26 October 2018
In the past year, two decisions have illustrated how the Courts of England & Wales can tailor the relief awarded at the end of a life sciences patent dispute in order to fit its particular practical and commercial context: Regeneron v Kymab & Novo Nordisk and Edwards Lifesciences LLC & Ors v Boston Scientific Scimed Inc.
In these cases, the final injunction was either never sought or it was stayed in order to avoid serious reputational harm and disruption to patient treatments. Certain exemptions and qualifications to the injunctions were also applied.
Details of the circumstances and reasoning by which the relief was applied are as follows:
The Regeneron case concerned two patents:
Regeneron brought an infringement claim against Kymab arguing that the patents covered three strains of Kymab mice.
The case is subject to permission to appeal to the Supreme Court, but at the Court of Appeal it was held that "in situ replacement" of V, D and J gene segments of the endogenous locus with human V, D and J gene segments, claimed in the patents, should be construed to mean that only positional replacement of the mouse gene segments is required; not deletion.
On this basis, the Kymab mice were found to infringe, because they are produced using a technique in which the mouse gene is displaced.
The Court of Appeal then followed this substantive judgment with a decision on the form of relief to be awarded to Regeneron.
The key points of the award were as follows:
The injunction, the order for deliver up or destruction and the order to disclose were, however, all stayed pending Kymab's application for leave to appeal to the Supreme Court and the decision of that court if leave to appeal were granted. This was because, on the balance of justice, Kymab would otherwise suffer serious loss and damage that would be extremely difficult to quantify.
In particular, serious reputational and financial harm would be caused and the final injunction would terminate or seriously disrupt projects for the development of antibodies to treat a range of diseases for which there was a significant unmet clinical need.
The stay was not obtained, however, without Kymab giving an undertaking that it would not dispose of or remove from the jurisdiction mice or antibodies made in infringement of the patents. It would be allowed to continue in certain research partnerships provided it did not commercialise any products that resulted.
The Edwards Lifesciences LLC & Ors v Boston Scientific Scimed Inc case concerned Edwards' claim that Boston's Sapien 3 valve for use in transcatheter aortic valve implementation (TAVI) procedures infringes at least one if its patents. The Court of Appeal upheld the first instance decision of His Honour Judge Hacon, sitting in the Patents Court, that Sapien 3 did indeed infringe a valid Edwards' patent.
As a consequence, the issue of the injunctive relief to be awarded, which had been stayed by HHJ Hacon pending appeal, was remitted to the Patents Court to be determined by Mr Justice Arnold.
Arnold J ordered the following relief:
Finally, for those Sapien 3 devices that Edwards could continue to sell, payments on account to Boston for future sales were ordered until a final amount payable in compensation could be determined at a later date. The payment on account was set at 5% of the net sales of TAVI kits incorporating Sapien 3.
The English courts have demonstrated a number of times in the past that they will adopt a flexible and creative approach to relief at interim and final stages of a case.
Often the relief will be adapted to the commercial circumstances of the parties. This will usually take account of the potential damage that may be caused to one party by awarding an injunction (or even maintaining a preliminary injunction) when an appeal of the final decision is pending.
In Regeneron and Edwards cases the court goes a step further to closely examine evidence of the impact of an injunction on the important public policy issues of patient safety and medical research.
by multiple authors