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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 Sole traders, informal partnerships and outdated partnership deeds are common.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: Medical devices Data protection and life sciences Pharmaceuticals—regulatory framework Research and development Daily and weekly news alerts New and updated content Trackers Useful information UK medical devices regulation—where are we now? Life Sciences analysis: As expected, 2025 has become a pivotal year in the UK’s shift towards a new post‑ Brexit medical devices regime (see our earlier updates here and here). The Medicines and Medical Devices Act 2021 ( MMDA 2021) grants broad powers to the Secretary of State to set provisions that amend or supplement existing requirements. Although we are still awaiting the draft core regulations, some reforms are already in force. Freshfields’ Life Sciences team sets out recent highlights stemming from a series of consultations by the UK’s Medicines and Healthcare products Regulatory Agency ( MHRA), indicating the direction of travel. See News Analysis: UK medical devices regulation—where are we now? Med Tech Europe responds to European...
Alaska Airlines Inc v Virgin Aviation TM Ltd and another company [2025] EWHC 2505 ( Comm) What are the practical implications of this case? The principal outcomes of Mr Justice Foxton’s analysis can be stated as follows: Where an unjust enrichment claim founded on failure of basis is invoked to stop payment of a contractual amount, the correct characterisation is that this engages the defence of circuity of action (para [49]). In that scenario, circuity of action does not mean the debt is never due; rather, it supplies a defence to liability. A broadly drafted no set off clause captures such a defence, so summary judgment can be granted (para [52]). To reach those conclusions, Foxton J reviewed a range of authorities in which no set off provisions were relied upon (see especially para [47]), and he also considered and clarified other...
According to an official paper dated 8 October 2025, the European Commission intends to publish guidance on the EU AI Act’s relationship with other digital rules starting in Q3 2026, implying the documents could appear shortly before or after core provisions begin to apply. An annex to the Apply AI Strategy—an effort to accelerate AI uptake in priority industries—states the Commission will ‘develop guidelines on the EU AI Act’s interplay with other Union law from Q3 2026’. The annex outlines timelines for planned AI measure. Some projects are pinned to precise quarters, while others are slated to kick off from a broader window, implying activity may not commence until that point. Overall, the schedule signals a staggered roll-out across actions......
In this issue: Intellectual property Research and development Post-market Medical devices Pharmaceuticals—regulatory framework Disputes and regulatory enforcement Borderline products Competition in life sciences Daily and weekly news alerts New and updated content Trackers Latest Q& A Useful information Intellectual property Damages inquiry in trade mark infringement—economic benefits approach preferred over comparables analysis ( Merck KGa A v Merck Sharp & Dohme LLC) IP analysis: The High Court gave judgment in an uncommon inquiry into damages arising from breach of contract alongside trade mark infringement, deciding that: (1) damages should be assessed by reference to a notional licence fee; (2) the evidence demonstrated that a comparables-based licence analysis was an unreliable foundation for valuing that notional licence; and (3) in those circumstances, the suitable valuation method was the economic benefits approach. Using that...
Damages inquiry in trade mark infringement—economic benefits approach preferred over comparables analysis ( Merck KGa A v Merck Sharp & Dohme LLC) Merck KGa A v Merck Sharpe & Dohme LLC and other companies [2025] EWHC 2376 ( Ch) What are the practical implications of this case? Most IP disputes conclude once liability is resolved, meaning the High Court seldom addresses the mechanics of damages. This decision offers useful direction for those advising on quantification in trade mark infringement, notably when choosing between a comparables methodology and an economic benefits analysis for determining a hypothetical licence fee. Evidential standards for comparables analysis The court dismissed the claimant’s comparables methodology because expert scrutiny showed it rested on an unreliable study that failed to produce statistically meaningful findings. Although fact-sensitive, it underscores a clear point for practitioners: any comparables exercise must be grounded in robust, defensible...
In this issue: Medical device Research and development Post-market Competition in life sciences Intellectual property Pharmaceuticals—regulatory framework Advertising of medicines Lex Talk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Trackers Useful information Medical device Med Tech Europe leads industry call for EU to provide medical device regulatory relief by early 2026 Med Tech Europe, alongside 35 national associations, has pressed the European Commission to act quickly on regulatory hurdles impacting the medical device and diagnostic sectors. Although EU officials are gathering evidence to underpin future reforms of the medical device and in vitro diagnostic regulations—aimed at simplification and greater efficiency—the signatories to the open letter contend that prompt relief is also crucial. They urge a blend of short-term actions with longer-term legislative change. In...
