
Case No: HP-2025-000006; HP-2025-000012; HP-2025-000014;
HP-2025-000015; HP-2025-000017
The Rolls Building
7 Rolls Buildings
Fetter Lane
London EC4A 1NL
Before:
HIS HONOUR JUDGE HACON
(Sitting as a Judge of the High Court)
Between:
(1) ASTRAZENECA AB | Claimants |
- and - | |
GLENMARK PHARMACEUTICALS EUROPE LIMITED - and - TEVA UK LIMITED - and - GENERICS (U.K.) LIMITED (t/a VIATRIS) - and - SANDOZ LIMITED - and - BESTWAY PHARMACY NDC LIMITED | Defendant in HP-2025-000006 Defendant in HP-2025-000012 Defendant in HP-2025-000014 Defendant in HP-2025-000015 Defendant in HP-2025-000017 |
MR. GEOFFREY PRITCHARD KC , MR. THOMAS LUNT and MR. DHEEMANTH
VANGIMALLA (instructed by Freshfields LLP) appeared for the Claimants
MS. ANNA EDWARDS-STUART KC (instructed by Pinsent Masons LLP) appeared for Teva
MR. SIMON PAUL (instructed by Pinsent Masons LLP) appeared for Sandoz
MS. KATHRYN PICKARD KC (instructed by Powell Gilbert LLP) appeared for Glenmark
MR. ADAM GAMSA (instructed by Taylor Wessing LLP) appeared for Generics (t/a Viatris)
APPROVED JUDGMENT
ON COSTS
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HIS HONOUR JUDGE HACON:
Introduction
This is a hearing about costs. The five combined proceedings concern a patent owned by one of the parties, AstraZeneca AB. The patent claims a compound called dapagliflozin and its use in the treatment of type 2 diabetes. At all material times the patent was the subject of Supplementary Protection Certificates, in effect extending the monopoly afforded by the patent, but in this judgment it is sufficient for me to speak simply of the patent. I will collectively refer to the patentee and its UK subsidiary, also a party, as “AZ”.
In the substantive actions, four manufacturers and one wholesaler of generic pharmaceuticals alleged that the patent was invalid. AZ’s case was that the patent was valid and infringed by those parties. I will refer to the generic manufacturers as “Glenmark”, “Teva”, “Viatris” and “Sandoz”. “Bestway” is the wholesaler. Collectively, I will call those parties “the Generic Companies”.
The proceedings are now concluded. In a judgment dated 28th April 2025, Dr. Tappin KC found the patent invalid. On 16th July 2025, the Court of Appeal dismissed AZ’s appeal. On 31st July 2025, AZ’s application to the Supreme Court for permission to appeal further was dismissed.
During the course of the proceedings, there were several interim hearings, principally concerning AZ’s applications for interim injunctions against the various Generic Companies, seeking to restrain them from marketing generic dapagliflozin. Interim injunctions were granted, either at first instance or by the Court of Appeal.
An upshot of the now final and binding decision that AZ’s patent is invalid was that the interim injunctions in force against all the Generic Companies have lapsed. They are now free to advertise and sell their dapagliflozin products.
Costs orders have been made in respect of the substantive proceedings at first instance and on appeal and also in respect of some of the interim applications, but there remain outstanding issues of costs which were reserved at four first instance interim hearings and in a consent order. Three of the hearings were before Dr. Tappin and a fourth more involved hearing was before me. By agreement between the parties. to save further time and costs I will resolve all the reserved costs orders.
Background
An abbreviated account of the procedural history follows. In October, November and December 2023, Viatris, Teva and Glenmark respectively issued claim forms seeking a finding that the patent was invalid. The trial on validity was heard in March 2025. At that stage the proceedings concerned only the three joined claims of Viatris, Teva and Glenmark.
Before judgment was given AZ applied for an interim injunction against Glenmark to restrain the marketing of their dapagliflozin products pending the Form of Order hearing following judgment in the validity proceedings. Shortly afterwards AZ issued claim forms alleging infringement of the patent. The application for interim relief against Glenmark was heard and refused by Dr. Tappin on 27 March 2025.
