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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 Sole traders, informal partnerships and outdated partnership deeds are common.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 a ruling dated 16 June 2025, the UPC determined that Curio Bioscience Inc.’s array offering ‘literally’ mirrors the core elements of a patent held by 10x Genomics Inc. for detecting nucleic acids in tissue samples. The court dismissed Curio Bioscience’s assertions that its product sat outside the patent’s scope, reasoning that the mode of manufacture and certain technical distinctions did not change the product’s capacity to infringe. The judges said the contested embodiment makes literal use of the claim’s teaching, and concluded that every necessary design feature appears in Curio Bioscience’s array... 10x Genomics’ patent concerns a method for detecting and analysing nucleic acids, including DNA, within a tissue sample. According to the patent, the technology enables detailed mapping of genetic information inside tissues, with potential application in fields such as cancer research. 10x Genomics contended that Curio’s kits, which rely on...
GPAI model developers should still get a final draft of the EU Code of Practice from the Commission in July 2025, despite a potential ‘stop the clock’ on the EU AI Act, MLex has learned Bilateral talks are continuing, and the draft is foreseen for the first week of July. MLex earlier reported that the Commission was weighing a hold on the EU AI Act after a critical letter from the Trump administration in the US and a visit to Washington by the Commission’s Executive Vice- President for Tech Sovereignty, Security and Democracy, Henna Virkkunen. The matter was recently put on the agenda of a meeting of EU digital ministers, where Virkkunen formally indicated that parts of the EU AI Act could be paused if technical standards and administrative guidance are not ready when the rules take effect. The EU AI Act phases in over...
In this issue: Medical devices Commercialisation Pharmaceuticals—regulatory framework Intellectual property Research and development Data protection and life sciences Daily and weekly news alerts New and updated content Trackers Useful information Medical devices Commission seeks views on high-risk AI classification and obligations The European Commission has opened a public consultation to help shape the roll-out of the EU AI Act’s measures for high-risk AI systems. Led by the Commission, the exercise looks to collect real-world examples and to clarify how the rules apply to high-risk uses—covering systems that are essential to product safety under EU legislation and those that can markedly affect health, safety, or fundamental rights. Contributions will inform Commission guidance on how to categorise these systems and define the related obligations across the AI value chain. A broad range of...
EU trade chief Maroš Šefčovič will meet the Chinese commerce minister on 3 June 2025 to press on with talks aimed at settling the ongoing row. The mooted curbs stem from an inquiry opened in April 2024 by the European Commission under the International Procurement Instrument ( IPI), a trade defence mechanism that took effect in August 2022. Through the IPI, the EU may levy price penalties on bidders, bar them from EU tenders, or use a mix of both steps in combination. Any such limits must be proportionate and in the ......
In this issue: Intellectual property Medical devices Pharmaceuticals—regulatory framework Borderline products Commercialisation Advertising of medicines Lex Talk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Trackers Useful information Intellectual property Chris Weekes, Technical Assistant at D Young & Co, reviews a landmark ruling on infringement of a second medical use patent, indicating how the Unified Patent Court ( UPC) may handle such claims. See News Analysis: First UPC infringement decision for second medical use claims. Medical devices MLex reports that the European Commission is weighing a delay to the EU AI Act entering into application amid disputes over a code of practice for AI models, mounting industry resistance, and slippage in drafting technical standards. The move, still unconfirmed, could pause enforcement timelines to allow targeted amendments aimed at...
Sanofi Biotechnology SAS & Regeneron Pharmaceuticals Inc v Amgen Inc & Others ( UPC_ CFI_505/2024). Background Article 54(5) of the EPC 2000 permits purpose‑limited product claims—often termed ‘second medical use claims’—to protect a known product for a particular therapeutic use, provided that use is both novel and inventive. These claims are highly attractive, as they can secure protection for employing an existing medicine in a fresh therapeutic method. Yet the scope of third‑party activities barred by such claims has long been uncertain, prompting a series of recent rulings across Europe. Consequently, differing and evolving infringement standards have emerged between jurisdictions. A common tactic of generic pharmaceutical companies to try to avoid infringement is ‘skinny labelling’, whereby protected indications are carved out of the summary of product characteristics ( Sm PC) to steer clear of liability linked to those indications. The UK Supreme Court endorsed this...
The AI Act follows a staggered timeline for when its different chapters take legal effect, although the enforcement rules and sanction regime will only apply with the bulk of the provisions starting 2 August 2026 The AI Act is being phased in, with different chapters activating at separate times, while the enforcement mechanisms and penalties start alongside most provisions on 2 August 2026. The early roll-out has been demanding, with the Commission juggling the creation of a new AI Office, the publication of administrative guidance, and the orchestration of a code of practice for general-purpose AI models. That code has become especially divisive, touching on delicate matters such as copyright safeguards in developing generative AI and approaches to societal risks, which ultimately led to the legal deadline being missed. It has also turned into a source of friction with the US...
