[2] For instance:
(1) in Dr Reddy's Laboratories (UK) Ltd v Boehringer Ingelheim International GmbH [2025] EWHC 2834 (Pat), on 5.11.25, Michael Tappin KC (sitting as a Deputy High Court Judge), under the heading 'The applicable principles' said, at paragraphs 20 to 30 (DR is the claimant (to a patent revocation claim)/respondent to the application for an injunction; BI DE is the defendant to the claim/applicant for an interim injunction; DR had started producing a generic product, during the currency of the claim, where the claim was listed for trial October 2026; SSHSC - Secretary of State for Health and Social Care were granted permission to intervene)
'It was, of course, common ground that I should approach the application for an interim injunction applying the guidelines laid down by Lord Diplock in American Cyanamid v Ethicon [1975] AC 396. They were stated as follows by Arnold LJ in Dapa II CA at [18]:
(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.
In relation to (2) and (3), DR emphasised what Floyd LJ said in Neurim v Mylan [2020] EWCA Civ 793 at [16]:
"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."
The difficulty in ascertaining whether the boundary between the adequate and the inadequate has been crossed is illustrated by the judgments of the Court of Appeal at a later stage in the Neurim v Mylan litigation: [2022] EWCA Civ 370, referred to in Dapa II CA at [28]-[31]. Arnold LJ held that there had been no material change of circumstances and so damages would be an adequate remedy for the claimants, whereas Birss and Newey LJJ held that they would not (but the fact that damages would not be an adequate remedy for the defendants and the preservation of the status quo meant that the injunction should be refused). Birss LJ emphasised that just because a court can conduct a damages enquiry and arrive at a figure it regards as just does not mean that damages are an adequate remedy if the uncertainties are significant.
DR pointed out that in American Cyanamid at p.408, when speaking of preserving the status quo, Lord Diplock said (DR's emphasis):
"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…"
DR's submission...was that Lord Diplock's words mean that this approach only applies in cases where all relevant matters will remain the same until judgment after trial if an interim injunction is granted, and that if relevant matters will change before judgment after trial even if an interim injunction is granted it is no longer "a counsel of prudence" to grant an interim injunction if "other factors appear evenly balanced". However, DR did not cite any authority in support of such a proposition, and the preservation of the status quo is often taken into account even in cases in which relevant matters will have changed by the time of judgment after trial.
In Dapa II CA at [20] Arnold LJ cited the observation of Lord Hoffmann in National Commercial Bank of Jamaica v Olint [2009] UKPC 16 at [17]:
"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.'"
I have had that well in mind, along with what Lord Hoffmann said in the Olint case at [16]:
"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."
BI referred me to what Arnold LJ said in Dapa II CA at [22]-[26]:
"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.
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.
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. …
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).
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."
However, the question is whether those factors are present in this case. I agree with the submission of [counsel for] SSHSC that one should not proceed on the basis of rebuttable presumptions, but on the evidence before the court in each case.
Carrying out the exercise required by American Cyanamid in pharmaceutical patent cases can be difficult because it involves assessing the likelihood of events happening in the future on each hypothesis that needs to be considered (injunction 'wrongly' granted and injunction 'wrongly' withheld). However, in many cases the period that needs to be considered is relatively short (often because it is common ground that the trial should be expedited regardless of whether an injunction is granted), and the market is a relatively stable one and will continue to be so in the absence of generic entry.
30. This case is very different. DR has now decided to launch its generic empagliflozin product at a time when the market for empagliflozin is likely to be about to change significantly in a manner which is unpredictable, even without generic entry. Moreover, it has done so having just agreed to a trial date in October 2026, meaning that it is necessary to consider what will happen during and after a period of about 14-15 months until the form of order hearing following judgment after the trial. That means that the uncertainties involved, and the difficulty in assessing whether granting or withholding an injunction is more likely to produce a just result, are increased.'
