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The Patents Court has granted Boehringer Ingelheim (BI) an interim injunction restraining Dr Reddy's Laboratories (Dr Reddy's) from launching its generic version of drug empagliflozin in the UK pending trial in October 2026. Michael Tappin KC, sitting as a Deputy Judge of the High Court determined that an injunction should be granted because, while damages were an inadequate remedy for either party, the balance of justice favoured maintaining the status quo (Dr Reddy's Laboratories v. Boehringer Ingelheim Ltd [2025] EWHC 2834 (Pat), 5 November 2025).
Background
The case concerned empagliflozin, an SGLT2 inhibitor marketed by BI as Jardiance®, approved (amongst other indications) for treatment of type 2 diabetes (T2D). Dr Reddy's sought revocation of EP1730131 (EP'131) (the compound patent, now expired), an SPC/GB14/070 (SPC) and EP2981255 (EP'255) covering empagliflozin. An additional patent EP1888552 (EP'552) was later added to the proceeding by way of BI's counterclaim for infringement. The trial is scheduled for October 2026.
Dr Reddy's obtained a marketing authorisation in May 2025 with a skinny label for T2D. In September 2025 Dr Reddy's gave BI notice that it intended to commence sales of empagliflozin in the UK, prompting BI's application for an injunction.
Dapagliflozin litigation
Also relevant was the litigation concerning dapagliflozin, another SGLT2 inhibitor approved for T2D, in which AstraZeneca's application for an interim injunction had been refused at first instance on the basis that AstraZeneca's potential losses from generic launch could be quantified and compensated by damages, whereas Glenmark's losses could not. That decision was subsequently overturned by the Court of Appeal, with an injunction being granted on the basis that the High Court had applied too high a standard when assessing whether damages would be adequate for AstraZeneca, especially given the risk of price erosion.
At the subsequent trial in that case, the patent and SPCs were invalidated by the High Court ([2025] EWHC 1012 (Pat)), with the decision upheld after an expedited appeal ([2025] EWCA Civ 903). The Supreme Court subsequently refused permission to appeal.
This led to the lifting of the interim injunctions followed by rapid generic entry, consequential price reductions and NHS issuing guidance recommending dapagliflozin as the preferred first-line SGLT2 inhibitor for new patients.
Applicable law - American Cyanamid principles
The Court applied the well-known guidelines in American Cyanamid v Ethicon [1975] AC 396: whether there is a serious issue to be tried, whether damages are an adequate remedy and, if damages would not be adequate for either party, which course of action would cause the least risk of injustice.
The judge also referred to the three factors outlined by Arnold LJ in the dapagliflozin injunction appeal decision as relevant to situations involving at-risk launch of a generic drug:
- Market dynamics after generic entry: when a generic enters a previously monopolised market, that triggers a downward price spiral and a recategorization by the NHS Drug Tariff;
- Difficulty restoring original prices: even if patentee wins at trial, raising prices back to pre-entry levels is practically constrained by the NHS resistance and risks loss of goodwill;
- Clearing the way: a generic's plans for launch of a product must be made in advance usually with awareness of potential infringement risk. Courts may consider that a generic could have "cleared the path" by bringing timely revocation proceedings.
The judge made clear that the question he had to answer in the BI case was whether those factors were present in the case before him, based on the evidence available – the court should not proceed on the basis that these were presumptions which would apply automatically unless the generic company could successfully rebut them.
Damages inadequate for both parties
The judge considered a considerable amount of evidence in detail, including on questions such as (i) the way in which the market for empagliflozin would evolve over the 14-15 month period between the injunction hearing and the final hearing following judgment after trial in the case and (ii) whether other companies would launch generic empagliflozin in the UK in the same period. Ultimately, he came to the conclusion that damages would be an inadequate remedy for both parties.
For BI, there was a real risk of multiple generics entering before trial and potential Drug Tariff recategorisation. The Secretary of State for Health and Social Care had intervened to provide evidence on NHS pricing from the head of the Medicines Framework and Reimbursement Team of the Department of Health and Social Care (DHSC). This evidence was described by the judge as "extremely valuable" and explained that (contrary to the position assumed in the dapagliflozin injunction appeal decision) the DHSC would not resist recategorisation (and, therefore, the restoration of prices) if an originator company were successful in defending the validity of its patent rights after generics had launched. However, on the evidence before him, the judge concluded that there was nevertheless a substantial risk that in practice BI would not be able to return to its current price levels if generic launch were allowed to go ahead, in particular due to the complicating factor of the availability of generic dapagliflozin for T2D, which might be a more attractive option to the NHS.
For Dr Reddy's, damages were also hard to quantify given the uncertainty over the way in which the market would develop, especially with possible generic competition and loss of first-mover advantage.
Balance of the risk of injustice
In going on to consider the risk of injustice, the judge referred to the dapagliflozin injunction appeal decision, which had noted the relevance of a generic company failing to 'clear the path' for launch by bringing revocation proceedings in advance. In this context the judge noted that Dr Reddy's had not sought an early trial listing or expedition. Weighing up different factors, he concluded that preservation of the status quo coupled with Dr Reddy's failure to clear the way favoured the grant of an injunction.
Key takeaways
Interim injunctions remain a hot topic in pharma cases and recent interventions by the Secretary of State for Health and Social Care on NHS pricing, indicating willingness to restore originator prices post-generic entry, add a new dimension to the issue. Originators will not be able to rely on automatic assumptions/rebuttable presumptions of irreparable harm from price erosion in the face of threatened generic launch; each case will turn on its own facts. While we expect generics to rely more heavily on similar evidence/interventions from the Secretary of State in future, this decision shows that the UK courts are willing to grant interim injunctions to prevent generic launch where the originator is able to point to sufficient evidence of unquantifiable harm and the balance of the risk of injustice on the particular facts of its case.
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