Patent law trumps clinician preference

The UK Patents Court has recently reaffirmed a very pro-patent stance on granting injunctions against infringers.

Birss J followed up a finding that Edwards Lifesciences’ PASCAL transcatheter mitral valve repair devices infringed 2 patents of Abbott’s Evalve division with an immediate permanent injunction despite Edwards’ protests that 30-40% of clinicians preferred to use their device.

Edwards argued that, in the public interest, there should be no injunction or alternatively that the injunction should not apply if a clinician declared that certain prescribed medical criteria applied.

Birss J found that in the absence of objective evidence that there are in fact patients who ought not to be treated using the patent owner’s device (Abbott’s MitraClip) but could be treated with the infringing device, the injunction should apply.

The Court would only vary the injunction to protect the lives of patients for whom there was no other treatment and Edwards had not even sought to establish that such a group of patients existed.

The application to vary the injunction on the ground of public interest

Edwards argued that the Court should respect the clinicians’ preference, especially where their preference was based on their reasonable assessment of available information. The Court held that even where one doctor might consider, based on their experience and assessment, that one device was preferable in terms of the balance of risk, that is not sufficient to engage public interest for refusing or limiting the injunction. The reasonableness of the clinicians’ choice or opinion was not enough. Birss J commented that not all reasonable opinions are equal.

The Judge held that Edwards’ application for a variation of the injunction failed because they had not even sought to establish a factual position to meet the legal test he espoused. However, he went on to consider the evidence which had been presented. He found that there was no hard data from which to infer clinical superiority of the Edwards’ PASCAL device for any indications or cohort of patients. Birss J referred to the preferences of clinicians and found their views to be reasonably held but he considered them to be only provisional opinions as they were not substantiated by reliable clinical data.

Edwards’ case was not assisted by the Judge’s finding that the written evidence about clinician feedback from one of their key witnesses had been incomplete and selective and could not be relied upon without corroboration. He also disregarded a separate factual statement from an Edwards’ witness as being inadmissible expert evidence.

The Judge did grant a very limited carve-out which Abbott had agreed for the very few patients for whom an Abbott implantation had been unsuccessful but where an Edwards’ device might succeed.
The earlier Boston Scientific case

The Judge contrasted the circumstances of this case with the earlier dispute between Boston Scientific and Edwards (in which the author and his firm represented Boston). In the Boston case, where Edwards were similarly trying to avoid an injunction after a finding they had infringed but this time for an aortic valve replacement device, Edwards had shown clinical proof that there was a relatively small cohort of patients for whom no other device was suitable. This cohort was excluded from the injunction.

In the Boston case, clinicians had been using the Edwards’ device for a long period of time and Boston had limited sales of its device. Boston accepted that there should be a transitional period to allow clinicians who had used the infringing Edwards’ device to retrain on other devices. Much of the argument in that case was about the length and practical implementation of that transitional period. By contrast, in the Abbott case, the PASCAL device was in its early stages of use and at a preliminary injunction hearing in May 2019 Edwards had agreed to restrict the supply of the PASCAL device ahead of trial to a maximum of 10 patients for whom the MitraClip device had failed, so the issue of a transition for retraining did not arise.

Legal Basis for Decision

The legislative provisions and qualifications

Birss J undertook a detailed analysis of the legislative scheme for patents, noting references in the UK Patents Act to the public interest and in particular to the specific limited exceptions and qualifications of the rights of patent owners to prevent infringement, including provisions applying specifically in the medical field, such as the availability of compulsory licences and government intervention through Crown Use. He noted the importance of long-term legal certainty for those undertaking innovation in knowing the patents they obtained could be used to underpin their return on investment. The Judge concluded that where parliament had clearly considered the circumstances in which there should be exceptions to the principle that patent owners had a right to prevent infringement of their patents, he should be very careful to apply the law consistent with their intention, notwithstanding that the Senior Courts Act gave him discretion to do so.