(2) see FCMB Bank (UK) Ltd v Collins [2025] 11 WLUK 78, Edmund Burge KC sitting as a Deputy High Court Judge on 7.11.25 (only Westlaw Case Digest currently available);
(3) in International SOS Assistance UK Ltd v Secretary of State for Defence [2025] EWHC 2634 (TCC), an unsuccessful tenderer for a MOD contract, commenced proceedings against the defendant, alleging breaches of the Public Contracts Regulations 2015 ("the Regulations"). Pursuant to regulation 95, those proceedings triggered the automatic suspension of the Defendant's power to award the contract. Eyre J on 20.10.25, under the heading 'The Approach to be taken', said, at paragraphs 27 to 36:
'27. Regulation 96(2) provides that when deciding whether to lift the automatic suspension the court must consider whether it would have granted an interim injunction preventing the relevant public body from entering into the contract if regulation 95 (imposing the automatic suspension) had not been applicable. O'Farrell J explained the approach to be taken thus in Camelot UK Lotteries Ltd v Gambling Commission [2022] EWHC 1644 (TCC) (2022) 202 Con LR 89 at [47] and [48]:
[47] "The applicable principles for determining such an application are set out in American Cyanamid Co v Ethicon Ltd [1975] 1 All ER 504 at 509–510, [1975] AC 396 at 407–408 per Lord Diplock; National Commercial Bank Jamaica Ltd v Olint Corp Ltd [2009] UKPC 16, [2009] 5 LRC 370, [2009] 1 WLR 1405 per Lord Hoffmann at [17]–[18]; Covanta Energy Ltd v Merseyside Waste Disposal Authority [2013] EWHC 2922 (TCC), (2013) 151 ConLR 146 per Coulson J (as he then was) at [34], [48]; and summarised in Alstom Transport UK Ltd v Network Rail Infrastructure Ltd [2019] EWHC 3585 (TCC), [2020] BLR 95, at [29].
[48] The relevant questions for the court, when determining an application to lift the automatic suspension in a procurement challenge case, are as follows:
(i) Is there a serious issue to be tried?
(ii) If so, would damages be an adequate remedy for the claimant(s) if the suspension were lifted and they succeeded at trial; is it just in all the circumstances that the claimant(s) should be confined to a remedy of damages?
(iii) If not, would damages be an adequate remedy for the defendant if the suspension remained in place and it succeeded at trial?
(iv) Where there is doubt as to the adequacy of damages for either of the parties, which course of action is likely to carry the least risk of injustice if it transpires that it was wrong; that is, where does the balance of convenience lie?"
28. The courts have considered sundry circumstances in which it has been said that damages would not be an adequate remedy for a claimant and where it has been said that it would not be just to confine the claimant to a damages remedy. That issue is to be addressed by reference to the circumstances of the particular case and there is no general rule that damages either always will be or will never be an adequate remedy in a particular category of case.
29. There will be cases where the difficulties in the calculation of the damages are such that the court cannot be confident that it will be able to quantify the claimant's loss properly and fairly. In such cases the prospect that the court will not be able properly to reflect the claimant's loss in a damages award can mean that it is unjust to confine the claimant to its damages remedy. This can be the position where the court would have to take account not only of the lost chance of a tenderer being successful in a fair tender process but also the lost chance of it then being called upon to perform services under a framework contract (see Lettings International Ltd v London Borough of Newham [2007] EWCA Civ 1522 at [33] – [35]). It can also be the position where the allegation is that the tenders were evaluated by reference to undisclosed criteria (see Morrison Facilities Services Ltd v Norwich City Council [2010] EWHC 487 (Ch), at [31] – [34) and NATS (Services) Ltd v Gatwick Airport Ltd [2014] EWHC 3133 (TCC), [2015] PTSR 566 at [80] – [83]). Another example is that of a case where it is said that a tenderer was materially misled and where it would be necessary to analyse whether different responses in communications would have made a difference to the bid (see Covanta Energy Ltd v Merseyside Waste Disposal Authority (No 2) [2013] EWHC 2922 (TCC) at [53]).
30. Care is needed before the court can conclude that difficulties in the evaluation exercise mean that damages will not be an adequate remedy (see Openview Security Solutions Ltd v London Borough of Merton [2015] EWHC 2694 (TCC) at [28] [32] and Medequip Assertive Technology Ltd v Royal Borough of Kensington and Chelsea [2022] EWHC 3293 (TCC) at [41] – [43]). It is to be remembered that the courts are well-used to determining damages by assessing the value of a lost chance and to doing so on the basis of incomplete information. It is relevant to note the high level of difficulty which has to be shown before the court will accept that damages will not be an adequate remedy. In Morrison Facilities and Covanta the court was concerned with circumstances in which the fair and proper assessment of the damages would have been "virtually impossible". In Lettings International the court accepted that the proper quantification of the damages would be "very problematical". In NATS Services Ltd there would have been "great difficulty in estimating the damages".
