Evalve Inc. v Edwards Lifesciences Ltd
Jurisdiction | England & Wales |
Judge | Mr Justice Birss |
Judgment Date | 12 March 2020 |
Neutral Citation | [2020] EWHC 513 (Pat) |
Court | Chancery Division (Patents Court) |
Docket Number | Case No: HP-2019-00003 |
Date | 12 March 2020 |
[2020] EWHC 513 (Pat)
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY LIST (ChD)
PATENTS COURT
Royal Courts of Justice
The Rolls Building
7 Rolls Buildings
Fetter Lane
London EC4A 1NL
Mr Justice Birss
Case No: HP-2019-00003
Richard Meade QC, James Abrahams QC, Michael Conway and Jennifer Dixon (instructed by Taylor Wessing) for the Claimants
Piers Acland QC and Kathryn Pickard (instructed by Powell Gilbert) for the Defendant
Hearing dates: 15th, 16th, 17th, 21st and 22nd January 2020
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
This judgment deals with what the parties called the Public Interest trial. It was scheduled to come after the main patent trial. The issue to be decided is Edwards' submission that even if Edwards' PASCAL product is found to infringe a valid claim of one of Abbott's patents, nevertheless no final injunction should be ordered because to do so would be contrary to the public interest. At the time the Public Interest trial was heard, the main trial had taken place but no judgment had been given. In fact as things have turned out I have finished both judgments at the same time and they are handed down on the same day. The main patent judgment is [2020] EWHC 514 (Pat). In it I conclude that PASCAL infringes both patents.
The patents, EP (UK) 1 408 850 and EP (UK) 1 624 810 relate to medical devices used to treat mitral valve regurgitation by a transcatheter technique. The patents protect a successful Abbott product called MitraClip which has been on the market since 2008. An explanation of the anatomy of the heart and the disorder these devices treat is given in the main judgment. Importantly, mitral valve regurgitation is a common disorder with the prevalence rising sharply with age. Before the MitraClip there was no effective transcatheter treatment available. The only effective treatments involved open heart surgery. Those patients with progressive mitral valve regurgitation have a poor prognosis and without treatment many will die within a year of diagnosis. However a significant number of the elderly patients with mitral valve regurgitation are not strong enough to be able to have open heart surgery. That is why the ability to treat the disorder by a transcatheter technique, which does not involve open heart surgery, is so significant.
In fact today there are two kinds of MitraClip on the market, the NTR and XTR. This pair of products is the third generation of MitraClips on the market and a fourth generation (G4) has been approved in the USA. Approval for the G4 is being sought in Europe.
Edwards' PASCAL product is another transcatheter treatment for mitral valve regurgitation. Both PASCAL and MitraClip operate in essentially the same way, clipping the two leaflets of the valve together, hopefully leading to a reduction in mitral valve regurgitation. The general technique is called edge to edge valve repair. PASCAL and MitraClip are the only transcatheter edge to edge devices approved in Europe today. The term “eeTVR” refers to edge to edge transcatheter valve repair.
Edwards' case can be put a number of ways. One way of putting it is that there is a body of doctors in the UK whose reasonable clinical opinion is that, at least for certain patients, PASCAL would be a better device to use for that patient than any of the MitraClip products and therefore given that, it would not be in the public interest toprevent these doctors from doing this by an injunction preventing sales of PASCAL. Another way of putting it is that there are doctors who prefer, on reasonable grounds, to use PASCAL in certain cases instead of MitraClip. Although it is possible to think of differences between these two ways of putting it, in this case nothing turns on that sort of distinction.
Edwards advances a set of particular circumstances for which it contends that, if any one or more of them are applicable to a given patient, then given the differences in design and functionality between MitraClip and PASCAL, a reasonable doctor would (or some reasonable doctors do) decide that the PASCAL would be better than the MitraClip in that case. In this respect Edwards relies on a set of defined medical criteria which relate to the circumstances and also a set of features of the PASCAL product. Although Edwards' primary case is that no injunction at all should be granted for this reason, Edwards also advances a fall back position amounting to a conventional injunction to be granted but qualified by carving out from the injunction supplies of PASCAL for use in patients to whom one or more of the defined medical criteria apply. A mechanism is proposed whereby the doctor would make a declaration about those circumstances in order to be permitted to be supplied with a PASCAL device.