In this issue: Post-market Intellectual property Pharmaceuticals—regulatory framework Research and development Medical devices Daily and weekly news alerts New and updated content Trackers Useful information Post-market What’s next for UK product liability? Andrew Austin, partner; Harriet Hanks, counsel; and Rachel Duffy, senior associate at Freshfields LLP, examine the UK Law Commission’s review of the domestic product liability framework for defective goods, with a particular lens on emerging technologies such as artificial intelligence, and set against notable recent developments in the EU. See News Analysis: What’s next for UK product liability? EMA updates pharmacovigilance requirements and ends Eudra Vigilance pilot phase The European Medicines Agency ( EMA) has released guidance following adoption of Commission Implementing Regulation ( EU) 2025/1466, which amends Regulation ( EU) No 520/2012. This change formally concludes the Eudra Vigilance signal detection pilot for Marketing...
News Analysis: UK product liability reform—new redress rules for AI systems? We recently discussed the likelihood of forthcoming changes to the UK product liability framework (see News Analysis: UK product liability reform—new redress rules for AI systems?), which could result in the UK’s product liability regime being brought into closer alignment with the new EU Product Liability Directive (the Revised EU PLD—see Practice Note: The Revised EU Product Liability Directive). The Law Commission has since confirmed a formal review of the UK’s product liability regime within its 14th work programme. For now, the apparent emphasis of that review is on ‘emerging technologies’, with a particular spotlight on AI......
While contesting the validity of the patent covering the diabetes medicine dapagliflozin—a case Astra Zeneca ultimately failed to win—the pharmaceutical heavyweight applied for and obtained four temporary injunctions preventing rival generics producers from releasing their own formulations. When the final judgment went against it, at the trial's conclusion, the business also failed in contending that it should be spared liability for the expenses incurred in securing those injunctions......
( Modernatx, Inc v Pfizer Ltd and other companies [2025] EWCA Civ 1032) What are the practical implications of this case? Selection from lists and classes in prior art The Court of Appeal reaffirmed that prior art only anticipates a claim where it contains an individualised description of the very invention asserted. Merely assembling elements from two or more enumerations—such as a roster of modified nucleosides alongside a set of percentage substitutions—will not strip novelty unless the earlier disclosure unmistakably directs the reader to that precise pairing. This approach, consistent with EPO Boards of Appeal jurisprudence and domestic authorities including Dr Reddy’s Laboratories v Eli Lilly, is of particular significance for those drafting or contesting patents in areas where inventions are characterised by combinations of known attributes. Applying that test, the court found the UPenn application canvassed a wide spectrum of modified...
In this issue: Business transactions Commercialisation Medical devices Pharmaceuticals—regulatory framework Advertising of medicines Post-market Daily and weekly news alerts New and updated content Trackers Useful information Business transactions Med Tech Europe issues position paper on due diligence and sustainability reporting legislative reforms Med Tech Europe has released a position paper on proposed changes to the Corporate Sustainability Due Diligence Directive ( CSDDD) and Directive ( EU) 2022/2464, the Corporate Sustainability Reporting Directive ( CSRD). It supports limiting due diligence responsibilities to Tier 1 suppliers and welcomes the removal of a harmonised EU civil liability regime. The paper further recommends extending monitoring timelines from 12 months to five years, capping sanctions at 5% of turnover, and retaining limited assurance requirements under the CSRD. Its overarching objective is to ease administrative load while keeping...
Peter Dunn v Kostas Kazolides [2025] EWHC 2212 ( Ch) Mr Dunn, a former chartered accountant and insolvency practitioner, brought a claim for almost £9m against Mr Kazolides. The High Court held that Mr Kazolides (represented at trial by Dov Ohrenstein of Radcliffe Chambers and Canfields Law Solicitors) had given a guarantee in relation to a Cypriot company that owed substantial sums to Mr Dunn, yet the claim was dismissed. How could Mr Kazolides nevertheless prevail in his defence and avoid any liability to pay under the guarantee? By way of background, under a joint venture agreement, Mr Dunn advanced funds to the company to finance the development and sale of seven villas in Cyprus. The agreement stipulated that the loan became repayable upon ‘the insolvency of the company’ and, as the judge found, it also contained a guarantee from Mr...
In this issue: Intellectual property Pharmaceuticals—regulatory landscape Medical devices Commercialisation Life sciences and data protection Medicines advertising Lex Talk® Life Sciences: a Lexis®Nexis community News alerts—daily and weekly Updated and new content Trackers Useful information Intellectual property Bayer keeps Xarelto profits from period of sales ban On 1 September 2025, a London court decided that Bayer may retain the profits it gained from sales of its blood‑thinning medicine Xarelto during an interim sales ban that stopped generic drugmakers from infringing a patent that has since been revoked. See News Analysis: Bayer retains Xarelto profits earned during sales ban. Judgment Alert: Sandoz Ag v Bayer Intellectual Property Gmb H [2025] EWHC 2201 ( Pat). The judgment for this case has been published. See: [2025] EWHC 2201 ( Pat). Judgment Alert: Generics ( UK) Ltd v...
