Actavis Strikes Again: Edwards Lifesciences Find Success in Second High Court Heart Valve Case of 2020

For the High Court of England and Wales, Mr Justice Birss judged that Meril's Navigator device, a catheter based delivery system for their MyVal transcatheter heart valve, infringed an Edwards Lifesciences patent covering their SAPIEN valve, under the doctrine of equivalents. The decision provides further guidance on the application of Actavis vs Lilly and is another example of its positive influence for patentees. This was the second decision involving Edwards Lifesciences handed down by Birss J in 2020. The first decision resulted in an injunction being awarded against Edwards Lifesciences.

In the wake of the global pandemic, Edwards Lifesciences vs Meril was conducted as a hybrid hearing with up to six participants from each party attending in court and others attending remotely using videoconferencing software. Edwards contended that Meril's MyVal and Navigator devices infringed EP(UK) 1,267,753 entitled "Minimally-invasive heart valve" and EP(UK) 3,494,929 entitled "Low profile delivery system for transcatheter heart valve".

EP(UK) 1,267,753 was found to be invalid, so the case came to rest on the construction of EP(UK) 3,494,929 and the doctrine of equivalents established by Actavis vs Lilly. Claim 1 of EP(UK) 3,494,929 was construed as requiring a balloon catheter and a guide catheter as two separate and distinct elements. In contrast, the Navigator device was judged to have only a balloon catheter. However, it was determined that the balloon catheter also functions similarly to a guide catheter in that it can be flexed by a pull wire actuated from a handle.

The inventive concept of the Edwards Lifesciences patent was judged to relate to an improvement giving the operator a visual indication of the amount of flex in the device. Birss J stated that "the Navigator provides the same advantages as the claimed invention and in the same way. The fact that the pull wire is attached to part of the balloon catheter and so there is no need for a separate guide catheter makes no difference to the way the invention of claim 1 works". Thus the first Actavis question, which asks "does the variant achieve substantially the same result in substantially the same way as the invention?", was answered in the affirmative. The second question, which asks whether this would have been obvious to the skilled reader, was also answered in the affirmative.

The third and final Actavis question asks whether the skilled reader would have concluded that the patentee intended strict compliance with the literal meaning of the claim. Mr Justice Birss concluded that "the reader would see that the inventor described the invention by reference to what was then a conventional set up with a balloon catheter and separate guide catheter. The reader would see that the inventor recognised that off-balloon crimping - which does require both catheters and relative movement - was not an essential feature of the flex indication invention and so claimed the flex indication invention separately from it." In other words, the skilled reader would understand that the context in which the inventive concept had been claimed was not an intentional limitation on the inventive concept, so did not require a strict, literal reading of the claim.

This case demonstrates that UK courts are willing to find infringement even in cases where the claim does not literally cover the infringing product. It will thus be seen by patentees as a useful safety net against unintentionally narrow claims, and by non-patentee market operators as a further difficulty in knowing that a market space is safe to enter.