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 Sole traders, informal partnerships and outdated partnership deeds are common.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
In this issue: Medical devices Research and development Data protection and life sciences Pharmaceuticals—regulatory framework Commercialisation Intellectual property Lex Talk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Trackers Useful information Medical devices EU AI Act’s interplay with medical device rules outlined in draft of guidance MLex notes that an initial draft on how the EU AI Act dovetails with medical device legislation tackles anticipated issues around the AI law’s alignment with product safety obligations, in particular post‑market surveillance, conformity assessments and real‑world evaluations. See: EU AI Act's interplay with medical device rules outlined in draft of guidance. Med Tech Europe urges Commission to permit pre‑submission clinical strategy discussions Med Tech Europe, together with the Association of the European Self‑ Care Industry, Med Tech & Pharma Platform and the...
It’s in the wording—two recent UK rulings show how collaboration agreements and employment arrangements with people engaged in R& D can unravel Bionome Technology Ltd v Clearwater [2024] EWHC 3155 ( Ch) Hill v Touchlight Genetics Ltd and other companies [2025] EWHC 107 ( Pat) Key takeaways The upshot from these disputes is that the Courts of England & Wales will focus on the natural, ordinary meaning of the chosen words—assessed in their full context—when reaching an interpretation. An assignment of IP rights may fail to take effect for a range of reasons: for example, non-compliance with required legal formalities, or a conclusion that—on the proper construction of the instrument—it was not sufficiently explicit that the IP was intended to pass, and therefore ineffective in law. Accordingly, assignment wording must be prepared and reviewed with real care and precision, with drafters keeping...
Set out as a Q& A, the paper aims to guide medical device makers and healthcare professionals on how the EU AI Act’s obligations align with those in Regulation ( EU) 2017/745 (the Medical Devices Regulation) and Regulation ( EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation) (together, the Medical Device Regulations ( MDRs)). An initial draft, seen by MLex, will be discussed at a meeting of a specialist subgroup of the European AI Board—an EU forum of national authorities—on 3 March 2025, with a final text potentially put to the board for approval in June 2025. Under the EU AI Act, where an AI system forms a product or a safety component of a product that requires third-party conformity assessment under sectoral law, it is classified as ‘high-risk’ and must observe a notably strict due diligence framework. This guidance is a first move to...
In this issue: Medical devices Pharmaceuticals—regulatory framework Intellectual property Borderline products Research and development Data protection and confidential information Daily and weekly news alerts Trackers New and updated content Useful information Medical devices Inside the EU’s headache to designate AI models ‘with systemic risk’ MLex: The EU AI Act imposes stringent obligations on AI models judged to carry a ‘systemic risk’. Yet fresh trends — including a novel Reinforcement Learning-centred paradigm and improved compute efficiency — are undermining the principal designation approach before the provisions even bite. Work on alternative designation benchmarks is already under way, but EU officials are likely to struggle to match a technology accelerating at a blistering pace. See News Analysis: Inside the EU’s headache to designate AI models ‘with systemic risk’. Commission opens consultation on electronic instructions for use for certain medical devices The European Commission has launched a feedback window on a draft implementing regulation that would permit...
The EU AI Act adopts a layered regime for AI systems, imposing transparency duties on every model and reserving stricter risk‑management obligations for the most potent ‘systemic’ ones. These obligations are being hammered out through a code of practice intended as a key compliance tool for model providers. Yet that code could prove marginal if models are not correctly classified for systemic risk Under the Act, a model is chiefly deemed systemic when its training consumed more than 10^25 floating‑point operations. According to research institute Epoch AI, several flagship systems have already crossed this line, including: Open AI’s o1 Anthropic’s Claude 3.5 Sonnet Mistral AI’s Large 2 These are commonly viewed as ‘frontier’ models, pushing the limits of this disruptive technology. Nonetheless, recent developments increasingly call into question whether the volume of compute used in the pre‑training stage is the most...
