Medtronic (Minneapolis) and Edwards Lifesciences (Irvine, California) were not strangers in patent lawsuits. Edwards is specializing in the production of artificial heart valves and new hemodynamic monitoring technology, whereas Medtronic is specializing in the production of medical devices. In the past, the two companies have problems in patent infringement lawsuits over annuloplasty procedures and endovascular graft (1,2). However, currently another latest patent infringement lawsuit has been occurred and reported between Medtronic and Edwards Lifesciences. Edwards claimed that it has prior intellectual property rights on the new transcatheter aortic valve technology.
Transcatheter aortic valve replacement or TAVR is the latest technology used principally for the treatment of aortic stenosis, a condition in which one of the major valves of the heart, the aortic valve, becomes tight and stiff, usually as a result of aging (3). Since many patients who need aortic valve replacement for aortic stenosis are too sick to undergo major valve replacement surgery, they are unable to get the treatment they need. With the transcatheter aortic valve, this issue is bypassed because this valve can be implanted in the heart by accessing the patient’s heart through an artery in the groin. The valve can be inserted through a wire that can be pushed to the heart and the old valve is simply pushed to the side when the new valve is implanted. This technology has been in use in the US with Edwards’ Sapiens valve since 2011 and has saved the lives of many patients with aortic stenosis (4). Medtronic’s CoreValve uses similar technology and has won patent fights in Europe and has been in use internationally. However, within U.S., Medtronic has not been able to win the patent lawsuit that was slapped on them by Edwards Lifesciences and therefore, Edwards dominates the American market for TAVI, which is growing considerably.
Brief History of the Edwards and Medtronic Patent Lawsuit
The Edwards Lifesciences’ transcatheter aortic valve comes under the Andersen family of patents and they argue that Medtronic’s CoreValve revalving technology is an infringement of their intellectual property rights and affects their ability to pursue the development of this innovative technology aggressively for the use of American patients (5). This suit was first filed in 2008 in the US District of Delaware in which Edwards argued for a ban on the sale of CoreValve products in the United States. In 2010, the verdict was delivered by a federal jury that found Medtronic’s Corevalve to be a wilful infringement on the Andersen family of patents and Edwards Lifesciences was awarded as much as $74 million in damages. In Europe, the corresponding patent infringement lawsuits have played out in Medtronic’s favor. In England, a UK trial court found in 2009 that Medtronic had not infringed on the Edwards’ patent since the CoreValve used a different technology as compared to the Sapiens valve (6)....