Patents - Evalve Inc. and Others v Edwards Lifesciences Ltd. #2

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Jane Lambert

Patents Court (Mr Justice Birrs) Evalve Inc and others  v Edwards Lifesciences Ltd (#2) [2020] EWHC 513 (Pat) (12 March 2020)

A month after their trial before Mr Justice Birss in Evalve Inc and others v Edwards Lifesciences Ltd (#1) [2020] EWHC 514 (Pat) (12 March 2020 and nearly two months before they know who had won, the parties found themselves back in the Rolls Building which I blogged in Patents - Evalve Inc. and Others v Edwards Lifesciences Ltd (#1) 29 March 2020 for a further trial before the same judge. The issue in the second trial was whether Edwards Lifesciences Ltd. should be injuncted and, if so, on what terms should it lose the patent action.  In his judgment in Evalve Inc and Others v Edwards Lifesciences Ltd  (#2) [2020] EWHC 513 (Pat) (12 March 2020) which he delivered the same day as his judgment in the patent action, Mr Justice Birss referred to it as "the public interest trial".

The reason why it was referred to by that name is that there were doctors who considered that the defendant's PASCAL transcatheter valve repair system was more suitable for some patients than the claimants'  MitraClip and that there were even some patients who had tried a MitaClip unsuccessfully but who had been treated successfully with a PASCAL device. The defendant contended that if it lost the patent action it should be allowed to continue to supply its PASCAL devices to doctors who wanted them and particularly to doctors treating patients for mitral valve regurgitation who could not be fitted with the MitraClip.  The claimants were prepared to allow a carve-out from any injunction that might be granted to allow such patients to be treated but otherwise opposed the defendant's contention.

Mr Justice Birss's reviewed s.61 (1) (a) of the Patents Act 1977, art 3 of Directive 2004/48/EC  of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights ("the Enforcement Directive") OJ L 157, 30.4.2004, p. 45–86 (the enforcement directive), arts 28 (1) and 30 of the Agreement on Trade-Related Aspects of Intellectual Property Rights ("TRIPS") and s. 37 (1) and s.50 of the Senior Courts Act 1981.  He also referred to the Court of Appeal's decision in Shelfer v City of London Electric Lighting Co. [1895] 1 Ch 287, Coventry and others v Lawrence and another  [2014] LLR 423, [2014] 2 All ER 622, [2014] 2 P &CR 2, [2014] HLR 21, [2014] AC 822, [2014] UKSC 13, [2014] PTSR 384, [2014] 1 AC 822, [2014] Env LR 25, [2014] BLR 271, [2014] 2 WLR 433, 152 Con LR 1, Chiron v Organon No 10 [1995] FSR 325),  Edwards Lifesciences LLC v Boston Scientific Scimed Inc [2018] EWHC 1256 (Pat) and a number of other cases. He considered the damages that might be paid to the claimants in lieu of an injunction anticipating that the defendant might require some profit for supplying PASCAL devices in the UK if such supply was to be worthwhile,  Finally, his lordship looked at cases in the rest of Europe and the USA where similar issues had arisen.

From those authorities, the judge summarized the following  principles at paragraph [73] of his judgment:

"i) A general injunction to restrain future infringements is the normal remedy for the patentee.
ii) The burden is on the defendant to give reasons why such an injunction should not be granted.
iii) All the circumstances should be considered. The public interest, such as the impact on third parties, is a relevant consideration. This applies under domestic law (Coventry v Lawrence) and under Art 3 of the Enforcement Directive.
iv) In a proper case, the public interest may justify refusal of or carve out from injunction, and an award of damages in lieu. Smallness of the damages in lieu is not determinative. Even if the damages were a large sum of money and/or one which was difficult to calculate, it might still be in the public interest to refuse an injunction or carve scope out of it.
v) The starting point of any consideration of the public interest in relation to a remedy after a patent trial is that the patent system as a whole is already criss-crossed with provisions which strike balances between different public interests.
vi) The availability of an exclusionary injunction is an important manifestation of the monopolistic nature of a patent right. While monopolies in general are against the public interest, once a patent has been found valid and infringed, the patent monopoly is something which it is in the public interest to protect by an injunction in order to further the purposes of the system as a whole, such as to promote investment in innovation.
vii) Therefore when, as here, various public interests are engaged and pull in different directions, one should have in mind that the legislator is better equipped than the courts to examine these issues and draw the appropriate broad balance. The jurisdiction to refuse or qualify a patent injunction on public interest grounds is not there to redraw the broad balance of public interests set by Parliament in the patent system. The power should be used sparingly and in limited circumstances."

