Dr Reddy's Laboratories (UK) Ltd v Boehringer Ingelheim International GmbH [2025] EWHC 2834 (Pat)
On 5 November 2025, Dr Michael Tappin KC (sitting as a High Court Judge) granted Boehringer Ingelheim (“BI”) an interim injunction against Dr Reddy’s (“DR”) to restrain them from marketing or offering generic empagliflozin for sale in the UK.
The BI group is the proprietor of a number of patents relating to empagliflozin, which it markets and sells under the brand name Jardiance®. Empagliflozin is a sodium-glucose cotransporter-2 (“SGLT2”) inhibitor used in the treated of type 2 diabetes melitus, chronic kidney disease, and heart failure. Earlier this year, in parallel litigation, the Patents Court held at [2025] EWHC 1012 (Pat) that a number of IP rights relating to dapagliflozin, another SGLT2 inhibitor, were invalid. This judgment was upheld by the Court of Appeal at [2025] EWCA Civ 903 (and permission to appeal to the Supreme Court was refused). Subsequently: (i) generic dapagliflozin has been launched in the UK; and (ii) NHS England has circulated draft guidance stating that, given the costs savings of using generic dapagliflozin, clinicians should consider prescribing dapagliflozin instead of empagliflozin.
Against the backdrop of the Court of Appeal’s judgment in the dapagliflozin litigation, DR – having issued proceedings in 2024 to invalidate certain BI patents relating to empagliflozin – indicated that would start selling generic empagliflozin in the UK before the trial in relation to BI’s patents. BI accordingly applied for an interim injunction to restrain DR from marketing and selling generic empagliflozin in the UK.
The Secretary of State for Health and Social Care (“SSHSC”) applied to intervene in the injunction application in light of findings made by the Court of Appeal in the dapagliflozin litigation in order to file clarificatory evidence as to how the Department for Health and Social Care (“DHSC”) approaches questions of pharmaceutical pricing and reimbursement. SSHSC’s application to intervene was allowed, with the Judge noting that SSHSC’s evidence contained “…an extremely valuable account of the pricing and reimbursement system operated by the DHSC and in my view any court hearing an application for an interim injunction in a pharmaceutical patent case would benefit greatly from reading them.”
Turning to the interim injunction, the Judge held:
- The usual American Cyanamid test applied, and that whilst there were unique factors to consider in relation to cases where generic pharmaceutical companies sought to enter the market, “…the question is whether those factors are present in this case. I agree with the submission of Mr Lomas for the SSHSC that one should not proceed on the basis of rebuttable presumptions, but on the evidence before the court in each case.”
- Damages would likely be inadequate for both parties.
- In the circumstances, the balance of convenience favoured maintaining the status quo pending trial. In particular, it was relevant that DR’s evidence had not set out why it had changed its position in relation to launching generic empagliflozin and, following the judgment of the Court in SmithKline Beecham plc v Apotex Europe Ltd [2003] EWCA Civ 132, [2003] FSR 31 it was relevant that DR had not taken sufficient steps to clear the path ahead of launch.
Thus the injunction was granted against DR.
Andrew Lomas
appeared for the Secretary of State for Health and Social Care, instructed by the Government Legal Department.