Note that Edwards' primary case that no injunction at all should be granted would mean that PASCAL products could be sold for use in any patients, irrespective of the medical criteria referred to. There is evidence that when the two products are both available side by side then PASCAL represents 30–40% of the eeTVR market. Although the numerical evidence was very sparse, doing my best having heard the evidence I have little doubt that that sort of market share is much bigger than would be represented purely by the application of the defined medical criteria.
At times in argument there was reference to the idea of trying to identify the reasonable opinion of a single notional reasonable doctor instead of referring to a class of doctors holding a certain reasonable view. The distinction between these two ideas does not matter in this case.
Edwards also says that there are patients for which in the reasonable opinion of the doctor, in what I will call extreme cases within the defined medical criteria, no MitraClip would be able to treat the patient but a PASCAL would be able to treat them, or at least would be likely to do so.
Finally Edwards says that in cases in which MitraClip implantation has been unsuccessful but a doctor reasonably believes a PASCAL would be an appropriate treatment to try after that failure, then supply for that purpose should be permitted. Abbott agrees with this and is willing to accept a carve out from the injunction on that basis. Nevertheless Abbott contends that the likelihood of this taking place is very small because if one device has not been successful the likelihood that the other one would work is remote.
Abbott's position is that an injunction should be granted with the sole qualification just referred to. No other carve outs should be granted nor should the court accept Edwards' case that no injunction be granted. There are some disputes on the law and also disputes on the facts. Abbott contends that the fact that there are some doctors today who would prefer to use PASCAL over MitraClip (and are not negligent in having that view) does not justify refusal of the injunction. Abbott argues that Edwards has not established, and indeed has not tried to establish, that there is any class of patient for whom PASCAL is objectively the only viable treatment or is objectively a better treatment than MitraClip. Abbott contends that on the evidence, while there are patients for whom the transcatheter edge to edge technique cannot be used, there has not been shown to be any patients for whom it can be said, before attempting treatment, that PASCAL would or could work when MitraClip would not. In other words, according to Abbott, on the evidence before the court all patients who could be treated at all by eeTVR can be treated using MitraClip and that is so both objectively and in the reasonable opinion of doctors as it stands today. It may be in the future that reliable evidence will emerge to show that there are patients who can only be treated by PASCAL or for whom PASCAL is objectively better, but Edwards has not attempted to prove it in this case and it has not emerged yet in the clinical literature. In relation to Edwards' defined medical criteria, Abbott contends the evidence does not make that case good either individually or in combination.
Abbott argues that while it is apparent that there are some doctors today who would prefer to use PASCAL over MitraClip and are not negligent in having that view, on the state of the evidence available, that is a “mere” preference and is not founded on a sufficient objective evidence to justify a carving out from the injunction (or outright refusal) on public interest grounds.
The witnesses
Abbott called five fact witnesses: Santosh Prabhu, Hugues Gervais, Martin Townsend, Erwan Donal, and Joanne Barrette.
Santosh Prabhu is the Divisional Vice President of Product Development within the Structural Heart Division of the Abbott group of companies. The focus of his evidence dealt with the details of the four generations of MitraClip. Mr Prabhu was cross-examined and gave his evidence fairly. He explained that the independent grasping feature of MitraClip G4 was developed in part in response to clinical feedback, including requests from users. The PASCAL has an independent grasping feature and I infer that one reason for the feature's introduction into MitraClip was a response to PASCAL.
Hugues Gervais is the Divisional Vice President of Abbott Vascular Inc.'s Structural Heart business unit in EMEA. His evidence described the potential impact on Abbott's business of PASCAL being able to enter the UK market prior to May 2024. Mr Gervais was cross-examined. He was a...
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