Abbott unit secures injunction against Edwards
An English High Court judge has issued an injunction against Edwards Lifesciences, handing a victory to Abbott Laboratories subsidiary Evalve.
Yesterday, March 12, Justice Birss handed down two judgments, finding that Edwards had infringed two patents and rejecting Edwards’ argument that it was against the public interest to impose an injunction.
Evalve’s two patents, EP (UK) 1,408,850 called "Devices for capturing and fixing leaflets in valve repair" and EP (UK) 1,624,810 called "Fixation devices and systems for engaging tissue", relate to medical devices used to treat mitral valve regurgitation by a transcatheter technique.
Mitral valve regurgitation, which is prevalent in 1.7% of the population, is a disorder characterised by the inability of the mitral valve to close fully and stop blood flowing back from the left ventricle into the left atrium instead of flowing to the aorta.
The patents protect Abbot’s product MitraClip which has been on the market since 2008 and, according to the court, Edwards’ Pascal product infringes both of these.
In the first decision, Birss concluded that both of Evalve’s patents were valid and had been infringed.
Birss, in the second judgment, added: “Both Pascal and MitraClip operate in essentially the same way, clipping the two leaflets of the valve together, hopefully leading to a reduction in mitral valve regurgitation.”
Edwards had argued that the injunction shouldn’t apply at all, allowing for the Pascal devices to remain on the market.
As a fall-back position, Edwards also advanced a “set of particular circumstances for which it contends that, if any one or more of them are applicable to a given patient, then given the differences in design and functionality between MitraClip and Pascal, a reasonable doctor would (or some reasonable doctors do) decide that the Pascal would be better than the MitraClip in that case”.
Edwards requested a carve-out from the injunction to allow Pascal to be supplied for use in patients to whom one or more of the defined medical criteria apply, and proposed that doctors would need to make a declaration about those circumstances in order to obtain a Pascal device.
While granting the injunction, Birss allowed for a carve out for situations in which a Mitraclip implantation has already been unsuccessful, but refused to allow any further carve outs.
A spokesperson for Edwards said: “We respectfully disagree with the decision, as Edwards continues to strongly believe that its differentiated Pascal technology does not infringe the patents invoked by Abbott and intends to appeal. Edwards is not updating its financial guidance.”
Did you enjoy reading this story? Sign up to our free daily newsletters and get stories sent like this straight to your inbox.