The following day, 28 March 2025, there was a hearing to determine consequential matters. Permission to appeal was refused. However, AZ stated their intention to seek permission from the Court of Appeal and Glenmark undertook not to market its dapagliflozin products until the end of the hearing of AZ’s further application for permission. AZ was ordered to pay Glenmark's costs of the interim injunction application.
On 31 March 2025, the Court of Appeal gave AZ permission to appeal. By an order dated 11 April 2025, the Court of Appeal allowed the appeal and enjoined Glenmark from selling its products until the conclusion of the form of order hearing in the validity proceedings.
In a subsequent order dated 16 April 2025 the Court of Appeal set aside Dr. Tappin’s costs order and instead ordered that those costs were to be reserved to the form of order hearing in the validity proceedings. AZ’s costs of the successful appeal, on the other hand, were to be paid by Glenmark.
Judgment on the validity of the patent was handed down on 28 April 2025. The patent was found invalid. On the same day a consequential hearing took place. By this time AZ had issued claim forms against Glenmark and Teva alleging infringement of a patent by marketing of their respective dapagliflozin products. AZ stated that they would bring a similar action against Viatris. AZ further indicated their intention to appeal the decision to revoke the patent and to seek interim relief against Glenmark, Teva and Viatris pending the outcome of the appeal.
At the hearing on 28 April 2025 various rulings and directions were made consequential to the judgment. Dr. Tappin stated that the Court of Appeal’s order that Glenmark was restrained until ‘the form of order in the validity proceedings’ meant the hearing at which it would be determined whether there should be an interim injunction pending the appeal of the validity proceedings. Directions were given for that hearing. Undertakings were given by Teva and Viatris not to market until that same hearing.
The costs of the bulk of the hearing of 28 April 2025 were reserved to a future hearing to determine the costs of the actions. Costs in so far as they concerned the dispute about how to deal with AZ’s intention to seek injunctive relief pending appeal were reserved to the hearing of AZ’s application for that relief.
Shortly afterwards it came to AZ’s attention that Sandoz had supplied generic dapagliflozin products to a pharmaceutical wholesaler, Bestway. On 30 April 2025 there was a hearing at short notice following which Sandoz was restrained from selling its products pending the hearing of AZ’s application for interim relief pending the outcome of their appeal. Sandoz was also required to recall the products supplied to Bestway. By a consent order dated 26 May 2025 Bestway was restrained from selling Sandoz’s dapagliflozin products pending the same hearing.
In May 2025 AZ applied for an interim injunction pending their appeal in the validity proceedings. The application was made against Glenmark, Teva and Viatris, Sandoz and Bestway. It was heard on 14, 15 and 28 May 2025. An injunction was granted against each of them on 28 May 2025 or, in some cases, undertakings were continued. Those injunctions and undertakings were later extended until the decision of the Supreme Court on AZ’s application for permission to appeal. The injunctions and undertakings have now fallen away.
By a consent order dated 3 July 2025 it was ordered that the following costs should be determined at a further hearing: (1) the costs of the application for an interim injunction against Glenmark heard on 27 March 2025; (2) the costs of the hearing on 28 April 2025 in so far as they were directed to arrangements for a hearing of AZ’s application for interim relief pending appeal from the order in the validity proceedings; (3) the costs of the application against Sandoz for interim relief heard on 30 April 2025; (4) the costs of the application against Bestway for interim relief, settled by the consent order dated 6 May 2025; (5) the costs of the application against all the Generic Companies heard on 14, 15 and 28 May 2025 for interim relief pending the outcome of the appeal in the validity proceedings.
This is the hearing on costs contemplated by the order of 3 July 2025.
Application of 9 April 2025
I begin with the costs of the application for an interim injunction against Glenmark of 9 April 2025. As I have said, it was unsuccessful at first instance but successful on appeal, with the costs order at first instance being replaced on appeal by an order of costs reserved.
The law
The starting point for any order as to costs is CPR 44.2, including rule 44.2(2) which provides:
‘(2) If the court decides to make an order about costs –
(a) the general rule is that the unsuccessful party will be ordered to pay the costs of the successful party; but
(b) the court may make a different order.
