Edwards Lifesciences LLC v Boston Scientific Scimed Inc

When deciding whether to stay or qualify a patent injunction because of public interest, the court must exercise a flexible, fact-sensitive discretion. The central consideration is proportionality. This requires balancing the patentee’s interest in preserving its monopoly against the public interest, including patients’ health, while considering whether financial compensation provides an adequate remedy and whether suitable alternatives exist.

Where the evidence shows that some patients have no suitable non-infringing alternative, the injunction may be qualified for those patients without a fixed expiry date. The qualification may instead be subject to a later application if circumstances change.

The claimant sought revocation of patents owned by the defendant. Following an earlier judgment holding one patent invalid and another valid and infringed, the Patents Court granted an injunction concerning the Sapien 3 heart valve.

The Court of Appeal dismissed both parties’ appeals in [2018] EWCA Civ 673 and remitted the question whether the injunction should be stayed or qualified to permit continued supply of the valve. The parties agreed that a stay and qualification were required in the public interest. The issues were their duration and scope, the level of payments on account, and an application for samples of a proposed replacement device.

1. Applicable approach. The court had jurisdiction under section 50 of the Senior Courts Act 1981 to award damages in substitution for an injunction. The discretion concerning injunctive relief was flexible and fact-sensitive, following Lawrence v Fen Tigers Ltd [2014] UKSC 13. Public interest was a relevant factor. The parties also accepted that the court should act consistently with Article 3 of the European Parliament and Council Directive 2004/48/EC of 29 April 2004 on the enforcement of intellectual property rights, with proportionality as the key consideration.
2. Proportionality. The balance was between Boston’s interest in maintaining the monopoly conferred by the patent and the public interest in ensuring appropriate treatment for patients with aortic stenosis. There was no evidence that continued sales would cause Boston irreparable harm or that Edwards could not meet a future financial award. Conversely, some patients had no suitable alternative device.
3. Stay. The evidence concerning retraining clinicians and specialist nurses was uncertain. The realistic estimate was that retraining was likely to take at least one year. The injunction was therefore stayed for 12 months, with Edwards given permission to apply for an extension if necessary.
4. Qualification. Supplies to patients for whom the Sapien 3 was the only suitable device were excepted without a fixed time limit. Boston could apply to terminate the exception if a suitable non-infringing device became available. Supply required a declaration from the responsible clinician confirming that the patient fell within one of the relevant groups.
5. Other orders. Payments on account were fixed at 5% of the net sales value of kits incorporating the Sapien 3. The application for samples of the Sapien 3 Ultra was refused as premature, since provision of a Product Description and inspection by independent experts might make samples unnecessary.

1. Patents Court: In [2017] EWHC 405 (Pat), the court held that one patent was invalid and that another was valid and infringed. An injunction was subsequently ordered and stayed pending appeal in [2017] EWHC 755 (Pat).
2. Court of Appeal: In [2018] EWCA Civ 673, both appeals were dismissed. The issue of any exception or limitation to the injunction was remitted to a Patents Court judge.
3. Patents Court: The present court determined the remitted issue by granting a 12-month stay and an ongoing patient-specific qualification.