Featured documents
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 Sole traders, informal partnerships and outdated partnership deeds are common.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
Most recent News
Barclays Bank plc v VEB. RF [2024] EWHC 3088 ( Comm) Contrary to this, the Russian bank commenced proceedings in the Russian courts. The English bank applied to the English courts for anti‑suit and anti‑enforcement injunctions, which were granted. The Russian bank then initiated arbitration proceedings, as it was originally required to do. During the contractual notice period, however, the English bank notified the Russian bank that the dispute should be transferred to the English courts. The Russian bank maintained that the English bank had waived that right......
On 14 March 2025, delegates from EU Member States examined the interaction between the two regimes, aiming to pinpoint compliance hurdles for both supervised organisations and supervisory authorities. Following this exchange of views, Poland, the current chair of the EU diplomatic discussions, collated the contributions and prepared a synopsis — obtained by MLex — setting out principal takeaways on the core issues identified. The resulting summary will be tabled for debate at a meeting of national representatives. Differing regulatory approaches Most European governments underlined how the two laws diverge in regulatory design. The EU GDPR safeguards personal data through a fundamental‑rights lens, while the AI Act functions as product‑safety legislation, imposing targeted obligations calibrated to the level of risk. For a number of Member States, this divergence in underlying logic could produce contradictory regulatory outcomes, whereby an AI system is judged compliant with the AI Act but not...
Commission Guidance—clarifying early obligations Since the very start of the year, the Commission has issued six notable guidance documents to help support compliance with the EU AI Act. On 4 February 2025, it unveiled the AI Literacy Repository to support Article 4, in force from 2 February 2025, which obliges organisations to actively promote AI literacy internally (see: LNB News 05/02/2025 43). The repository showcases practical training initiatives from early adopters and provides a benchmark for companies developing internal competence frameworks. On the same day, it released draft Guidelines on Prohibited AI Practices under Article 5, also applicable from February, offering legal interpretation with illustrative examples (see: LNB News 05/02/2025 39). Prohibitions include subliminal manipulation, exploitative systems, real-time biometric surveillance, and social scoring. Although non-binding, the guidelines act as authoritative reference points for organisations and should be built directly into risk...
In this issue: Research and development Pharmaceuticals—regulatory framework Advanced therapeutics Commercialisation Medical devices Advertising of medicines Intellectual property Daily and weekly news alerts New and updated content Trackers Useful information There will be no Weekly Highlights on 24 April 2025 Research and development Commission updates guidelines on responsible use of generative AI in research On 10 April 2025, the European Commission’s Directorate‑ General for Research and Innovation released the second edition of its guidance on the responsible use of generative artificial intelligence ( AI) in research. Targeted at researchers, research organisations and funders, the update complements the EU Artificial Intelligence Act ( EU AI act). It details core principles—reliability, truthfulness, respect and accountability—for AI use. The guidance also calls for transparency about the AI tools employed, safeguards for sensitive data and...
Rukhadze and others v Recovery Partners GP Ltd and another [2025] UKSC 10 Background This appeal concerns the fiduciary ‘profit rule’. Fiduciaries, including trustees and company directors, owe a duty of loyalty to their beneficiary or principal (the person for whom they hold or administer property, eg the company in the case of a director). That duty includes a requirement that, where a fiduciary derives a profit by virtue of their position, they must account for that gain to the principal, unless the principal has given fully informed consent. The respondents to this appeal are a company incorporated in the British Virgin Islands (to which the claims of another such company have been assigned) together with an English LLP. The individual appellants were engaged by the respondents and occupied roles of trust and responsibility (for example serving as directors), thereby owing fiduciary duties to them. In...
In this issue: Medical devices Research and development Pharmaceuticals—regulatory framework Business transactions Data protection Post-market Commercialisation Daily and weekly news alerts New and updated content Trackers Useful information Medical devices MLex: With core provisions of the European Artificial Intelligence ( AI) Act edging towards applicability, companies and legal advisers are wrestling with whether, when and in what way the EU rulebook bites on their AI models and systems. Key uncertainties include the Act’s reach during development, any extraterritorial impact, how fundamental legal terms should be read, and the breadth of the scientific research and development exemption. See: Applicability of EU’s AI rulebook raises string of thorny questions. Commission publishes AI Continent Action Plan The European Commission has unveiled the AI Continent Action Plan to position Europe as a global AI frontrunner. The programme seeks to convert Europe’s established industries and talent base into engines for AI innovation and sits within a wider push to enhance Europe’s...
The EU AI rulebook adopts a phased rollout: some headline provisions take effect from August 2025, with most following in 2026. As these milestones approach, organisations are rushing to interpret an opaque legal text. Uncertainty stems from doubts about Regulation ( EU) 2024/1689 (the AI Act), notably its relevance during development, any extraterritorial reach, the meaning of central legal concepts, and the limits of the scientific research and development exemption. Development phase The AI Act indicates it does not extend to research, testing, or development activities for AI systems or models before they are placed on the market or put into service. However, a European Commission question‑and‑answer paper on general‑purpose AI ( GPAI) recognises that certain duties for model providers, implicitly or explicitly, relate to the development stage. These include: Notifying the regulator if providers anticipate GPAI models will exceed the Act’s training compute...
