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Case notes
Recent patent, SPC and parallel-trade decisions from the UK courts, the Unified Patent Court, the Court of Justice of the EU and the European Patent Office, each summarised in plain English with what it means if you source, launch or buy the product concerned. Short, sourced to the judgment, and reviewed when the position changes.
Also in News: Regulatory changes (3) · Guides: Explainers (24) · Prices (7) · Glossary (3)
UPC member states · 16 July 2024 (revoked); 25 November 2025 (Court of Appeal, patent upheld) · 2 min read
Evolocumab and alirocumab (Repatha, Praluent): the UPC's first revocation, reversed
In July 2024 the UPC revoked Amgen's PCSK9 antibody patent in all 17 member states for lack of inventive step, the court's first revocation on the merits. On 25 November 2025 the Court of Appeal set that aside and upheld the patent. A rehearing application followed in January 2026.
UPC member states · Portugal · 8 May 2025 (Lisbon, refused); 13 August 2025 (Court of Appeal, granted) · 2 min read
Nintedanib (Ofev): when 'preparing to launch' becomes an infringement across 17 countries
Holding a marketing authorisation is not, by itself, a threat to infringe, but applying for the pricing and reimbursement step that lets you sell can be. On that basis the UPC Court of Appeal reversed Lisbon and enjoined Zentiva's generic nintedanib in every UPC country where the patent was in force.
United Kingdom · Netherlands · Germany · 8 October 2024 (High Court judgment; order 7 November 2024); 23 July 2025 (Court of Appeal) · 2 min read
Enzalutamide (Xtandi): when the compound patent holds, the SPC date is the date
The UK Court of Appeal upheld Astellas's enzalutamide compound patent and SPC in July 2025, rejecting obviousness attacks it found tainted by hindsight. Dutch and German courts reached the same result, so generic enzalutamide stays off those markets until the SPCs expire.
United Kingdom · 28 April 2025 (High Court); 16 July 2025 (Court of Appeal) · 3 min read
Dapagliflozin (Forxiga): the UK SPC that fell three years early
The UK courts held AstraZeneca's basic patent for dapagliflozin invalid for lack of plausibility, and both UK SPCs fell with it. Generic dapagliflozin reached the UK market in August 2025, almost three years before the SPCs were due to expire.
UPC member states · 26 June 2024 (Hamburg); 20 December 2024 (Court of Appeal); 19 June 2025 (rehearing refused) · 2 min read
Eculizumab (Soliris) biosimilars: the UPC's first pharma injunction decisions went to the biosimilars
The UPC refused Alexion preliminary injunctions against two eculizumab biosimilars because the patent's validity was not certain enough to justify them. The Court of Appeal upheld the refusals in December 2024 and declined a rehearing in June 2025, leaving the biosimilars on the EU market.
European Patent Office · Europe · Autumn 2024 and May 2025 (Boards of Appeal); further oppositions and appeals pending · 2 min read
Semaglutide (Ozempic, Wegovy): why generics abroad do not mean generics in Europe
The European Patent Office has revoked some of Novo Nordisk's secondary semaglutide patents and upheld others, but the compound protection that matters runs into the early 2030s in Europe. Generic launches outside Europe in 2026 are not a source of supply for the EU or UK.
European Union · 19 December 2024 (joined cases C-119/22 and C-149/22) · 2 min read
Combination-product SPCs: the CJEU's 2024 test, and why the combination is the weak point
A combination of two active substances is a product in its own right and may have its own SPC, but only if the combination falls under the invention of the basic patent; it is not enough that the patent names it. The ruling leaves combination SPCs easier to attack than the single-substance SPCs they sit beside.
United Kingdom · France · Germany · Netherlands · Sweden · 12 April 2024 (High Court); 24 May 2024 (Court of Appeal) · 3 min read
Rivaroxaban (Xarelto): one dosing patent, two Europes
After the rivaroxaban compound SPC expired on 1 April 2024, Bayer's remaining once-daily dosing patent was revoked in the UK for obviousness and the Court of Appeal agreed within six weeks. Courts in France and South Africa took the same view; Germany, Sweden and the Netherlands upheld the patent.
United Kingdom · France · Netherlands · April 2022 (High Court); 4 May 2023 (Court of Appeal) · 2 min read
Apixaban (Eliquis): four years of UK generics while Europe stayed protected
The UK courts held BMS's apixaban compound patent invalid for lack of plausibility, taking the UK SPC (due to run to 19 May 2026) with it. Teva launched a UK generic in May 2022. A Paris court upheld the same patent a year later, so the UK was generic for four years while most of Europe was not.
European Union · 16 March 2023 (joined cases C-438/21 P to C-440/21 P) · 2 min read
Tecfidera (dimethyl fumarate): the clock that blocks generics when the patent cannot
The Court of Justice upheld the EMA's view that Tecfidera was not covered by the same global marketing authorisation as the older product Fumaderm, so Tecfidera's own eight-plus-two years of regulatory protection applied and generic applications could not proceed until it expired, patent position notwithstanding.
European Union · European Economic Area · 17 November 2022 (C-147/20, C-204/20, C-224/20, C-253/20 and C-254/20) · 2 min read
Repackaging and rebranding parallel imports: the rules as they stand
A parallel importer may repackage only as far as is objectively necessary to sell in the destination market. Relabelling with a new anti-tampering seal is the default; putting the medicine in a new box is allowed only where relabelled packs would meet strong resistance from a significant part of the market. A generic may be rebranded to the originator's name only where the two products are identical and the rebranding is objectively necessary.