English court issues mixed ruling in heart valve patent clash
The English High Court has handed a mixed ruling in a dispute between Edwards Lifesciences and its competitor Meril Life Sciences.
In a partial victory for medical device company Edwards, the court found that Meril had infringed a patent covering a heart valve delivery system. However, the decision also provides freedom to operate for Meril on its competing heart valve product and delivery system.
Justice Colin Birss—in a decision handed down yesterday, September 29—concluded that while Meril had infringed claims in one patent, the other patent cited by Edwards in opposition was invalid and so not infringed.
Edwards is respectively the owner and exclusive licensee of two patents: EP (UK) 1,267,753 called “Minimally-invasive heart valve” and EP (UK) 3,494,929 entitled “Low profile delivery system for transcatheter heart valve”. The patents protect Edwards’ product family of prosthetic heart valves called Sapien.
India-based Meril was accused of infringing the patents through the sale of its Tavi product, which consists of a transcatheter heart valve called MvVal, and a catheter based delivery system for Myval called the Navigator.
In response, Meril denied infringement and counterclaimed for revocation of both patents on the grounds of obviousness, insufficiency and added subject matter.
Yesterday, Birss sided with Edwards on infringement of the ‘929 patent.
While Birss found that claims 1 and 2 of the patent were invalid, he concluded that claims 4, 5, 7, 8, 9, 11,12 and 13 were independently valid, making the ‘929 patent partially valid.
Meril, according to the court, infringed six of the claims which are dependent on claim 1 and, although the literal infringement of claims 1 and 12 was not established, Meril’s Navigator product infringed each of them on the doctrine of equivalents.
One alternative design of Navigator, which Meril sought a declaration of non-infringement for, was also found to infringe. In a win for Meril, Edwards accepted that another design did not infringe its patent.
The court also found that while the Myval product falls within claim 1 of the ‘753 patent (which claims a prosthetic heart valve device), the claim was invalid as it lacked an inventive step.
Meril had contended that the ‘753 patent was obvious in light of published application WO 98/29057 (Cribier) which was published in July 1998, when read in conjunction with US patent number 5,411,552 (Andersen US) which was published in May 1995.
“A major plank of Edwards’ case is that it fails to face up to Cribier’s criticisms of the Andersen design … Although other points were taken too, in my judgment it is the criticisms of Andersen in Cribier and their significance for the skilled team which is the key issue. The case turns on those,” said Birss.
The trial was conducted as a “hybrid” hearing using an audio/video system provided privately by the parties.
It is the first of three technical trials of patent disputes between these parties concerning Myval and Navigator, with the other two trials scheduled for before the summer vacation in 2021.
A spokesperson for Edwards said: “The decision to pursue this litigation was not taken lightly. Edwards’ goal is to improve and save patients’ lives through the advances of true innovation to address unmet patient needs.”
“We are pleased that the court and patent system recognises and protects our decades of work on the Sapien innovations.”
Daniel Lim, one of the Kirkland & Ellis lawyers representing Meril, said: “The judgment gives our client Meril valuable commercial certainty and reassurance as to its freedom to operate over both of the patents asserted by Edwards in this trial.
“In this regard, the practical significance of the finding of non-infringement in respect of Meril’s delivery system design around should not be overlooked,” he added.
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