Cure Vac On 27 March 2025, Cure Vac announced that the EPO has formally permitted it to retain a revised version of its m RNA technology patent. As of 28 March 2025, the EPO’s full written decision was not yet publicly available. In a statement, Alexander Zehnder, Cure Vac’s Chief Executive, said the bid to secure the patent is a ‘multi-step process’ in Europe and the US. He added that the ruling is a significant milestone on a journey they expect will result in acknowledgement of Cure Vac’s substantial contribution to safe and effective COVID-19 vaccines as one of the earliest pioneers of m RNA technology......
In this issue: Intellectual property Advertising of medicines Competition in life sciences Commercialisation Post-market Data protection and life sciences Pharmaceuticals—regulatory framework Research and development Lex Talk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Trackers Useful information Intellectual property Could we…and would we..? UK Co A confirms that it is bound by previous precedent on second medical use SPCs On 28 January 2025, the UK Court of Appeal delivered its long-anticipated ruling in Merck Serono v Comptroller- General of Patents. The panel of three LJs— Lewison, Arnold and Birss—held that existing binding UK authority on second medical use supplementary protection certificates ( SPCs) constrained the court, so it could not depart from that line. The judges further observed that, even if a departure from their own case law were...
Justice Richard Arnold granted Astra Zeneca leave to appeal and permitted lorries carrying about 175,000 packs of Glenmark’s generics to move on to wholesalers, provided they did not reach pharmacy shelves while the case continued at any point during those interim proceedings. In this way, Glenmark could keep its first-to-market advantage, while causing only minimal detriment to Astra Zeneca should the Court of Appeal later be persuaded to issue an injunction against supply. The judge said this approach maintained the status quo with the least possible prejudice to Glenmark’s position overall. The hearing was arranged at short notice, just days after the High Court refused Astra Zeneca an injunction to block the diabetes generic from sale while the court considered whether the patents supporting the branded medicine were valid in law. Glenmark, Generics ( UK) Ltd and Teva...
On 21 March 2025, the Paris Local Division rejected Mul- T- Lock France’s argument that permitting competitor IMC Créations to bring infringement actions for the UK, Spanish and Swiss designations of a European patent would create a ‘significant imbalance’ between the sides. Through this ruling, the court affirmed its long-arm jurisdiction to address infringement occurring beyond the EU where the defendant is established within the EU, enabling rights-holders to advance multi-jurisdictional infringement proceedings via a single claim. Bardehle Pagenberg LLP partner Tilman Müller- Stoy observed that this sets up a structurally asymmetric scenario, effectively compelling the alleged infringer to defend on numerous fronts with several national revocation actions. The decision concludes a run of 2025 judgments on European courts’ reach in patent matters. In January 2025, the UPC first signalled it could hear accusations that German subsidiaries of Kodak infringed patents in the UK, since the...
Apothekerkammer Nordrhein, Case C-517/23 (27 February 2025) What are the practical implications of this case? The judgment clarifies for the pharmacy sector which promotional practices fall within the Directive’s reach, assessed by whether the communication seeks to encourage the prescribing, supply, sale or consumption of medicinal products. After reviewing Doc Morris’ discounts and payments, the court drew a distinction between measures connected to prescription-only medicines ( POMs) and those concerning non-prescription medicines. It decided that advertising aimed purely at influencing a customer’s choice of pharmacy, by offering discounts or payments linked to the purchase of POMs, is not caught by the Directive. Such measures do not promote the prescribing or consumption of unspecified POMs, given that prescribing decisions rest solely with the doctor. However, the court indicated a different outcome where the incentive provided to customers who buy POMs consists of discounts or vouchers...
Directive ( EU) 2024/2853 (the EU Product Liability Directive) Directive ( EU) 2024/2853 (the EU Product Liability Directive) revamps the product liability framework established by Council Directive 85/374/ EEC (the 1985 Directive), signalling the EU’s resolve to tackle issues arising from the digital economy and new technologies. With digital and AI offerings now widespread, the EU has refreshed its legal benchmarks to safeguard consumers and enhance accountability. Following the European Commission’s withdrawal on 11 February 2025 of a specific AI product liability directive proposal, this regime will operate as the prevailing benchmark for AI-related product liability for the foreseeable future. Liability for defects now extends to digital offerings—software and AI systems included—with updated criteria for determining defectiveness. Manufacturers and other liable actors are responsible under the Directive for damage to protected legal interests arising from a product defect. It preserves the no-fault model...
Rukhadze v Recovery Partners GP Ltd [2025] UKSC 10 What are the practical implications? The majority concluded that the liability to account for unauthorised gains is strict in nature and does not turn on whether the principal might have earned an equivalent profit, or would have agreed to the fiduciary retaining some or all of it if permission had been sought. It is, in short, enough that there is a sufficient connection between the fiduciary obligation and the gain. What was the background? The facts are complex but can be outlined very briefly so as to frame the issue now before the Supreme Court. The dispute followed the death of the Georgian billionaire Patarkatsishvili (known as ‘ Badri’, a name familiar to aficionados of oligarch litigation). The claimants (and associated parties) agreed with his family that they would deliver services to recover his assets...
