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You are here: BAILII >> Databases >> England and Wales High Court (Patents Court) Decisions >> Astrazeneca AB & Anor v Glenmark Pharmaceuticals Europe Ltd [2025] EWHC 1339 (Pat) (28 May 2025) URL: https://www.bailii.org/ew/cases/EWHC/Patents/2025/1339.html Cite as: [2025] EWHC 1339 (Pat) |
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BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY LIST (ChD)
PATENTS COURT
7 Rolls Buildings Fetter Lane London EC4A 1NL |
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B e f o r e :
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(1) ASTRAZENECA AB (2) ASTRAZENECA UK LIMITED |
Claimants |
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- and – |
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GLENMARK PHARMACEUTICALS EUROPE LIMITED |
Defendant in HP-2025-000006 |
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- and - |
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TEVA UK LIMITED |
Defendant in HP-2025-000012 |
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- and - |
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GENERICS (U.K.) LIMITED (t/a VIATRIS) |
Defendant in HP-2025-000014 |
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- and - |
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SANDOZ LIMITED |
Defendant in HP-2025-000015 |
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- and - |
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BESTWAY PHARMACY NDC LIMITED |
Defendant in HP-2025-000017 |
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2nd Floor, Quality House, 6-9 Quality Court, Chancery Lane, London WC2A 1HP.
Telephone No: 020 7067 2900. DX 410 LDE
Email: info@martenwalshcherer.com
Web: www.martenwalshcherer.com
MS. ANNA EDWARDS-STUART KC and MR. TIM AUSTEN (instructed by Pinsent Masons LLP) appeared for Teva
MR. JEFF CHAPMAN KC and MR. SIMON PAUL (instructed by Pinsent Masons LLP) appeared for Sandoz
MS. KATHRYN PICKARD KC (instructed by Powell Gilbert LLP) appeared for Glenmark
MR. BRIAN NICHOLSON KC (instructed by Taylor Wessing LLP) appeared for Generics (t/a Viatris)
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Crown Copyright ©
HIS HONOUR JUDGE HACON:
Introduction
Letters
The law
"(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."
.
"[21] In patent infringement claims, it is often the case that damages will be an adequate remedy for the claimant if it is successful at trial because a final injunction will restore the claimant's monopoly and the claimant can recover damages for its lost profits due to lost sales and/or price depression as a result of infringing acts in the intervening period. This is so even though the quantification of such damages may be heavily disputed. As Floyd LJ explained in Neurim Pharmaceuticals (1991) Ltd v Generics UK Ltd [2020] EWCA Civ 793, [2021] RPC 7 ('Neurim I) 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.'
[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.
[22] 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. Counsel for Glenmark submitted that there were three such cases, but two do not correspond to the situation I have described. One is the apixaban case discussed in paragraph 69 below, where there is evidence of an unexplained price rise recently after a long period of price depression following the judgment of this Court (Sandoz Ltd v Bristol-Myers Squibb Holdings Ireland [2023] EWCA Civ 472, [2023] RPC 12). The other is Cephalon Inc v Orchid Europe Ltd [2010] EWHC 2945 (Pat), which concerned parallel imports. His best example is the Neurim case discussed in paragraphs 27 to 31 below, where there is evidence that product was returned to Category C and the reimbursement price returned to the original price after the defendant's substantive appeal was dismissed (Neurim Pharmaceuticals (1991) Ltd v Generics UK Ltd [2022] EWCA Civ 699, [2022] RPC 19, 'Neurim III'), but no further details. It appears, however, that there was only one generic company on the market during the intervening period.
[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 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.
[27] Returning to the first of these factors, as Floyd LJ noted in Neurim I at [13], 'whether a price spiral will occur in the period until trial in any given case is intensely fact specific'. In Neurim I itself Marcus Smith J held that damages would be an adequate remedy for the claimants, and therefore refused to grant an interim injunction. This Court upheld his decision at least in part because the evidence fell a long way short of establishing that any generic company in addition to the defendant was likely to enter the market in the period up to trial and therefore a downward price spiral was unlikely: See Floyd LJ at [46] and [50].
[28] There was a sequel to Neurim I after the trial. Marcus Smith J held that the patent was valid, granted a final injunction, refused permission to appeal and refused the defendant a stay of the injunction. This Court granted the defendant permission to appeal, expedited the appeal and granted the defendant a stay of the injunction pending the appeal: Neurim Pharmaceuticals (1991) Ltd v Generics UK Ltd [2022] EWCA Civ 370 ('Neurim II'). The three members of the Court gave slightly different reasons for reaching the last conclusion.
