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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...
See full statement. Dordaviprone tackles a major unmet need for people with rare, high‑grade brain tumours. Deal to introduce a near‑term commercial prospect to Jazz’s pipeline. The agreement reflects cash consideration of roughly $935m, equating to $8.55 per share. DUBLIN and DURHAM, NC, 4 March March 2025 (GLOBE NEWSWIRE) Jazz Pharmaceuticals plc (Nasdaq: JAZZ) (‘Jazz’ or the ‘Company’) and Chimerix (Nasdaq: CMRX) (‘Chimerix’) today reported they have signed a definitive agreement under which Jazz will acquire Chimerix for $8.55 per share in cash, for total consideration of approximately $935m. The deal has received approval from both businesses and is targeted to complete in the second quarter of 2025. Chimerix’s lead clinical asset, dordaviprone, is a novel, first‑in‑class small molecule in development for H3 K27M‑mutant diffuse glioma, a rare, high‑grade brain tumour that most often affects children and young adults. There are currently no US Food and Drug Administration (FDA)‑approved treatments specifically for patients with H3 K27M‑mutant diffuse glioma; radiotherapy remains the most common approach. A New Drug Application (NDA)...
The Court of Appeal affirmed a decision dismissing assertions by Accord Healthcare, Sandoz and Teva that chemists would have deemed it 'immediately obvious' to create Astellas' patented cancer therapy, enzalutamide, because the expert evidence failed to explain why a particular atomic group would have been selected by chemists. The Xtandi patent is held by the University of California and is licensed on an exclusive basis to Astellas Pharma Inc. Writing for a panel of three justices in November 2024, Judge Richard Arnold said the judge was entitled to treat that omission as relevant when evaluating the expert’s evidence. The generics contended that a poster and presentation slides had disclosed a molecule akin to Astellas' claimed enzalutamide. According to the Court of Appeal judgment, they argued that the irresistible conclusion was that the patented invention was obvious. The claimed compound is differentiated by a defined substituent on its lower ring—an atom or set of atoms replacing a hydrogen on the hydrocarbon ring...
What is meant by ‘personalised medicines’? The expression ‘personalised medicine’, sometimes called ‘targeted medicine’, commonly refers to therapies aimed at rare conditions. As outlined in this Practice Note, these medicines often involve small‑molecule products repositioned for fresh indications or for subsets of existing patient cohorts that share a predictive biomarker of disease. They can also be biological medicines characterised by functional attributes. Such products present distinct challenges for securing patents and for patent enforcement, some of which are yet to be determined by the English courts. This Practice Note also sets out the limits of patent protection and supplementary protection certificates (SPCs) for these approaches, and signposts other rights relevant to research in this field, including the protection afforded by data and market exclusivity. What are rare diseases? Rare diseases are conditions that affect a small minority of the population. In the US, a rare disease is defined by the Orphan Drug Act as a disease or condition affecting fewer than 200,000 people in the US. In...
What are pharmaceutical incentives? In the EU, protection mechanisms and incentives for medicinal products, grouped under the term pharmaceutical incentives (PIs), are in place. PIs comprise legislative measures that give originator pharmaceutical companies (originators) a degree of advantage over companies selling medicines with the same active substance at far lower prices (generic or biosimilar companies)-ranging from market protection (MP), through extensions of patent rights, to several years of market exclusivity for a medicinal product. Rationale behind PIs PIs were introduced in the EU to encourage and support originators in discovering and developing new medicinal products. While innovation and discovery typically require considerable time and financial investment, only limited effort is needed to use the knowledge generated afterwards. When a generic or biosimilar company reproduces an invention, it often does not bear the substantial research and development (R&D) costs of creating it and can therefore sell the resulting medicinal product at a price well below the originator’s. The prospect of this may discourage originators, who cannot recover the...