Injunctions: an increasingly flexible and pragmatic approach

Posted on 02 July 2018

Injunctions: an increasingly flexible and pragmatic approach

In recent years, the UK courts have demonstrated that they are prepared to be flexible and pragmatic when considering remedies for patent infringement.  Whilst the default remains that a successful patentee will usually be entitled to a permanent injunction preventing further sales of an infringing product following a finding of infringement, this will not always be the case, as has been demonstrated by two recent decisions.

Edwards Life Sciences v Boston Scientific: Stay of injunction to allow re-training by clinicians

Having found one of Boston's patents valid and infringed by Edwards Sapien 3 product, the Court had to consider what was appropriate in terms of injunctive relief.  The parties accepted that the injunction should be stayed for a period (and then qualified for a further period), having regard to the impact an injunction would have on the health of patients with aortic stenosis.  It was also accepted that a number of clinicians who were currently trained to use the Sapien 3 would need retraining to use another device, but the parties did not agree over how many clinicians this would apply to, and as to how long they would need.  Boston therefore argued for a stay of two-three months, whereas Edwards sought a stay of 18 months.

The Judge decided that there was considerable uncertainty as to how long the re-training process would take but that it was likely to be at least a year; he therefore allowed continued implantation of the Sapien 3 for a 12 month period (also granting Edwards permission to apply to extend the stay if this is necessary). In addition, for a small but growing number of patients, the Sapien 3 is the only suitable device and so the Court provided an exception for such patients, giving Boston permission to apply to terminate the exception if non-infringing and suitable devices become available.

Regeneron v Kymab: Stay of injunction pending appeal

In March 2018, the Court of Appeal found that various strains of Kymab's transgenic mice would infringe Regeneron's patents. Again, the Court was then required to consider the appropriate form of injunction against Kymab. It was accepted that the injunction should not prevent Kymab from doing any acts for the purpose of a medicinal product assessment (i.e., for experimental purposes) but Kymab also sought a stay of the injunction (and other orders) pending its application for permission to appeal to the Supreme Court, offering certain undertakings to the Court.  Specifically, Kymab wanted to pursue current and future collaborations funded by the Gates Foundation and a collaboration with Heptares.

The Court of Appeal accepted that, if it did not stay the orders for an injunction (and delivery up/destruction), Kymab would suffer serious loss and damage which would be extremely difficult to quantify; it would also end or at least seriously disrupt its collaboration projects and cause it serious reputational and financial harm (including the prospect of researchers being made redundant).  Whilst there was a risk of irreparable harm to Regeneron (e.g., it is in competition with Kymab in relation to certain targets, and the collaborations represent significant lost opportunities for Regeneron), this could be ameliorated by the undertakings offered by Kymab.  These undertakings included not to commercialise any product developed under its partnership with the Gates Foundation prior to the determination of its appeal, to limit other collaborations to those identified in the evidence, and to transfer to the Gates Foundation all rights it has to any products developed using Kymice prior to the patents (meaning Kymab could not commercialise any product even after the patents had expired). 

The Court also rejected Regeneron's argument that, as a condition of the stay, Kymab should be required to ring-fence some of its assets, e.g., by placing a substantial sum in escrow. There was a real prospect that this would drive Kymab out of business, frustrate any further appeal and terminate its humanitarian work with the Gates Foundation and others.

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