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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 Sole traders, informal partnerships and outdated partnership deeds are common.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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PSN Recruitment Ltd (trading as Cosmopolitan) v Ludley and Greenscape Specialist Recruitment Ltd [2023] EWHC 3153 ( IPEC)) What are the practical implications of this case? This judgment strengthens established principles on confidentiality and the law of confidence, and clarifies how protected confidential material should be assessed and categorised. Whilst it cannot be presumed that any client database is automatically confidential, a significant line of authority indicates that lists containing active and target client contact details typically satisfy the requirements for confidence, and this ruling now further endorses that stance. The decision also highlights the need for parties to provide full cooperation to the court and to avoid obstructive conduct, reflected both in the approach to the damages award and, more broadly, in Her Honour Judge Clarke’s remarks on the defendant’s behaviour and conduct throughout. In particular, Ludley’s destruction of evidence and his breach of the duty owed to...
In September 2021, the MHRA opened a consultation (see: LNB News 16/09/2021 90) to reform the UK’s medical device regulatory regime. The government issued its detailed reply in June 2022 (see: LNB News 27/06/2022 48), yet no tangible changes have followed. In January 2024, the MHRA set out a comprehensive Roadmap, with timelines, charting the move towards the future regulatory framework for medical devices, alongside updated guidance on putting forthcoming regulations into practice (see: LNB News 09/01/2024 30)... No indication of substantive changes to the 2022 regulatory proposals The key message is that there appears to be no major deviation in substance from the government’s detailed 2022 stance. That said, the publications were not accompanied by draft regulations. The ‘ Core Regulations’—which will deliver the principal substantive updates, such as changes to the classification of certain device types, clarification of what is required of...
In this issue: Disputes and regulatory enforcement Research and development Post-market Medical devices Regulatory framework for medicinal products Advertising of medicines Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Disputes and regulatory enforcement Newron Pharmaceuticals S. P. A. v The Comptroller General of Patents, Trade Marks and Designs — Patent: interpretation. The Court of Appeal ( Civil Division) upheld a ruling that the relevant marketing authorisation did not approve a triple combination of safinamide, levodopa and peripheral decarboxylase inhibitors, but instead authorised only safinamide as the active substance. The appeal turned on the construction of ‘product’ in Article 3(b) of Regulation ( EC) 469/2009 on supplementary protection certificates for medicinal products. The issue emerged from therapy for Parkinson’s disease using safinamide (marketed as Xadago). Xadago had...
In this issue: Intellectual property Research and development Post-market Regulatory framework for medicinal products Data protection and life sciences Advertising of medicines Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Intellectual property Astrazeneca UK Ltd v Tesaro, Inc — Patent— Royalties The Court of Appeal ( Civil Division) allowed the defendant’s appeal from a High Court decision which, on construing a licence agreement with the claimant, had required payment of royalties on all net sales of Zejula in each country where at least one licensed patent was in force. The claimant had granted two patent sub-licences, and the licensed patents claimed second medical uses of the active substance Niraparib. The defendant obtained marketing authorisations to sell Niraparib under the brand Zejula. A royalties dispute followed. Central to the issue was...
In this issue: Regulatory framework for medicinal products Competition in life sciences Medical devices Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Regulatory framework for medicinal products EESC’s opinion on proposal to revise European Pharmaceutical Framework published The European Economic and Social Committee’s opinion on the planned overhaul of the European Pharmaceutical Framework has been released in the Official Journal of the EU. The Committee welcomes the European Commission’s proposal, seeing it as a chance to refine existing provisions and bolster Europe’s competitiveness and sustainability. It also wishes to reiterate its 2021 view on the Pharmaceutical Strategy and, above all, endorses improved affordability as a principal aim of the reform. See: LNB News 07/02/2024 32. Competition in life sciences CMA investigates anticipated acquisition of Olink by Thermo Fischer Scientific The CMA has begun an investigation and issued an invitation to comment on the anticipated acquisition of Olink Holding AB by...