Rule 44.2(4) is also of relevance. It provides:
‘(4) In deciding what order (if any) to make about costs, the court will have regard to all the circumstances, including –
(a) the conduct of all the parties;
(b) whether a party has succeeded on part of its case, even if that party has not been wholly successful; and
(c) any admissible offer to settle made by a party which is drawn to the court’s attention, and which is not an offer to which costs consequences under Part 36 apply.’
All the parties relied on a fairly short note in the White Book regarding the costs of interim injunctions, at 44.2.15(1) which states:
‘Costs of interim injunctions
1. Where the purpose of an interim injunction is to 'hold the ring' until trial, the costs of the application will usually be reserved: Richardson v Desquenne et Giral UK Ltd [1999] C.P.L.R. 744; [2001] F.S.R. 1, Picnic at Ascot v Kalus Derigs [2001] F.S.R.
2. The Desquenne principle overrides the usual rule that the unsuccessful party bears the costs because, in a case where the injunction is granted on the balance of convenience, at that stage there is no winner or loser: Wingfield Digby v Melford Capital Partners (Holdings) LLP [2020] EWCA Civ 1647. Where however the injunction is granted not merely on the balance of convenience and the issues considered on the application will not be revisited in the substantive proceedings, if there is a winner and a loser on those issues, the loser should pay the winner’s costs: Koza Ltd v Koza Altin Isletmeleri AS [2020] EWCA Civ 1263.’
All the parties endorsed this note as stating the correct approach to interim costs and said that the Desquenne principle applies to the costs in issue from the hearing of 9 April 2025. The principle is not directly relevant to the assessment of costs at a reserved hearing but the words ‘at that stage’ in the first sentence of paragraph 2 imply that by the time of the reserved hearing it will generally be possible to identify the winner and the loser. As I will come on to, all the parties endorsed that implication.
The argument on law for the Generic Companies was largely presented by Teva. There was a nuance with regard to the Desquenne principle. AZ and Teva submitted that the principle applies only when interim relief is decided on the balance of convenience in a strict sense. By that, they meant that it does not apply where the outcome turns on whether either party has suffered irreparable harm or where the court decides the balance of irreparable harm favours one side or the other. Glenmark and Sandoz argued that ‘balance of convenience’ should be interpreted in a broader sense, covering also decisions turning on irreparable harm. If AZ and Teva are right, the application of the Desquenne principle may be surprisingly narrow. However, on the facts before me the principle apples whatever its scope may be.
As I have said, AZ and the Generic Companies all assert that it is possible to identify which party was successful at the interim hearing and to award costs accordingly. But they differ as to what ‘successful’ means.
AZ submit that the successful party was the one which succeeded in respect of the issue at hand: whether interim relief should be granted. AZ obtained the injunction they sought, albeit on appeal. In the result, AZ are the successful parties and are entitled to their costs. In support of this, AZ cited Richardson v Desquenneet Giral UK Ltd [2001] F.S.R. 1 and Picnic at Ascot v Klaus Derigs [2001] F.S.R. 2. Neither judgment was directly concerned with the present issue and in my view neither assists AZ. I will return to Desquenne when dealing with the arguments of the Generic Companies.
AZ pointed to other authorities, namely Koza v Koza Altin Isletmeleri AS [2020] EWCA Civ 1263, Neurim Pharmaceuticals (1991) Ltd v GenericsUK Ltd (trading asMylan) [2020] 1362 (Pat) and Andrew Hicks EngineeringLimited v Jenks Associates Limited [2023] EWHC 2031 (Ch).
In Koza, the Court of Appeal stated that reserving the costs of an interim hearing was not an invariable principle of law and that depending on the facts other orders could be made at the interim stage, reflecting what had been said in Picnic at Ascot.
