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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 Sole traders, informal partnerships and outdated partnership deeds are common.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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ABPI is the UK’s largest trade association for the pharmaceutical sector in the UK. Its members must adhere to the ABPI Code of Practice for the Pharmaceutical Industry ( ABPI Code), which is enforced by the PMCPA in the UK. The Code sets detailed requirements on advertising of prescription-only medicines, interactions between pharmaceutical companies and the healthcare sector, and public disclosure of transfers of value in the UK. These provisions aim to secure compliance with UK medicines advertising and anti-bribery laws. Although only ABPI members are obliged to comply with the ABPI Code, many non-members voluntarily choose to follow it, as it is viewed as the gold standard for compliance in the sector. A new 2024 edition of the ABPI Code was introduced on 1 October 2024 and will replace the 2021 edition from 1 January 2025 after a short...
In this issue: Advertising of medicines Medical devices Research and development Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Advertising of medicines 2024 ABPI Code released governing prescription medicine advertising and ethical pharma-healthcare sector conduct The Association of the British Pharmaceutical Industry ( ABPI) and the Prescription Medicines Code of Practice Authority ( PMCPA) have issued the latest ABPI Code of Practice, which will take effect on Tuesday, 1 October 2024. Following a wide-ranging consultation, the 2024 Code replaces the 2021 edition and refreshes the voluntary standards that regulate promotion of prescription-only medicines and engagement between the pharmaceutical industry and the healthcare sector. These rules extend beyond UK legislation and, in practice, are observed by almost all pharmaceutical companies in the UK. From 1 October 2024 to 31 December 2024, any...
In this issue: Intellectual property Data protection and life sciences Pharmaceutical regulation Medical devices Research and development Advertising of medicines Daily and weekly news alerts New and updated content Dates for your diary Trackers Latest Q& A Useful information Intellectual property Bayer sees off IP firm’s move to overturn European MRI patent Law360 reports that Bayer AG has defeated a challenge from De Simone & Partners seeking to revoke its patent for a contrast agent that boosts MRI scan quality, after European patent officials confirmed the invention included a new compound not seen before. Further reading: Bayer defeats IP firm’s attempt to have European MRI patent rejected. Data protection and life sciences Uber hit with €290m over unlawful data transfers to the US Over the summer, the Dutch data protection authority ( Autoriteit...
The Technical Board of Appeal ( TBA) at the European Patent Office decided on 2 July 2024 that the German pharmaceutical heavyweight may retain its patent. It threw out an appeal by the Italian business De Simone, which had maintained that the company had largely duplicated the same chemical compounds reported in earlier studies, according to the ruling made public on 16 September 2024. Bayer contended that gadolinium chelate compounds perform better in MRI scans because they exhibit higher relativity—the measure of an MRI contrast agent’s sensitivity—than the compounds that were used before......
In this issue: Competition in life sciences Research and development Pharmaceutical regulation Data protection and life sciences Advertising of medicine Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Competition in life sciences CMA succeeds in bid to reinstate £100m pharma cartel penalties Law360 reports that, on 6 September 2024, the UK Court of Appeal confirmed fines exceeding £100m against several pharmaceutical firms over a suspected price-fixing cartel, concluding that the Competition and Markets Authority had advanced its case appropriately. See: CMA wins application to revive £100m pharma cartel fine. Comment: Illumina’s EU court success bolsters dealmakers’ rights According to MLex, Illumina’s 3 September 2024 victory saw the EU’s highest court prioritise corporate rights and the ‘requirements of the business world’ within merger control. The ruling offers comfort to critics of a new regime intended to catch so-called killer acquisitions. With that shortcut removed, the Court of Justice has...
The report observes that the main factor behind the widening productivity gulf between the EU and the US — which began in the mid‑1990s — is Europe’s missed chance to harness the first internet‑led digital revolution, both by founding new tech companies and by diffusing digital technologies throughout the broader economy. Spotlight on digital technologies Draghi’s analysis notes that, stripping out the tech industry, EU productivity over the last twenty years is broadly on a par with the US. However, Europe trails in the breakthrough technologies set to underpin future growth. Since 2017, about 70% of foundational AI models have originated in the US, and just three American hyperscalers capture more than 65% of the global as well as the European cloud markets, the report states. In practice, the EU cloud services market has largely slipped to US-based providers. Quantum computing is flagged as the next major wave of...
