Medical devices

Pinsent Masons paves way for Neovasc heart valve patent

A bitter dispute rages in the US and Europe over innovative implants for mitral heart valves. Last week, the Munich Higher Regional Court handed down a decisive verdict in this case. The Edwards Lifesciences subsidiary CardiAQ is not entitled to co-ownership rights of a basic patent for the technology of Neovasc Tiara (case ID: 6 U 2408/17). Neovasc can now continue its patent application in Europe.

25 March 2019 by Mathieu Klos

Neovasc, Edwrs Lifescience, CardiAQ Neovasc's patent protects a model of heart valve that can be used for minimally-invasive procedures. ©Damien/ADOBE STOCK

Munich Higher Regional Court completely rejected an entitlement action by CardiAQ. In 2014, the US medical device manufacturer filed a lawsuit before the Munich Regional Court for the complete surrender of ownership, but this was only partially granted. This ruling has now been overturned by the court.

Neovasc is now the sole owner of EP 2566 416, which protects a transcatheter called mitral valve prothesis. However the entitlement action has prevented the patent from being granted since 2014, in accordance with EPO rules.

The court has not yet given reasons for its decision. But it is assumed that an appeal to the German Federal Court of Justice will not be permitted. In order to stand a chance at co-ownership, CardiAQ must file an appeal against denial of leave to appeal. If the judgment is final, the EPO will continue to grant the patent.

Michael Schneider, Pinsent Masons, patent litigation

Michael Schneider

Future market

In contrast to aortic valve prostheses, the market for artificial mitral heart valves is relatively small. The process involved to implant heart valves is highly complex and requires open heart surgery. Neovasc’s patent, however, protects a version that can be used for minimally-invasive procedures. The market value of the technology is estimated at several hundred million euros.

Originally, Neovasc and CardiAQ worked together on the development. Neovasc then filed a US patent, for which CardiAQ demanded co-ownership. In the course of the dispute, the startup CardiAQ was bought by Edwards Lifesciences. A US court finally appointed Edwards Lifesciences as co-owner.

Due to a breach of trade secrets, Neovasc paid damages to CardiAQ amounting to $120 million. Nevertheless, Nevasc can market its product in the US independently of Edwards Lifescience.

New ground

While there has been numerous patent cases involving heart valves in Europe, most concern prostheses for aortic heart valves. For example, Boston Scientific and Edwards Lifesciences settled a dispute in January. Medtronic is the third biggest market player in this segment. In the past, Hoffmann Eitle has represented Medtronic against both Edwards Lifesciences and Boston Scientific.

Nevertheless, the Munich patent attorney firm was at Edwards Lifesciences’ side in this dispute. This is because Hoffmann Eitle was already working for CardiAQ before it was bought out by the US group.

Patent attorney Michael Schneider brought his client Neovasc to Pinsent Masons, from his previous law firm Gowling WLG. Schneider moved to Pinsent Masons in 2017 together with attorney Peter Koch.

Niels Hölder, Hoffmann Eitle, patent litigation

Niels Hölder

Both originally came to the client via US law firm Wilson Sonsini, and London patent law firm Mathys & Squire.

The latter is handling the patent application. Schneider and Koch brought Wachenhausen & Kollegen on board for the entitlement action. The Munich patent attorney firm also advises Neovasc on the patent strategy.

For Edwards Lifsciences CardiAQ
Hoffmann Eitle (Munich): Niels Hölder, Mike Gruber, Anne Schön (patent attorney)

For Neovasc Tiara
Pinsent Masons (Munich): Michael Schneider, Peter Koch
Wachenhausen & Kollegen (Munich): Marc Wachenhausen, Thorsten Haslinde (both patent attorneys)

Higher Regional Court Munich, 6th Civil Senate
Konrad Retzer (preciding judge), Stefanie Ruhwinkel, Marianne Neumman