In this issue: Disputes and regulatory enforcement Competition in life sciences Research and development Medical devices Data protection and life sciences Regulatory framework for medicinal products Post-market Lex Talk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Disputes and regulatory enforcement Exclusion and limitation of liability clauses—carve outs for fraud and reasonableness under the Unfair Contract Terms Act 1977 ( Innovate Pharmaceuticals Ltd v University of Portsmouth Higher Education Corp) This dispute centred on construing a contract under which the University of Portsmouth ( Uo P) agreed to undertake scientific research to develop a liquid aspirin medicine (the Drug) for the treatment of brain cancer. Innovate pursued damages of £100m for alleged breach, yet Uo P...
On 12 January 2024, the United Kingdom formally put its name to the 2019 Hague Convention on the recognition and enforcement of foreign judgments in civil and commercial matters (the Hague Judgments Convention). This News Analysis examines what the Hague Judgments Convention sets out, and why the UK’s decision to join it is especially significant for Banking & Finance practitioners in particular. What is the Hague Judgments Convention? The Hague Judgments Convention establishes a shared framework of rules for recognising and enforcing civil and commercial court decisions originating from States that become parties to it (the Contracting States). The EU and Ukraine are, at present, Contracting States to the Hague Judgments Convention; however, a range of other states have signed, among them the US and, now, the UK. The Tracker— Hague Judgments Convention offers details on whether a jurisdiction has signed the...
Innovate Pharmaceuticals Ltd v University of Portsmouth Higher Education Corp [2024] EWHC 35 ( TCC) What are the practical implications of the case? The ruling is significant for commercial practitioners as it explores the drafting and interpretation of exclusion and limitation provisions, especially where a clause states ‘unless fraudulent’ or similar wording. This matters to both contract drafters and litigators: properly construed, the references to fraud in the exclusion and limitation clauses were confined to fraudulent misrepresentation. As the claim did not allege fraudulent misrepresentation, the judge decided that, even if any breach of contract had been carried out dishonestly, Uo P could still invoke the relevant protections. In addressing UCTA 1977, the judge recognised that assessing whether a term is ‘reasonable’ under UCTA 1977, Sch 2, s 11 is inherently fact-specific and outlined a range of pertinent...
In this issue: Advertising of medicines Medical devices Regulatory framework for medicinal products Intellectual property Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Advertising of medicines The 2024 ABPI Code of Practice—what are the key proposed changes? The Prescription Medicines Code of Practice Authority ( PMCPA) has opened a consultation to revise the 2021 Association of the British Pharmaceutical Industry ( ABPI) Code of Practice. The consultation invites views on amendments to clauses of the Code and on the PMCPA’s operation and complaints management procedures. Jayne Packham, Expert ABPI Code of Practice Trainer and Consultant at Jayne Packham Consultancy, explores what has prompted the proposed updates, the principal proposals and the next steps. See News Analysis: The 2024 ABPI Code of Practice—what are the key proposed changes? Medical devices European Commission proposes to extend transition period to apply IVDR The European Commission has proposed giving companies additional time to apply...
The PMCPA has opened a consultation to revise: the 2021 ABPI Code of Practice the Constitution and Procedure, setting out how the PMCPA functions and how complaints are handled What has triggered the update? Revisions to the ABPI Code typically follow shifts in International/ European Codes of Practice or UK legislation. On this occasion, the PMCPA/ ABPI and the pharmaceutical sector are leading the changes, tightening specific clauses, embedding learnings from cases and ensuring the Code remains fit for purpose. The Constitution and Procedure has not been refreshed since 2019 and is due an update. It is continually stress-tested via the complaints process, company appeals against PMCPA Panel decisions and the landmark 2023 case that resulted in Novo Nordisk being suspended from the ABPI for two years. See: LNB News 17/03/2023 14. What are the key proposals to the ABPI Code? QR codes to...
