United Kingdom: Food and Drugs Law

This September edition examines pivotal developments in life sciences patent law across Europe, with the Unified Patent Court continuing to refine its jurisprudence on added matter, intermediary liability, and procedural standards. National courts in the UK, France, and the Netherlands deliver significant rulings on supplementary protection certificates, pro-drugs, and the boundaries of pharmacy exemptions that will shape patent strategy for pharmaceutical and medical device companies.

Nomio, a broccoli-based sports supplement gaining popularity among endurance athletes, has secured patent protection for its innovative use of sulforaphane to enhance exercise performance and treat metabolic conditions. This analysis explores how the company leveraged university research to protect both therapeutic and non-therapeutic applications of their simple three-ingredient formula, demonstrating that even products with common ingredients can achieve robust patent protection through novel use claims.

The UK Patents Court has upheld Novartis' patent and SPC protecting Entresto, its blockbuster heart failure treatment combining valsartan and sacubitril, rejecting all validity challenges from generic manufacturer Accord Healthcare. The judgment provides crucial guidance on plausibility requirements where experimental data have been generated but not fully disclosed in the patent specification, clarifying when qualitative disclosure of positive results suffices without detailed numerical data.

The UK Patents Court has upheld Novartis' patent and SPC protecting Entresto, its blockbuster heart failure treatment combining valsartan and sacubitril, rejecting all validity challenges from generic manufacturer Accord Healthcare. The judgment provides crucial guidance on plausibility requirements where experimental data have been generated but not fully disclosed in the patent specification, clarifying when qualitative disclosure of positive results suffices without detailed numerical data.

The UK government has proposed amendments to the Health Bill that could introduce an MHRA licensing regime for medical devices used in aesthetic treatments. While no new requirements are in effect yet, these enabling provisions signal a shift toward greater regulatory oversight of the devices and technologies increasingly used in non-surgical cosmetic procedures, prompting providers to review their equipment governance and compliance frameworks.

The UK has approved a marketing notice for the "Sunshine" tomato, a gene-edited variety engineered to contain elevated levels of provitamin D3. This milestone marks the first precision-bred tomato to receive approval under England's post-Brexit regulatory framework, bringing a new dietary source of vitamin D closer to commercialisation while demonstrating the practical implementation of the Genetic Technology (Precision Breeding) Act 2023.

The UK's medicines regulator is proposing fundamental changes to how gene therapy products are defined, shifting from origin-based classifications to mechanism-driven frameworks. This consultation raises critical questions about where regulatory boundaries will be drawn for synthetic biology, genome editing platforms, and engineered cell therapies as biotechnology advances beyond traditional biological manufacturing.

A mother shares the heartbreaking story of her 22-year-old daughter's death from ketamine addiction, revealing how recreational drug use spiraled into a debilitating condition called ketamine bladder that caused chronic pain and ultimately led to fatal complications. The case exposes critical gaps in healthcare support for ketamine addiction and raises urgent questions about education, treatment pathways, and the accessibility of this Class B substance.

The phrase "clinically proven" is one of the most powerful claims in a beauty marketer's ‘Arsenal’*. It sounds scientific, authoritative, and reassuring. But in a ruling published in April 2026,...