariffs would cover most goods entering from the EU. In exchange for dialling back a threatened 30% levy, the EU will buy hundreds of billions of dollars’ worth of US energy and increase investment in the American market. Trump argued the agreement would draw the EU and the US closer and settle long-running trade disputes between his administration and Europe. “ It’s a very powerful deal,” he said. “ It’s the biggest of all the deals.” Von der Leyen likewise sounded upbeat, admitting there was “heavy lifting” at the outset but saying both sides had arrived at a satisfactory settlement. She noted the EU had long run a trade surplus with the US and that the aim was to rebalance commerce so the...
In this issue: Medical devices Intellectual property Data protection and life sciences Pharmaceuticals—regulatory framework Research and development Competition in life sciences Daily and weekly news alerts New and updated content Trackers Useful information Medical devices Government supports new UK medical device rules following consultation The Medicines and Healthcare products Regulatory Agency ( MHRA) has issued the government’s concluding response to its consultation on planned updates to medical device legislation, setting out future pathways to market for medical devices. The government will advance three principal changes: adopting an international reliance framework, removing the UKCA marking requirement once devices carry unique device identification ( UDI), and revising the classification of in vitro diagnostic ( IVD) devices. Collectively, these measures are intended to modernise oversight while promoting innovation and protecting patient safety. See: LNB News 23/07/2025 14. AI...
The conclusive edition of the General- Purpose AI ( GPAI) Code of Practice appeared on 10 July 2025. It succeeds three prior drafts, issued in November 2024, December 2024, and March 2025. Pending scrutiny and validation by the European Commission and Member States, the 10 July text is treated as definitive in advance of the GPAI provisions of Regulation ( EU) 2024/1689 (the EU AI Act) taking effect on 2 August 2025. Commission guidance clarifying key notions linked to GPAI models, released on 18 July 2025, sits alongside the Code of Practice as an accompaniment. This Code is a voluntary instrument, supported by the EU AI Office and produced by a consortium of academics and industry participants, intended to assist GPAI model providers in fulfilling the corresponding obligations of the EU AI Act (see: LNB News 18/07/2025 40, LNB News...
On 18 July 2025, the Commission issued administrative guidance on the EU AI Act’s rules for GPAI models, designed to clarify scope, core concepts and how these interact with a related code of practice. The guidance sets out key legal terms to map the reach of the EU AI Act’s global partnership and artificial intelligence ( GPAI) regime and pinpoint which businesses must comply. An initial draft was released in April 2025 to gather views from stakeholders. Following that consultation, the Commission’s AI Office outlined the principal revisions to EU Member States at a European AI Board meeting in late June 2025. The GPAI provisions will apply from 2 August 2025... Definition of GPAI models The guidance introduces a quantitative test to determine whether a model qualifies as a GPAI model—and is therefore within the AI Act’s remit—based on the computing power used for...
A three-judge panel affirmed the conclusions of Michael Tappin KC, who sat as a deputy High Court judge, dismissing Astra Zeneca’s attempt to overturn his ruling that its dapagliflozin patent added nothing beyond an earlier international patent application. Justice Richard Arnold, writing for the court, said specialists reading Astra Zeneca’s claims would have a ‘legitimate reason to doubt’ that dapagliflozin would serve as an effective therapy for diabetes. The row centres on Astra Zeneca’s patent for the dapagliflozin molecule, which lapsed in May 2023. Astra Zeneca had obtained supplementary protection certificates for the compound, due to run until May 2028. A number of generic manufacturers — including Teva Pharmaceutical Industries Ltd, Glenmark Pharmaceuticals Europe Ltd and Generics ( UK) Ltd — petitioned the High Court to revoke the patent and, by extension, the supplementary protections, seeking to pave the way to market their own...
In this issue: Intellectual property Pharmaceuticals—regulatory framework Competition in life sciences Medical devices Post-market Disputes and regulatory enforcement Daily and weekly news alerts New and updated content Trackers Useful information Intellectual property Pfizer targets Moderna’s remaining m RNA safeguards. Law360, London: On 10 July 2025, Pfizer urged an appeals court to strike out excess patent rights supporting Moderna’s m RNA vaccine after a core patent was thrown out. See: Pfizer takes aim at Moderna’s leftover m RNA protections. Judgment Alert: Generics ( UK) Ltd v Astrazeneca Ab [2025] EWCA Civ 903. The judgment in this matter has been released. See: [2025] EWCA Civ 903. Pharmaceuticals—regulatory framework Government announces regulatory reforms in Life Sciences Sector Plan, ABPI warns on pricing. The Department for Science, Innovation and Technology ( DSIT) and partner departments set out reforms in a new Life...