31. The fact that the loss of the contract in question would harm a claimant's prospect of obtaining other contracts and would cause a loss which would be difficult to identify can be a factor meaning that damages would not be an adequate remedy and that it would be unjust to confine the claimant to its damages remedy. However, caution is needed before the court can conclude that the loss of the contract will have such an impact. The fact that a tenderer fails to obtain a contract will not have that consequence without more even if the tenderer was the incumbent under the contract which is being replaced. Nor is it sufficient either that the lost contract was prestigious or that there is said to be an impact to the claimant's reputation. What is required is cogent evidence demonstrating the prospect that financial loss will be suffered in circumstances where that loss will not be recoverable in damages. See NATS Services Ltd at [84] – [85]; Openview Security Solutions Ltd at [35] and following; Bombardier Transportation UK Ltd v London Underground [2018] EWHC 2926 (TCC) at [57] and following; Draeger Safety UK Ltd v London Fire Commissioner [2021] EWHC 2221 (TCC) at [35] and [41]; Kellogg Brown & Root Ltd v Mayor's Office for Policing [2021] EWHC 3321 (TCC) at [76] and following; Camelot at [98]; and One Medicare v NHS Northamptonshire Integrated Care Board [2025] EWHC 63 (TCC) at [45].
32. There will be cases where the loss of a tender will cause the collapse of a business or of a substantial part of a business. The prospect of such an outcome can be a matter which makes it unjust to confine a claimant to its remedy in damages. However, such cases will be rare and the court will require detailed and cogent evidence as to the effect of the loss of the contract before accepting that a particular case was in that category (see TES Group Ltd v Northern Ireland Water Board [2020] NIQB 62 at [31] and [32]).
33. There will be rare cases in which a procurement claim succeeds but where the court is precluded from awarding damages because the relevant breach is not sufficiently serious to warrant such an award (see Braceurself Ltd v NHS England [2024] EWCA Civ 39, [2024] KB 913). In such a case there is scope for the argument that damages would not be an adequate remedy for a claimant which might succeed in its procurement claim but then receive no compensation. Such cases are rare and I will address below the approach to be taken in respect of that argument in the circumstances of this case.
34. If a serious issue has been shown and the court is not satisfied that damages will be an adequate remedy it must turn to consider the balance of convenience. The approach to be taken was summarized thus by O'Farrell J in Camelot at [126]:
"The balance of convenience test requires the court to consider all the circumstances of the case to determine which course of action is likely to carry the least risk of injustice to either party if it is subsequently established to be wrong. When determining where the balance of convenience lies:
(i) the court should consider how long the suspension might have to be kept in force if an expedited trial could be ordered: DWF LLP v Secretary of State for Business, Innovation and Skills [2014] EWCA Civ 900 per Sir Robin Jacob at [50];
(ii) the court may have regard to the public interest: Alstom Transport v Eurostar [2010] EWHC 2747 (Ch) at [80];
(iii) the court should consider the interests of the successful bidder, alongside the interests of the other parties: OpenView [2015] BLR 727 at [14];
(iv) if the factors relevant to the balance of convenience do not point in favour of one side or the other, then the prudent course will usually be to preserve the status quo (or, perhaps more accurately, the status quo ante), that is to say to lift the suspension and allow the contract to be entered into: Circle Nottingham Ltd v NHS Rushcliffe Clinical Commissioning Group [2019] EWHC 1315 (TCC), (2019) 185 ConLR 139, at [16]."
35. There is a public interest in the award of public contracts being made in a lawful and transparent manner but there is also a public interest in public authorities being able to obtain the benefits which they believe flow from the contract in question (see Draeger at [49]). There will often be differing views as to the extent to which new arrangements are in fact different from those already existing and as to the extent of any benefit flowing from the changes. A mere assertion of benefit by a public body cannot close down consideration of the point but the court must proceed on the basis that the public bodies are better placed than the court to determine whether changes will be beneficial (see Medequip at [109] – [110]).
36. As O'Farrell J explained it is necessary to consider whether it would be possible for the trial to be expedited and to have regard to how long the suspension would last if there were to be expedition. I set out my understanding of the approach in somewhat stark terms in Medequip at [59] and the position is rather more nuanced than my language there might suggest. It is nonetheless necessary to have regard to the scope for expedition. In doing so the court must consider the extent to which expedition with retention of the suspension protecting the interests of a claimant would be practicable and would reduce the risk of injustice being caused to the public by the retention of the suspension.'