In Neurim Pharmaceuticals Marcus Smith J took the view that a distinction was to be drawn between the circumstance of an interim injuncted being granted and that where it is not granted. In the latter case, what Marcus Smith J characterised as the ‘exceptional’ case of costs being reserved to the trial judge as proposed by Neuberger J in Picnic at Ascot, did not apply:
‘4. Accordingly, one can see that where an interim injunction is granted, it is (in the usual case) wrong to say that the defendant was the unsuccessful party or that the claimant was the successful party. Ex hypothesi, the claimant only succeeded by meeting the low requirement of serious issue to be tried.
In this case, of course, the interim injunction was not granted. More to the point, the reason it was not granted was not because there was no serious issue to be tried (I found there was – and, at least at the hearing, there was little push-back on this point from Mylan), but because damages were (as I found) an adequate remedy. The application therefore failed at what I called Stage 2 of the American Cyanamid process.
I do not consider that the reasoning of Neuberger J automatically or inevitably translates to this case. Whereas the merits of the dispute are revisited, indeed determined, at trial, the question of the adequacy of damages is principally one to be assessed at the interlocutory stage. It therefore seems to me that this case should not be treated as one of those exceptional cases where costs are reserved to the trial judge, but rather are dealt with now.’
I need not explore Picnic at Ascot to state a view as to whether Neuberger J intended an order of ‘cost reserved’ in the circumstances he was discussing to be exceptional, or the general rule as indicated in the White Book. On appeal from the hearing of 9 April 2025 an injunction was granted, not refused.
In AndrewHicks Engineering there had been an application for an interim injunction following which the case settled. The argument was about the correct order as to costs for the interim hearing. AZ drew my attention in particular to the following sub-paragraphs of paragraph 78 of the judgment:
(4) Where there is sufficient material on which the court can ascertain which is the successful party and which the unsuccessful, the general rule applies, and the unsuccessful pays the costs of the successful unless there is good reason to decide otherwise.
(5) Where the matter settles after an interim injunction application has been dealt with simply on the ‘balance of convenience test’, whether by imposing an injunction or accepting undertakings, there will not normally be a proper basis for making a costs order at all, let alone ascertaining the successful and unsuccessful parties, and the proper order is no order.’
With regard to how costs should be assessed at the reserved hearing, the foregoing passage of the judgment assists only where an interim injunction has been decided on the balance of convenience and there is no trial. In such instances the proper order is no order as to costs because no winner or loser can be identified. This again implies, however, that were there has been a trial one might expect it to be possible to identify the successful and unsuccessful parties.
The Generic Companies argued that on the facts of this case, that Glenmark was successful at trial meant that it was also retrospectively successful at the interim stage because the patent, which founded the AZ claim to interim relief, was all along invalid. The costs of the interim application should follow the event.
Teva referred to the following passage from the judgment of the Court of Appeal in Wingfield Digbyv Melford Capital Partners (Holdings) LLP [2020] EWCA Civ 1647 at [41]:
‘As Mr Shepherd correctly said his clients had secured the return of the laptop (the return of which they had never asked for before issuing proceedings) and had secured the benefit of preventing (for the time being) the convening of a meeting of limited partners and the use of information obtained either electronically from them or by other means and whether lawfully or otherwise. The second of these benefits is, in our judgment, without significance on the question of costs. Whenever a claimant successfully seeks an interim injunction preventing the defendant from doing something (whether using a right of way, working for a competitor or infringing a patent) the defendant will be stopped from doing whatever it is for the time being. That was precisely the case in both Desquenne and Picnic at Ascot. However, the judge's decision that he was unable to resolve the merits of the disputes means that the basis on which those orders were obtained and continued, without objection from the Appellant, may prove in the end to have been unfounded. ‘Success’ of this type is only a provisional one. On the other hand, a ‘costs reserved’ order does not mean that claimants generally, or these Respondents in particular, will never recover the proper proportion (if not all) of their claimed costs: the matter is open and the costs have been neither won nor lost by either side at this stage.’
Thus, a ‘costs reserved’ order at an interim hearing means that the award of costs for that hearing remains open because success by one party or the other is only provisional. On the other hand, as noted in the White Book, the words ‘at that stage’ suggest that by the time that the trial is over it will generally be possible to decide which side has won and which has lost.