TRIPS and the Enforcement Directive

The Judge considered TRIPs and the impact of the EU IP Enforcement Directive which requires remedies to be “…fair and equitable and shall not be unnecessarily complicated or costly, or entail unreasonable time-limits or unwarranted delays …and… shall also be effective, proportionate and dissuasive and shall be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse”.

Birss J agreed with Jacob LJ in the Virgin case when he said that enforcement would need to be grossly disproportionate to justify an exception to the expected remedy and with Aldous LJ in several cases in which he had said that denying an injunction was akin to granting a compulsory licence without satisfying the legislative requirements for compulsory licences. (Edwards could not apply for a compulsory licence because the 3-year post-grant period had not passed.)

Adequacy of damages in lieu

The Judge also observed that in considering a variation of the injunction he was required to consider the adequacy of damages in lieu of the injunction as a remedy for the patent owner. The parties had not addressed damages in their evidence or applications. In future, an infringer seeking to avoid an injunction will need to do so. Birss J pointed out that there may be circumstances in which the award of a royalty in lieu of an injunction would mean that the successful patent owner is forced to suffer loss in the public interest!

The applicable principles

Birss J summarised the applicable principles as follows:

• A general injunction to restrain future infringements is the normal remedy for the patentee.
• The burden is on the defendant to give reasons why such an injunction should not be granted.
• All the circumstances should be considered. The public interest, such as the impact on third parties, is a relevant consideration. This applies under domestic law (Coventry v Lawrence) and under Art 3 of the Enforcement Directive.
• In a proper case the public interest may justify refusal of or carve out from injunction, and an award of damages in lieu. Smallness of the damages in lieu is not determinative. Even if the damages were a large sum of money and/or one which was difficult to calculate, it might still be in the public interest to refuse an injunction or carve scope out of it.
• The starting point of any consideration of the public interest in relation to a remedy after a patent trial is that the patent system as a whole is already criss-crossed with provisions which strike balances between different public interests.
• The availability of an exclusionary injunction is an important manifestation of the monopolistic nature of a patent right. While monopolies in general are against the public interest, once a patent has been found valid and infringed, the patent monopoly is something which it is in the public interest to protect by an injunction in order to further the purposes of the system as a whole, such as to promote investment in innovation.
• Therefore when, as here, various public interests are engaged and pull in different directions, one should have in mind that the legislator is better equipped than the courts to examine these issues and draw the appropriate broad balance. The jurisdiction to refuse or qualify a patent injunction on public interest grounds is not there to redraw the broad balance of public interests set by Parliament in the patent system. The power should be used sparingly and in limited circumstances.”

Summary of finding

The Judge summarised his finding in paragraph 88 -

“It is in the public interest that doctors should have freedom to exercise clinical judgment and choice however that is not the only public interest engaged when a final injunction restraining infringement of a valid patent would restrict clinical choice. I am not persuaded that the public interest in allowing doctors to exercise their clinical judgments in the best interests of their patients is sufficient to justify the refusal or carving out from a patent injunction. It would be a wide exception. To give effect to that interest in that way would mean that throughout the field of inventions of life saving products, just because the defendant's embodiment of the patentee's invention happened to have some clinically tangible differences from the patentee's own commercial embodiment of their invention, then there would be no exclusionary monopoly. In my judgment balancing the public interests to reach that result would be a matter for Parliament and should not be created by the courts. The patent system is set up in such a way that it does restrict the choice open to doctors by restricting the products available to them from which they can choose. That restriction is in the public interest overall because it promotes innovation.”

References

Evalve Inc and Ors v Edwards Lifesciences Limited [2020] EWHC 513 (Pat)
Validity and Infringement Judgment [2020] EWHC 514 (Pat)
Edwards Lifesciences v Boston Scientific [2018] EWHC 1256 (Pat)
Enforcement Directive 2004/48/EC