In this issue: Intellectual property Data protection and confidential information Disputes and regulatory enforcement Regulatory framework for medicinal products Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Intellectual property High Court SPC ruling on ex tunc application of Court of Justice judgments ( Merck v Comptroller- General) The matter ( Merck Serono v The Comptroller General of Patents, Designs and Trade Marks) concerned Merck’s recent challenge to a UK Intellectual Property Office ( IPO) ruling that its supplementary protection certificate ( SPC) bid for the medicine cladribine contravenes Article 3(d) of Regulation ( EC) 469/2009 (the SPC Regulation). In short, marketing authorisations ( MAs) had already been issued for the active substance. On appeal, Merck invited the court to decline to follow the Court of Justice of the European Union’s ruling in Santen ( Case C-673/18)—which overturned Neurim ( Case C-130/11) and held that a new...
In this issue: Regulatory framework for medicinal products Advertising of medicines Medical devices Research and development Brexit Lex Talk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Dates for your diary Trackers Latest Q& As Useful information Regulatory framework for medicinal products European Medicines Agency sets out a five-year AI agenda: DLA Piper’s Danny Tobey and Marco de Morpurgo (partners), Keo Shaw (of counsel) and Coran Darling (law clerk) review the EMA and Heads of Medicines Agencies’ Multi‑ Annual Artificial Intelligence Workplan 2023–28. See News Analysis: European Medicines Agency publishes five‑year AI workplan. MHRA confirms online roll-out of the IRP: From 1 January 2024, the Medicines and Healthcare products Regulatory Agency’s International Recognition Procedure is live and innovators of new medicines may now lodge...
Merck Serono SA v The Comptroller- General of Patents, Designs and Trade Marks [2023] EWHC 3240 ( Ch) What are the practical implications of this case? The judgment affirms the settled principle from Court of Justice Case C-61/79, Denkavit Italiana: the default position is that Court of Justice judgments take effect ex tunc, and only in rare, exceptional situations will a deviation from that rule be warranted. The Court further indicated that it will generally be insufficient for a party to contend that its conduct, or the steps it adopted, rested on a legitimate expectation that a particular course would be followed (here, the grant of Merck’s SPC application) under the law as it then stood. In practical terms, parties—most notably originator pharmaceutical companies—should recognise that CJEU rulings issued after an SPC filing can still influence whether the SPC is ultimately granted, even where the...
On 18 December 2023, the EMA and HMA unveiled their 2023–2028 Multi‑ Annual AI Workplan. Designed to support the European Medicines Regulatory Network ( EMRN) — a co‑ordinated network of national competent authorities across EEA Member States working with the EMA and the European Commission — the plan encourages adoption of AI for internal regulatory activities and outlines a proposed pathway for regulatory evolution to capture AI’s promise in the medical field. Anticipated gains include higher productivity, automation of repetitive, time‑intensive tasks, and capacity to absorb and utilise far larger data sets in decision‑making. The Workplan Acknowledging that health regulators, like the regulated sector, are progressively deploying and building AI‑enabled tools, the Workplan presents a collaborative, co‑ordinated strategy for the coming five years to realise AI’s benefits in medicines regulation, while deliberately identifying and managing the attendant risks. Developed under the guidance of the HMA‑ EMA Big Data...
The 2023 festive period kept the UK’s innovative pharma sector—and their legal and regulatory functions—exceptionally busy. Companies are already poring over two fresh price control schemes for 2024. Alongside shifts to the UK pricing framework, there are plans to refresh advertising requirements and the mechanism for deciding advertising complaints. On 13 December 2023, the ABPI unveiled proposals to revise the 2021 ABPI Code of Practice for the Pharmaceutical Industry ( ABPI Code) and the PMCPA Constitution and Procedure (which outlines how advertising complaints are determined). Businesses have until 29 February 2024 to feed into the consultation. While many suggested amendments to the ABPI Code simply clarify existing provisions, the planned changes to the complaints pathway will catch the eye of in-house legal teams. The aim is to make the PMCPA complaints process less rigid and more adaptable. That could expedite more...