Macdonald Hotels Ltd v Bank of Scotland Plc [2025] EWHC 32 ( Comm) Relevant facts The High Court examined allegations brought against Bank of Scotland Plc ( BOS) by Macdonald Hotels Limited ( MHL) arising from the compelled sale of three properties: the Randolph Hotel, the Old England Hotel and the Marine Hotel (the Hotels). MHL contended that disposals occurred when valuations were unusually depressed, contravening implied terms of a facility agreement and, in relation to the Randolph, express provisions in a shareholders agreement. MHL further maintained that BOS ought to have allowed repayment by alternative means (including third‑party refinancing) and/or over an extended timescale. Resolving the dispute required review of years of dialogue, intricate documentation, and numerous detailed amendments. Careful consideration was required to identify and fully determine the issues arising in the case. This note concentrates on the funding...
The EU AI Liability Directive The EU AI Liability Directive surfaced on the Commission executive’s list of files to be scrapped at the eleventh hour, following pressure from EU digital chief, Henna Virkkunen, and as part of a wider push to reduce and simplify the regulatory framework. At a press briefing on the Commission’s 2025 work programme (which outlines upcoming initiatives and those to be abandoned), Šefčovič, responsible for deepening the Commission’s relations with lawmakers and Member States, said Commissioners had been examining how files marked for withdrawal were advancing through the co‑legislative process. ‘ When we observe that these particular proposals are stuck, at times for many years, we harbour serious doubts that they will progress this year,’ he said. The EU AI Liability Directive, a plan to harmonise certain administrative aspects of AI‑related damage claim proceedings, has indeed advanced little since it was...
In this issue: Pharmaceuticals—regulatory framework Medical devices Advanced therapeutics Research and development Intellectual property Daily and weekly news alerts New and updated content Trackers Useful information Pharmaceuticals—regulatory framework The European Commission has endorsed its 2025 Work Programme, summarising achievements since 2019 and setting out priority actions for 2025, including 18 new legislative proposals, alongside plans to implement the 2024–29 political guidelines. This programme is underpinned by the newly launched Competitiveness Compass, a strategic reference point to direct the Commission’s agenda over the next five years. See: LNB News 12/02/2025 67. With a strong push for simplification, the Commission’s 2025 Work Programme also confirms the withdrawal of 37 pending proposals—among them the AI Liability Directive—to streamline EU law and lessen regulatory burdens for businesses. See: LNB News 13/02/2025 21. The Medicines and Healthcare products Regulatory Agency ( MHRA) has issued a...
In this issue: Post-market Commercialisation Competition in life sciences Medical devices Data protection in life sciences Pharmaceuticals—regulatory framework Intellectual property Lex Talk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Trackers Useful information Post-market Industry coalition urges withdrawal of AI Liability Directive Med Tech Europe, with 11 other industry bodies, issued a joint statement urging withdrawal of the proposed AI Liability Directive ( AILD). They say it would add needless legal complexity, undermine EU competitiveness and deter artificial intelligence ( AI) innovation. The group insists the newly adopted Product Liability Directive should be implemented and reviewed before any further liability regimes are considered. They also warn the AILD could unsettle established contractual liability practices and conflicts with the EU’s Sustainable Prosperity Deal and the Draghi Report’s call for a...
In this issue: Competition in life sciences Disputes and regulatory enforcement Medical devices Research and development Advanced therapeutics Borderline products Post-market Pharmaceuticals—regulatory framework Daily and weekly news alerts New and updated content Trackers Useful information Competition in life sciences EU introduces competitiveness compass The European Commission has unveiled the competitiveness compass, a strategic blueprint to steer its work over the next five years, setting out priority measures to strengthen Europe’s competitiveness. This constitutes the Commission’s first major initiative of the current mandate. Building on the recommendations in the Draghi report, ‘ The future of European competitiveness’, released in September 2024 (see: LNB News 10/09/2024 44), the compass seeks to place Europe at the forefront of developing, manufacturing and marketing next‑generation technologies, services and clean products, while delivering climate neutrality. Although...
