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From stalemate to statute—the Data (Use and Access) Act’s journey and the key data protection and ePrivacy changes

Information Law analysis: This News Analysis considers the key changes to data protection and ePrivacy law which will come about as a result of the Data (Use and Access) Act 2025, which received royal assent in June 2025, and how organisations should prepare for such changes. Written by Bryony Long, partner and co-head, and Zahra Laher, knowledge lawyer, at Lewis Silkin.

Life Sciences weekly highlights—14 August 2025

This week's edition of Life Sciences weekly highlights includes an analysis by Freshfields LLP on the UK Law Commission’s review of the product liability regime, with a focus on AI technologies and recent EU developments, an analysis by Pinsent Masons of the High Court’s ruling in Samsung Bioepis v Alexion, which invalidated Alexion’s eculizumab patent and found no infringement, underscoring the importance of precise drafting in biologic patents and a Law360 story on the Court of Appeal’s ruling in a long-running patent infringement dispute between coronavirus (COVID-19) vaccine developers, upholding Moderna’s mRNA patent against Pfizer/BioNTech. Also included is news that the MHRA has been designated as a WHO-Listed Authority, launched a consultation seeking UK stakeholder feedback on the revised ICH M4Q(R2) and announced that UK licence holders must now independently monitor US FDA Warning Letters, the EMA updated its guidance on paediatric submissions, as well as news that the European Commission published a study on legal and regulatory challenges to AI deployment in healthcare across the EU, the MHRA launched a stakeholder survey on the health institution exemption for medical devices and updated guidance on adverse event reporting requirements for digital mental health technologies, following the implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, and the DHSC dispute resolution panel ruled that Haleon must remain in the voluntary branded medicines pricing scheme (VPAG) for 2024, despite its claim of administrative error in joining, among other stories.

When sequence precision backfires—Invalidity and non-infringement of Eculizumab Patent with 22-Amino Acid Leader (Samsung v Alexion)

IP analysis: The High Court held that Alexion’s patent for eculizumab, which claimed a light chain sequence including a 22-amino acid leader, was invalid and not infringed by biosimilars from Samsung Bioepis and Amgen. Although the biosimilars matched the therapeutic sequence of eculizumab, they lacked the leader sequence specified in the patent. Central to the dispute was whether the claimed sequence covered the clinically used eculizumab, which lacks the leader sequence. The court rejected Alexion’s purposive construction, and the claimants conceded the patent should be revoked on that basis. Even if infringement had been found, the patent would have failed for obviousness. The case underscores the importance of precise sequence drafting in biologic patents, especially where production processes remove non-functional regions. It shows the risks of relying on broad claim constructions that diverge from the literal sequence disclosed and used in practice. The multi-jurisdictional nature of these proceedings (including before the UPC) served to highlight deficiencies in Alexion’s case, where inconsistent arguments across different fora impacted on credibility. While decisions of other courts, including the UPC, should be brought before the UK court, they will not be material to the judge’s decision making. Written by Jennifer McDowall, associate at Pinsent Masons.

UK product liability reform—new redress rules for AI systems?

Life Sciences analysis: Andrew Austin, partner; Harriet Hanks, counsel; Rachel Duffy, senior associate and Alexandra Yang, trainee associate of Freshfields LLP, consider the UK Law Commission’s project to review the current UK product liability regime for defective products, especially with a view to focussing on the rise of technologies, such as artificial intelligence, and in light of significant recent EU developments.