Edwards Lifesciences Corporation & Anor v Meril GmbH & Anor

MR. JUSTICE MEADE:

1. This is a hearing which was originally arranged as the pre-trial review in a patent action in which the trial was due to begin after the forthcoming court vacation, but has become, instead, a hearing about how to manage the whole of these proceedings with a view to bringing them, if possible, to an orderly conclusion.

2. The action is a patent action about THV devices, which are medical devices for use in the heart. The overall dispute has been case-managed into a number of patent actions. One has taken place already with a result which I think I can best describe as complex, but inconclusive, and there remain more trials to take place. There are two more infringement and validity trials and a public interest trial still in the court diary.

3. I will refer to the defendants collectively as “Meril”; it has indicated that it no longer wishes to defend the UK proceedings. Its evidence states that it finds the costs too great and it prefers to leave the UK market rather than to carry on. I am in no position to assess whether that is the whole of Meril's reasoning or whether it might also have felt concerns about the merits. Dr. Turner QC, who appears for Meril, says that it is only the costs. I have no way of determining that and I do not need to.

4. There are proceedings in numerous other European jurisdictions (I do not need to list all of them) as well as in the European Patent Office and the US, and Meril is not seeking, so far as I am aware, to withdraw from any of them.

5. In those circumstances, the primary question for me is how to wrap things up from here. The position of Edwards (by “Edwards” I include both claimants), for whom Miss May QC, appears, is that there are only two appropriate courses. They say either that Meril must admit infringement, as well as withdrawing its defence and counterclaim based on invalidity or, alternatively, if Meril will not make an admission, then there must be a trial to determine the question of infringement because even if an injunction, an inquiry and delivery up are ordered (which Meril accepts) Edwards would have an outstanding claim in the prayer for a declaration of infringement. Edwards has proposed that if there has to be such a trial, it can consider all the remaining patents that are in issue between the parties in both the remaining patent and validity trials in a three-day hearing (one day pre-reading and two days in court), in the slot currently reserved for the next trial, starting in mid-April.

6. Meril is unwilling to make the admissions that Edwards say would obviate a trial.

7. First of all, I think it is appropriate to identify the relief that is sought and that appears in the draft re-re-amended particulars of claim and is as follows: AND THE CLAIMANTS CLAIM (1) A declaration that the Patents and each of them have been infringed by the Defendants’ actions with respect to the Myval Device. (2) An injunction to restrain the Defendants and each of them (whether acting by themselves, through their respective directors, officers, servants, agents or otherwise howsoever) from infringing the Patents and each of them. (3) An inquiry as to damages suffered or, at the Claimants’ election, an account of profits made, by reason of the acts of infringement / threatened infringement of the Patents and each of them by the Defendants and each of them. (4) An order for delivery up or destruction upon oath of all articles and materials in the possession, custody or control of the Defendants and each of them, the use, keeping, sale or supply of which would constitute a breach of the injunction in paragraph (2) above. (5) An order for appropriate measures for the dissemination and publication of the judgment and order, at the expense of the Defendants. (6) Costs. (7) An order that the Defendants pay the Claimants all sums found due together with interest pursuant to section 35 A of the Senior Courts Act 1981 or the Court’s equitable jurisdiction for such period and at such rate as the Court considers fit. (8) Further or other relief.

8. The relief sought is of the conventional kind in a patent action: a declaration, an injunction, an enquiry or account, delivery up and so forth.

9. There are a number of strands at play here and, to some extent, they are pragmatic, sensible matters that need raising and disposing of and, to some extent, they are tactical jockeying which is taking place on both sides.

10. I will first of all get out of the way what I think are the practical, significant points that have been raised. It has been submitted for Edwards that the ordinary form of relief is, or may be, inappropriate or inadequate in the current circumstances, in the absence of a judgment of the court, because if, for example, an injunction in the ordinary form directed simply to the patents is granted, it may simply defer an argument about what products that injunction covers.

11. I have to say that this seems to me a little bit academic, but there is no reason to leave a doubt, where doubt is not needed, and I therefore asked Mr. Turner, for Meril, whether he would agree that the injunction should be not only directed in terms of the not infringing the patents (identified by number, as is normal), but also in relation to the specific products identified in the Particulars of Infringement, and he agreed that that was appropriate. Similarly, any inquiry as to damages or account that is ordered can also be specified to be general and in relation to the specific products pleaded.