[29] My reasoning was that there had been no relevant change of circumstances since Neurim I, and therefore it remained the case that damages would be an adequate remedy for the claimants: [26]-[31]. Even if the claimants would suffer damage which would be adequately compensated by an award of damages, the damage to the defendant would be more difficult to quantify and adequately compensate: [32]-[33]. Even if both sides were equally likely to suffer damage that could not be adequately compensated, it was prudent to preserve the status quo, which was that the defendant was on the market: [34].
[30] Birss LJ said at [37]:
'… I would hold that there is a material risk that damages will be an inadequate remedy for each party in the relevant circumstances (for Mylan if no stay is granted but Mylan win the appeal, and for Neurim/Flynn if a stay is granted and Mylan lose the appeal). This is clearly so for Mylan but I believe it is also true for Neurim/Flynn. If Neurim/Flynn win the appeal then there will be a damages enquiry relating to Mylan's patent infringement. The various features of this market and the complexities, actual and potential, are all matters which the Patents Court is familiar with and can handle. The court is well able to conduct a damages enquiry in the circumstances of this market and to arrive at a figure it finds to be just. However that does not mean that damages are an adequate remedy. The uncertainties in this case, relevant to either side, are very significant. In mathematical terms a numerical result can always be found but the error bars will be large. In my judgment the decisive factor here, given that the appeal has been expedited and will be resolved before the patent expires, is the preservation of the status quo. That status quo is that Mylan is on the market and has been since September 2020. The uncertainties do not justify disturbing that state of affairs.'
[31] Newey LJ said at [38]:
' … Like Birss LJ, I take the view that damages will not necessarily be a fully adequate remedy for Neurim/Flynn should they succeed on the appeal, but it seems to me that the risk of uncompensatable loss to Mylan in the absence of a stay is greater and, perhaps more importantly, that preservation of the status quo favours the grant of a stay.'
[32] The importance of preserving the status quo is illustrated by the decision of HHJ Hacon sitting as a High Court Judge in a case which has some similarities with the present, Bayer Intellectual Property GmbH v Aspire Pharma Ltd [2024] EWHC 711 (Pat), [2024] FSR 23. The compound patent protecting rivaroxaban was due to expire on 1 April 2024, but Bayer had a patent ('EP 961') which protected tablets for once-daily administration. Six generic companies brought claims for revocation of EP 961. The claims were tried by HHJ Hacon and the trial concluded on 22 February 2024. Not having been informed of the significance of the date of 1 April 2024, HHJ Hacon told the parties that he planned to hand down judgment on 9 April 2024 with argument on the form of order on 11 or 12 April 2024. The defendants, and one other generic company, subsequently indicated an intention to launch generic rivaroxaban products for once-daily administration immediately after 1 April 2024. Bayer applied for an interim injunction to restrain them from doing so until the FOO hearing. HHJ Hacon heard the application on 25 March 2024. On 27 March 2024 he granted the injunction for the reasons given in his judgment of that date.
[33] As HHJ Hacon explained, the short and crucial point about the application was that it was designed to preserve the status quo for a period of only 9-10 days. He doubted that either Bayer or the respondents would suffer a great deal of irreparable harm on the alternative hypotheses of an injunction being granted or not. He did not consider that Bayer was not at risk of any irreparable harm at all because there would be uncertainties, but they would be modest. The same applied to the respondents. The decisive consideration was the one he identified at [56]:
'The Court of Appeal has emphasised the importance of maintaining the status quo in circumstances such as those of this application. It seems to me that it is all the more important where the period in question is so short. And as I have said, it would change the status quo in respect of any application there may be after judgment is handed down. That has the potential to give rise to significant irreparable harm to Bayer.'"
The evidence
Background
Preliminary issues
AZ's standing
"... However it must be remembered that the grant of an interlocutory injunction is a discretionary remedy that should be available to prevent injustice. It would be unusual to grant an interlocutory injunction to protect a property right if no damages for infringement could be recovered. But if the claimant has a cause of action to protect a property right recognised by the law, there is no reason in principle why the court should not grant an interlocutory injunction to protect that right, even if damages are not recoverable."
First mover advantage and clearing the path
"The status quo is that there is only one generic supplier in the market place."
All three members of the panel identified the potential importance of the status quo, Birss LJ and Newey LJ giving it particular emphasis. I have no doubt that the status quo they had in mind was the reality of the position on the ground at the time of the relevant hearing: who was on the market and who not. That is the meaning I will apply in this case.
Potential irreparable harm to AZ
AZ's submissions
"44. The following comments apply on the assumption that AZ succeed on appeal but, as explained above, there are material and unpredictable difficulties in restoring its price/market share.
