The issue of whether public health policy considerations can prevent the grant of a final injunction is a live one as the number of disputes in the biologics field increases. In this decision of the UK High Court of Justice, public health considerations led to the stay of the injunction and also its qualification for an indefinite period with respect to those patients for whom the infringing product was the only option.
The transcatheter heart valve (“THV”) called “Sapien 3” developed by Edwards was found to infringe a Boston patent. An injunction was stayed pending appeal and on dismissing both sides’ appeals, the Court of Appeal remitted to the High Court the issue of what exception or limitation, if any, should be made to the injunction ordered at first instance.
The THV implant, or “TAVI”, is becoming an increasingly common procedure to combat aortic stenosis in the UK. Sapien 3 was found to be the only option for certain patient groups including for example the 5% of aortic stenosis patients in need of a “transapical” delivery of the THV (the Sapien 3 being the only device in the UK with this compatibility) and “Intermediate Risk Patients” under the age of 75 (for which only the Sapien 3 has been approved in the UK). More generally, withdrawing the Sapien 3 would require re-training of a significant number of clinicians in alternative devices leading to sustained loss of availability of TAVI procedures, longer waiting lists and a greater overall risk of death for patients.
Arnold J, citing Lord Neuberger, ruled that the principles in Lawrence v Fen Tigers Ltd  UKSC 13 constituted the correct approach:
- The court’s discretion to award damages in lieu of an injunction should not be fettered as a matter of practical fairness this was highly fact-sensitive.
- The prima facie position though is that an injunction should be granted and the legal burden is on the defendant to show why it should not.
- It would normally be right to refuse an injunction if it would be oppressive to the defendant to grant one, although if this were not the case then it did not necessarily mean an injunction should be granted.
- It is hard to see how the public interest could not be a relevant factor if it arose.
Arnold J added that Article 3 of the Enforcement Directive contained a requirement for proportionality in any injunction granted, and public interest consideration was a component of this requirement.
Mr Justice Arnold’s findings
Arnold J stated that given that a stay and qualification of an injunction would deprive Boston of the remedy to which it would ordinarily be entitled, the stay and nature and duration of the qualification of the injunction must be proportionate. They must strike a balance between Boston’s interest in maintaining its monopoly and the public interest in ensuring that patients receive appropriate treatment.
As regards the stay of the injunction, Arnold J found that due to Boston’s small market share (5-6%), continued sales of the Sapien 3 would not cause Boston irreparable harm that could not be compensated for financially. He applied a one year stay on the basis that this was a good estimate of how long it would take to re-train the relevant medical clinicians. As there was some uncertainty in the evidence, he granted Edwards permission to apply to extend the stay if it subsequently became clear that the re-training period would take longer.
Regarding the nature and duration of the qualification, Arnold J held that an exception should apply whenever the Sapien 3 was the only suitable device for a patient. Boston had accepted that there should be an exception but argued that it should last for 6 months after the end of the stay. Arnold J agreed with Edwards that there was no basis for such a limitation and held that the time limitation for this exception was indefinite. However he allowed Boston to apply to remove the exception in due course if other devices became suitable and available to these patients.
Balancing considerations on whether to grant a final injunction
Although future cases will be fact-sensitive and subject to the court’s discretion, the balancing considerations appear to be the harm to the patentee if a full injunction were not granted on the one hand versus the health consequences for patients if the infringing product were made unavailable. On the former, relevant factors would seem to be the extent to which financial remedies would provide adequate compensation and whether the patentee was exploiting the particular market. On the latter, factors including the clinical outcomes of the infringing product, the availability of viable alternatives and the severity of the patients’ prognosis seem relevant, along with what the barriers to patient care using other products would be and the timeframe for circumventing these.