In this issue: Data protection and life sciences Post-market Commercialisation Pharmaceuticals—regulatory framework Research and development Medical devices Daily and weekly news alerts New and updated content Trackers Useful information Data protection and life sciences Council adopts European Health Data Space Regulation The Council of the European Union has approved the European Health Data Space ( EHDS) Regulation, designed to improve cross-border availability of health information across the European Union. The measure will strengthen people’s oversight of their electronic health data and permit its secondary use for scientific research. Member States must set up digital health authorities and uphold the European electronic health record exchange format. The Regulation will apply 20 days after it appears in the Official Journal of the European Union, signalling a major move towards the digitalisation of healthcare across Europe. Refer to: LNB News 21/01/2025 58......
Halozyme Inc v Comptroller- General of Patents, Designs and Trade Marks [2024] EWHC 3202 ( Pat) What are the practical implications of this case? In practical terms, little has shifted. The decision will not deter the UK IPO from continuing its Sm PC/ EPAR-led approach when identifying what constitutes an active ingredient. The court did not determine whether there are situations where other materials should be taken into account; it simply concluded that, on these facts, the Hearing Officer was entitled to ignore them because they were of no assistance. It remains worth watching how future cases develop on this point, particularly in contrasting contexts yet to be tested, such as pro-drugs, where the UK IPO’s practice is to grant SPCs on the basis that pro-drugs are different chemical entities from the parent drugs even if the pro-moiety would not meet the Forsgren (...
In this issue: Intellectual property Medical devices Commercialisation Data protection and confidential information Pharmaceuticals—regulatory Research and development Daily and weekly news alerts New and updated content Trackers Latest Q& A Useful information Intellectual property Court of Justice sets an ‘invention’ benchmark for SPC eligibility in combination products. EU Law: Ravi Srinivasan and Graham Lewis, partners, and James Egleton and James Smythies, associates, at J A Kemp, examine the joined rulings in Teva and Merck, addressing how to judge the availability of supplementary protection certificates ( SPCs) for fixed combination products. See News Analysis: Court of Justice introduces an ‘invention’ test for combination products to be eligible for SPC protection. Medical devices MHRA issues guidance on new Medical Devices Post- Market Surveillance requirements. The Medicines and Healthcare products Regulatory Agency ( MHRA) has published a suite of...
Teva BV; Merck Sharp & Dohme LLC , Joined Cases C-119/22 and C-149/22 The decision confirms that, for the purposes of Regulation ( EC) 469/2009 (the SPC Regulation), a medicine composed of two active substances, A+B, is to be treated as a distinct ‘product’ from the corresponding single-ingredient monotherapies. Consequently, it is permissible to obtain separate SPCs, on the same patent, for both (i) monotherapy A and (ii) the combined therapy A+B. Nevertheless, the judgment overlays an ‘invention test’ on the grant of combination SPCs. Hence, to secure an SPC for the A+B pairing, it must now be shown that the combination constitutes a feature necessary to resolve the technical problem addressed by the basic patent... Teva v Merck Sharp & Dohme and Merck Sharp & Dohme v Clonmel Healthcare , Joined Cases C-119/22 and...
In this issue: Medical devices Intellectual property Research and development Daily and weekly news alerts New and updated content Trackers Useful information Medical devices UK medical devices regulatory reform—where are we now and what’s next for 2025? The UK Medicines and Healthcare products Regulatory Agency’s ( MHRA) post- Brexit overhaul of the medical devices regime is solidifying, marked by new Post Market Surveillance ( PMS) regulations laid before Parliament in October 2024 and an additional government consultation focused on selected aspects of the forthcoming core rules. 2025 is set to be decisive, with the cornerstone draft ‘core’ legislation expected. By Harriet Hanks, counsel, Andrew Austin, partner, Emily Bloxsome and Honor May, associates, and Charlotte Case, trainee, Freshfields LLP. See News Analysis: UK medical devices regulatory reform—where are we now and what’s next for 2025? MDCG updates guidance on IVD...