12. I am conscious in saying this of the decision of the Court of Appeal in Coflexip v Stolt Comex Seaways MS Ltd [2001] RPC and in particular to paragraph 14 of the judgment of Aldous LJ, which was as follows: "It is important that an order, such as an injunction, is drafted so as to set out, with such clarity as the context admits, what may not be done. It is for that reason that the standard form of injunction is in the terms restraining the defendant from infringing the patent. Such an injunction is limited in term and confined to the right given by section 60(1) and (2) of the Patents Act. It also excludes acts, carried out by the defendant and which fall within the ambit of the monopoly, but are excluded from infringement by the Act ; for example private use coming within section 60(5) (a) of the Act . Such an injunction is confined to the monopoly as claimed. The claim has been construed by the court with the aid of the parties and in the context of the acts alleged by the plaintiff to infringe and any other potentially infringing acts which the defendant wishes to bring before the court. Of course a dispute can arise as to whether acts, not brought before the court, amount to a breach of the injunction. But such a dispute arises against the background where the ambit of the claim and therefore the injunction has been the subject of consideration by the court and has been construed by it."

13. Normally, as Aldous LJ explained, and for the reasons he gives, the injunction ought to be framed in terms of infringement of the patent, but the reasons he gave for that approach, rather than the approach of identifying specific products, do not apply in this case because the defences under the Act have no relevance. It would be appropriate, to deal with another one of his points, to make clear that the injunction is to last only for the life of the patents, but that is a small point. I therefore do not overlook the guidance of the Court of Appeal, but the court always has a degree of flexibility and in the present case I think it is appropriate to deal with the injunction and the inquiry as to damages in that way.

14. That, in a sense, is the easy part of the dispute before me today. The more contentious matter relates to whether I ought to direct a trial to take place to consider and determine the issues of infringement.

15. Edwards accepts, as I understand it at least, that if Meril were to admit infringement, there would be no need for a trial and, indeed, there would be no pressing need for a declaration, although I think it is submitted that one might yet be appropriate, but in any event, there would be no need to explore the merits in detail in order to consider whether to grant a declaration. Meril, on the other hand, is unwilling to give any such admission. Edwards' submission is that the only way for Meril to extricate itself from these proceedings is to make such admissions and that there is no other procedural means for an order to be made against a surrendering defendant other than under CPR Part 14 on the making of appropriate admissions.

16. I will therefore first of all consider the position in relation to the making of admissions. Parties make admissions for all sorts of reasons. These reasons include admitting that something is true when, and because, it is obviously true, but also for more pragmatic reasons, such as that the litigation is no longer worth it or that a point within the litigation is not worth contesting from a cost/benefit point of view. Of course, it is frequently the case that a party making an admission spells out in doing so that they are doing it only for the purposes of the proceedings in which they are made. I agree with the submissions on behalf of Meril that the court should be careful not to remove the incentive from parties to make admissions by making it unduly onerous to do that.

17. Of course, one way out of the procedural complications that the parties and the court find itself in this case would be for Meril to make admissions and qualify them at the same time, but it is unwilling to do that and this is where I think both sides are, to some extent, jockeying for position, because what both sides have in mind is how the disposition of these proceedings will be presented to the UK body of customers, and to the trade generally, and to foreign Courts.

18. Meril is concerned that it should not be put in the position of making an admission which is represented to customers, here or abroad, or other Courts, as being a real acceptance of the truth of Edwards' case. On the other hand, Edwards says it does not want a situation where it is unclear to the National Health Service or other potential customers that Meril has really given in and is really off the market.

19. From a practical point of view, I consider that any order I make that includes an injunction and an order for damages of the kind I have indicated already will make it unambiguous that Meril is off the market. No doubt both sides will want to explain what has gone on and its consequences but, were Meril to make an admission, I think it is important that it should be allowed to make the reasons clear. I think, ultimately, Miss May, for Edwards, accepted that Meril ought to be able to say that they had only done it for pragmatic reasons, although she earlier said that it would be an abuse of process for Meril to seek to do that (a submission that I reject).

20. In my view, although both sides are quite clearly very keen to get their message out, any order that I make will be clear on its face about what conclusion the court has reached. In any event, I cannot compel Meril to make an admission, if they do not want to, and I therefore have to proceed on the basis that they are not going to do that.

21. That being so, what is the right way forward? I do not accept that the only way for a defendant which wants to give up is to do that under CPR Part 14, and I certainly do not accept that the court lacks power to implement a surrender by a defendant other than under CPR Part 14. I could, for example, in my view, allow the defendants to amend their pleadings to admit simply that the relief claimed ought to be given or, in a more artificial sense, I could direct the trial to take place tomorrow and give only relief that I thought was appropriate in the absence of Meril in the exercise of my powers under CPR Part 39, or I could strike out the defence on the basis that Meril does not intend to support it with evidence at trial and use my powers under CPR Part 3 which arise when I strike out a statement of case. So I do not accept the submission that is made on behalf of Edwards that the only route forward for me is under CPR Part 14.

