Tailored injunctive relief in life sciences patent cases

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:

Stay and exemption to final injunction to avoid serious harm and allow certain research

The Regeneron case concerned two patents:

• The first patent claimed methods of modifying the antibody variable regions of an endogenous immunoglobulin in a mouse embryonic stem cell by in situ replacement of the mouse V, D, J gene segments with orthologous human V,D and J gene segments to enable production of hybrid antibodies, and the resultant mice, eukaryotic cells and embryonic stem cells.
• The second patent claimed transgenic mice that produce hybrid antibodies containing human antibody heavy chain V, D and J gene segments, and in situ replacement of mouse light chain V and J regions with human V and J regions.

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:

• A final injunction which would restrain Kymab from further infringement – an exemption to the final injunction was provided to clarify that activities for the purpose of a medicinal product assessment are permitted (mirroring the new exemption in s.60(6D)-(6E) Patent Act 1977). An exemption was also provided that allowed steps to produce non-infringing mice. This was in order to allow a number of technical advances to be preserved which were unrelated to the patents in dispute.
• An order for delivery up or destruction of infringing mice, mouse embryonic stem cells or mouse eukaryotic cells, and antibodies produced – again, there was an exemption for the above in respect of keeping for the purposes of a medicinal product assessment, but it was also stipulated that delivery up should be to an agreed third party to avoid Regeneron learning aspects of confidential information.
• An order for disclosure of information relating to mice and antibodies made or kept by Kymab in infringement of the patents in issue, but disposed of in the UK and so no longer under their possession or control. Requests by Regeneron for a wider class of information in order to police use of the patented subject matter in other jurisdictions were, however, refused – they were not necessary to protect Regeneron's rights in the UK.
• The Court also granted an enquiry into the damages suffered, or at Regeneron's option, an account of profits made by Kymab, but refused to grant an order to publicize their judgment on the substantive case – this would serve no proper purpose and would merely cause Kymab embarrassment.

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.

Qualifications to final injunction and stay to protect patients

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:

• A stay of the final injunction prohibiting sales of Sapien 3, for at least 12 months – the purpose of the stay was to provide sufficient time for clinicians working in TAVI centres to overcome the internal governance hurdles necessary to adopt a new device. It was also important to allow the re-training of an estimated 60 clinicians to use the alternative device to Sapien 3 and therefore avoid the disruption of patient treatment.
• An unlimited qualification to the injunction for particular patient groups – it was found that there is a small but growing number of patients for whom the Sapien 3 device is currently the only suitable device. The purpose of the unlimited qualification was therefore to enable the continued treatment of this class of patients with Sapien 3, provided the need to use it has been certified by a clinician.

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.

A flexible and creative approach

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.