Teva relied on the following paragraphs from Bean on injunctions, 15th edition at paragraph 5-44:
‘Whether the interim injunction is granted or refused, the court may reserve the interim costs to the trial judge.
This option may be appropriate where the application is decided on the balance of convenience and the judge is simply ‘holding the ring’ pending a trial or other determination (Desquenne et Giral UK Ltd v Richardson [1999] C.P.L.R. 744; [2001] F.S.R. 1). This was followed in Picnic at Ascots Inc v Derigs [2001] F.S.R. 2 where Neuberger J suggested that the usual order where a claimant obtained an interim injunction was for costs to be reserved. He noted that the facts were still to be contested and costs orders should not discourage defendants from agreeing to a sensible interim course. The costs in such circumstances could be determined once the true merits of the application were able to be assessed. The effect of this is that such costs will follow the outcome of the trial unless otherwise ordered (or need to be provided for if the claim is compromised before trial).
5-45 As Moore-Bick LJ said in R. (Hysaj) v Secretary of State for the Home Department [2015] 1 W.L.R. 2472 ‘in some cases, of which Desquenne et Giral UK Ltd v Richardson is an example, it may be appropriate to defer making an order for costs until the outcome of the substantive proceedings is known, but that will not invariably be the best course'. However, a court may order that the claimant should recover his costs in any event where the merits of the application were so obvious that it should not have been contested or when it is clear that a trial is unlikely to take place. The defendant may get his costs if the injunction application was brought in an over-aggressive way and concluded by undertakings which could have been obtained by pre-action dialogue (Pathology Group Ltd v Reynolds [2011] EWHC 3958 (QB)). A court will still be willing to make a cost order to mark any improper or unreasonable conduct by one of the parties in the course of an interim application.
The risks with a determinative costs order is that it may later transpire that the injunction was obtained or declined on an incorrect basis rendering it unjust for the party successful at the interim stage to have had his costs paid by the losing party. As Andrew Smith J observed in Dar Al Arkan Real Estate v Al Refai [2015] EWHC 1793, there Is no straightforward legal mechanism to require a recipient to disgorge costs already paid.
The Court of Appeal reaffirmed the Desquenne approach of reserving costs in Wingfield Digby v Melford Capital Partners (Holdings) LLP [2020] EWCA Civ 1647; [2021] 1 W.L.R. 1553. In a hotly disputed case, in which the underlying issues are impossible to determine at the interim stage, it is often wrong to try to identify a winner and a loser and so costs should generally be reserved unless there are some special factors in play.
Where the purpose of the injunction is not to ‘hold the ring’ until trial, there is no reason to reserve the costs.
In Koza Ltd v Koza Altin Isletmeleri AS [2020] EWCA Civ 1263; [2020] Costs L.R. 1479 the Court of Appeal determined costs following an unsuccessful appeal against an interim injunction preventing the dissipation of the company’s assets. The controlling individual was ordered to pay them in person as a costs order against the company would prejudice the successful party.’
In the final sentence of paragraph 44 the authors appear to assume that the costs of interim proceedings will usually follow the outcome of the trial.
Teva also referred to paragraphs 12 to14 of Desquenne. At the end of paragraph 14 Morritt LJ says this:
“It follows from what I have said already, that it seems to me that the only proper exercise must be that the costs of both parties are to be reserved to the trial judge because only then can it be determined which party is successful and which is unsuccessful.”
That sentence once more implies that the costs of an interim application will ultimately depend on which party is successful at trial.
It might be thought that if costs of an interim application to restrain acts by the respondent will usually follow the event, the appropriate order at the interim stage, where decided on the balance of convenience, should generally be costs in the case. The judge at the interim stage will be aware of other factors there may have been which are to be taken into account for an order as to costs and may be better placed to assess their relevance than will be the trial judge.
However, thought not stated, I would imagine that the rationale for reserving the costs may be that matters could emerge by the end of the trial which will shine a light on the merits of application for interim relief. For instance, cross-examination may reveal that written evidence presented at the interim stage was in retrospect unreliable.
