Practice - Injunctions pending Appeal Evalve Inc v Edwards Lifesciences Ltd

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Jane Lambert

Patents Court (Mr Justice Birss) Evalve Inc and others v Edwards Lifesciences Ltd [2020] EWHC 1524 (Pat) (18 June 2020)

In  Evalve Inc and others v Edwards Lifesciences Ltd #1 [2020] EWHC 514 (Pat) (12 March 2020)). Mr Justce Birss held that two patents that protected the market for a device known as the MitraClip were valid and infringed.   In Evalve Inc and others v Edwards Lifesciences Ltd (#2) [2020] EWHC 513 (Pat) (12 March 2020) Mr Justice Birss rejected the defendant's contention that it should be allowed to market its product notwithstanding the judgment on the ground that some patients were assisted by a product that competed with the MitraClip but not by the MitraClip itself. I blogged about those cases in  Patents - Evalve Inc. and Others v Edwards Lifesciences Ltd. #1 27 March 2020 NIPC Law and Patents - Evalve Inc. and Others v Edwards Lifesciences Ltd. #2 30 March 2020.

The claimants sought a perpetual injunctions and their costs.  The defendants applied for permission to appeal and a stay pending appeal.   There was also a dispute over the subsequent use of disclosed documents,  Those matters came on before Mr Justice Birss on 21 April 2020.   The judge gave permission to appeal and dealt with costs and disclosure.   He stayed the injunction pending appeal upon the following undertaking from the defendant:

"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."

His lordship set out his reasons in Evalve Inc and others v Edwards Lifesciences Ltd [2020] EWHC 1524 (Pat)  which he handed down on18 June 2020.

The judge considered the following passage from Lord Justice Buckley's judgment in Minnesota Mining and Manufacturing Co v Johnson & Johnson Ltd [1976] RPC 671, 676:

"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 do justice by staying the injunction pending the appeal, the plaintiff's position being suitably safeguarded. On the other hand it may, in some circumstances, be fair to allow the injunction to operate on conditions that the plaintiff gives an undertaking in damages or otherwise protects the defendant's rights, should he succeed in his appeal. In some cases it may be impossible to devise any method of ensuring perfect justice in any event, but the court may nevertheless be able to devise an interlocutory remedy pending the decision of the appeal which will achieve the highest available measure of fairness. The appropriate course must depend on the particular facts of each case."

The Court of Appeal had applied those principles in Novartis AG v Hospira UK Ltd   [2014] WLR 1264, [2013] CP Rep 37, [2013] WLR(D) 188, [2014] RPC 3, [2013] EWCA Civ 583, [2014] 1 WLR 1264 which had to consider the converse case of a patentee who had lost at trial but sought an interim injunction pending appeal.  At paragraph [16] Mr Justice Birss directed himself that "the test is the balance of justice.  The court considering the terms of any stay pending appeal will endeavour to arrange matters so that the Court of Appeal is best able to do justice between the parties once the appeal is heard."

The defendant contended that it would suffer irreparable damage from an injunction pending appeal were it ultimately to succeed as it would lose its toehold in the market.   It had not been planning to expand its business greatly in the UK even if it had succeeded and the claimants ought to be able to live with its activities for which the claimants could be compensated in damages.  The claimants replied that they had won snd the activities contemplated by the defendant were tantamount to a full-scale rollout of its product.

Mr Justice Birss said at [38[:

"In my judgment, the fair way to hold the ring is to take a course between the extremes proposed by each party, by allowing Edwards to continue to carry out that activity at those centres, with a fresh limit of 10 patients up to the hearing of the appeal. The period of this order will be similar to the period covered by Henry Carr J's order. I recognise it delays the launch which Edwards wishes to undertake. However this approach will allow Edwards to maintain the relationships it has already built up relating to PASCAL in the UK and maintain a UK presence, without expanding it significantly until after the appeal."

Anyone wishing to discuss this article or relief pending appeals generally should call my clerk Stephen Somerville on +44(0)7986 948267 or send me a message through my contact page while this emergency continues, I shall gladly respond by phone, Zoom or email.