The Court of Appeal has set aside the Competition Appeal Tribunal’s decision that had scrapped the penalties, finding the tribunal misconstrued the regulator’s case about a market‑sharing arrangement that pushed up prices of life‑saving hydrocortisone tablets. According to the appeal judges, the tribunal erred in thinking the CMA alleged the companies had knowingly broken competition law. Because the tribunal misread the case advanced by the CMA, the two were, as the judgment put it, largely ‘passing each other like ships in the night’. The judgment stresses that the CMA’s case contained no accusation of misconduct or dishonesty by any party or witness. Requiring the authority to prove dishonesty would make enforcement unworkable; the legislation does not demand it and, consequently, neither should the tribunal. The Court of Appeal further held that the regulator properly tested the companies’ witnesses in...
The Court of Justice found that the European Commission’s zeal to net potentially risky transactions had distorted the equilibrium of merger control and the 'effectiveness, predictability and legal certainty that must be guaranteed to the parties to a concentration'. The ruling will come as a relief to businesses and their advisers who have bristled at the peril created in 2021, when the Commission adopted a policy of pulling in deals that had not been notified in Member States yet could still be referred to Brussels. For those doing deals, the decision reads like a wish fulfilled. The court stressed that EU merger rules had created an 'effective and predictable' oversight regime, mindful of 'legal certainty' and premised on having transactions examined straightforwardly and in the most fitting forum. To achieve that, there must be a 'clear allocation' of competences between the...
In this issue: Competition and life sciences Medical devices Research and development Lex Talk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Competition and life sciences EU mistaken to scrutinise Illumina’s US$8bn Grail purchase, the Court of Justice rules. Law360 reports that on 3 September 2024 the Court of Justice of the European Union concluded the European Commission lacked the power to review Illumina’s US$8bn takeover of cancer detection company Grail and to unwind the transaction, marking a setback for the EU’s merger control regime. See: EU wrong to probe Illumina’s US$8bn Grail deal, Court of Justice says. Medical devices Med Tech Europe responds to the EU AI Act’s entry into force. Med Tech Europe has issued a response outlining its perspective following the 1 August 2024 entry into...
The Court of Justice stated that the Commission is not permitted to examine transactions referred by national competition authorities in the EU where there is no European link and the deals fail to meet domestic value thresholds. Handing down its judgment, the Court underlined that notification thresholds are a vital safeguard for predictability and legal certainty for undertakings. Businesses must be able to establish with ease whether a planned transaction requires a preliminary review and, if so, which authority will handle it and under what procedural rules. Responding to the ruling, Margrethe Vestager, Vice- President of the Commission, observed that some transactions falling short of EU notification thresholds may still pose risks to competition within Europe. She added that the Commission will consider next steps to ensure it can scrutinise the limited number of cases where a deal could affect Europe but does not...
In this issue: Research and development Medical devices Pharmaceuticals—regulatory framework Life sciences competition Advertising of medicines News alerts—daily and weekly Fresh and updated content Key dates for your diary Trackers Useful information Research and development UK unveils five‑year £400m public–private investment vehicle to bolster life sciences The Voluntary Scheme for Branded Medicine Pricing, Access and Growth ( VPAG) Life Sciences Investment Programme opened on 28 August 2024. This new joint public–private fund, worth up to £400m, is the first major collaboration of this scale globally. Over the next five years, it will strengthen clinical trials, enhance medicines manufacturing, and widen patient access to cutting‑edge therapies. The VPAG Investment Programme will establish 18 clinical trial hubs to accelerate getting new medicines to patients, allocating 75% of funding to expand commercial trial capacity (ie workforce and infrastructure, including the hubs), 20% to sustainable improvements in pharmaceutical manufacturing, and 5% to modernising Health Technology Assessment ( HTA)...
