On January 17, 2014, Edwards Lifesciences Corporation filed a petition with the Patent Trial and Appeal Board requesting inter partes review of U.S. Patent No. 6,306,141, assigned to Medtronic Vascular, Inc.
The ‘141 Patent is entitled “Medical Devices Incorporating SIM Alloy Elements.” The ‘141 Patent states that it relates to “a medical device containing a shape memory alloy element.” The patent discloses using stress and temperatures below body temperature to restrain a metal alloy. The alloy expands to its original shape after being released from its restraint and exposed to body temperature. In one example, the ‘141 Patent describes that the disclosed device enables doctors to treat damaged or diseased heart valves with a less invasive transcatheter heart valve procedure. Figures 3 and 4 of the ‘141 Patent, shown below, illustrate a “side elevation view of a partial section of a catheter” in stressed (Figure 3) and unstressed (Figure 4) configurations.
The petition seeks to review all claims of the ‘141 Patent. Edwards’ petition submits that the claims of the ‘141 Patent should be found invalid due to inherent anticipation, obviousness, and double-patenting.
This is not the first time that the ‘141 patent has been subject to a petition for inter partes review. In May 2013, Lombard Medical filed a petition for inter partes review of Claims 1-10 and 18-22 of the ‘141 Patent. Lombard Medical’s products, according to its website, include the AORFIX™ endovascular stent graft. According to a Lombard press release, on October 17, 2013, Lombard was granted a non-exclusive license by Medtronic to the ‘141 Patent, and Lombard formally requested a withdrawal of its inter partes review petition with the USPTO.
The ‘141 Patent has also been previously litigated. The ’141 Patent, among others, was previously asserted by Medtronic against W.L. Gore & Associates, Inc. in 2006; Gore’s EXCLUDER® AAA, TAG, and VIABAHN SFA® endoprosthesis devices were at issue. The parties entered into a confidential settlement in 2009.
Medtronic also previously asserted the ’141 Patent, among others, against AGA Medical in 2007. AGA’s AMPLATZER® Septal Occluder, Duct Occluder, and Vascular Plug devices were at issue. The parties entered into a settlement in 2010 in which AGA received a non-exclusive license to patents including the ’141 Patent in exchange for $35 million. AGA Medical was subsequently purchased by St. Jude Medical in October 2010 for $1 billion.