A view could be taken, advanced by neither side, that where a patentee successfully applies for an interim injunction and the patent is found invalid, the patentee’s justification for seeking interim relief is counterbalanced by the finding of invalidity, which is an outcome that was not available information at the interim stage. On that view, the unsuccessful party at trial no more qualifies as the paying party for the interim hearing within the meaning of 44.2(2)(a) than does the unsuccessful party at the interim hearing. Such a view, on appropriate facts, could lend favour to no order as to costs. However, both sides’ case here was that the successful and unsuccessful parties at the interim hearing can generally be identified by the time that the trial is concluded and can be here. The parties just differed as to which was which.
I have reached the view that the authorities cited to me imply that once the trial is concluded, it will indeed be possible to identify a successful party and the unsuccessful party and that this identification will apply not only to the substantive proceedings but, on facts such as those here, also to the interim stage. In this instance the unsuccessful party was AZ.
It seems to me that such a result is not unjust on the facts of this case. AZ started proceedings for infringement more than a year after Glenmark, Teva and Viatris issue proceedings to invalidate AZ’s patent. AZ had a great deal of time to reflect on the merits of seeking to show that their patent was both valid and infringed. The Generic Companies had signalled their intention to market their dapagliflozin products once they had marketing authority. AZ must have realised that in the event they were to start proceedings against one or more of the Generic Companies there was a good possibility that this would include resisted applications for an interim injunction. Presumably AZ came to the view that the costs orders following such applications were part and parcel of the risk that they were willing to take. An important part of this risk was the possibility that the basis for any relief, including interim relief, namely that the patent was valid, was a flawed basis.
AZ argued that a special factor arose on the facts of the application of 9 April 2025, namely that Glenmark did not take appropriate steps to clear the way to marketing its products, pointing to the criticism of Glenmark made by the Court of Appeal in this regard. In brief, Arnold LJ took the view that Glenmark should have been more assertive in its application for an expedited trial by suggesting that it might be able to launch its products in January 2025, which may have made a trial by January 2025 more likely, foreclosing the need for interim relief.
Glenmark acknowledged the criticism, although pointed out that Dr. Tappin at first instance had thought otherwise, taking the view that Glenmark should not be criticised. Dr. Tappin accepted that Glenmark was not able to give a date by which it would be able to launch its products. That is by the way. However, I accept Glenmark's submission that Glenmark’s conduct was reflected in an adverse order from the Court of Appeal on the costs of the appeal and that the Court of Appeal’s decision to reserve the costs at first instance could be taken to have cleared the slate.
Glenmark pointed to what it says is the considerable commercial benefit gained by AZ from keeping Glenmark off the market. It seems to me that this is beside the point. Glenmark will be entitled to seek compensation under AZ’s cross-undertaking. I must assume for present purposes that Glenmark will be properly compensated.
I will make the order appropriate to the facts of this case. In respect of the application of 9 April 2025 AZ must pay Glenmark's costs. I will return to Glenmark’s application for an interim payment.
Hearing of 28 April 2025
Next are the costs that were reserved at the hearing on 28th April 2025. This followed the judgment in which AZ’s patent was found invalid. To recap, earlier the Court of Appeal had reversed his decision refusing Glenmark interim relief, granting an interim injunction pending ‘the form of order in the validity proceedings’.
Glenmark understood ‘the form of order in the validity proceedings’ to mean the hearing of 28 April 2025. In fact, the position of all three Generic Companies then in the proceedings, Glenmark, Teva and Viatris, was that unless AZ obtained a further injunction on that date, they would be free to market their products. However, Dr. Tappin ruled that the order of the Court of Appeal was to be construed to mean that the injunction against Glenmark could continue until a hearing specifically dedicated to whether AZ was entitled to interim relief pending the appeal from the finding that the patent was invalid. In consequence AZ remained protected until that subsequent hearing. The judge gave directions for evidence in advance of the hearing and reserved the costs of resolving the matter to that later hearing. They fall to be dealt with now.
It seems to me that these costs form part of the costs of that subsequent hearing which I will deal with shortly.