Counsel for Pfizer and its collaborator Bio NTech told the Court of Appeal on 10 July 2025 that the High Court had ‘fallen into error’ when assessing whether a central claim of Moderna’s patent was both novel and obvious at the time it filed the application. Tom Mitcheson KC, appearing for Pfizer, made clear that only Claim 3 of the surviving Moderna patent remained in dispute in these proceedings. Its challenge to Claim 5 fell away because it is not part of Moderna’s pending claim requests before the European Patent Office. Accordingly, Mitcheson said that their position on novelty is now ‘even stronger’ than it was before the trial judge. Moderna began the case in 2022 by issuing suits against Pfizer and Bio NTech in the US......
In this issue: Research and development Medical device Pharmaceuticals—regulatory framework Data protection and life sciences Advertising of medicines Daily and weekly news alerts New and updated content Trackers Useful information Research and development Commission launches strategy to boost life sciences in Europe The European Commission has unveiled a Life Science Strategy to make Europe the most attractive global base for life sciences by 2030, while tackling long-standing structural barriers that have suppressed competitiveness and restricted patient access to cutting-edge therapies. With support exceeding €10bn per year, the plan seeks to speed innovation, improve market entry, and strengthen public confidence across the full life sciences value chain. See: LNB News 04/07/2025 32. Government’s 10 Year Health Plan for England outlines regulatory priorities The government’s 10 Year Health Plan for England signals a regulatory reset to position the NHS as a world leader in digital health and life sciences. Reforms will accelerate clinical trial...
In this issue: Medical devices Research and development Pharmaceuticals—regulatory framework Lex Talk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Trackers Latest Q& A Useful information Medical devices New MDCG guidance on the interplay between the MDR/ IVDR and the EU AI Act Hélène Boland, senior associate, and Fabien Roy, partner at Hogan Lovells, outline the principal insights from MDCG 2025-6 on how the Medical Device Regulation ( MDR) and In Vitro Diagnostic Medical Device Regulation ( IVDR) intersect with the EU AI Act. See News Analysis: New MDCG guidance on the interplay between the MDR/ IVDR and the EU AI Act. MHRA announces AI Airlock expansion and joins global health AI regulatory network The Medicines and Healthcare products Regulatory Agency ( MHRA) has invited applications to an enlarged AI Airlock programme after last year’s pilot. The agency has also become the first founding member of Health AI’s new...
On 19 June 2025, the Medical Device Coordination Group ( MDCG) issued fresh guidance ( MDCG 2025-6) on how Regulation ( EU) 2017/745 (the Medical Devices Regulation, MDR), Regulation ( EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation, IVDR), and Regulation ( EU) 2024/1689, the EU AI Act, interrelate. The document supplies a first set of answers to the most frequently asked questions on the joint application of the EU AI Act and the MDR/ IVDR for manufacturers of AI systems used for medical purposes ( MDAI). The MDCG guidance clarifies a few points: manufacturer vs provider and user vs deployer The MDCG explains that references to ‘manufacturer’ within the meaning of the MDR/ IVDR should be understood as referring to ‘provider’ in accordance with the EU AI Act......
A victim of crime Under VPA 2024, a ‘victim’ is any person who has suffered harm directly from being subjected to criminal behaviour, or from seeing, hearing or otherwise directly experiencing its effects as it occurred. Someone is also a victim where any of the following apply: their birth was the direct consequence of criminal behaviour the death of a close family member was the direct result of criminal behaviour they are a child who is a victim of domestic abuse that amounts to criminal behaviour ‘ Harm’ covers physical, psychological or emotional harm, as well as financial loss. There is no requirement for the offence to have been reported, for any investigation to have taken place, or for any charge or conviction to have followed. Permitted disclosures The following are permitted disclosures under VPA 2024, section 17: disclosures made to the police or......
In this issue: Post-market Disputes and regulatory enforcement Medical devices Pharmaceuticals—regulatory framework Data protection and life sciences Research and development Borderline products Advertising of medicines Daily and weekly news alerts New and updated content Trackers Useful information Post-market MHRA launches landmark post-market surveillance changes for medical devices in Great Britain. The Medicines and Healthcare products Regulatory Agency ( MHRA) has put into effect the Medical Devices ( Post-market Surveillance Requirements) ( Amendment) ( Great Britain) Regulations 2024, SI 2024/1368, representing the first substantial revision of PMS rules for medical devices in Great Britain. See: LNB News 17/06/2025 16. Disputes and regulatory enforcement UPC supports sales prohibition on kits infringing 10x Genomics patent Law360: The Unified Patent Court’s ( UPC) Local Düsseldorf Division has held that Curio Bioscience’s Seeker Spatial Mapping Kits infringe patents owned by 10x...
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When evaluating a general damages claim, the practitioner ought initially to refer to the Judicial College Guidelines (JCG)...
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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