Dr Reddy’s Laboratories (UK) Limited v Boehringer Ingelheim International GmbH [2025] EWHC 2834 (Pat)
Boehringer sought an interim injunction, applying the American Cyanamid principles, to prevent Dr Reddy’s from launching a generic version of the drug empagliflozin for which Boehringer holds several patents.
Empagliflozin is an inhibitor of the sodium-dependent glucose co-transporter SGLT2. It is licensed for the treatment of type 2 diabetes, heart failure, and chronic kidney disease. Dr Reddy’s had sought declarations of invalidity in respect of two of Boehringer’s patents, and the trial was listed for October 2026. At the time of the hearing, Dr Reddy’s was the only generic company ready and willing to launch generic empagliflozin in the UK.
An alternative SGLT2 inhibitor, dapagliflozin, is also licensed to treat type 2 diabetes. The patent protecting dapagliflozin was declared invalid on 28 April 2025, a decision upheld by the Court of Appeal on 16 July 2025. On 31 July 2025 the Supreme Court refused permission to appeal. A number of generic dapagliflozin products were immediately launched, in response to which the reimbursement price for dapagliflozin declined rapidly and the NHS issued guidance recommending that dapagliflozin be the first-line SGLT2 inhibitor for new patients and that existing empagliflozin patients be pro-actively switched to dapagliflozin.
Dr Reddy’s contended the likely consequence would be a rapid and significant decline in the empagliflozin market – around 90% within 3-9 months – and that such decline would make the empagliflozin market commercially unattractive for any third party entrant. Therefore, said Dr Reddy’s, it was likely to be the only company supplying generic empagliflozin, there would be no price spiral, and damages would be an adequate remedy for Boehringer.
The Judge however agreed with Boehringer that the decline in the empagliflozin market would not be so rapid or significant, that there was a real risk of other generic companies entering the market before trial, and that damages would not be an adequate remedy for Boehringer (including because it would suffer non-financial loss to jobs, product pipelines, and partnership programmes).
Weighing up the balance of convenience, the Judge granted an interim injunction to preserve the status quo and because Dr Reddy’s had failed to take effective steps to clear the way.
Mark Vanhegan KC and Christopher Hall represented Dr Reddy’s. Edward Cronan represented Boehringer.