Boston Scientific and Edwards Lifesciences settle heart valve dispute

Medical device manufacturers Boston Scientific and Edwards Lifesciences have reached an agreement to settle all global outstanding patent disputes. Since 2015 the battle has mainly played out in the US and Germany, but further disputes over heart valve patents occurred in the UK, France, Ireland and Canada.

18 January 2019 by Mathieu Klos

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The settlement was announced earlier this week, with all pending cases or appeals in courts and patent offices dismissed. Neither party will litigate patent disputes related to current portfolios of transcatheter aortic valves, certain mitral valve repair devices, and left atrial appendage closure devices. Any injunctions currently in place will be lifted.

Both companies agreed on cross licences for their portfolios concerning these technologies. In addition, Edwards has made a one-off payment to Boston Scientific of US$180 million. The firms agreed on no further royalties. All other terms of the agreement remain confidential.

The companies can consider the settlement a success: Edwards Lifescience because its competitor was not able to stop the company from marketing the newest version of its main product (Sapien 3 Ultra) permanently, and Boston Scientific because the conditions for entering the heart valve market have improved.

Frank Peterreins

Frank Peterreins

Intense dispute

The market for heart valves is highly competitive. Edwards is the market leader, with a turnover of €150 million for its products in Germany alone. Boston Scientific, on the other hand, has a small market share.

The dispute was triggered in 2010 by Boston Scientific’s acquisition of heart valve manufacturer Sadra Medical in a move to enter the lucrative market.

To further strengthen its position, Boston Scientific took action against Edwards Lifescience’s patents. The company filed numerous oppositions with the European Patent Office against patents owned by the market leader. However, since the current heart valve technology is fairly new, there were no nullity suits, even  against Boston Scientific patents by Edwards Lifescience.

In October 2015, Boston Scientific sued the market leader before Düsseldorf Regional Court for infringement of a patent. This was followed by two counterclaims from Edwards Lifescience. In the meantime, six infringement suits were pending in Germany. The amount in dispute was between 10 and 30 million euros. Edwards Lifescience also filed entitlement actions at Munich Regional Court against Boston Scientific’s patent applications to the EPO as well as actions against two patents, that Boston claimed to be infringed.

Only last November the Regional Court Düsseldorf issued a preliminary injunction against Edwards which prohibited the US medical technology manufacturer from marketing its Sapien 3 Ultra heart valves in Germany (case ID: 4c O 53/18).

According to the court, the product infringes the German part of patent EP 2 949 292 B1 for a replacement valve of Symetis, a subsidiary of Boston Scientific. The company enforced the ruling against a security deposit of €10 million. Later Edwards Lifesciences appealed against the decision. Boston did not enforce the decision in the main trial, however. The court ordered a security deposit of €90 million.

For Boston Scientific
Peterreins Schley (Munich): Frank Peterreins, Thomas Adam; patent attorneys: Jan-Malte Schley, Markus Coehn, Matthias Traut
Simmons & Simmons (London): Michael Burdon
Taliens (Paris): Jean-Frédéric Gaultier
In-house legal (Maple Grove): Pete Gafner (head of litigation), Todd Messal (Senior Managing Counsel)

Boris Kreye

For Edwards Lifesciences
Bird & Bird (Munich): Boris Kreye, Daniela Kinkeldey, Michael Alt (both patent attorneys); associates: Dr. Katharina Pehle, Sebastian Wolf, Marie-Theres Schmid (patent attorney)
Eisenführ Speiser (München) Rainer Fritsche (patent attorney)
Powell Gilbert (London): Tim Powell u.a.
Bird & Bird (Paris): Anne-Charlotte Le Bihan
In-house legal (Irvine): Keith Newburry (vice president, chief intellectual property counsel), Ryan Lindsey (senior patent counsel)

Updated at 21.01.2019