In a recent High Court case involving rival medical devices for the treatment of mitral regurgitation, the High Court has upheld the patentee’s right to an injunction despite the existence of a body of doctors who believed that the defendant’s infringing device was better for patients with particular anatomies. The case underlines the importance placed by the courts on promoting innovation through a robust patent system, even though this restricts the choices open to doctors in some instances.
The dispute – Evalve and Abbott v Edwards Life Sciences[i]
Mitral regurgitation is a serious heart condition caused by the inability of the mitral valve to close fully to stop blood leaking back into the left atrium. The patents, owned by Evalve and licensed to Abbott, related to a transcatheter technique for treating this condition, which avoided the need for open-heart surgery. This was important as many patients with this condition were elderly and would not be strong enough for such surgery. Edwards’ product, known as PASCAL, operated in essentially the same way as Abbott’s product, MitraClip, and had been held to infringe the patents. Edwards argued that, despite this, there was a public interest in its device remaining available to doctors, because it was better for some patients. In view of this public interest, it said, no injunction should be granted (in which case damages would be payable instead). Alternatively, any injunction should contain a ‘carve out’ allowing the PASCAL to be supplied for use in patients to whom certain medical criteria applied. Abbott argued that it was entitled to an unqualified injunction. However, it was willing to accept a carve out allowing the PASCAL to be supplied in cases where the MitraClip had already been unsuccessful if a doctor reasonably believed it would be appropriate to try the PASCAL.
Insufficient evidence of public interest
On the evidence, the Court concluded that, despite the fact that a body of doctors believed that PASCAL was better for some patients, there was no reliable clinical data identifying a class of patients for which PASCAL was likely to be the only viable treatment or for whom it would be a better treatment. On this basis, the judge, Birss J, granted the injunction sought by Abbott subject only to a carve out in cases where a MitraClip implantation had been unsuccessful.
When may the public interest prevail?
The usual position is that the patentee is entitled to its injunction. An important consideration here is that granting damages instead of an injunction would be tantamount to granting a compulsory licence in circumstances where the conditions for granting such a licence under the Patents Act 1977 are not met. The public interest may, however, justify refusal of an injunction or a carve out in some cases. In a medical case a sufficient public interest is likely to involve the need to protect the lives of patients for whom the defendant’s product is the only suitable treatment. There must be sufficient objective evidence to find that there are patients who ought not to be treated using the available product but who could, in the reasonable opinion of a body of doctors, be treated using the rival product. It is not enough that doctors merely have a preference for one product above another.
Implications of the case
The case provides a good illustration of the kind of things the court will consider in such cases. Essentially, it is trying to balance the wider public interest in encouraging innovation - for example in developing new drugs - through the patent system against the public interest in preserving the health of individuals, and it makes it clear that the burden on the defendant in arguing against the imposition of an unqualified injunction is high. The starting point is that there are already a number of statutory exceptions in the Patents Act that take account of the public interest, so that it will only be in exceptional cases that a separate public interest defence will be needed. For example, the Crown Use exception allows life-saving drugs to be made available to the NHS without the patentee’s permission in certain circumstances, an exception that, the judge comments, could potentially be relevant in the case of a “novel pandemic disease”.
[i] Evalve Inc., Abbott Cardiovascular systems Inc. and another v Edwards Lifesciences Ltd.  EWHC 513 12.03.20