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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 Sole traders, informal partnerships and outdated partnership deeds are common.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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High Court Judge Richard Meade dismissed the application by Pfizer Inc and Bio NTech SE to get both of Moderna TX Inc's patents chucked The bid by the two pharmaceutical groups to invalidate both Moderna TX patents was thrown out, and they did not persuade the court that one patent would have been obvious to a skilled practitioner. That patent relates to broad m RNA alterations designed to trigger an immune response. In his 153-page judgment, Meade said a skilled person would be reduced to blind trial-and-error, without any sense of what might succeed or why, to replicate Moderna’s framework. Pfizer and Bio NTech accepted that, if Moderna’s rights were upheld, their own vaccine work would have trespassed on those protections. However, they did succeed in knocking out one narrower m RNA patent, showing the claimed invention was obvious in light of an earlier patent...
By declining to apply the two-year statute of limitations that usually governs CAT claims, the specialist antitrust tribunal ruled that allegations brought by the UK Department for Health and Social Care ( DHSC) and other government bodies could instead benefit from the more flexible timetable used in the High Court, where the authorities first issued proceedings before the case was sent to the CAT. The crux was whether the claims—part of years of EU and UK enforcement concerning Lundbeck’s antidepressant, citalopram—were “made” or commenced within two years of the Court of Justice’s March 2021 judgment upholding €146m in fines against the defendants. Although these proceedings did not formally start until the transfer from the High Court to the CAT in July 2023, the tribunal decided it was sufficient that the government filed a claim form within the two-year window, in February 2023. As the...
In this issue Intellectual property Competition in life sciences Pharmaceutical regulation Medical devices Research and development Advertising of medicines Lex Talk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Intellectual property Unified Patent Court cuts ribbon on Milan Central Division: Law360 notes the UPC is preparing to launch its specialised life sciences division in Milan, which commentators expect to be a busy third venue within the year‑old patent framework that alone hears revocation actions. See: Unified patent court cuts ribbon on Milan Central Division. Samsung bioepis denies infringing blood treatment patent: Law360, London: Samsung Bioepis has opposed Alexion’s attempt to stop sales of a biosimilar of a rival’s patented blood treatment medicine, telling the court the product does not...
Samsung Bioepis UK Ltd argued at the High Court on 30 May 2024 that its version of Soliris will not infringe the patent of Alexion Pharmaceuticals Inc because it does not fall within its scope In a defence that has now been made public, Samsung Bioepis reiterates that, even aside from scope, the Alexion patent is invalid, reflecting the allegations in a separate invalidity action it filed against its competitor in May 2024. The company stated it “has not infringed and does not threaten to infringe the patent”, adding that “no... consent is required” for it to continue with its biosimilar plans. Soliris, the brand name for eculizumab, is used to treat several rare haematological conditions, including paroxysmal nocturnal haemoglobinuria, in which the body attacks and destroys its own red blood cells. Alexion, a rare diseases specialist acquired by Astra Zeneca for US$39bn in 2021, won its...
Europe’s highest appeals tribunal handed down nine decisions, dismissing almost all aspects of challenges brought by Servier SAS and the generic-drug firms it is alleged to have paid unlawfully to stave off rivals to its perindopril, a treatment for high blood pressure and heart failure. Servier’s lone success, per a High Court notice, was a trimming of the European Commission penalty linked to its pact with Lupin Ltd, reduced from €37.1m to €34.75m. The bench threw out appeals by Lupin itself and by Unichem Laboratories Ltd and its subsidiary Niche Generics Ltd, Matrix Laboratories Ltd, Teva Pharmaceutical Industries Ltd and Biogaran SAS. It thereby affirms the judgments of the General Court finding that accords entered into by Servier and Biogaran were market‑exclusion arrangements that curtailed competition. Those undertakings therefore remain responsible for the fines levied by the commission, the court said in...
In this issue: Medical devices Pharmaceuticals—regulatory framework Advertising of medicines Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Medical devices MHRA issues updated transparency guidance for machine learning medical devices. The Medicines and Healthcare products Regulatory Agency ( MHRA) has jointly released new transparency guiding principles for machine learning medical devices ( MLMDs). This update builds on earlier principles for good machine learning practice in medical device development, which the MHRA produced with fellow regulators, the FDA and Health Canada, in 2021. Rory Trust and Annalise Slocock of Burges Salmon LLP review the new transparency guiding principles. See News Analysis: MHRA, FDA and Health Canada release transparency guidance for machine learning medical devices......
Published in 2021, the guidelines aim to enhance the safety and performance of AI and machine learning ( ML) medical devices throughout their lifecycle. These updated principles centre on transparency for MLMDs, outlining expectations for developers and manufacturers so that patients and clinicians receive sufficient clarity when such devices are employed. Navigating the boundary between regulated medical devices and looser digital health tools is a familiar task for both makers and regulators. AI/ ML offerings add extra complexity, notably concerning intended purpose, ongoing change, and openness. The principles set out a benchmark of good practice for MLMDs that developers should factor into market access and regulatory planning for AI/ ML solutions, irrespective of whether they consider their product to be a medical device. What is ‘transparency’ under the new guidance?......
