Lapsed patent meaning

A three-judge panel affirmed the conclusions of Michael Tappin KC, who sat as a deputy High Court judge, dismissing AstraZeneca’s attempt to overturn his ruling that its dapagliflozin patent added nothing beyond an earlier international patent application. Justice Richard Arnold, writing for the court, said specialists reading AstraZeneca’s claims would have a ‘legitimate reason to doubt’ that dapagliflozin would serve as an effective therapy for diabetes. The row centres on AstraZeneca’s patent for the dapagliflozin molecule, which lapsed in May 2023. AstraZeneca had obtained supplementary protection certificates for the compound, due to run until May 2028. A number of generic manufacturers — including Teva Pharmaceutical Industries Ltd, Glenmark Pharmaceuticals Europe Ltd and Generics (UK) Ltd — petitioned the High Court to revoke the patent and, by extension, the supplementary protections, seeking to pave the way to market their own dapagliflozin before 2028. The High Court first backed the generics in April 2025, observing that AstraZeneca appeared to have selected the compound through an ‘arbitrary selection’ from options already outlined in...

Bayer Intellectual Property GmbH & others v Aspire Pharma Ltd & others [2024] EWHC 711 (Pat) and Sandoz Ag and other companies v Bayer Intellectual Property GmbH and other companies [2024] EWHC 796 (Pat) What was the background? Xarelto® (rivaroxaban) is an anticoagulant and Bayer’s top-selling medicine. Patent disputes have been ongoing in the UK and elsewhere for years, though in the UK the conclusion may now be approaching. Bayer’s compound patent (EP 1 261 606) lapsed in December 2020, but a supplementary protection certificate (SPC) kept rivaroxaban under protection until it ended on 1 April this year. Bayer also owns a patent with Swiss-form claims that broadly concern using rivaroxaban in tablets for once-daily oral dosing, expiring in January 2026 (EP 1 845 961, the ‘Once-Daily’ patent). Starting in 2022, multiple generic companies launched revocation actions against the Once-Daily patent—the once-daily segment is where most prescriptions sit (although products suitable for administration twice or more daily became open to generic entry from 2 April 2024 following SPC...

This Practice Note sets out the duration of patent protection and the need to keep rights in force through periodic renewals to preserve that term. It further outlines the process for restoring a patent that has lapsed or is about to lapse. Obtaining a patent in the UK In the UK, patents may be secured in two forms, namely: UK national patents—are granted by the UK Patent Office under the Patents Act 1977 (PA 1977) UK designations of European patents (EP(UK) patents)—European patents are granted by the European Patent Office (EPO) under the European Patent Convention (EPC) but must be validated in the UK to have effect (be valid) here The UK, alongside Norway, Switzerland and Turkey, is a non‑EU contracting state to the EPC. Accordingly, the UK participates in the European patent system and may be designated in European patent applications. An applicant can also use the Patent Cooperation Treaty (PCT) system to apply to the World Intellectual...

A ‘patent’ is a legal instrument that grants an inventor monopoly rights. It safeguards novel inventions and can extend to elements such as the way things function, their composition, and the methods by which they are produced. A UK national patent, or a European patent designating the UK (EP(UK)), is infringed by carrying out acts in the UK without the permission of the patent proprietor (the patentee). Those infringing acts are prescribed by section 60 of the Patents Act 1977 (PA 1977) and include making, using, and importing a patented product or process. For detail on patent infringement, see Practice Note: Patent infringement...