In this issue: Intellectual property Data protection in life sciences Pharmaceutical regulation Commercialisation Medical devices Advertising of medicines Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Intellectual property Patents Court invalidates Abbott continuous glucose monitoring device patent in ongoing dispute with Dexcom ( Abbott Diabetes Care v Dexcom) The Patents Court ruled that Abbott’s patent EP ( UK) 3 730 044 B1 (‘ EP044’), covering aspects of continuous glucose monitors ( CGMs) featuring an integrated sensor together with a needle insertion and retraction mechanism, was obvious in view of earlier disclosures. Even had the patent endured, Dexcom’s G7 CGM would not have infringed, as its insertion mechanism does not function in the manner asserted in the claims. Mr Justice Mellor also offered guidance relevant to patent...
Abbott Diabetes Care Inc and others v Dexcom Inc and others [2024] EWHC 1664 ( Pat) What are the practical implications of this case? This ruling forms part of the parties’ wider, cross-border battle over CGM technology. The conclusions on infringement and validity are, for the most part, tethered to the facts of this dispute. Nonetheless, the court’s observations on the deployment of expert evidence will interest practitioners, and stand as a further reminder that experts instructed in patent litigation must operate in the correct technical domain. Here, the technological sophistication suggested that the hypothetical skilled team would need a broad span of knowledge and experience, which a lone expert might find difficult to encompass. Where more than one expert is retained, they should be permitted to review each other’s reports so that the combined competencies of the skilled team are mirrored in the...
More organisations across the UK look set to come under stricter cyber security oversight with the proposed Cyber Security and Resilience Bill. A string of cyber incidents (not always criminal breaches) has struck the Electoral Commission, the Ministry of Defence, the private pathology provider Synnovis and, most widely, the repercussions of Crowd Strike’s failed cyber security update. Enquiries remain in progress, notably for Synnovis. Together, these episodes—and the scant outline of the new Bill—prompt fresh scrutiny of how cyber security is regulated in the UK. UK Cyber Security and Resilience Bill In July 2024, at the opening of Parliament, the new government unveiled its Cyber Security and Resilience Bill. But what is it seeking to deliver? With current rules ‘now [having] been superseded in the EU’, the UK appears intent on closing the gap. The framework must be refreshed ‘to ensure that our...
In this issue: Medical devices Intellectual property Research and development Pharmaceuticals—regulatory framework Post-market Commercialisation Advertising of medicine Daily and weekly news alerts Dates for your diary Trackers Useful information Medical devices EMA launches pilot to advance orphan medical devices The European Medicines Agency has introduced a pilot programme to support the development and assessment of orphan medical devices across the EU. Via expert device panels, the initiative offers complimentary advice to selected manufacturers and notified bodies on orphan status and the data needed for clinical evaluation. The pilot is slated to run until the end of 2025. See: LNB News 07/08/2024 25. European Commission opens survey on wider use of electronic instructions The European Commission has begun a survey to expand the scope of Implementing Regulation ( EU) 2021/2226, allowing electronic Instructions for Use (e IFUs) for all...
In this issue: Medical devices Competition in life sciences Pharmaceuticals—regulatory framework 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 Medical devices EU Competent Authorities publish statement on medical devices regulatory framework status The European Commission is undertaking a targeted review of the medical devices regulatory regime set out in Regulation ( EU) 2017/745 (the Medical Devices Regulation, MDR) and Regulation ( EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation, IVDR), collectively the ‘ Regulations’. Following a workshop in France, national EU Competent Authorities have released a joint statement on the current state of the transition to these measures. Since their adoption seven years ago in 2017, stakeholders have faced a range of...
From Munich, the UPC’s office issued a decision that wiped out an Amgen patent across all 17 EU Member States, covering key patent venues including Germany, France, the Netherlands and Italy. The outcome represents a significant victory for Regeneron and Sanofi, which produce Praluent, a cholesterol therapy that competes with Repatha. According to the UPC, ‘ The patent as granted is invalid because it does not involve an inventive step’. Since 2014, the companies have been locked in a dispute with Amgen, which has maintained that the manufacture of Praluent infringes wording in multiple patents held by Amgen. In the US, the case appeared before a jury in a Delaware federal court, was subsequently overturned, and later proceeded to the highest court in the US in 2023, after many years of legal wrangling......
