Off label meaning

In this issue: Copyright & associated rights Designs Trade marks/passing off Patents General IP Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Copyright & associated rights Wine importer loses ‘battle of the bottles’ in copyright claim (Martin v Bodegas San Huberto SA) UK importers take heed—the Intellectual Property Enterprise Court has backed an artist’s claim that a label on wine bottles brought into and sold in the UK by a UK company infringed copyright in an original work and also amounted to passing off. The Argentinian supplier had commissioned a designer to craft an appropriate label, and the importer raised no questions about that choice. Of the three labels that formed the focus of the allegations, the court decided that one constituted a plainly substantial reproduction of the artist’s work—even though the copied element comprised only a very small segment of the original (Infopaq International...

Martin and another company v Bodegas San Huberto SA and others [2025] EWHC 1827 (IPEC) What are the practical implications of this case? While this case does not raise any new points of law, it serves as a clear warning to businesses and legal practitioners to stay alert to intellectual property risks around importation and distribution. Supply networks are often intricate, with legal and commercial factors at nearly every step. Packaging and labelling offer a prime illustration, particularly across food and drink, where market share battles are intense and traders know the value of eye-catching presentation. Yet in crowded markets, the push to attract consumers can unintentionally create intellectual property problems if a protected design is copied or a misleading link with another trader is suggested. The case highlights exposure for intermediaries, even if they only import and distribute and are unaware of any copying. It also exposes the danger of trusting suppliers without robust contractual safeguards. Importers and distributors should insist that supplier agreements clearly allocate responsibility for...

In this issue Air emissions and climate change Brexit Environmental enforcement and prosecutions Environmental taxes, reliefs and incentives ESG and sustainability Hazardous substances and chemicals Nature, biodiversity and habitat conservation Sources of environmental law Water, flooding and drainage Daily and weekly news alerts New and updated content Trackers Useful information Air emissions and climate change Friends of the Earth’s climate change case before the High Court A claim advanced by Friends of the Earth (FoE), together with two co‑claimants, Doug Paulley and Kevin Jordan, came before the High Court in a ‘rolled‑up’ hearing on 23–24 July 2024. See: LNB News 23/07/2024 15. CCC issues 2024 assessment of progress on cutting emissions The Climate Change Committee (CCC) has released its latest review of the government’s efforts to curb emissions. It stresses that the UK’s Third National Adaptation Programme needs bolstering, with explicit aims and measurable targets to confront escalating climate risks. The analysis...

This Practice Note examines unlicensed medicines and the routes by which they can reach patients across the EU and the UK, such as via the UK Specials regime. It then looks at deploying authorised medicines beyond the scope of their licence (commonly termed off-label use). Lastly, the Practice Note addresses liability questions linked to using medicines without a licence. The UK’s regime governing unlicensed products is largely rooted in EU legislation. Numerous EU-derived principles and obligations remain in UK domestic law, save where particular measures provide otherwise. The Note surveys both EU and UK frameworks: analysis of EU requirements should be treated as relevant to the UK system unless distinct UK rules departing from EU law are set out separately. It also summarises pertinent EU case law; for guidance on the extent to which UK courts and tribunals are bound after the Brexit implementation period, see Q&A: Are UK courts and tribunals bound by decisions of the Court of Justice of the European Union post-Brexit? The discussion covers availability routes,...

(OMPs) are medicines that help prevent, identify or treat rare illnesses and medical conditions. Because the number of people affected is very small, without incentives, pharmaceutical companies may doubt whether sales would cover the research and development (R&D) costs of medical products to detect, prevent and treat such disorders. In the relevant EU law, 'rare' is defined as affecting fewer than five in 10,000 people in the EU. Yet most rare conditions impact fewer than one in 100,000 people. Although each individual rare disease is uncommon, they carry major public health importance and significance. There are thought to be more than 6,000 distinct rare diseases; so, while each is infrequent on its own, together they account for a substantial patient population, roughly one in every 12 people in the EU (all rare diseases combined). In the absence of incentives, it is frequently not commercially feasible for pharmaceutical companies to develop and market OMPs, and only about 5% of rare diseases currently have an authorised treatment option available...

This Practice Note looks at product liability in the life sciences sector It centres on the strict liability framework in Directive 85/374/EEC (the Product Liability Directive (PLD)), its update by Directive (EU) 2024/2853 taking effect from December 2026, and the Consumer Protection Act 1987 (CPA 1987), and explores how these interact with the pharmaceutical and medical devices regulatory regimes. The proposed EU AI Liability Directive (AILD) and its implications are addressed. The Note outlines the statutory elements for establishing liability for defective products, the statutory defences available, and the forms of redress open to an injured party. It further examines responsibility arising from off‑label use of medicines and medical devices, and liability issues in the context of clinical trials. The UK’s product liability architecture predominantly originates in EU law. Numerous EU-derived principles and obligations have been carried over into UK domestic law, unless particular provisions state otherwise. Accordingly, the EU and UK positions are treated side by side: points on EU legal requirements should generally be read as applicable...