In this issue: Pharmaceuticals—regulatory framework Medical devices Post-market Competition in life sciences Advertising of medicines Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Pharmaceuticals—regulatory framework A regulation designed to streamline how changes to medicine approvals are processed has been issued in the EU’s Official Journal. Commission Delegated Regulation ( EU) 2024/1701 of 11 March 2024, amending Regulation ( EC) 1234/2008 concerning the review of variations to the terms of marketing authorisations for human medicinal products, has now been published. It enters into force on 7 July 2024 and applies from 1 January 2025. See: LNB News 17/06/2024 20. The Commissioner for Health and Food Safety is expected to reach agreement on the Council of the EU’s Recommendation on...
Drax Smart Generation Holdco Ltd v Scottish Power Retail Holdings Ltd; Drax Smart Generation Holdco Ltd v Scottish Power Retail Holdings Ltd [2024] EWCA Civ 477 What are the practical implications of this case? The Court of Appeal in Drax appears to have taken a commercially minded, substance‑over‑form stance when construing notification clauses. On one view, that marks a move away from the robust (and arguably overly stringent) approach seen in recent authorities, including the High Court’s decision in Drax and the Court of Appeal’s judgment in Decision Inc Holdings Proprietary Ltd v Garbett [2023] EWCA Civ 1284 ( Garbett). In Garbett, Newey LJ held that a similarly worded clause required the claimant to give an estimated amount for each individual breach, rather than a single global figure for the entire claim. Garbett can read as somewhat severe, and how far its reasoning coheres in...
One year on from the UK’s first Med Tech strategy in February 2023, the Department of Health and Social Care has released a reflection paper: The Medical Technology Strategy: One Year On (see: LNB News 06/02/2023 34). The government’s review covers progress across the 12 months to June 2024 and signals the next phase of work, setting out ongoing and upcoming initiatives with associated milestones. We outline a selection of key points below. Some highlights from the analysis The central ambition of ‘right product, right price, right place’ remains, as do the four core priorities: resilience and continuity of supply; supporting innovation and dynamic markets; enabling infrastructure; and targeted attention on priority issues and markets, eg diagnostics. The government reiterates that the Med Tech ‘innovation pathway’—the sequence from market entry through to adoption, eg by the NHS and...
In this issue: Intellectual property Research and development Pharmaceuticals—regulatory framework Competition in life sciences Lex Talk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Intellectual property EPO registers more than 27,000 patents in the Unitary Patent system The European Patent Office ( EPO) reports registering over 27,000 unitary patents in the Unitary Patent’s inaugural year, following its launch in June 2023. This means nearly one in four (23%) granted European patents now cover all participating Member States, with the share continuing to rise. The newly established Unified Patent Court ( UPC) has handled around 350 matters to date and also provides a single forum for disputes concerning both unitary patents and non‑unitary European patents. In addition, the European Commission plans a unitary...
In this issue: Pharmaceuticals—regulatory framework Intellectual property Medical devices Data protection and life sciences Research and development Disputes and regulatory enforcement Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Pharmaceuticals—regulatory framework ESG trends emerging from the UK’s new commitments to tackle AMR Harriet Hanks, counsel, James Smith, associate, together with trainees Samuel Kasadha and Shaurya Kothari of Freshfields Bruckhaus Deringer LLP, examine ESG developments arising from the UK’s renewed pledges to confront antimicrobial resistance ( AMR). See News Analysis: ESG trends emerging from the UK’s new commitments to tackle AMR. Council of the EU formally approves So HO Regulation The Council of the EU has granted formal approval to the Regulation on Substances of Human Origin ( So HO), aimed at enhancing the safety and quality of blood, tissues and cells used in healthcare, while enabling their movement across borders within the EU. With both the Council and the European...
The dispute stemmed from a 2012 agreement for the modernisation of DBS’ services (the ‘ Agreement’), under which TCS undertook to assume control of and operate DBS’ legacy platforms whilst creating new digital offerings. From day one, the programme suffered delays, prompting a reset of contractual milestones. TCS maintained that DBS was the source of those delays and, in particular, that DBS’ IT hosting provider, Hewlett Packard Enterprises ( HPE), caused a critical delay. DBS contended that the true cause was that TCS’ software was not ready to be deployed on the infrastructure owing to slippage in the development and testing of the software, and further said it bore no responsibility for HPE’s activities. TCS sought £110m in delay damages. DBS advanced a counterclaim for delay, together with claims tied to deficient software quality. A separate,...
