Evalve Inc & Ors v Edwards Lifesciences Ltd

When a successful patentee seeks to enforce an injunction pending an appeal, the court must seek to achieve the balance of justice. The aim is to arrange matters so that the appellate court can do justice whatever the result of the appeal. The court should assess the likely harm to each party, the prospect that the first-instance decision may be reversed, and the practical ability to compensate loss. It may stay an injunction on conditions, preserve the existing position, or devise an intermediate arrangement where neither extreme is fair. The appropriate order depends on the particular facts.

The judgment concerned consequential orders following findings that Edwards’ PASCAL device infringed two Abbott patents and that Edwards’ public interest defence substantially failed. Edwards sought a stay of the injunction pending appeal. Abbott opposed the stay, relying on the risk of substantial and unquantifiable commercial harm. The court therefore had to determine how the injunction should operate during the appeal, having regard to the parties’ evidence, the likely duration of the appeal, the existing limited use of PASCAL in the United Kingdom, and the competing risks of injustice.

1. Stay pending appeal. The court applied the balance-of-justice principles stated in Minnesota Mining and Manufacturing Co v Johnson & Johnson Ltd [1976] RPC 671. The objective was to arrange matters so that the Court of Appeal could do justice between the parties whatever the outcome of the appeal. The court could stay the injunction, allow it to operate subject to safeguards, or devise an intermediate remedy.
2. The court accepted that Edwards was likely to carry out 30–40 procedures before the appeal. It rejected the characterisation of that activity as small. In context, it amounted to a full-scale or near full-scale commercial launch and would cause Abbott substantial irreparable harm that would be difficult to quantify.
3. The court also recognised that refusing a stay altogether would cause Edwards unquantifiable harm by delaying its commercial launch and preventing it from building relationships while reimbursement was available. Edwards could, however, have sought to clear the way earlier.
4. The relevant status quo was not simply that MitraClip was marketed and PASCAL was not. PASCAL had already been used in two centres under the earlier undertaking. The fair course was therefore to preserve that limited activity without allowing significant expansion.
5. The injunction was stayed on terms requiring Edwards to limit PASCAL supply in the United Kingdom to the same two hospitals and no more than ten patients, subject to the detailed undertaking concerning attendance, proctors and broadcasting.

The judgment was a first-instance decision on consequential orders following the court’s earlier judgments on validity, infringement and the public interest defence. Permission to appeal was granted, but the injunction was stayed only on the stated conditions pending appeal.