UK Court of Appeal blocks Glenmark’s diabetes generic

AstraZeneca has secured a preliminary injunction against Glenmark's generic version of diabetes drug dapagliflozin in the UK. The Court of Appeal overturned a first-instance decision that had rejected the injunction request.

 

AstraZeneca is defending its EP 1 506 211 against Glenmark, Teva and Generics UK (Viatris). The patent expired in May 2023. However, the British SPCs based on the patent are valid until May 2028. These are GB13/021 relating to active ingredient dapagliflozin and SPC GB14/050 relating to a combination of dapagliflozin and metformin.

 

Dapagliflozin is an SGLT2 inhibitor which helps lower blood sugar levels and treats patients with type 2 diabetes. SGLT2 inhibitors have also shown benefits in reducing heart attack risk, helping patients with heart failure and slowing kidney disease progression.

 

 

AstraZeneca markets dapagliflozin under the brand name Forxiga. The company also holds market authorisations for products containing combinations of dapagliflozin with other active ingredients. Forxiga is indicated for treating type 2 diabetes, heart failure and chronic kidney disease.

 

Dapagliflozin now commands over 60% of the SGLT2 inhibitor market in the UK. Furthermore, heart and kidney disorders remain significantly underdiagnosed, with around 3.7 million people in the UK currently eligible for, but not taking, SGLT2 inhibitors.

 

 

In October 2023, Viatris launched revocation proceedings against the SPCs, claiming patent invalidity. Teva and Glenmark brought similar proceedings later that year (case IDs: HP-2023-000035, HP-2023-000040 and HP-2023-000046). All parties applied to the High Court for a January 2025 trial. However, judge Richard Meade scheduled the trial for mid-March instead.

 

In February 2025, Glenmark informed AstraZeneca it had obtained market authorisation for its generic dapagliflozin product and planned to launch on 17 March, despite the risk of infringement suits. The generic drug company does not dispute that its product would infringe the SPC if valid.

 

AstraZeneca notified Glenmark of its intention to seek an interim injunction to prevent sales of the generic product in the UK pending the form of order hearing following the validity trial.

 

In late March, interim judge Michael Tappin rejected the preliminary injunction application (case ID: HP-2025-000006), ruling that damages would adequately compensate AstraZeneca if the patent was found valid.

 

AstraZeneca appealed this decision. Shortly before Easter, the Court of Appeal under judge Richard Arnold granted the injunction until the conclusion of the form of order hearing in the revocation proceedings (case ID: CA-2025-000746). Contrary to judge Tappin’s finding, he determined that damages would not adequately compensate either party.

 

The ruling bars Glenmark’s generic product from the UK market.