Injunction granted against Edwards in heart valve patent dispute

Out-Law Legal Update | 02 Apr 2020 | 8:08 am | 3 min. read

Developers of innovative pharmaceuticals and medical devices will be buoyed by the confirmation that final injunctions will not be refused on public interest grounds, except in very limited circumstances.

In a dispute relating to a heart valve device, the High Court of England and Wales held that the patents in question were valid and infringed, and subsequently rejected public interest arguments that a final injunction should not be granted, save for a limited carve out.

Evalve, a subsidiary of Abbott Laboratories, owns two patents which cover the successful heart valve device MitraClip, which is used to treat mitral valve regurgitation, a serious heart condition.    

It launched patent infringement proceedings against Edwards, alleging that its PASCAL product infringed those patents. Edwards in turn argued that the patents were invalid.

MitraClip is successful because the alternative prior to its launch was open heart surgery, which is not suitable for elderly patients who form the majority of the patient group.

In earlier expedited proceedings where matters of infringement and invalidity were considered, PASCAL was found to infringe both patents, which were held to be valid.

A separate public interest trial took place in January of this year. Due to the finding of infringement and validity, an injunction against Edwards was a potential outcome, making the outcome of the public interest trial significant.

At that trial, both sides called experts to attest to whether there are patients who can be treated by PASCAL and not MitraClip. In doing so, Edwards hoped to gain a carve-out to the injunction so that it could sell its PASCAL product to at least a subset of patients.

Edwards also argued that there is a body of doctors who, on reasonable grounds, prefer to use PASCAL in certain cases, rather than necessarily needing to use PASCAL for clinical reasons.

Mr Justice Birss said: "When the court is considering withholding an injunction on public interest grounds, it is relevant to have regard to the fact that the patent legislation itself already places limits on patent rights in order to safeguard the public interest.  That includes the power to make life saving treatments available to the public without the permission of the patentee."  

Such powers included the availability of a compulsory licence, damages in lieu of an injunction or invoking the defence of 'Crown use'. None of these were available in this case. 

The choice available to clinicians was relevant in considering whether the public interest would be invoked.    

A doctor may reasonably believe that the balance of risk for one product may be more favourable than with the other, but the judge found that this is not sufficient to engage the public interest justification for refusing a patent injunction because it does not examine the basis for the reasonable views of doctors. 

Doctors make decisions based on the evidence that they have. When a new product comes onto the market there is sufficient evidence supporting its use to get clinical approval, but that is not the same as a firm body of evidence covering all of the circumstances which a doctor may encounter. Approaches may change as the evidence develops.

The court said that to engage the public interest, sufficient objective evidence is required to show that there are in fact patients who ought not to be treated using the patented device and who could, in the reasonable opinion of body of doctors, be treated using the rival product.

The judge also considered that the public interest in the freedom of doctors exercising clinical judgment should be balanced against the patentee's right to an exclusionary monopoly. He said that when opposing public interests are to be considered, the balance between them should be struck by parliament not the judiciary.

He was not persuaded that the public interest in allowing doctors to exercise their clinical judgment in the best interests of their patients is sufficient to justify the refusal or carving out from a patent injunction.

He further found that to refuse an injunction on public interest grounds would inevitably lead to patents being treated with PASCAL where MitraClip, objectively, is a perfectly adequate treatment. This would undermine the patent system.

The judge awarded the injunction against Edwards. However, he did permit a carve-out so that PASCAL may only be used where a MitraClip implantation has failed.

Christopher Sharp is a patent expert at Pinsent Masons, the law firm behind Out-Law.com