Michael Tappin KC, serving as a Deputy High Court Judge, concluded that Bayer AG had not promised to yield its own profits when it agreed to compensate Sandoz AG for any losses linked to the postponed 2024 roll-out of its generic medicine. Tappin J dismissed Sandoz’s demand for Bayer’s profits, finding the claim doomed to fail. The court considered the reach of Bayer’s undertakings during the interim injunction to be unmistakable. As Tappin J explained, Bayer agreed to comply with whatever order the court might issue to make good any loss Sandoz suffered because of the injunctions, and to be jointly and severally responsible for any monetary sum the court awarded for that purpose. Bayer was not undertaking to......
UPC Court of Appeal declines ECJ referral on costs deadline The UPC Court of Appeal has dismissed Expert e‑ Commerce Gmb H’s bid to involve the European Court of Justice in assessing whether the UPC’s time limits for claiming costs are excessively narrow. The application followed the German company’s failure to meet the cut-off to recover costs in proceedings against Seoul Viosys Co Ltd, a subsidiary of Seoul Semiconductor Co Ltd. The appellate judges concluded they cannot request the European Court of Justice to interpret the UPC Agreement. According to the ruling, that framework “forms part of international law” and does not constitute an EU regulation, directive or act. The court added that the same position applies to its Rules of Procedure. A request for a preliminary ruling must address the interpretation or validity of EU law, rather than construing national rules or matters of......
Purpose and scope The Early Access Service proposal builds on initiatives such as the Innovative Devices Access Pathway ( IDAP), as set out by the MHRA. According to the MHRA, IDAP demonstrated the value of co-ordinated regulatory support and a clearly targeted access route for medical devices. The service will apply to innovative devices that respond to clearly defined unmet clinical needs from the NHS, or that could significantly improve patient outcomes. In its statement of intent, the MHRA indicates that the initial emphasis will be on diagnostic devices tackling the most pressing needs and supporting financial sustainability for the NHS. The MHRA has also confirmed that the Early Access Service will be underpinned by the Unmet Clinical Need Authorisation ( UCNA) tool within the IDAP scheme......
UPC’s Court of Appeal declined Expert e- Commerce Gmb H’s bid to have the European Court of Justice opine on whether the UPC’s deadlines for claiming costs are unduly strict. The move followed the German company’s failure to meet the cut-off to recover expenses arising from litigation against Seoul Viosys Co Ltd, a subsidiary of Seoul Semiconductor Co Ltd. The appellate panel stated it has no authority to ask the European Court of Justice to construe the UPC agreement, which, it said, forms part of international law rather than an EU regulation, directive, or act. The court added that the same characterisation extends to its Rules of Procedure as well......
In this issue: Intellectual property Data protection and life sciences Confidential information Borderline products Daily and weekly news alerts New and updated content Trackers Useful information Intellectual property Court of Appeal upholds Patents Court finding that prostate cancer treatment was not obvious ( Accord v Astellas) This decision from Lord Justice Arnold is essential reading if you plan to brief an expert in a patent dispute. The Court of Appeal rejected an appeal against the Patents Court’s conclusion that the patent was not invalid over the prior art cited. The obviousness case fell down largely because the expert’s analysis was affected by hindsight. Written by Giles Parsons, partner at Browne Jacobson, and Annabel Taylor, trainee at Browne Jacobson. See News Analysis: Court of Appeal upholds Patents Court finding that prostate cancer treatment was not obvious ( Accord v...
Accord Healthcare Ltd and other companies v The Regents of the University of California and another company [2025] EWCA Civ 936 What are the practical implications of this case? Three principal messages from the judgment are summarised below: First, in advancing an obviousness challenge, one must articulate the background that would prompt the notional skilled person or team to conclude that a given step is obvious. The claimant’s expert did not indicate that he approached the question on the footing that the skilled team, after reading the prior art, would be motivated to explore alternatives to it. The expert also failed to set out any objective that a medicinal chemist would be pursuing at any material time whatsoever......
How have plans for UK data protection reform evolved since Brexit? Since Brexit, the UK’s approach to data protection reform has ebbed and flowed markedly, with successive governments seeking to carefully balance innovation, economic growth and individuals’ rights. The Conservative government aimed to pivot to a GDPR ( General Data Protection Regulation) lite regime by introducing the Data Protection and Digital Information Bill. That bill outlined a series of business‑friendly amendments to existing data protection rules and progressed reasonably well through parliament, only to be ultimately shelved following a change of government in 2024. Once in office, the Labour‑led administration reignited the agenda, bringing forward the Data ( Use and Access) Bill ( DUAB). While retaining the core UK GDPR framework, DUAB set out targeted reforms that indicate a shift towards a more UK‑specific regime centred on data‑driven innovation, enhanced public services and strong data...
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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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