Hearing of 30 April 2025
On 30 April 2025 AZ applied for an interim injunction against Sandoz. The injunction was granted. There was also an application against Bestway, settled by a subsequent Consent Order. The evidence and argument at the present hearing in relation to this has tended to speak only of Sandoz. Sandoz and Bestway were jointly represented and I can treat them as one. As the parties did, I will just refer to Sandoz for the most part.
I will give some more of the background. On three occasions in March and April 2025, AZ’s solicitors wrote to Sandoz to seek confirmation that Sandoz did not intend to launch a dapagliflozin product without first informing AZ of its intention. No response was received.
On 29 April 2025, Viatris learned that Sandoz had launched a generic dapagliflozin product on to the wholesale market. Viatris informed AZ. The significance from Viatris’s point of view was that Viatris felt that this entitled it to discharge the undertaking it had given not to market its own products pending a court ruling on whether or not Glenmark, Teva and Viatris should be restrained until the outcome of the appeal on validity. AZ sought relief from the court against both Sandoz and Viatris. It was listed to be heard on the morning of 30 April 2025. At 8.10 a.m. that morning, Sandoz's solicitors sent an e-mail stating:
“Sandoz can undertake not to dispose of any further product and are taking steps as of now to ensure that happens. Please provide the terms of the undertaking as soon as possible. In the circumstances we do not think that urgent interim relief is necessary.”
The hearing went ahead at 10.30 on 30 April 2025. The injunction was granted against Sandoz and Bestway, the wholesaler to which Sandoz had supplied its products. Costs were reserved.
AZ seek their costs from Sandoz and Bestway on an indemnity basis on the grounds that the application was successful and that Sandoz's surreptitious launch of its products deprived the court of the ability to rule upon interim relief in an orderly manner.
Sandoz argues that it was the successful party because AZ’s patent was subsequently revoked.
Sandoz also say that by the time they launched their product there had been a finding of invalidity. Also, AZ’s earlier correspondence had given a deadline of 1 April 2025 by which Sandoz had to confirm that it would not enter the market without notice. The deadline passed and AZ failed to follow through. AZ later gave another deadline: the date of the form of order hearing following judgment on validity. Sandoz submits that not all patentees seek interim relief and taking all the foregoing into account Sandoz was entitled to assume from AZ’s conduct that AZ did not intend to take the matter further once their patent was found to be invalid.
In addition, Sandoz point out that it was aware that the Court of Appeal's injunction against Glenmark lasted only until the form of order hearing following the judgment on validity and Sandoz knew the judgment had been handed down on 28 April 2025. Sandoz was further entitled to assume that the form of order hearing had taken place when judgment was handed down and that accordingly the injunction against Glenmark had expired.
Finally, Sandoz relies on the undertakings it offered on the morning of 30 April 2025.
It follows, Sandoz submits, that the hearing of 30 April 2025 was only made necessary by AZ’s failure to police the market, their failure to bring an application sooner and by failing to keep Sandoz properly informed. Sandoz is entitled to the costs of the hearing.
I do not find Sandoz’s arguments persuasive. Sandoz knew that the Court of Appeal had granted an injunction against Glenmark. Sandoz was aware that AZ had resisted Glenmark's marketing of generic dapagliflozin. I can see no reason why Sandoz might imagine that AZ would take a different stance towards them. Sandoz must have been aware of the likelihood, or at least of the real possibility, that AZ would continue to resist the marketing of generic dapagliflozin by anyone pending an appeal.
I have no doubt that the proper course that Sandoz should have taken was to find out if and when Glenmark and the other Generic Companies would be free to enter the market and that this should have been done at the very latest when Sandoz became aware that judgment on validity had been handed down. If there was to be a hearing about that, Sandoz was free to seek to be heard at the hearing. It seems that Sandoz made no attempt whatever to be properly informed.
Undertakings were not offered by Sandoz until the morning of AZ’s application against them. No precise terms were offered, rather a willingness to consider what AZ may require. It was too little, too late.
The cause of the hearing on 30 April 2025 was Sandoz's apparent wish to steal a march on any other generic company by launching its dapagliflozin products without telling anyone. The hearing on that date was entirely unnecessary, wasting the time of the court and costs. This was conduct out of the ordinary.