Our observations so far suggest the Unified Patent Court’s approach to inventive step is more all-encompassing, concentrating on whether the skilled person would have been prompted to contemplate the claimed solution and adopt it as a natural progression from the prior art. Further, in contrast to the EPO’s problem–solution methodology, the UPC does not yet appear persuaded that a reasonable expectation of success must be shown to establish obviousness. Given these differing frameworks, there is scope for divergent outcomes on identical facts. Even so, both the UPC and the EPO seem conscious of the danger of inconsistent rulings between the two systems. In this piece, we consider four EPO practices which, though not invariably applied today, may gain traction in the interests of harmonisation, as they arguably align more closely with the UPC’s stance on inventive...
In summary, the long‑anticipated substantive regime is edging closer. The consultation to revamp the regulatory regime for medical devices post‑ Brexit launched in September 2021, with the government’s detailed reply issued in June 2022 (see: LNB News 16/09/2021 90 and LNB News 27/06/2022 48). In early 2024, the MHRA set out a Roadmap detailing the milestones towards the future regulatory framework (see News Analysis: MHRA issues Roadmap towards new medical devices rules). There have been two key recent developments: New post-market Surveillance regulations laid before Parliament In October 2024, a new PMS Statutory Instrument ( SI) was laid before Parliament, representing the first significant update to the framework since the consultation. The MHRA’s goal is to bring in ‘clearer and more robust requirements’ to strengthen patient safety and support better traceability of incidents and reporting trends. The government characterised the PMS changes as a...
Meril Life Sciences PVT Ltd & others v Edwards Lifesciences Corporation UPC- Co A-551/2024 Background In late October 2023, Edwards commenced infringement proceedings against Meril, relying on its Unitary Patent ( EP 3,769,722), before the Nordic‑ Baltic RD. The patent had been granted in June 2023 and, in March 2024, Meril lodged an opposition, shortly before submitting a revocation counterclaim within the UPC action. Together with those revocation counterclaims, Meril also applied in the infringement case, asking the court to stay the proceedings pending a decision by the EPO’s Opposition Division on the validity of the EPO. Neither side sought expedition of the EPO proceedings. Nevertheless, following UPC notification to the EPO of the corresponding infringement case on 20 March 2024, the EPO fast‑tracked the matter, listing the hearing for 17 January 2025 and shortening the period for final written submissions from the...
In this issue: Intellectual property Research and development Medical devices Commercialisation Advertising of medicines Pharmaceuticals—regulatory framework Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Life Sciences Highlights 2024/2025 Life Sciences Highlights 2024/2025 Intellectual property UPC preliminary measures—emerging trends Interim measures, such as injunctions and the seizure of goods, available across all Unified Patent Court ( UPC) participating Member States, provide patentees with substantial leverage. As a safeguard, alleged infringers can submit protective letters; while these do not remove the possibility of a preliminary injunction, they may avert an ex parte grant. Stephanie Wroe, associate and Patent Attorney at D Young & Co, examines trends arising from the case law. See News Analysis: UPC preliminary measures—emerging trends. Research and development MHRA lays new clinical trials framework...
Urgency requirement Recent jurisprudence underscores that patentees must move quickly once they learn, or become aware, of infringing conduct. If the patentee does not respond without delay, preliminary measures are unlikely to be granted by the court. The authorities have not been entirely uniform on how swiftly an applicant must proceed in this context. In Ortovox v Mammut ( UPC_ CFI_452/2023), the court concluded that, once the applicant holds all information and documentation that credibly supports a promising legal action, there is a one‑month window in which to act. By contrast, in Dyson v Shark Ninja ( UPC_ CFI_443/2023), the allowed period was assessed as two months in which to take steps. That approach was subsequently confirmed in Hand held Products v Scandit ( UPC_ CFI_74/2024), where the court observed that filing the application for a preliminary injunction on the very day on which...
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
