Dapagliflozin (Forxiga): the UK SPC that fell three years early

What was decided

AstraZeneca’s European Patent (UK) 1 506 211 covered dapagliflozin, the SGLT2 inhibitor sold as Forxiga. The patent itself expired on 14 May 2023, but two UK supplementary protection certificates (SPC/GB13/021 and SPC/GB14/050) extended protection to 13 and 14 May 2028.

Generics (UK), Teva and Glenmark asked the Patents Court to revoke the patent. On 28 April 2025 the court agreed: the patent did not make it plausible that dapagliflozin was an SGLT2 inhibitor, let alone a selective one or a treatment for diabetes, and it made no technical contribution over an earlier application (WO 128) from which dapagliflozin was an arbitrary selection. An invalid patent cannot support an SPC, so both certificates fell with it.

The Court of Appeal (Lord Justice Arnold, with Lords Justices Peter Jackson and Stuart-Smith agreeing) dismissed AstraZeneca’s appeal on 16 July 2025. It declined to depart from its own 2023 apixaban decision on plausibility despite the European Patent Office’s later G 2/21 ruling.

Timeline

Date	Event
14 May 2023	Basic patent expires; SPCs take over, due to run to May 2028
April 2025	High Court refuses AstraZeneca an interim injunction against Glenmark; Court of Appeal grants one pending the validity judgment
28 April 2025	High Court holds the patent, and therefore the SPCs, invalid
16 July 2025	Court of Appeal dismisses the appeal
Late July 2025	Court of Appeal refuses extended interim relief; temporary injunction runs to 30 July
31 July 2025	Supreme Court refuses permission to appeal and interim relief (reported by Adalvo; to be confirmed)
7 August 2025	First UK generic launch (Adalvo)
September 2025	Dapagliflozin moves to Drug Tariff Category M; the 10 mg reimbursement price falls from £36.59 to £30.15
13 and 14 May 2028	The expiry dates the SPCs would have had

What it means if you are…

A parallel trader. The UK’s loss of exclusivity arrived three years before the date on the register. Anyone pricing UK demand for Forxiga against a 2028 SPC had the wrong date, and a UK-sourced generic at a Category M price now sits where a protected brand sat a year earlier. The position in other European countries depends on separate national proceedings and each country’s own SPC; a UK revocation changes nothing on the German or French register until a court there says so. Check each country, do not infer from the UK.

A generics or launch planner. Plausibility attacks on older compound patents can succeed in the UK, and the court will not wait for the SPC to run its course. The route was the usual one: clear the path by revocation, accept interim injunction risk while judgment is pending, and be ready to launch within days of the final refusal. The interim injunction against Glenmark, granted on appeal and then not extended, shows how finely balanced that period is.

A wholesaler or buyer. The reimbursement price moved within a month of generic entry once the product changed Drug Tariff category. Stock bought at the branded price in July 2025 was worth about 30 per cent less by September. The mechanics (Category C to Category M) are worth understanding for every UK loss of exclusivity.

Status and what to watch

The UK compound position is settled. AstraZeneca’s other dapagliflozin products and combinations, and its patents in other European countries, are separate questions. The “hold the ring” interim injunction practice used in this dispute is still being debated and will shape the next UK launch at risk.