Evalve Inc. v Edwards Lifesciences Ltd
| Jurisdiction | England & Wales |
| Judge | Mr Justice Birss |
| Judgment Date | 18 June 2020 |
| Neutral Citation | [2020] EWHC 1524 (Pat) |
| Docket Number | Case No: HP-2019-000003 |
| Court | Chancery Division (Patents Court) |
| Date | 18 June 2020 |
[2020] EWHC 1524 (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-2019-000003
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: 21st April 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 an aspect of the form of the order to be made following judgment in a patent action which was handed down on 12 th March 2020. The action is about two patents: EP (UK) 1 408 850 entitled “Devices for capturing and fixing leaflets in valve repair” and EP (UK) 1 624 810 entitled “Fixation devices and systems for engaging tissue”. The patents are held by the claimants Abbott. The 850 patent was filed on 27 th June 2002 and granted on 23 rd September 2009. The 810 patent was filed on 18 th May 2004 and granted on 5 th July 2017.
As the main judgment explains ( [2020] EWHC 514 (Pat)), the patents 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. Starting from before the earliest priority date of the patents, Edwards also sought to develop a transcatheter treatment for the disorder. Its original product was called MOBIUS, which worked in a different way. The MOBIUS project was stopped. Then Edwards produced a new product called PASCAL. PASCAL achieved CE mark approval in 2019.
These proceedings began in January 2019. On 4 th February Abbott applied for an interim injunction. In March 2019, Arnold J ordered that the trial be expedited. On 3 rd May 2019, Henry Carr J dealt with the injunction application. One of the issues was the scale of the activity Edwards proposed in the UK pending trial. At paragraph 31 the judge said this:
“31. First, Mr. Meade contended that the evidence of Mr. Estay on behalf of Edwards was vague as to Edwards' intentions pending trial and in particular as to the scale of its launch between now and judgment. To put it another way, while suggesting that Edwards' current intention is to provide for a few implantations at a few hospitals, Edwards reserves the right to itself fully to launch PASCAL onto the market pending judgment. I understood Abbott's concerns in this respect. A full-scale launch pending trial would raise different considerations from a controlled testing of the market. However, during the hearing, and no doubt in response to some indication from the bench, Mr. Purvis, on behalf of Edwards, stated that Edwards was prepared to offer an undertaking until judgment or further order, only to arrange for the implantation of PASCAL devices in 10 patients in two hospitals in the UK. That, I should say, is subject to a liberty to apply to discharge or vary the undertaking, for example, if reimbursement is granted sooner than is currently expected.”
Instead of granting an interim injunction, Henry Carr J accepted the undertaking from Edwards to limit their supplies of PASCAL in the UK to no more than 2 hospitals for the purpose of treating no more than 10 patients.
Directions for the trial of validity and infringement of both patents in December 2019 were given by Arnold J on 13 th June 2019. Not long after that, an issue arose about a “public interest” defence which Edwards contended would apply even if the PASCAL product was found to infringe a valid claim. On 25 th July 2019, directions were given by Arnold J for the public interest issues to be tried at a hearing at the beginning of the new term in January 2020.
I heard both trials. The two judgments were both handed down on 12 th March 2020. The main judgment [2020] EWHC 514 (Pat) dealt with validity and infringement, finding that both patents were valid and that PASCAL infringed each of them. The other judgment [2020] EWHC 513 (Pat) dealt with Edwards' public interest defence and substantially rejected it. The only exception to the injunction was a narrow one, which had been offered by Abbott, to cater for the case when a MitraClip implantation had already been unsuccessful.
The hearing to determine the consequential orders to make was on 21 st April 2020. There were a number of issues to be resolved: (a) a dispute about the terms of the exception, (b) permission to appeal, (c) a stay pending appeal, (d) costs and interim payments, and (e) CPR 31.22.
The dispute about the terms of the exception was really a further attempt by Edwards to craft a much wider exception to the injunction, having failed at the public interest hearing, and without giving Abbott the opportunity to test the evidence on which that application was based in cross-examination. I rejected it.
I gave permission to appeal and dealt with costs and CPR 31.22.
In relation to a stay of the injunction pending appeal, Edwards sought an order staying the injunction altogether pending appeal, contending that the number of PASCAL implantations likely to take place before an appeal was heard was small. At most between 30 and 40 by the end of Q1 2021. Abbott contend that this amounted to Edwards in effect coming on to the UK market in a real sense within the period and was likely to cause substantial and unquantifiable harm to Abbott.
I decided to grant a stay of the injunction, but only if Edwards gave an undertaking which was in the same terms as the undertaking they had given to Henry Carr J, that is to say to limit PASCAL to ten implantations in the two centres. At the hearing I gave reasons for the decision in abbreviated form, indicating that either party could ask for a fuller judgment if they wished. After the hearing there were further written submissions to resolve the form of the order itself. The order was sealed on 5 th May 2020.
The undertaking given by Edwards pending appeal are in this form:
i) Between the date of this Order and the making of the final order of the Court of Appeal on Edwards' appeal against this Order, Edwards will limit its supply of PASCAL in the United Kingdom to the 2 hospitals referred to in paragraph 1 of Schedule B to the Order of Mr Justice Henry Carr dated 3 May 2019 (the “Hospitals”) for the purpose of treating no more than 10 patients in total (such treatments being the “Procedures”).
ii) Edwards will not invite any clinician not based at the Hospitals to assist, attend or observe the Procedures (subject to paragraph iii below).
iii) Edwards may invite its employee representatives and up to 2 PASCAL proctors to attend each Procedure.
iv) For this purpose, “PASCAL proctor” means a physician with prior experience carrying out the PASCAL implantation procedure and who is attending the Procedure for the sole purpose of training the clinical team to carry out the Procedure.
v) Edwards will not broadcast any of the Procedures outside the Hospitals.
I was asked to give a judgment on the issue and so this is it.
Legal principles
The principles to be applied where the claim succeeds and the grant or stay of injunctive relief is being considered pending appeal were set out by the Court of Appeal in Minnesota Mining and Manufacturing Co v Johnson & Johnson Ltd [1976] RPC 671, 676 (Buckley LJ):
It is not in dispute that where a plaintiff has at first instance established a right to a perpetual injunction, the court has a discretion to stay the operation of that injunction pending an appeal by the defendant against the judgment. On what principles ought such a discretion to be exercised? The object, where it can be fairly achieved, must surely be so to arrange matters that, when the appeal comes to be heard, the appellate court may be able to do justice between the parties, whatever the outcome of the appeal may be. Where an injunction is an appropriate form of remedy for a successful plaintiff, the plaintiff, if he succeeds at first instance in establishing his right to relief, is entitled to that remedy upon the basis of the trial judge's findings of fact and his application of the law. This is, however, subject to the defendant's right of appeal. If the defendant in good faith proposes to appeal, challenging either the trial judge's findings or his law, and has a genuine chance of success on his appeal, the plaintiff's entitlement to his remedy cannot be regarded as certain until the appeal has been disposed of. In some cases the putting of an injunction into effect pending appeal may very severely damage the defendant in such a way that he will have no remedy against the plaintiff if he, the defendant, succeeds on his appeal. On the other hand, the postponement of putting an injunction into effect pending appeal may severely damage the plaintiff. In such a case a plaintiff may be able to recover some remedy against the defendant in the appellate court in respect of his damage in the event of the appeal failing, but the amount of this damage may be difficult to assess and the remedy available to the appellate court may not amount to a complete indemnity. It may be possible to...
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