45. In my First Statement at paragraphs 63-67, I referred to Joint Working projects. These are a suite of projects conducted by AZ in partnership with the NHS and seek to improve patient outcomes. As I mentioned in paragraph 59 of my First Statement, AZ estimates there are 3.7M people in the UK diagnosed with conditions making them eligible for treatment with an SGLT2 inhibitor such as dapagliflozin but not currently on treatment. The performance of the Joint Workings projects encourages the use of SGLT2 inhibitors such as dapagliflozin where appropriate including in such patients
46. However, if the revenue to Forxiga is materially damaged and does not restore to the original price almost immediately (as described above), then the cumulative result of the depression in the revenue stream together with a lack of predictability as to if (if ever) the revenue stream will be restored, there will be increasing pressure (accelerating month by month) on AZ to reduce its investment in these such projects. Quite how and when this pressure would crystallise is unpredictable, but it would occur in a matter of months following generic launch."
"14. AAH and Phoenix take as their primary position that Warner-Lambert will suffer no irreparable harm at all pending the hearing on 11th July. They say that over that very short period, it is extremely unlikely that Warner-Lambert will have to reduce their prices. If Warner-Lambert stand firm on their prices then damages, according to the usual measure, will be a perfect recompense for them.
15. I have to say that I am wholly unable to accept that submission. A launch on the scale which was contemplated and has begun would undoubtedly distort the market in Lipitor beyond the ability of any inquiry as to damages to compensate the claimants. One only has to think of the effect on Warner-Lambert's reputation when it is made clear that a price differential of 22.5% is available to purchasers of the generic product to see that some damage of an irreparable nature is bound to be incurred."
The VPAG Scheme
"7.6 Any Scheme Member that intends to change its overall distribution arrangements during the duration of the 2024 Voluntary Scheme will notify the Department of such changes as early as possible, and at least four (4) months in advance of any such change being made operational. Scheme Members are not required to notify the Department of routine commercial transactions that would not be expected to have a cost to the NHS.
...
7.8 If there are reasonable and objective grounds to believe that changes made to a Scheme Member's distribution arrangements during the duration of the 2024 Voluntary Scheme have, or would have, an adverse net impact on NHS expenditure in relation to the purchasing from that Scheme Member then the Department and the Scheme Member will discuss and agree any adjustments to those distribution arrangements and where the Scheme Member has influence on the pharmacy discount, this may include the Scheme Member separately paying a sum of money to the Department equal to any additional costs to the NHS."
"7.9. Paragraph 7.8 does not affect the right of Scheme Members unilaterally to offer or withdraw competitive trade discounts at any time, nor to determine individually how to
distribute their own products."
"6.30 Scheme Members may make temporary reductions to an NHS list price and increase the NHS list price to a level no more than the NHS list price before the reduction without the agreement of the Department. Scheme Members must inform the Department at least twenty one (21) calendar days before the changes take effect and provide information on the existing and new prices, and the expected duration of the reduction.
…
6.32 Where temporary price reductions or temporary price increases in NHS list prices have been made, Scheme Members will continue to be required to pay the Scheme Payment at the rate applying to all Scheme Members as a percentage of their Eligible Sales and in accordance with Chapter 5 and Annexes 3 to 5."
"4. Additionally, in case it assists the Court, the Interested Parties would like to take this opportunity to provide further information in relation to an aspect of the Court of Appeal's 16 April 2025 judgment in AstraZeneca AB, AstraZeneca UK limited v Glenmark Pharmaceuticals Europe Limited.
5. Paragraph 73 of the Court of Appeal Judgment accepts a submission, set out at paragraph 72, that:
'Now that it is clear that multiple generic entry is both a certainty and will happen more quickly even than Dr McGill feared, the correct conclusion is that AstraZeneca would be likely to reduce their actual price prior to the [final form of order] hearing and that, assuming they did so, they would have serious difficulty in raising them again.'
6. This echoes the statement, in paragraph 24 of the Court of Appeal Judgment, that:
'… 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'
7. The Interested Parties are concerned that these paragraphs of the Court of Appeal Judgment may reflect a misunderstanding, namely that obstacles would be raised to a price increase that would necessarily be difficult or even seriously difficult to overcome. This is not the expectation of the Department, which is that such a reduction and subsequent increase would be permissible on the basis of established arrangements for a temporary reduction of a list price."
