Evalve Inc & Ors v Edwards Lifesciences Ltd

For an interim injunction, the claimant must first show that refusing relief is likely to cause irreparable or unquantifiable harm. If damages would adequately compensate the claimant, there is no basis for restraining the defendant’s freedom of action. The court must assess which course is likely to cause the least irremediable prejudice, considering the position of both parties. A failure to clear the way of relevant patents does not establish irreparable harm, but may be material where the balance of harm is even, particularly when considering the status quo. On the evidence, a tightly limited product launch would cause no irreparable prejudice to the claimant, while an injunction would create greater uncertainty for the defendant. The injunction was therefore refused.

The claimants sought an interim injunction restraining the defendant from marketing the PASCAL transcatheter mitral valve repair device pending trial of patent infringement and invalidity claims concerning two patents. The defendant accepted that there was a serious issue to be tried. The claimants had obtained an expedited trial, which was expected to take place in December 2019, with judgment anticipated by the end of January 2020.

At the hearing, the defendant undertook, subject to liberty to apply, to limit implantation of PASCAL devices before judgment to 10 patients in two United Kingdom hospitals. The central issue was whether the American Cyanamid principles justified interim relief in light of the alleged harm to the claimants, the potential harm to the defendant, the defendant’s failure to clear the way, and the public interest.

1. The application for an interim injunction was refused. The defendant’s undertaking limited the proposed activity to 10 implantations in two hospitals, subject to liberty to apply.

2. The claimant had to establish that it would suffer irreparable or unquantifiable harm if relief were refused. The purpose of interim relief is to improve the prospect of doing justice at trial, and the court must assess which course is likely to produce the just result and cause the least irremediable prejudice. If damages would be an adequate remedy for the claimant, there is no ground for interfering with the defendant’s freedom of action.

3. The alleged loss of sales, cross-selling, damage to clinician relationships, brand damage and retraining costs did not establish irreparable harm. The proposed launch was too limited to create the asserted commercial or reputational effects, and any financial loss could be quantified. Damages were therefore an adequate remedy for the claimants.

4. Failure to clear the way does not itself establish irreparable harm. It is a material factor where the harm to both parties is evenly balanced, together with preservation of the status quo. The defendant’s failure to clear the way was not decisive because the balance was not even.

5. The court accepted that restraining the defendant could create difficulty in quantifying lost sales if the defendant were unable to compete when reimbursement became available. Even assuming some irreparable prejudice to the claimants, that prejudice was outweighed by the prejudice to the defendant. The public-interest issue, including the alleged clinical superiority of PASCAL, did not require determination.

6. The defendant was awarded its costs of the application, subject to a deduction for costs relating to the public-interest issue. The costs were summarily assessed at £200,000.

Not stated in the judgment.