Rancom Security Ltd v Girling and others [2023] EWHC 1115 ( Ch) What are the practical implications of this case? This judgment has two strands—a refresher on essential legal principles and a pragmatic guide for disputes practitioners, notably those pursuing civil fraud or dishonesty claims, when building a case. Conflicting evidence Beyond its survey of principle, the court offers a detailed account of how it confronts a routine but difficult problem: conflicting evidence. It sets out the framework for evaluating changing accounts, gaps in proof, defects in disclosure, and the way witness statements and the litigation process can shape witnesses' recollections. The judgment also illustrates the courts' approach to weighing credibility and drawing adverse inferences. While the findings inevitably turn on the facts, and arose within a dishonesty context, the court's treatment of these topics has broader resonance for any disputes lawyer. The sheer range of matters the judge...
Intricate tax planning may amount to confidential information, notwithstanding parallel arrangements by others ( Kieran Corrigan & Co Ltd v One E Group) Kieran Corrigan and Co Ltd v One E Group Ltd and others [2023] EWHC 649 ( Ch) (23 March 2023) What are the practical implications of this case? The ruling is indispensable reading for practitioners handling disputed confidentiality claims. The judge explored the nuanced considerations underpinning whether particular material is confidential, while also providing a crisp, thorough synopsis of the breach of confidence jurisprudence as a whole, beginning with the test in Coco v AN Clark ( Engineers) Ltd [1969] RPC 41. The discussion spans scenarios where products are already publicly available (yet secrecy is claimed in the design), where the confidential corpus blends ‘public’ with ‘private’ elements, and where numerous ‘public’ components are assembled to yield...
Inter Digital Technology Corp and others v One Plus Technology ( Shenzhen) Co and others [2023] EWCA Civ 166 What are the practical implications of this case? As is long recognised, standard-essential patents must be offered under clear, Fair, Reasonable and Non- Discriminatory ( FRAND) terms. In these matters, once technical trials determine, following detailed evidence, that one or more patents are truly essential and valid, a subsequent FRAND trial sets the conditions of a FRAND licence. As part of that process, and as confirmed by the Supreme Court in Unwired Planet v Huawei [2020] UKSC 37, the claimant’s existing licences are carefully examined to identify FRAND terms. Accordingly, SEP infringement actions in the courts of England and Wales commonly see defendants routinely pursuing pre-action disclosure of prior SEP licensing agreements. Given the highly confidential nature of those agreements, the court typically...
How to witness and attest a deed under the Law of Property ( Miscellaneous Provisions) Act 1989 ( Euro Securities & Finance v Barrett) Euro Securities & Finance Ltd v Barrett and others [2023] EWHC 51 ( Ch) What are the practical implications of this case? The safest route to prevent disputes over a deed’s validity is: all principal signatories execute at the same time and in the same location; any witness should be a non-party to the deed and observe the signatures physically, in person; and each witness should attest, separately, every signature they observed, doing so straightaway while remaining in the signatories’ presence. Each of these points ought to be documented in writing. That said, the judge in Euro Securities considered that the LP( MP) A 1989 may afford parties greater latitude. Although much of the discussion was obiter, in essence the judge...
TP ICAP Ltd v NEX Group Ltd [2022] EWHC 2700 ( Comm) The claims for breach of warranty stemmed from two probes: one by the US Commodities Futures Trading Commission concerning swaps trading linked to bond issuances and another by a Frankfurt public prosecutor targeting a named director of a group entity in relation to cum-ex trading during the relevant period. In essence, the alleged breaches concerned warranties addressing the following: that no group company, officer, or employee had been the subject of any non-routine investigation of any kind by a ‘ Governmental Authority’ within the prior 18 months; and that no circumstances existed which could reasonably be expected to result in litigation against a group company where the amount in dispute exceeds £500,000. Those warranties were, in places, qualified by a seller-awareness threshold (here defined as the actual knowledge, after...
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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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