Payone Gmb H v Logo [2024] EWHC 981 ( KB) What are the practical implications of this case? This decision draws attention to the considerations a court will assess when deciding if material mentioned at a hearing should be treated as being in the public domain and no longer protected by duties of confidence or related restraints. In this matter, the judge held that the documents had not become public and continued to attract confidentiality; however, the court underlined that the assessment is inherently one of fact and degree. The judgment further recorded that, if information has entered the public sphere, the court will not stand in the way of circulation, since doing so would lack any legitimate purpose. Parties engaged in litigation should therefore keep this ruling in view when selecting which documents and information to mention in, and place within the court...
AMR represents a mounting global public health threat, with some analyses attributing up to five million deaths each year. It is therefore unequivocally a core ESG priority for life sciences. In a year poised to be pivotal for coordinated action—underscored by its profile at the UN High Level Meeting in September 2023—the government has set out firm pledges. It has released the Second 5 year AMR National Action Plan for 2024–2029 (the Action Plan) (see: LNB News 08/05/2024 25), designed to advance the UK’s 20 year vision to contain AMR by 2040 and acting as a key strand of the UK’s recently revised Biosecurity Strategy. The Action Plan frames commitments across four pillars: cutting the need for, and unintended exposure to, antimicrobials; optimising antimicrobial use; driving innovation, and ensuring supply and access; acting as a...
An American pharmaceutical titan told Law360 that the EPO has confirmed the validity of its patent covering m RNA modifications—one of the core patents Moderna alleges Pfizer and Bio NTech have breached across several European courts. Moderna expects Pfizer and Bio NTech to challenge the ruling. ' We value the careful evaluation and strong grasp of the scientific and legal matters at stake in this review of issues......
In this issue: Research and development Medical devices Disputes and regulatory enforcement Competition in life sciences Pharmaceuticals—regulatory framework Daily and weekly news alerts Dates for your diary Trackers Useful information Research and development Council of EU approves EU AI Act The Council of the EU has signed off the EU AI Act. Once endorsed by the presidents of the Council and the European Parliament, the law will appear in the Official Journal of the EU and take effect 20 days later. Most rules will start to apply two years after entry into force, with certain provisions operating on a different timetable. See: LNB News 21/05/2024 9. DSIT publishes international scientific report on advanced AI safety The Department for Science, Innovation and Technology ( DSIT) has issued the interim International Scientific Report on the Safety of Advanced...
Bayer Intellectual Property Gmb H & others v Aspire Pharma Ltd & others [2024] EWHC 711 ( Pat) and Sandoz Ag and other companies v Bayer Intellectual Property Gmb H and other companies [2024] EWHC 796 ( Pat) What was the background? Xarelto® (rivaroxaban) is an anticoagulant and Bayer’s top-selling medicine. Patent disputes have been ongoing in the UK and elsewhere for years, though in the UK the conclusion may now be approaching. Bayer’s compound patent ( EP 1 261 606) lapsed in December 2020, but a supplementary protection certificate ( SPC) kept rivaroxaban under protection until it ended on 1 April this year. Bayer also owns a patent with Swiss-form claims that broadly concern using rivaroxaban in tablets for once-daily oral dosing, expiring in January 2026 ( EP 1 845 961, the ‘ Once- Daily’ patent). Starting in 2022, multiple generic companies launched...
In this issue: Disputes and regulatory enforcement Medical devices Intellectual property Research and development Pharmaceuticals—regulatory framework Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Disputes and regulatory enforcement A Merck-y saga—partial declaratory relief to be granted to pharmaceutical giant Merck KGa A following Merck, Sharpe & Dohme’s use of MERCK marks in the UK ( Merck v Merck) In an exacting judgment stretching to 514 paragraphs, Mr Justice Edwin Jones reviewed 55 occasions on which the claimant, Merck KGa A, said five defendants, among them Merck, Sharpe & Dohme LLC (collectively MSD), deployed the word ‘ Merck’ contrary to the parties’ 1970 Agreement, infringed Merck KGa A’s UK trade marks, and ultimately defied an injunction made in July 2020. Eschewing contempt proceedings, Merck KGa A instead pursued...
A Merck-y saga— Merck KGa A to obtain partial declaratory relief following Merck, Sharpe & Dohme’s use of MERCK marks in the UK ( Merck v Merck) Merck KGa A v Merck Sharp & Dohme LLC and other companies [2024] EWHC 820 ( Ch) What are the practical implications of this case? This ruling stops short of laying down hard rules on when a court should exercise its discretion to issue declaratory relief, but it does consolidate several important authorities on the topic. The court referenced the following decisions: Nokia Corp v Inter Digital Technology Corp [2006] EWCA Civ 1618 Financial Services Authority v Rourke [2001] Lexis Citation 2268 Amstrad Consumer Electronics Plc v British Phonographic Industry Ltd [1985] Lexis Citation 1288 Invest Bank PSC v El- Husseini [2003] EWHC 3350 ( Comm) (not reported by Lexis...
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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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