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England and Wales High Court (Patents Court) Decisions |
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You are here: BAILII >> Databases >> England and Wales High Court (Patents Court) Decisions >> Dr Reddy's Laboratories (UK) Ltd v Boehringer Ingelheim International GmbH [2025] EWHC 2834 (Pat) (05 November 2025) URL: https://www.bailii.org/ew/cases/EWHC/Patents/2025/2834.html Cite as: [2025] EWHC 2834 (Pat) |
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BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY LIST (ChD)
PATENTS COURT
Fetter Lane London, EC4A 1NL |
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B e f o r e :
(sitting as a Deputy Judge of the High Court)
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| DR REDDY'S LABORATORIES (UK) LIMITED |
Claimant |
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- and - |
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| BOEHRINGER INGELHEIM INTERNATIONAL GMBH |
Defendant |
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- and - |
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| BOEHRINGER INGELHEIM LIMITED |
Proposed Part 20 Claimant |
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- and - |
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| SECRETARY OF STATE FOR HEALTH AND SOCIAL CARE |
Intervenor |
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Thomas Mitcheson KC, Edward Cronan and Thomas Lunt (instructed by Kirkland & Ellis International LLP) for the Defendant and the Proposed Part 20 Claimant
Andrew Lomas (instructed by the Government Legal Department) for the Intervenor
Hearing date: 24 October 2025
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Crown Copyright ©
The Deputy Judge:
The dapagliflozin litigation
The applicable principles
(1) Is there a serious question to be tried (or, in current terminology, does the claimant have a real prospect of success)? If not, no injunction should be granted.
(2) Would damages be an adequate remedy for the claimant for the loss sustained pending trial as a result of the defendant continuing the acts complained of if the claimant were to succeed at trial in establishing its right to a permanent injunction? If they would, and the defendant would be in a financial position to pay those damages, then no injunction should normally be granted.
(3) If not, would damages on the claimant's cross-undertaking be an adequate remedy for the defendant if the defendant were to succeed at trial in establishing its right to do acts which had been enjoined? If they would, and the claimant would be in a financial position to pay those damages, then an injunction should normally be granted.
(4) Where there is doubt as to whether damages would be an adequate remedy for either side or both, where does the balance of convenience lie? This depends on all the circumstances of the case. Where other factors appear to be evenly balanced, it is a counsel of prudence to preserve the status quo. There may be special factors which need to be taken into account.
"As the judge noted, when Lord Diplock spoke of damages being an "adequate" remedy, he was not suggesting that damages must provide a perfect remedy. As the judge also observed, there comes a point where "damages as a remedy falls so far short of the perfect, that the remedy can no longer be described as adequate." I agree with this. The boundary between the adequate and the inadequate is not a precise one. It is a matter for judicial evaluation on the evidence in any given case whether or not the boundary is crossed. If it is not crossed in relation to the claimant's loss then, normally, an injunction will not be granted."
"Where other factors appear to be evenly balanced it is a counsel of prudence to take such measures as are calculated to preserve the status quo. If the defendant is enjoined temporarily from doing something that he has not done before, the only effect of the interlocutory injunction in the event of his succeeding at the trial is to postpone the date at which he is able to embark upon a course of action which he has not previously found it necessary to undertake "
"In practice, however, it is often hard to tell whether either damages or the cross-undertaking will be an adequate remedy and the court has to engage in trying to predict whether granting or withholding an injunction is more or less likely to cause irremediable prejudice (and to what extent) if it turns out that the injunction should not have been granted or withheld, as the case may be. The basic principle is that the court should take whichever course seems likely to cause the least irremediable prejudice to one party or the other. This is an assessment in which, as Lord Diplock said in the American Cyanamid case [1975] AC 396, 408:
'It would be unwise to attempt even to list all the various matters which may need to be taken into consideration in deciding where the balance lies, let alone to suggest the relative weight to be given to them.'"
"The purpose of such an injunction is to improve the chances of the court being able to do justice after a determination of the merits at the trial. At the interlocutory stage, the court must therefore assess whether granting or withholding an injunction is more likely to produce a just result."
"22. Over the last quarter of a century, a considerable number of interim injunctions have been granted in cases where a generic pharmaceutical company has launched a product at risk of patent infringement. This class of cases is distinguished by three factors in particular.
23. First, the entry of one generic company into a market which has hitherto been monopolised by the patentee is often (but not always) followed by the entry of one or more additional generic companies into that market. This is liable to lead to price-cutting by all the suppliers in order to build or maintain market share, and a resultant downward price spiral. The effect of this on the patentee is liable to be exacerbated, if it continues, by recategorisation of the product under the NHS Business Services Authority ("NHSBSA") Drug Tariff, which affects the reimbursement price of pharmaceuticals dispensed against prescriptions which do not specify a brand.