Consequently, AZ are entitled to their costs of the hearing on an indemnity basis. AZ said they had to work through the night of 29 to 30 April 2025 and then had to spend time after the hearing negotiating and monitoring the recall process with Bestway. Neither surprises me. I will return to AZ’s application for an interim payment. Sandoz and Bestway were jointly represented and held common cause and therefore I find they are jointly liable for those costs.
Teva and Viatris were also present at the hearing of 30 April 2025. Teva does not claim its costs save in so far as they can be characterised as part of the general costs in the infringement proceedings. That is a matter which will have to be resolved elsewhere. Viatris was a party which was obliged to attend. On the one hand, for the reasons discussed in relation to the hearing of 9 April 2025, it is now clear that AZ had no right to restrain Viatris. On the other hand, as I have said, the hearing should never have taken place and responsibility for it cannot be ascribed to AZ. I make no order as to costs.
Hearing of 14, 15 and 28 May 2025
On 14, 15 and 28 May 2025 there was a hearing to deal with whether there should be a continuation of the interim injunctions restraining the sale of dapagliflozin products pending the outcome of the appeal against the order revoking the patent or, as the case may be, the continuation of undertakings to that effect. The respondents were Glenmark, Teva, Viatris, Sandoz and Bestway, with Sandoz and Bestway jointly represented.
The relief sought by AZ was granted and the costs were reserved. The interim hearing was decided on the balance of convenience (however construed) and pursuant to a principle established by the Court of Appeal that preserving the status quo was an important consideration in circumstances such as those before the court.
The key argument on costs at this hearing was the same as that I have discussed and decided in relation to the hearing of 9 April 2025: which side was successful at this interim stage. For the reasons given earlier, the starting point is that the Generic Companies should have their costs. There were additional arguments advanced by the Generic Companies as special factors to be taken into account. I need take those no further.
AZ pointed to arguments advanced by the Generic Companies that failed. I do not take the view that this is an instance where slicing and dicing issues and deciding who won and who lost each issue is appropriate. What matters is the identity of the successful and unsuccessful sides.
Because of the way that events unfolded there was an adjournment during the course of the hearing which has led to a dispute about the responsibility for the adjournment. In my view neither side was responsible. Taking a detailed matter very briefly, on the first day of the hearing I received a letter dated the same day, 14 May 2025, from the Department of Health and Social Care, the DHSC. An issue of fact had been raised in the evidence which had an important bearing on the irreparable harm liable to be suffered by AZ if there was no injunction. A similar fact had been assumed by the Court of Appeal in its judgment in the appeal from the hearing of on 9 April 2025. The letter suggested that the Court of Appeal had misunderstood the true position in relation that fact that and by implication suggested that I was liable to make the same mistake. As I said in my judgment, it appeared that there was a substantial risk that I would be giving judgment on a false understanding of the facts. AZ for its part became concerned that I may conclude from the letter that an expert witness from AZ had misled the court and that I would say so in my judgment. I accepted that this would have been a serious matter so far as Dr McGill and AZ were concerned. Accordingly the hearing was adjourned. This no doubt had an unfortunate effect on costs but the cause was the letter of 14 May 2025 having been filed very late. In a subsequent letter, dated 23 May 2025, the DHSC was at pains to say that its letter of 14 May 2025 should not be treated as evidence about anything or weighed in the balance by the court when reaching a judgment.
In my view, there are no significant additional factors in play. AZ must pay the costs of the Generic Companies. I will hear further argument on interim payment.
(For continuation of proceedings: please see separate transcript)
I take on board the points made by Mr. Pritchard and Ms. Edwards-Stuart. I certainly do not think that I am in a position to discriminate between the various Generic Companies. I do not know the extent to which there was duplication, if any, and who might have been responsible for that.
I am persuaded that the figures presented by the Generic Companies may be high and that there is some risk that 75% recovery in costs may not be realised when the matter goes to a detailed assessment.
I will therefore make an interim order for payment of costs in the sums of 65% of the total costs incurred in each case, as claimed by each of Teva, Glenmark, Viatris and Sandoz.
(For continuation of proceedings: please see separate transcript)
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