Applying these principles to the case before him, his lordship said at [88]:

"It is in the public interest that doctors should have freedom to exercise clinical judgment and choice however that is not the only public interest engaged when a final injunction restraining infringement of a valid patent would restrict clinical choice. I am not persuaded that the public interest in allowing doctors to exercise their clinical judgments in the best interests of their patients is sufficient to justify the refusal or carving out from a patent injunction. It would be a wide exception. To give effect to that interest in that way would mean that throughout the field of inventions of life saving products, just because the defendant's embodiment of the patentee's invention happened to have some clinically tangible differences from the patentee's own commercial embodiment of their invention, then there would be no exclusionary monopoly. In my judgment balancing the public interests to reach that result would be a matter for Parliament and should not be created by the courts. The patent system is set up in such a way that it does restrict the choice open to doctors by restricting the products available to them from which they can choose. That restriction is in the public interest overall because it promotes innovation."

He added at [89]:

"A different, and lesser point, is to have regard to the difficulties such a refusal would cause. These are illustrated by Edwards' approach in this case. Initially Edwards contended that no injunction should be granted at all in the public interest. That is logical if the basis for it is to allow doctors to exercise their clinical judgment freely. However it would inevitably lead to patients for whom MitraClip is, objectively, a perfectly adequate treatment receiving PASCAL instead, with consequent losses for the patentee. That would seriously undermine the purpose of the patent system itself. Edwards' fall back list of medical criteria is designed to meet that point. It could work if the criteria defined patients for whom PASCAL was objectively the only suitable treatment. However Edwards did not attempt to establish that because the state of the evidence available today does not allow that to be decided."

He concluded at paragraph [91] that the defendant's request must fail.  Although it was unnecessary to consider the merits of the competing devices, he did so between paragraphs [92] and [137].  He said at [137]:

"There is no reliable clinical data which identifies any class of patients for which it is more likely than not that PASCAL is the only viable treatment. Nor is there any reliable clinical data which identifies particular classes of patients or anatomies for which it is more likely than not that PASCAL would be a better treatment than the currently available MitraClip. The closest Edwards comes is in relation to the use of independent grasping in cases where there is a large flail or prolapse, tethered or restricted leaflets, or a short posterior leaflet, but the evidence is simply not there. Even if evidence does emerge in due course that PASCAL with independent grasping is better that third generation MitraClips without it, it may well be that the G4 MitraClip devices with their own independent grasping will be available by then."

Save for the carve-out that the claimants had accepted as mentioned above, the judge agreed to grant an injunction in the terms sought by the claimants.   Undertakings given to the late Mr Justice Henry Carr in earlier proceedings were to continue until a final order could be agreed by the parties or decided by the judge.

The importance of this case lies in the comprehensive analysis of legislation and case law and the distillation of the principles gleaned from those authorities.  Particularly noteworthy is his lordship's observation that 

"when, as here, various public interests are engaged and pull in different directions, one should have in mind that the legislator is better equipped than the courts to examine these issues and draw the appropriate broad balance. The jurisdiction to refuse or qualify a patent injunction on public interest grounds is not there to redraw the broad balance of public interests set by Parliament in the patent system. The power should be used sparingly and in limited circumstances."

Anyone wishing to discuss this article should message me through my contact page during the current emergency.   I shall be glad to respond by phone, VoIP or email as the case may require.

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