UK High Court revokes AstraZeneca’s SPC and patent for diabetes drug dapagliflozin

The UK High Court has found AstraZeneca’s patent EP 1 506 211 invalid (UK [2025] EWHC 1012 (Pat)). Although AstraZeneca will likely appeal the decision, it represents a setback. The manufacturer of the diabetes drug dapagliflozin had recently won a preliminary injunction against Glenmark’s generic version in the UK.

As the patent expired two years ago, this decision mainly affects the SPC, which is valid until May 2028. In addition to Glenmark, AstraZeneca is fighting with competitors Teva and Generics over diabetes drugs based on dapagliflozin.

Invalid for plausibility

Notably, Michael Tappin, sitting as a deputy judge of the High Court, made the decision based on the plausibility argument. In conclusion he says, “I recognise that, (…), dapagliflozin has proved to be successful but, to echo what Meade J said in Apixaban HCat [21], while no judge wants to revoke a patent for a breakthrough, later findings about dapagliflozin do not enter the picture and my task has been to assess the validity of the Patent based on its disclosure.”

Indeed, his reasoning echoes the judgment in the pharmaceutical cases concerning apixaban and pregabalin. However, this approach has not yet made it to the Supreme Court and takes a different direction from, for example, the EPO’s Enlarged Board of Appeal in G 2/21.

Tappin justified his decision in the dapagliflozin case with a lack of information in the patent application. “It is not for me to speculate about why the patent was drafted in the way it was, and in particular why it contained no data about the performance of dapagliflozin in any assay. If it had done so, the outcome of these proceedings could well have been different; indeed, they may never have taken place at all,” he stated.

Status quo remains

In his ruling, Tappin refers several times to the economic success of AstraZeneca’s blockbuster, marketed under the brand Forxiga. Forxiga is indicated for treating type 2 diabetes, heart failure and chronic kidney disease. The company also holds market authorisations for products containing combinations of dapagliflozin with other active ingredients. SPC/GB13/021 relates to dapagliflozin and, with its associated paediatric extension, is due to expire on 13 May 2028. SPC/GB14/050 relates to a combination of dapagliflozin and metformin and is due to expire on 14 May 2028.

The ruling has caused a stir for its dogmatic approach to the plausibility argument in pharmaceutical proceedings. AstraZeneca has stated in its Q1 results that it will appeal the decision. The company can maintain its preliminary injunction against Glenmark until there is a final decision on validity. The current market status therefore remains unchanged.

AstraZeneca’s Director Patents moves on

A Taylor Wessing team led by Matthew Royle, Andrew Payne and Alex Walker represented claimant Generics throughout the proceedings. Tom Mitcheson was KC.

AstraZeneca relied on a Freshfields team led by partner Christopher Stothers and Laura Whiting. The team also included senior associate Nicholas Fischer, as well as Aidan Southall and Jeremy Manger. The barristers were Lindsay Lane KC and Stuart Baran.

The representatives cooperated with AstraZeneca’s in-house team around legal director Dom Hornblow and litigation counsel Marcus Heifetz.

AstraZeneca’s Director Patents Rose Hughes left the company this week. The patent attorney is joining Cambridge-based pharma IP boutique Evolve, where she will advise the pharma and biotech industries on IP strategy. AstraZeneca has yet to appoint a successor.

Pinsent Masons represented Teva. Glenmark relied on a team from Powell Gilbert led by Tom Oliver and Penny Gilbert.