"4. ... Although NHS bodies have interests that are liable to be affected by the decision whether to grant an injunction restraining generic entry, and the Interested Parties have written to the Court to ensure that those interests have been drawn to the Court's attention and are taken into account in the form of any relief it grants, the Interested Parties are (of course) neither parties to the Proceedings, nor respondents to any injunction application. They have not sought to put any witness statement(s) before the Court; nor to make extensive submissions; they have restricted themselves to writing three relatively circumscribed letters to the Court. The Interested Parties are mindful that the parties have, by contrast, filed substantial amounts of evidence; that delays to the disposal of the applications presently being heard have the potential to cause prejudice; and that there has already been an adjournment of the hearing over to 28 May 2025. Given this context, the Interested Parties wish to clarify that they are not, at this advanced stage, seeking to put any evidence before the Court in the form of a witness statement; nor are they seeking to have this letter treated by the Court as containing evidence, to be weighed in the balance with or against that adduced by any of the parties. What it is nevertheless legitimate for the Interested Parties to do, they would respectfully suggest, is to make clear by means of correspondence whether they do or do not accept a particular proposition about the NHS. This is particularly so in light of the suggestion that, by failing to express their position in relation to evidence given by Dr McGill about the NHS, the Interested Parties can be taken to have implicitly endorsed that evidence."
"However, the Interested Parties in no way accept that any NHS body would pursue a policy directed to deterring an originator drug company from restoring historic levels of actual selling and/or list prices, following an earlier reduction in the face of generic competition, that was sought to be reversed following the vindication of the originator's patent rights so as to eliminate that competition."
Harm to AZ's relationships
"32. As I explained in paragraph 48 of my First Statement, I expect that the NHS will be resistant to price restoration of dapagliflozin given the sheer size of the market. I fully maintain that statement and wish to add further detail to it.
…
34. Second, from my experience, AZ has observed that the NHS resistant to price increases. AZ has experiences this resistance in a number of ways:
…
(c) Due to the NHS's position and as a matter of reality (since the NHS is by far the largest consumer of medicines in the UK), when AZ negotiates with the NHS on price (for example, under tenders or when negotiating deals for new indications under an existing drug as referred to above), the NHS adopts a negotiating position in which the price should not exceed what has been previously offered. The NHS has a stronger than usual negotiating position in relation to dapagliflozin since, if it does not agree with AZ's position on price, the NHS is able to promote treatment with patient using other gliflozins.
(d) To give an example, as part of a Health Technology Appraisal of an AstraZeneca product, a senior member of NHS England informed me that he expected AZ to submit a lower price for a particular indication of a medicine because he was aware that such a price had been offered previously. He made clear that even though AstraZeneca was entitled to submit the higher price under the later submission, it would be viewed badly by NHS England if we did so and would count against us in negotiations in the future. I am also informed by our Legal Director, Dominic Hornblow, that in almost every NHS vaccine tender he has been involved in, the NHS seeks to set the expectation that prices should come down across successive tenders but should not go up. These examples speak to the fact that the NHS is extremely resistant to prices going back up."
"Third, aside from the NHS, I am informed by Mr O'Toole that an increase in prices of Forxiga after a period of reduced prices (owing to generic entry and then removal) would upset relationships between AZ and retail pharmacists. This is because, even if AZ is able to re-assert fully or partially the original price, that action would be perceived by retail pharmacists as a unilateral action by AZ against their interests and a displacement from the lower price to which they had become accustomed."
"9. If AstraZeneca prevails in any appeal and generic dapagliflozin has to be removed from the UK market I do not consider that there would be any resistance or resentment in the wholesaler or pharmacy levels of the supply chain. I hold this view for a number of reasons:
9.1 Over such a short period of time the market would not have become accustomed to the lower costs of dapagliflozin and many pharmacies may continue to hold branded stock for some or all of the period in question (depending on the rate at which they dispense the product). The wholesaler and pharmacy part of the supply chain would just be happy to have been given access to cheaper stock for that time within the overall context of their product costs across all products stocked.
9.2 The effect of this sort of temporary price reduction on overall pharmacy costs is limited as dapagliflozin is one of very many products that a pharmacy will dispense each week. As an illustration, Well pharmacies (the primary retail pharmacy brand operated by Bestway) dispense on average approximately 8,200 prescription items per store per month.
9.3 In reality, we are always seeing availability and stocking problems for different products where the price is going up and down continuously. Any return of the market to the branded dapagliflozin pricing would not be seen as exceptional by a retail pharmacy. Further, paramedics will not hold a negative view in relation to a product manufacturer when considering product pricing due to the fact that they only buy through wholesale channels."
The respondents' submissions
Discussion
Potential irreparable harm to the respondents
Conclusion