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UK – Edwards Lifesciences LLC v Boston Scientific

07 Mar 2017

Edwards Lifesciences LLC v Boston Scientific Scimed Inc, UK, High Court, Hacon HHJ sitting as a Deputy High Court Judge, 3 March 2017

These proceedings concerned an application brought by Edwards Lifesciences LLC (“Edwards”) seeking revocation of two European Patents (UK) – EP (UK) 2 749 254 and EP (UK) 2 926 766 – owned by Boston Scientific Scimed Inc (“Boston Scientific”). The patents both concerned transcatheter heart valves.

Transcatheter heart valves are replacement heart valves which are introduced into a blood vessel using a needle puncture via the skin rather than through open heart surgery. The claimed valves were characterized by the presence of a fabric seal at the distal end of the valve which was “bunched up” in a deployed position or where a seal was established by providing “at least one sac disposed about the exterior of the valve”.

Edwards alleged that the patents lacked novelty and/or inventive step over four items of prior art.

In relation to novelty, the judge, noted that it could be the case that an item of prior art might anticipate a claimed invention even if it did not disclose all of the features of an invention, if a person skilled in the art would inevitably infer that the missing integers would be present. However, reviewing the prior art, the judge concluded that none of the identified prior art disclosed all of the features of the claimed invention and in no case was it inevitable that the presence of the missing features would be inferred by a person skilled in the art.

On the question of inventive step, the judge concluded that most of the arguments put forward by the claimants were over reliant on hindsight and the imaginative skill of their experts and that no convincing reason had been identified for focussing on particular aspects of the prior art as suitable for modification. However, in relation to an attack based on an endograft used to treat abdominal aortic aneurysms (i.e. a different type of heart defect in a different part of the heart), the judge concluded that such an endograft would be of interest to a team working with trans-catheter heart valves and rendered the invention in EP(UK) 2 749 254 obvious. However as the prior art endograft lacked any disclosure of the concept of using a sac as a seal, EP (UK) 2 926 766 was inventive over this art.

The judge dismissed arguments that the disclosure of either patent was insufficient and/or the separation of the features of the claim from the context of the specific embodiments caused the content of the patents to extend beyond that in the application as originally filed.
Arguments on non-infringement turned on a specific interpretation of the definition of the term “sac” which the judge considered did not apply. The judge therefore concluded that EP (UK) 2 926 766 was both valid and infringed.

The judgment can be found here.

Headnote: Nicholas Fox, Simmons & Simmons LLP