24. Secondly, the practical ability of the patentee to restore its previous price if successful at trial is generally constrained by NHS resistance to such price rises. Although in theory there is little to stop patentees raising their prices, at least in the absence of recategorisation, this would lead to a loss of goodwill which is generally regarded by patentees as unacceptable. So far as I am aware, there are very few, if any, cases in which a patentee, having cut its prices due to generic competition following the refusal of an interim injunction before trial, has successfully raised its prices back to where they were after having prevailed at trial.
25. The first two factors can lead to the conclusion that damages will not be an adequate remedy for the claimant because of the uncertainty involved. It is usually the case that damages will not be an adequate remedy for the defendant either, however, because it will have no track record of selling the product in question to enable its lost sales to be quantified. Moreover, establishing the relevant counterfactual can be particularly difficult if it is either known or probable that other generic companies would have entered the market in the meantime, because then there will be uncertainty as to the extent to which the defendant would have benefitted from being the first generic entrant (e.g. by establishing relationships with customers for the product in question).
26. This leads to the third factor, which is that a generic company intending to launch a product at risk must first obtain an MA in order lawfully to be able to market its product and must have a source of supply of a product which has obtained all necessary regulatory approvals. This must be planned some time in advance. Furthermore, the generic company will usually be well aware of the risk of infringement. Typically, it will only launch at risk if it thinks it has a sufficiently strong case that the patent (or SPC) is invalid. In such circumstances the decision of this Court in SmithKline Beech[am] plc v Apotex Europe Ltd [2003] EWCA Civ 132, [2003] FSR 31 establishes that it is proper for a court to take into account, when considering the balance of the risk of injustice and deciding to preserve the status quo, that the generic company could have "cleared the path" for its launch by bringing proceedings for revocation of the patent sufficiently far in advance."
The evidence
i) to clarify the position of the DHSC regarding reversing of temporary reductions of list prices covered by the VPAG and approval of revised distribution arrangements;
ii) to provide an explanation of how categorisation decisions are taken in relation to the listing of prices under Part VIIIA of the Drug Tariff;
iii) to provide an explanation of the ways in which NHS bodies can properly influence prescribing decisions, and how they can and do react to changed positions on cost effectiveness;
iv) to provide an explanation of prescriber decision-making autonomy within that framework of proper influence by NHS bodies and how prescribers can take into account the resourcing implications of their prescribing decisions.
The empagliflozin market and how it may develop
"Furthermore, depending on indication (Appendix 1), switching from other SGLT2is (empagliflozin, canagliflozin, ertugliflozin) to generic dapagliflozin also offers enhanced value, with an additional £266m estimated annualised cost avoidance possible from switching eligible patients to generic dapagliflozin, over a three-month period. Switching patients more gradually over 12 months reduces the estimated in year saving by £57m.
The greatest volume of prescribing is in T2DM, and this is where initial focus is recommended. A second medical use patent has been granted for the use of dapagliflozin in the treatment of chronic kidney disease (CKD) in patients who do not have T2DM. This patent became effective from 17 September, and so, for the time being, treatment of CKD in patients without T2DM should be considered a patent protected indication.
We recommend that ICBs take the following action:
1. Update clinical pathways, guidelines, and formularies to recommend generic dapagliflozin as the first-line SGLT2i for indications other than CKD in patients without T2DM, considering clinical appropriateness.
2. Review potential savings opportunities from switching other SGLT2is to generic dapagliflozin. A tool has been developed to support ICBs to estimate potential savings. By the end of 2025, metrics will also be available in ePACT2 to help monitor changes in prescribing to dapagliflozin for patients switched from another SGLT2i or for new initiations.
3. Support switching in GP practices, using proactive approaches (e.g. system searches) and reactive tools (e.g. prescribing pop-ups) to facilitate change.
4. Assess and monitor SGLT2i uptake - data from the National Diabetes Audit and CVDPREVENT suggests that fewer than 50% of people eligible for SGLT2is are currently prescribed these medicines. Take action to support quality improvement and ensure generic dapagliflozin is offered first-line where indicated and licensed.
Clinical appropriateness should always be considered, and any switches should be discussed and agreed with patients through shared decision-making.
We appreciate your continued efforts to improve outcomes and value in medicines optimisation. Please cascade this information to relevant teams and stakeholders within your system."
DR's plans
Possible further generic competition
Serious issue to be tried
Would damages be an adequate remedy for BI?
Would damages be an adequate remedy for DR?
Balance of the risk of injustice