In this issue: Intellectual property Competition in life sciences Research and development Borderline products Advertising medicines Daily and weekly news alerts New and updated content Trackers Useful information Intellectual property In light of the evidence—documentary analysis defeats inventor’s account of patent entitlement ( Hill v Touchlight Genetics) This dispute concerned entitlement to an invention by Dr Hill, with the exact timing decisive. A service agreement between her and the defendants ( Touchlight) was said to assign only part of her rights, leaving a remainder allegedly infringed by the defendant. Although the inventor placed significant weight on her testimony, there was a substantial body of contemporaneous documents. In dismissing the claim, the court conducted a meticulous review of presentations, emails and draft patents to resolve the timing question. The decision shows that, in such exercises, what a...
Facts The defendant in the proceedings, Ms Lawrence, entered into a loan agreement with a lender, for whom HNW, the claimant in the matter, acted as the security agent for the lender. The purpose of the loan agreement was to help finance Ms Lawrence’s development of a property. That property was also secured separately by a legal mortgage, operating as continuing security to the lender under the loan terms. Although HNW was not itself a party to the loan agreement, the loan agreement nonetheless contained an express provision said to grant HNW certain third party rights to enforce its terms; namely, that, even though HNW Lending Ltd was not a party to this Loan Agreement, HNW Lending Ltd could take the benefit of and specifically enforce each and every express term of the Loan Agreement, together with any term implied under it pursuant to the...
In this issue: Research and development IP Pharmaceuticals—regulatory framework Advertising of medicines Commercialisation Medical devices Daily and weekly news alerts New and updated content Trackers Useful information Research and development New Clinical Trials Regulations will bring UK closer to EU regime Rory Trust, director, and Fraser Campbell, trainee solicitor at Burges Salmon LLP, review the incoming UK Clinical Trials Regulations set to commence in 2026, also contrasting the UK and EU clinical trial frameworks, among other aspects. The legislation has now been enacted and, following a 12-month implementation window, will apply from April 2026. It represents the most substantial overhaul of UK clinical trial rules in two decades. See News Analysis: New Clinical Trials Regulations will bring UK closer to EU regime. MHRA launches major clinical trials overhaul, real-world data consultation and Inclusion and Diversity Plan...
The decision in Generics ( UK) Ltd v Astra Zeneca AB [2025] EWHC 1012 ( Pat) highlights the growing divergence between UK patent law and the European Patent Office’s approach, particularly in the aftermath of the Enlarged Board of Appeal’s G 2/21... Reassertion of the plausibility standard At the centre of the dispute was Astra Zeneca’s patent for dapagliflozin, an inhibitor of the sodium-dependent glucose co-transporter protein SGLT2, employed to reduce blood glucose for treating type II diabetes... Although EP1506211 expired in May 2023, Generics UK, Teva and Glenmark pursued declarations of invalidity and the revocation of the related Supplementary Protection Certificates, SPC/ GB13/021 and SPC/ GB14/050. They argued that... the patent did not make it plausible that dapagliflozin is a (selective) SGLT2 inhibitor or is useful in the treatment of diabetes... the patent offered no technical contribution over the prior art ( WO...
In this issue: Intellectual property Post-market Competition in life sciences Commercialisation Data protection and life sciences Advanced therapeutics Pharmaceuticals—regulatory framework Research and development Daily and weekly news alerts New and updated content Trackers Useful information Intellectual property Patenting AI innovations in healthcare—navigating European patent law Jack Severs (partner) and Joe Spencer (associate) of Gill Jennings & Every LLP explore what is considered patent-eligible in European AI healthcare. See News Analysis: Patenting AI innovations in healthcare—navigating European patent law. Dapagliflozin— UK court reaffirms plausibility standard despite G 2/21 In Generics ( UK) Ltd v Astra Zeneca AB, the High Court of England and Wales delivered a thorough restatement of the UK tests for inventive step and sufficiency, anchored in the idea of ‘plausibility’. Ian Jones, partner at Gill Jennings & Every LLP, assesses the ruling. The...
Illiquidx Ltd v Altana Wealth Ltd and others [2025] EWHC 299 ( Ch) What are the practical implications of this case? This decision highlights the need for precise, clear definitions and clauses in NDAs, especially concerning the boundaries of confidential information and what falls within the public domain. Equally, spelling out permitted disclosures reduces uncertainty; providing information to third parties does not, on its own, render it public or remove its confidentiality. The court will evaluate disclosures on their individual facts, with the key consideration being how far the veil of secrecy still remains. It is also prudent to set out contractually how confidential information will be handled if a commercial relationship ends or breaks down unexpectedly. Measures might include requiring confidential information (and any materials that contain it) to be returned, deleted, or destroyed. For trade secret protection, the absence of an NDA does not...