22. That does not deal, however, with Edwards' submission that it has, on the pleadings, a claim to a declaration which has to be ruled upon, and action that I might take against Meril's pleaded case cannot peremptorily get rid of a claim that Edwards has made for a declaration.

23. In my view, the court has a flexible discretion which will be exercised in different ways at different stages of the proceedings to make a declaration or not. Miss May accepts, for Edwards, that in a situation where, for example, a defendant never put a defence in, in the first place, and a patentee sought judgment in default, the court would be entitled not to grant a declaration, although it might be persuaded to do that in some circumstances, an example of which could be found in the decision of Lewison J (as he then was) in Lever Fabergé Ltd v Colgate-Palmolive Company [2005] EWHC 2655 (Pat) .

24. Similarly, a court might decide to go ahead and grant a declaration and, indeed, give a judgment on the merits in circumstances where a defendant gives up right at the end of the proceedings as, for example, Laddie J did in SmithKline Beecham v Connaught [1999] FSR 284 , when the court has already looked at the case in detail and is in a position to assess the merits so as to grant a declaration. But I do not believe there is any obligation on the court to grant a declaration at any stage; the court is entitled to consider whether it should do so or not on the basis of, among other things, the amount of information it already knows about the case.

25. Both sides cited to me some authorities which they said bore on this question. In my view, the most relevant, because it was the most similar in context to the current situation, is the decision of Vos J (as he then was) now the Master of the Rolls, in Fresenius v Carefusion [2011] EWHC 2959 (Pat) , where a decision of the Court of Appeal rendered a patent trial unnecessary and the patentee wanted to give up, allowing the revocation of the patent in suit. The most relevant parts of the judgment, which are too long to include in this judgment are paragraphs 12-29, 33-34, and 39-44. The Judge said he did not think it mandatory for the court to go ahead and rule in the circumstances he was considering of whether the particular reasons for revocation of the patent were made out; it was enough to revoke the patent. So in the present case, if I conclude it is enough in practical terms to decide that relief for infringement ought to be granted, I am not obliged to ensure that the Court determines the reasons why there has been infringement.

26. It is submitted for Edwards that there is a distinction between the situation which arose there and the situation in the case before me, because the judge in that case was considering revocation, the validity side of a patent action, and I am considering infringement.

27. I reject that submission. My reading of the judgment is that that was the context , but not the limit of the reasoning of the judge, and he was simply making a decision, most clearly to be seen in paragraph 42, where he said that the court is here to comply with the legitimate demands and requirements of the parties to resolve live disputes. It is not in a normal case here to resolve disputes that may or may not exist or may have already arisen in other jurisdictions. He referred to the overriding objective, making it clear it is to deal with the case justly, while saving expense and allotting an appropriate share of the court's resources.

28. In my view, therefore, that case supports the submission that I am not constrained to have to consider the question of whether there should also be a declaration if I do not think that it is an appropriate use of the court's resources.

29. The parties also referred to the well-known decision of the Court of Appeal in Yousef Jameel v Dow Jones [2005] EWCA Civ 75 in a very different context, where the question was what to do with defamation proceedings, where the truth or falsity of the claims would probably not be decided and, anyway, the circulation of the defamatory statements complained of had been very limited.

30. I found of particular assistance in that decision paragraph 54, which explains that abuse of process is a concern not merely to the parties, but also to the court, whose function includes allotting its resources appropriately, and also paragraphs 59-60 and 68-69, which make clear that vindication by a claimant is not the be-all and end-all of the exercise of the court's powers.

31. I consider myself to be in a position at the moment where, without further detailed education about the nature of the dispute, it would not be appropriate for me to grant a declaration of infringement because I simply do not know enough to make a declaration that I could consider to be sound. The question for me is therefore largely a pragmatic one, which is, whether it is appropriate to have a two-day trial, with a day of pre-reading, and one or two days (at least, I suspect), of judgment writing, in order for the court to put itself in the position to be able to grant a declaration in which it has confidence. I should make it clear that that assumes that the trial would be attended by Edwards alone.

32. Miss May advanced four reasons why it was important to Edwards to have a declaration, although, of course, this is all undermined slightly by the fact that if an admission is made by Meril -- even one that it qualifies by saying it has done so for pragmatic reasons and does not in fact think there has been infringement -- then there will not be a trial and there will not be any declaration.

33. The four reasons were as follows: first, that an injunction would be ineffective in the absence of a declaration. I reject that for reasons I have already given. It is possible to make the injunction effective by spelling out the products that have been alleged to infringe and if there should be hereafter some dispute about a design around (which seems to me very unlikely) I think the additional benefit of having had a trial already is likely to be minor, or nil.

