Medical devices

Life Sciences weekly highlights—18 September 2025

This week's edition of Life Sciences weekly highlights includes news analysis by Shoosmiths LLP of the Court of Appeal’s ruling in a closely watched dispute over mRNA vaccine technology, upholding Moderna’s patent against Pfizer/BioNTech. Also included is news that the Advisory Council on the Misuse of Drugs (ACMD) launched a consultation to review the impact of 2018 changes to the Misuse of Drugs Regulations 2001 regarding cannabis-based products for medicinal use, the Court of Justice delivered its judgment on a second reference for a preliminary ruling in Kwizda Pharma II concerning a borderline case between a medicinal product and a food for special medical purposes, the ICH adopted guidelines on the use of real-world data for observational studies, the Association of the British Pharmaceutical Industry (ABPI) published a report that assesses the UK’s attractiveness in global pharmaceutical investment, the Medical Device Coordination Group (MDCG) updated its manual on borderline and classification for medical devices, the Department for Science, Innovation and Technology (DSIT) announced £3.6m funding for regulated mental health tech devices and the MHRA published a blog outlining the implementation of the new Decentralised Manufacturing (DM) legislation, among other stories.

MHRA outlines strategy to strengthen its role in global health regulation

The Medicines and Healthcare products Regulatory Agency (MHRA) has set out plans for a new five-year strategy designed to strengthen its position as a global leader in health regulation. The agency highlights that personalised medicine, AI-based diagnostics and global supply chain challenges require a regulator that is adaptable and responsive. Its approach seeks to empower patients by introducing a clearer, risk-proportionate regulatory framework. This aims to ensure more agile regulation, maintain public trust and better reflect patient needs across the UK.

ACMD launches consultation on medicinal cannabis regulation impact

The Advisory Council on the Misuse of Drugs (ACMD) has launched a consultation to review the impact of 2018 changes to the Misuse of Drugs Regulations 2001 regarding cannabis-based products for medicinal use (CBPMs). The review aims to assess whether the legislation achieved its intended impact and identify any unintended consequences. The call seeks input from healthcare professionals, researchers, manufacturers, patients and regulatory bodies. The review specifically focuses on CBPMs that have not undergone medicines regulator assessment. The consultation closes on 17 October 2025.

Selection, motivation, and success—lessons from Moderna v Pfizer (Modernatx Inc v Pfizer Ltd and other companies)

IP analysis: In a closely watched dispute over mRNA vaccine technology, the Court of Appeal upheld the validity of European Patent (UK) No 3 590 949 (‘EP949’), Moderna’s patent for mRNA molecules with all uracil nucleotides replaced by N1-methylpseudouridine–a modification at the heart of COVID-19 vaccine development. Pfizer/BioNTech’s challenge failed on both novelty and obviousness: the court found that the prior art (the UPenn patent application) did not clearly and unambiguously disclose Moderna’s specific combination, and that inventive step cannot be denied simply because a modification is “obvious to try” without a concrete expectation of success. For patent practitioners, the judgment reinforces that selection inventions are protected where prior art lacks a direct pointer, and that robust, practically relevant expert evidence is essential in complex biotech litigation. The decision sets a high bar for invalidating foundational patents in fast-moving scientific fields, especially where the technology is central to public health innovation. Written by Ruby Zahra, associate at Shoosmiths LLP.