Evalve Inc & Ors Edwards Lifesciences Ltd

A patent claim must be construed according to its language read in context, without importing limitations from the specification absent good reason. In assessing obviousness, the skilled person reads the prior-art document as a whole, but the context in which a particular disclosure appears remains relevant to whether it is an obvious starting point. A disclosure that instructs the skilled person to modify an embodiment is not necessarily enabling for novelty if the modification can produce materially different results. The doctrine of equivalents applies where a variant achieves substantially the same result in substantially the same way, unless strict compliance with the claim language was intended to be essential.

The claimants owned or exclusively licensed two European patents concerning catheter-delivered devices for repairing mitral valve regurgitation. They alleged that the defendant’s PASCAL device infringed both patents. The defendant denied infringement and challenged validity on grounds including lack of novelty, obviousness and added matter.

The first patent concerned detachable capture devices with independently movable proximal and distal elements. The second concerned fixation devices having closed and inverted positions, gripping elements and concave fixation elements. The central issues were claim construction, the effect of the cited prior art, enablement, infringement and infringement under the doctrine of equivalents.

1. Construction of the 850 patent. The word “independently” in claim 1 referred to independence between the distal elements as a class and the proximal elements as a class, rather than left/right independence between individual elements. Limitations disclosed elsewhere in the specification were not imported into the claim. The PASCAL device therefore satisfied the relevant construction and the claims were not obvious over Deem, which described the relevant figure 44 device as a temporary grasper rather than a detachable implant.
2. Added matter. The application as filed disclosed the claimed retractable and extendable proximal and distal elements, including their relationship to the catheter and capture-device shafts. The alleged intermediate generalisation arguments were permissible only to the extent properly identified in the Statement of Case. The added-matter objections failed.
3. Infringement of the 850 patent. The PASCAL elements were interlockable because their shapes allowed one element to fit within the other. The device infringed the relevant claims.
4. Construction of the 810 patent. A “free end” meant the portion of a fixation element free to move relative to the first end so that it could change direction; it did not mean only the extremity or an unobstructed tip. “Closed” and “inverted” had independent meaning. The closed position minimised the device’s profile, while the inverted position was inverted relative to the closed position.
5. Goldfarb. Goldfarb disclosed making the figure 18 device detachable. A detachable device based on that figure would have been obvious, but the disclosure was not enabling for novelty because the instruction required modification of the depicted device and did not establish that all possible implementations would materially produce the same claimed result. The figure 18 device also lacked the required closed position.
6. Equivalents. Applying the three questions in Actavis v Lilly [2017] UKSC 48, PASCAL achieved substantially the same result in substantially the same way as the claimed device. The skilled reader would not regard strict compliance with the literal allocation of structural parts as essential. PASCAL therefore infringed claim 1 of the 810 patent, including Modified Conditional Amendment F, and the associated dependent claims.
7. Conclusion. Both patents were valid and infringed by PASCAL.