Evalve Inc & Ors Edwards Lifesciences Ltd

A final injunction is the normal remedy for infringement of a valid patent. The court may refuse or qualify it on public-interest grounds, but the jurisdiction must be used sparingly and must not redraw the broad balance struck by Parliament in the patent legislation.

In medical-device cases, reasonable clinical preference for a competing product is insufficient. The defendant must establish by objective evidence that patients face serious risks to life or health for which the patented product is not an adequate treatment, while the rival product is the only suitable treatment. A mere difference in clinical design, or provisional medical opinion based on limited evidence, does not satisfy that threshold.

The claimants owned patents concerning transcatheter devices for treating mitral valve regurgitation. The defendant marketed the competing PASCAL device. In the related patent judgment, [2020] EWHC 514 (Pat), the court found that PASCAL infringed both patents.

The defendant accepted that infringement would ordinarily justify an injunction, but argued that the injunction should be refused or qualified because reasonable doctors might prefer PASCAL for particular patients. It relied on clinical differences between PASCAL and MitraClip, including challenging anatomies and failed MitraClip implantation. The central issue was whether those considerations engaged a sufficient public interest to justify withholding or carving out a patent injunction.

1. Outcome. The court granted an injunction restraining infringement. The only carve-out was for supplies where a MitraClip implantation had already been unsuccessful. The wider refusal and proposed medical-criteria carve-out were rejected.
2. The governing principles were drawn from the statutory discretion, the Enforcement Directive and Coventry v Lawrence. The normal remedy for infringement of a valid patent is an injunction, and the defendant bears the burden of showing why it should not be granted. All the circumstances, including effects on third parties and proportionality, may be considered.
3. The patent system already contains legislative safeguards for public interests, including compulsory licensing, Crown use and specified infringement exceptions. The court must not use the injunction jurisdiction to recreate a broad compulsory-licensing scheme or disturb the balance selected by Parliament. The power to refuse or qualify relief on public-interest grounds is therefore exceptional.
4. Reasonable clinical preference, even where doctors act non-negligently and in good faith, is not enough. The relevant public interest arises only where objective evidence establishes that some patients face serious risks to life or health because the patented product is not an adequate treatment, while the rival product is the only suitable treatment. The court must examine the evidential basis for the clinical opinions, not merely their reasonableness in context.
5. The evidence showed that doctors might prefer PASCAL for particular anatomies, but those views were provisional and based on device characteristics, limited clinical literature and inference. There was no reliable clinical evidence that PASCAL was the only viable treatment, or objectively superior to the current MitraClip products, for any identified class of patients.
6. The court also held that a decision whether to award damages in lieu must be made with sufficient information about adequacy and quantification of compensation. A future inquiry should not ordinarily be ordered before refusing an injunction. A reasonable royalty is not the only possible measure, and the appropriate measure remains compensatory.
7. The existing undertaking was continued temporarily pending consequential orders.

First-instance decision of the High Court (Patents Court). The judgment records the related patent judgment, [2020] EWHC 514 (Pat), in which infringement was found.