A judge in the England issued an injunction yesterday barring Edwards Lifesciences from selling its Pascal transcatheter mitral valve repair (TMVR) device in the U.K.
A different judge had previously denied Abbott’s petition for such an injunction. Yesterday, Judge Colin Birss of the High Court of England and Wales also ruled that two patents held by Abbott unit Evalve for its MitraClip TMVR device were valid and that Edwards’ Pascal device infringed them.
The decisions came after two separate trials, at which Edwards had argued that Abbott’s MitraClip patents were invalid, and that barring Pascal sales in the U.K. would go against public interest.
Edwards contended that Pascal was “significantly different” from MitraClip and other TMVR devices and thus could be used in patients who were unsuited to treatment with those devices. The company also argued that physicians who prefer Pascal to MitraClip should have access to it, and that Pascal should be available for patients in whom MitraClip implantation was unsuccessful. Abbott agreed to and Birss ordered a “carve-out” of the injunction allowing for Pascal to be used in those patients.
Birss decided that giving doctors the choice was not enough to deny Abbott’s petition for an injunction.
“It is manifest that there is a wealth of data underpinning the use of MitraClip, by contrast there is much less data on Pascal,” Birss wrote. “I find that overall there is, at least yet, no hard clinical data from which to infer any objectively superior performance by Pascal over MitraClip in any circumstances in any patients.”
Edwards said it respectfully disagrees with Birss’ decision.
“Edwards continues to strongly believe that its differentiated Pascal technology does not infringe the patents invoked by Abbott and intends to appeal,” a company spokeswoman said in an email to MassDevice. “Edwards is not updating its financial guidance.”
Currently, TMVR procedures are not covered by the UK’s National Health Service, resulting in a very small number of such procedures in the country, according to court documents. However, NHS England is expected to begin paying for the procedure, according to a report by Law360.