In this issue: Medical devices Disputes and regulatory enforcement Pharmaceutical regulation Competition in life sciences Advertising of medicines Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Medical devices EU AI Act appears in the Official Journal The Official Journal now includes Regulation ( EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024, establishing harmonised rules for artificial intelligence and amending Regulation ( EC) 300/2008, Regulation ( EU) 167/2013, Regulation ( EU) 168/2013, Regulation ( EU) 2018/858, Regulation ( EU) 2018/1139 and Regulation ( EU) 2019/2144, together with Directive 2014/90/ EU, Directive ( EU) 2016/797 and Directive ( EU) 2020/1828 (the EU Artificial Intelligence Act or EU AI Act). See: LNB News 12/07/2024 26. King’s Speech 2024—key Life sciences...
The Competition and Markets Authority ( CMA) approved the transaction unconditionally at the initial stage of its review, as recorded in the authority’s case register. A Thermo Fisher spokesperson acknowledged the ruling in a statement on 8 July 2024, describing it as the final regulatory clearance needed for the transaction. The statement said the company was pleased to have secured all approvals necessary for its acquisition of Olink, and that it expects to complete the purchase within the coming few days ahead......
In this issue: Intellectual property Competition in life sciences Medical devices Research and development Commercialisation Daily and weekly news alerts New and updated content Dates for your diary Trackers Latest Q& A Useful information Intellectual property Law360 reports that, on 2 July 2024, the UK High Court upheld the validity of one of Moderna’s two key UK patents, concluding Pfizer and Bio NTech infringed protections covering m RNA vaccine technology. See: Pfizer, Bio NTech infringed Moderna’s m RNA vaccine patent. Competition in life sciences Per Law360, on 8 July 2024 the Competition and Markets Authority indicated it will not contest Thermo Fisher Scientific Inc’s planned US$3.1bn acquisition of Swedish biotech Olink Holding AB, after commencing an initial review earlier this year. See: UK clears Thermo Fisher’s US$3.1bn Olink...
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This Practice Note This Practice Note reviews mechanisms used in settling litigation. A Tomlin order consists of a consent order paired with a schedule. It operates to stay proceedings on terms that have been agreed. The provisions contained in the schedule may remain confidential. This Practice Note describes the scope of confidentiality attaching to the schedule and sets out how it differs from a standard consent order. Sample wording for a Tomlin order is included, alongside links to precedents, as well as guidance on court approval. It also addresses varying, setting aside and enforcing a Tomlin order, including the considerations the court will take into account when handling applications for each. Further guidance is provided on interpreting and applying the relevant provisions of the CPR; however, some courts and divisions impose very specific requirements for both drafting and approval, and for approaching the schedule and confidentiality issues. Accordingly, you must consider the particular rules and court guide provisions in the forum where your claim is proceeding when drawing up the Tomlin order...
Date [ date ] Parties [ name of Landlord ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Landlord) [ name of Tenant ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Tenant) [ [ name of Guarantor ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Guarantor) ] [ [ name of Mortgagee ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Mortgagee) ] Definitions Within this Deed, the terms below shall be interpreted as follows: [ Annual Rent • the annual sum reserved under the Lease; ] [ Insurance Rent • the Tenant’s share of the Landlord’s costs of insuring the Property (as set out in the Lease); ] Lease • the lease of the Property dated [ date ], entered into between (1) [ the Landlord OR [ name ...
I, [ name ], of [ address ], solemnly and sincerely state that: [ Matters to be verified, set out in numbered paragraphs ] I make this solemn statement in good conscience, believing it to be true, and pursuant to the provisions of the Statutory Declarations Act 1835. DECLARED at [ details ] this [ day ] day of [ month and year ] Before me ................................................................................ [ signature of the person before whom the declaration is made ] A [ commissioner for oaths OR [ solicitor OR [ insert other qualification ] ] authorised to administer oaths ]...
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