On 8 May 2025, Rain Newton- Smith, chief executive of the Confederation of British Industry, argued that the narrow trade agreement should open the door to closer collaboration so both economies can thrive. The US and UK confirmed a tariff reduction covering more than US$400bn in goods and services, unveiled the same day by President Donald Trump and Prime Minister Keir Starmer. Newton- Smith added that, once the immediate reaction subsides, it will be vital to assess the consequences and join forces with partners to broaden its scope, and urged ministers to engage with business to clarify how best to capitalise on the opportunities the deal offers. Announced on television following a phone call between Trump and Starmer, the arrangement trims duties on British cars from 25% to 10% and lifts tariffs on selected metals, according to the two leaders. A 10%...
AI healthcare in Europe AI is transforming healthcare by sharpening diagnostic accuracy, forecasting patient risk, and speeding up drug discovery and development, thereby streamlining development pipelines. Predictive AI models can be trained on extensive historical clinical data to deliver reliable predictions and estimations that support a wide range of healthcare tasks. For example, by training an AI system on archives of medical images linked to specific diseases, the model can then analyse a patient’s scan to judge whether the patient has a condition in practice. Contemporary models can detect disease with high precision and, with improved confidence, uncover abnormalities that might otherwise be overlooked by human reviewers. The rapid advance of AI technologies in healthcare also opens new and attractive opportunities to secure intellectual property. While obtaining patent protection for AI-led innovations may involve navigating intricate legal and technical issues, these obstacles can be...
The Court of Appeal On 8 May 2025, the Competition and Markets Authority ( CMA) said the Court of Appeal had restored private equity group Cinven’s liability to £51.9m, reversing the cut to £37.1m that the company persuaded the Competition Appeal Tribunal to impose in 2023. CMA head Sarah Cardell welcomed the outcome as a clear, decisive victory for the CMA and an endorsement of its mission to defend consumers and curb unlawful conduct. Cardell added that charges levied on the NHS — and therefore on taxpayers — must be fair at all times too......
In this issue: Medical devices Research and development Pharmaceuticals—regulatory framework Post-market Daily and weekly news alerts New and updated content Trackers Useful information Medical devices AI model providers get confirmation of delays to EU Code of Practice MLex reports that developers of general-purpose artificial intelligence ( GPAI) systems — including Open AI, Google and Microsoft — have been informed that the statutory deadline for a definitive Code of Practice to support compliance with the EU AI Act will be missed, and publication may not arrive for a few more months. The postponement reflects work to align the Code with guidance on GPAI obligations, and efforts to secure buy-in from major AI firms while under pressure from the US government. See: AI model providers get confirmation of delays to EU Code of Practice. Med Tech’s paper to support...
EU AI Act timeline for GPAI Code of Practice Under the EU AI Act, the Code of Practice must be finalised by 2 May 2025 at the latest, and the European Commission’s AI Office is obliged to take the ‘necessary steps’ so the Code is recognised as an official compliance instrument. Yet, earlier this week the EU AI Office informed participants in the drafting work that ‘the final GPAI Code of Practice and the Commission guidelines on GPAI [are] expected to be published ahead of August 2025’. Its communication further notes: ‘ This extension of the deadline comes as a result of prioritising extended feedback cycles (as requested by all stakeholders), and to give stakeholders four weeks to respond to the consultation on guidelines’. According to the Commission’s updated website, the definitive Code will be presented at the closing plenary session and issued by August 2025,...
Hill v Touchlight Genetics Ltd and other companies [2025] EWHC 107 ( Pat) What are the practical implications of this case? Rarely in patent litigation does the outcome hinge so squarely on human shortcomings, but here it did: the claimant-inventor’s account proved unreliable. Judges are acutely aware that memory can be fragile, and over the many years of this quarrel it appears the claimant’s recollection of what happened shifted. The dispute neatly illustrates how testimony of fact fares when set against contemporaneous paperwork. Courts often attach great weight to documents made at the time. Where the two versions part company, a witness’s credibility will usually be damaged. Legal advisers often face a sensitive dilemma when evaluating a witness’s reliability—particularly where the witness is also their client. A central task for an adviser is to coolly test the merits of the client’s case, which may...
In this issue: Medical devices Pharmaceuticals—regulatory framework Post-market Research and development Commercialisation Daily and weekly news alerts Trackers Useful information Medical devices Navigating EU AI Regulation in 2025—key developments and strategic implications for business As the first elements of the EU AI Act take effect, the European Commission has released guidance, introduced compliance support tools, and signalled robust enforcement. In parallel, it has withdrawn the proposed EU AI Liability Directive and presented the AI Continent Plan to strengthen Europe’s AI infrastructure and data ecosystem. This article sets out the principal updates and actionable insights for business leaders preparing for the next phase of AI regulation. Written by Barry Scannell, partner at William Fry and member of the Irish government’s AI Advisory Council. See News Analysis: Navigating EU AI Regulation in 2025—key developments and strategic implications for business. Main challenges of EU AI Act- GDPR interplay identified by Member States MLex: EU Member States cite...
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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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