In TAVR Case, U.S. Appeals Court Affirms Infringement Ruling Against Medtronic

Posted in Cardiovascular by Brian Buntz on November 13, 2012

Edwards Lifesciences Corp. has won a recent patent suit in the U.S. Appeals Court against Medtronic, agreeing with an earlier ruling in which the Delaware Federal District Court found Medtronic liable for $73 million in damages. The Delaware court, however, dismissed Edwards’ attempt to use an injunction to block Medtronic from marketing the CoreValve in the United States. The Federal Circuit Court, however, advised that an injunction should be reconsidered. 

In an interview conducted earlier this year, Nathan Lowenstein, a partner at Goldberg, Lowenstein & Weatherwax LLP (Los Angeles) explained that an injunction against the CoreValve could be a bigger threat for Medtronic than monetary damages. “That being said, some courts have been reluctant to grant injunctions in cases involving medical devices, such as in the Edwards/Medtronics case,” he said, pointing to the previous ruling by the Delaware Federal District Court . “If a patent dispute results in a running royalty on a device whether by settlement or otherwise, the royalty may affect the product pricing or the profit seen by the manufacturer."

SapienAt issue in this case is the infringement of United States Patent No. 5,411,552, which was issued May 2, 1995. The patent covers a collapsible stent that carries a valve that is inserted into the heart using a balloon catheter. Following the patent's filing, Edwards continued to address “questions such as size reduction, material and design optimization, and stent valve sterilization,” explained co-inventor Lars L. Knudsen in a later report, adding that “much more work had to be done before anybody ever even contemplated using this for a human.” 

This factored into the ruling as this excerpt illustrates:

...if a person of ordinary skill in the art could not make and use the invention disclosed in the patent without undue experimentation, the patent is invalid. However, some routine amount of experimentation to make and use the invention is allowable. 

The patent need not contain a working example if the invention is otherwise disclosed in such a manner that one skilled in the art to which the invention pertains will be able to practice it without an undue amount of experimentation.

The record also recounts how the inventors of the technology, Henning R. Andersen, MD; John M. Hasenkam, MD, and then medical student Lars L. Knudsen initially met skepticism for their pioneering work on transcatheter aortic valve replacement technology, noting that medical journals initially refused to publish their work. Eventually, however, their work was honoered as “most exciting” and was praised by the CoreValve founder and the CoreValve CEO. 

Following the news announcement, Edwards Lifesciences’ shares gained $1.09, closing at $87.75 on November 13. Medtronic stock fell by $0.19 to $41.30. 

This news follows on the heels of FDA's decision last month to expand the indication of the Sapein to treat high-risk aortic stenosis patients  both transfemorally and transapically. Before that decision, the device was only approved in the United States for the treatment of inoperable patients via the transfemoral approach. 

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz. 



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