34. The second reason was that a declaration would be a pithy summary of the court's conclusions. Miss May relied in connection with that on the decision in the Duchess of Sussex v Associated Newspapers [2021] EWHC 510 (Ch) , the consequentials decision of Warby LJ. I agree that a declaration can be a pithy summary of the court's conclusions, but of course he made that statement in the context where he had considered the merits, on a summary judgment application, and was in a position to provide a pithy summary by way of a declaration in terms in which he could be confident and which reflected the result of judicial determination. To my mind, it does not begin to stand for the proposition that the court must always, regardless of the resource needed, consider the merits in order to put itself in a position to grant a declaration, in order to provide a pithy summary. The result of the proceedings may be pithily indicated by other means, including, in particular, in this case, by an injunction, as I have indicated already.

35. The third reason was to make the EPO proceedings effective in this somewhat complex sense: EPO proceedings continue in this case, and a possible result of those is that an auxiliary request will be upheld which corresponds to one of the subsidiary claims in issue in the present proceedings. I accept that this was an entirely legitimate concern for Edwards to raise. I asked Dr. Turner about it, with the result that it was conceded by him that the injunction ought also to list out the subsidiary claims in issue which would have the result that if, for example, claim 1 of one of the patents is revoked by the EPO, but an auxiliary request is allowed corresponding to an existing claim, then it will be clear that that falls within the scope of the injunction. This does not provide for the situation where a different claim emerges from the EPO proceedings, but that is an inherent difficulty with parallel EP proceedings and there is nothing I can do to deal with that now

36. The fourth reason why a declaration is important to Edwards is for its possible utility in other jurisdictions. There is no concrete evidence about that before me, other than the fact that proceedings in other jurisdictions are going on. That would not stop me taking account of it and, in a number of other cases concerning Arrow declarations and the like, the court has simply taken judicial notice of the fact that decisions of the Patents Court are given weight abroad. But the current situation is rather different from that, because whatever step is taken by me here, the court in another jurisdiction will be aware that Meril’s attitude is that they gave up for pragmatic reasons, and any trial that were undertaken as Edwards seeks would have been unopposed by Meril.

37. I am not persuaded that either a judgment made because Meril, under (it would say) coercion, gives an admission, or a judgment made after consideration of the merits when Meril is not present will have material weight in any foreign jurisdictions. It is established on the authorities that it is entirely proper for a patentee bringing proceedings in the UK to want to get a decision which can be considered in other jurisdictions. But that is not the same thing as saying that the court should go ahead and give an inappropriate amount of resources to litigation here, simply so that can happen.

38. In my view, at least in the circumstances of this case, that is a relatively insubstantial reason and certainly not a reason to devote considerable further court resources to this litigation.

39. I ought also to say that Meril had an application, which is also before me in a formal matter today, to strike out Edwards' claim on the basis that it is an abuse. I do not think this adds very much, but to be clear, I reject it. Edwards is, quite properly, seeking to bring these proceedings to an orderly conclusion, and there can be nothing abusive in that. At the most, Meril’s application would seem to be on the basis that if Edwards carries on when there is nothing left to fight over, then that might be an abuse later. I do not think I need to turn my mind to that any further.

40. I therefore consider that I could give effect to Meril's giving up in a number of different procedural ways. I consider that the amount of court resources that would be required to go forward and have a trial of the claim to a declaration would not be merited. In my view, I have the power to conclude now that the additional benefit of a declaration is minimal and to grant final relief that omits it. I therefore propose to make an order in terms of the prayer, as modified in the senses that I have already indicated, but without a declaration and I will not order a trial to take place in April.

41. The basis for my decision so far has been by way of considering what powers the court has and what its jurisdiction is to grant or withhold a declaration. But I also agree with the submission made by Dr. Turner, for Meril, that I could have reached the same practical resting point as a matter of pure case management under CPR Part 3, because I could have given judgment entering relief in the way that I have indicated already and stayed the claim for a declaration, which I would have done on the basis that it seemed extremely unlikely ever to matter.

42. So I think I can get to the practical upshot of my decision in one of two ways: I think the more sound way is simply to make an order bringing the proceedings to a final conclusion with relief that does not include a declaration and refusing a trial to consider a declaration, but I could and would have stayed the claim to a declaration as a matter of pure case management.

43. I ought also to say that in reaching this conclusion, I have had in mind that the amount of court time sought by Edwards is really very substantial. I accept the submission made on Edwards' behalf that it is a lot less than if all the trials had gone ahead, but none the less, one day's reading, two days in court and judgment-writing time is a lot of time to ask for the making of a declaration without the attendance of the other side and which would probably not be of practical (as opposed to presentational) importance. That has been an important part of my thinking.

44. That is my conclusion and those are my reasons.