The medical device companies appeared before the high court Nov. 5 to argue their sides in a case involving the burden of proof in a dispute brought by an alleged infringer against the patent holder.
Medtronic has argued that Boston Scientific and its Guidant subsidiary must prove that Medtronic’s technologies infringe on their exclusively licensed patents, rather than asking Medtronic to prove that it’s products are not in violation. Boston Scientific has argued that it does not bear that burden, since the company didn’t file the lawsuit to begin with. Since Medtronic brought the initial lawsuit while still under a licensing agreement for the CRT patents in question, it created a unique situation that raises questions about who is actually the plaintiff and who is the defendant in this case.
The 2 patents in the case, covering cardiac resynchronization therapy, have since spawned an entire family of CRT patents that weren’t in existence when Medtronic and Boston Scientific inked the licensing deal that’s at the center of the case.
Ken Kuwayti, co-chair of the commercial litigation group and a partner at Morrison & Foerster, told MassDevice.com that the justices seemed more sympathetic Tuesday to Medtronic’s arguments than to Boston Scientific, which licenses the patents from Mirowski Family Ventures.
"My reading of the argument is that the MVF parties where given a harder time by the justices," Kuwayti told us. "[Medtronic was] really emphatic that the Declaratory Judgment Act is a procedural statute that shouldn’t affect substantive rights and that the burden of proof is a substantive right. That argument seemed to resonate with the justices. I think a lot of the justices picked up on that, and in their questions they really pressed that point with [MFV and Boston Scientific]."
The respondents, MFV and Boston Scientific, argued that Medtronic should bear the burden of proof because the "default rule" places that burden on on the party seeking relief – in this case, Medtronic.
"The most compelling issue on the other side is that Medtronic was in some way disturbing the status quo. Here you had an agreement in which the parties had agreed to a license to the patent, and Medtronic is the 1 that’s disturbing that by saying, ‘We’re going to challenge the validity of the patent, because we don’t think we infringe it or we don’t think it’s valid,’" Kuwayti said.
The justices are expected to rule on the case by the end of June 2014.
The lawsuit has taken may turns since its inception in 2003, including a note of support from the U.S. Solicitor General in favor of Medtronic, ultimately landing in the Supreme Court after lower courts bounced back and forth on the issue.
Judge Susan Robinson of the U.S. District Court for Delaware ruled in April 2011 that the burden rested on the patentee, in this case Mirowski Family Ventures, which owns a pair of patents issued to CRM pioneer Dr. Morton Mower. Mower’s CRT helps the hearts left and right ventricles beat simultaneously, increasing the heart’s efficiency, and MFV exclusively licenses both patents to Guidant Corp, which Boston Scientific acquired 2006 for an eyebrow-raising $26 billion.
Medtronic in 1991 entered into a sublicense agreement for the patents with Eli Lilly (NYSE:LLY), which owned Guidant at the time. The agreement gave Medtronic leverage to challenge 1 of the patents, which the medical device company began doing in 2003. Over the course of several years Medtronic, Eli Lilly and MFV battled over the validity of 1 of the CRT patents and whether or not Medtronic’s devices infringed on the technology and in 2007 MFV handed Medtronic a list of technologies that it deemed in violation.
The case finally closed on a question over who was responsible for providing the burden of evidence – the patentee, MFV, or the defendant, Medtronic.
MFV and Boston Scientific appealed Robinson’s decision, arguing that Medtronic bore the burden of proof since it originally filed the lawsuit. Last fall a panel of judges on the U.S. Court of Appeals for the Federal Circuit agreed, concluding that the lower court had mistakenly but the burden of proof on MFV when Medtronic had "disturbed the status quo" with its lawsuit.