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UK – Edwards Lifesciences v. Boston Scientific Scimed

08 Jun 2018

Edwards Lifesciences LLC v. Boston Scientific Scimed Inc, High Court of Justice, London, UK, 24 May 2018, [2018] EWHC 1256 (Pat)

In this judgment of 24 May 2018, the latest in a saga during which the Court of Appeal had upheld an infringement decision of the Patents Court, Arnold J determined the details of a final injunction. In particular, Arnold J determined the length of time for which the injunction should be stayed, and the scope and duration of a qualification to the injunction once in place. This was in circumstances where the continued supply of an infringing medical device was in the public interest and, so far as the author is aware, is the first time that an Order of the Patents Court has taken account of the life-saving nature of an infringing product.

This case had been remitted back to the Patents Court by the Court of Appeal following their decision to uphold HHJ Hacon’s decision that one of Boston’s patents relating to a type of replacement heart valve (EP (UK) 2 926 766) was valid and infringed.

At the hearing before Arnold J, it was common ground that the injunction granted by HHJ Hacon should be stayed for a period of time (so as to allow for clinicians to be re-trained using non-infringing devices) and then qualified for a further period (so as to allow for the continued use of the infringing devices in the small but growing number of patients for whom it is the only option). As noted above, this was on the basis that the continued supply of Edwards’ transcatheter heart valve, Sapien 3, was in the public interest. The dispute was therefore focussed on (a) the length of the stay and (b) the scope and duration of the qualification.

With respect to the length of the stay, having accepted Edwards’ estimate that there were 60 clinicians who were likely to need re-training, Arnold J granted an initial stay of the injunction for 12 months (with permission for Edwards to apply to extend the stay in the event that 12 months proved to be insufficient).

On the exception to the injunction, Arnold J rejected Boston’s submission that the exception should be time-limited (to a period of six months after the end of the stay). Instead, he granted Boston permission to apply to terminate the exception in the event that a device that was both non-infringing and suitable for all the patients in question became available.

It was also common ground that the supply of Sapien 3 should be permitted where there is an appropriate declaration from the responsible clinician certifying that the patient in question falls into one of the groups for whom there is no alternative to the Sapien 3.

At the handing down hearing, Arnold J further held that the declaration should be anonymised prior to being issued to Edwards so as to protect the patient from any misuse of their sensitive information, that Edwards should give an undertaking not to use the data to identify patients in view of the implementation of the General Data Protection Regulation and that Edwards should provide the anonymised declarations to Boston on a quarterly basis.

A copy of the decision can be read here.

Headnote by Olivia Henry, Bristows LLP