Patents: injunctions and public interest in medical device cases

By Audrey Horton

05-2020

The Patents Court has rejected a public interest defence and granted an injunction, following a finding that patents for a medical device were valid and infringed.

Background

Section 61(1) of the Patents Act 1977 (1977 Act) sets out remedies for patent infringement, which include injunctions restraining the defendant from any act of infringement.

The Intellectual Property Enforcement Directive (2004/48/EC) provides that remedies for infringement of patents and other intellectual property rights must be just and equitable, and also effective, proportionate and dissuasive.

Under the Senior Courts Act 1981, the court has the power to grant an injunction, where it is just and convenient, which may be made unconditionally or conditionally, or damages in lieu of an injunction.

In Shelfer v City of London Electric Lighting Co, the High Court held damages could only be awarded in lieu of an injunction where:

  • The injury to the plaintiff was small and could be adequately compensated by a small money payment.

  • Damages were capable of being estimated in money.

  • It would be oppressive to the defendant to grant an injunction ([1895] 1 Ch 287).

In Chiron v Organon No 10, the High Court considered the protection of the public interest in the context of patents when an infringer was seeking to invoke that public interest as a reason to withhold an injunction, and held that the infringer was effectively seeking to obtain a compulsory licence without having established the grounds set out in the 1977 Act ([1995] FSR 325).

Facts

A marketed a medical device. E planned to launch a competing device. Both A's and E's products operated in essentially the same way and were the only devices of this type currently approved for use in Europe.

A issued patent infringement proceedings and E counterclaimed alleging invalidity.

The Patents Court refused to grant an interim injunction because an expedited trial had been ordered and E had agreed to distribute only a small specified quantity of its devices before the outcome of the trial (www.practicallaw.com/w-020-9368).

At trial, the Patents Court held that E had infringed two patents.

A argued that an injunction should be granted with the sole qualification that E's product could be supplied where A's product had been unsuccessful and a doctor reasonably believed it would be appropriate to try E's product instead.

E argued that no injunction should be granted because this would be against the public interest, or alternatively that any injunction should include an exception for the use of E's product for patients with certain medical conditions. E proposed a mechanism for doctors to make a declaration about those circumstances in order to be permitted to be supplied with E's device.

Decision

The court granted an injunction in the terms requested by A.

A general injunction to restrain future infringements was the normal remedy for the patentee. The burden was on E to give reasons why such an injunction should not be granted. All the circumstances ought to be considered. The public interest, such as the impact on third parties, was a relevant consideration. Public interest might justify refusal of or a carve-out from an injunction, and an award of damages in lieu. Smallness of the damages in lieu was not determinative. Even if the damages were a large sum of money or were difficult to calculate, it might still be in the public interest to refuse an injunction or carve scope out of it.

The patent system already has provisions which strike balances between different public interests. The availability of an exclusionary injunction follows from 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 in the public interest and is protectable by an injunction in order to further the purposes of the system as a whole, such as to promote investment in innovation.

Where there are conflicting public interests, Parliament rather than the courts should examine these issues and draw the appropriate broad balance. The court's jurisdiction to refuse or qualify a patent injunction on public interest grounds should be used sparingly and in limited circumstances.

The fact that reasonable doctors would choose E's drug or device in preference to A's product was not sufficient to refuse or limit a patent injunction on public interest grounds. Patent law does not contain any express limitation preventing injunctions in the case of life-saving drugs or devices, or provide for compulsory licences to competitors.

Here, E's product was different from A's embodiment of the invention protected by the patent. The differences were tangible clinically even if not significant in terms of patent law. However, these differences did not create a relevant public interest because it did not necessarily mean that, if the choice had not been available, all the patients could not have been treated adequately with A's product.

Even if reasonable doctors believed that the differences between the products meant that there were some patients for whom A's product was not an adequate treatment but E's product was, this was still not sufficient justification for refusing or limiting an injunction on public interest grounds, because it did not examine the basis for the reasonable views of doctors.

What was required for the public interest was sufficient objective evidence to find that there were patients who ought not to be treated using the available product from A, but who could, in the reasonable opinion of a body of doctors, be treated using E's product.

Here the evidence showed that there was no reliable clinical data which identified any class of patients for which it was more likely than not that E's product was the only viable treatment. Nor was there any reliable clinical data which identified particular classes of patients or anatomies for which it was more likely than not that E's product would be a better treatment than the currently available product from A.

It followed that E's case that the injunction should be refused or contain wider carve-outs failed. An injunction would be granted on the terms sought by A: that the only carve-out would be where A's product had already been unsuccessful.

Comment

This decision provides a useful analysis of the law relating to public interest and patent protection for manufacturers of medical devices and pharmaceuticals. It emphasises the policy reasons behind the granting of injunctions for infringement of valid patents, and stresses that Parliament, rather than the courts, is best placed to decide when the public interest justifies refusing or limiting an injunction.

Case: Evalve Inc and others v Edwards Lifesciences Ltd [2020] EWHC 513 (Pat).

First published in the May issue of PLC Magazine and reproduced with the kind permission of the publishers. Subscription enquiries 020 7202 1200.