Advocate General Athanasios Rantos In a non-binding opinion, Advocate General Athanasios Rantos advised that the Court of Justice should confirm the General Court’s earlier ruling dismissing objections by Teva Pharmaceutical Industries Ltd and Cephalon Inc. to the penalty the European Commission imposed in 2020. He concluded that the General Court applied the proper test when assessing whether Teva and Cephalon’s 2005 settlement — which ended patent‑infringement litigation between the companies — contravened the EU’s antitrust laws. According to Rantos, the General Court was rightly attentive to the restrictive provisions, namely the non‑compete and non‑challenge undertakings, which in substance required the parties to refrain from entering the market......
Merck Serono v Comptroller- General of Patents [2025] EWCA Civ 45 The dispute centred on Merck’s bid for an SPC covering cladribine for treating multiple sclerosis, relying on its 2017 marketing authorisation for Mavenclad®. The request was found not to satisfy Article 3(d) of Regulation ( EC) 469/2009 (the EU SPC Regulation) owing to the presence of an earlier marketing authorisation for a medicinal product with cladribine as the active ingredient. In reality, two prior authorisations existed: one for Leustat®, granted in 1995, and another for Letak®, granted in 2004. Each authorisation concerned a medicinal product comprising cladribine as an active ingredient for the therapy of hairy cell leukaemia. Those earlier approvals long pre-dated Mavenclad®, both designating cladribine as the active substance and addressing hairy cell leukaemia, rather than multiple sclerosis, thereby preventing full compliance with Article 3(d). Merck’s SPC...
In this issue: Pharmaceuticals—regulatory framework Medical devices Data protection and life sciences Research and development Commercialisation Daily and weekly news alerts New and updated content Trackers Useful information EMA publishes strategy through 2028 On 18 March 2025, the European Medicines Agency ( EMA) and the Heads of Medicines Agencies ( HMA) released their joint EU medicines agencies’ network strategy to 2028. It sets six priorities, including adoption of AI, progress in regulatory science and action on antimicrobial resistance. Consultation feedback questioned the network’s capacity to deliver; nevertheless, 19 of 24 submissions backed the plan, while two trade bodies were neutral. The blueprint targets post-pandemic pressures and readiness for forthcoming pharmaceutical law reforms, with a focus on the EU’s competitiveness in developing and manufacturing medicines. See: LNB News 24/03/2025 18. Commission opens consultation on new Life Sciences strategy The European Commission has opened a call for evidence on its planned Life Sciences strategy. The...
In this issue Advanced therapeutics Medical devices Competition in life sciences Commercialisation Data protection and life sciences Daily and weekly news alerts New and updated content Trackers Useful information Advanced therapeutics MHRA and NICE announce joint regulatory reforms to speed up medicine approvals On 17 March 2025, the Medicines and Healthcare products Regulatory Agency ( MHRA) and the National Institute for Health and Care Excellence ( NICE) set out revised regulatory pathways as part of broader government changes. From July 2025, the MHRA will allow point-of-care production of personalised therapies, and NICE targets completing 60% of technology appraisals within 240 working days in 2025/26. The bodies will introduce a joined-up scientific advice offer and run marketing authorisation and technology appraisal in parallel to shorten timelines for new medicines. See: LNB News 18/03/2025 38. EMA and HMA issue joint...
In this issue: Medical devices Post-market Pharmaceuticals—regulatory framework Commercialisation Daily and weekly news alerts New and updated content Trackers Useful information Medical devices AI model providers see European Commission finalise panel of scientific experts MLex: The European Commission has adopted an Implementing Act establishing and governing a scientific panel of independent experts to advise and assist EU and national authorities in enforcing the EU AI Act’s provisions for general-purpose artificial intelligence models. The definitive Act departs materially from an earlier draft on sensitive points, including conflicts of interest, internal procedures and transparency. Commission updates AI procurement model clauses following EU AI Act adoption On 5 March 2025, the European Commission issued updated model contractual clauses for AI procurement, revising the September 2023 version to align with the EU AI Act adopted in June 2024. The update delivers a...
The secondary legal Act sets out a series of alterations when compared with the draft that was published for public consultation in October 2024 (see: LNB News 21/10/2024 6), notably concerning the way the panel will operate, the manner in which tasks are undertaken, and the level of support afforded to national authorities. Panel operation The condition for the Commission to appoint scientific experts—previously framed as an absence of any conflict of interest—has been narrowed to a focused requirement of independence from any general‑purpose AI model provider, rather than a blanket prohibition on any potential interest. As the Act states, ‘the expert shall be neither an employee nor party to a contractual arrangement with such a provider for the duration of the term’. Accordingly, activity for entities outside the Global Partnership on Artificial Intelligence ( GPAI) market, as well as for right holders or think tanks, is not...
Popular documents
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 ]...
Discover more from LexisNexis
