A Recent Supreme Court Decision Made It Easier to Invalidate Vague Medical Device Patents

Medical device companies will have to pay more attention during patent procurement to precisely defining their inventions.

By Jeremy Lowe


On June 2, 2014, the Supreme Court ruled unanimously in Nautilus Inc. v. Biosig Instruments Inc. that Biosig Instruments’ heart-rate monitor patent was invalid. Biosig had sued Nautilus Inc., its competitor, for allegedly infringing the patented monitor, and the District Court and the Court of Appeals for the Federal Circuit found that the patent was valid in favor of Biosig. Writing for the high court, Justice Ruth Bader Ginsburg disagreed with the lower courts’ rulings, saying the claimed “spaced relationship” design in Biosig’s patent may well be too vague to meet the patentability standards.

Previously, the Federal Circuit would not invalidate a patent as indefinite so long as the claims, which define the metes and bounds of the patent, were “amenable” to interpretation and not “insolubly ambiguous.” The high court rejected that amorphous standard, and in its place established a new standard that the claims must define the patent with “reasonable certainty.” The Supreme Court was explicit that the new standard is meant to eliminate uncertainty for industry by changing the current practice of drafting patent claims that incentivizes vagueness and ambiguity.

Bruce Cazenave, CEO of Nautilus, stated that the high court’s ruling “will help protect both Nautilus Inc. and all other companies from increasing, unnecessary, and costly patent litigation that is taxing our already overburdened court system.”

That prediction will not likely find much traction, however. Rather, medical device companies will have to pay more attention during patent procurement to precisely defining their inventions while facing pressure from the new “first-to-file” patent laws that compel companies to win the race to the patent office. Furthermore, litigants and courts alike will have to quickly move away from the earlier amorphous standard and engage in more exacting evidentiary and legal analyses. At the end of the day, the high court’s decision will not likely reduce patent litigation. But it may very well change who wins and who loses.

—Jeremy Lowe is a partner with the Axinn law firm in Connecticut. He is a trial and appellate lawyer who represents medical device companies in patent cases and other complex litigation matters. He can be contacted at jlowe@axinn.com.  




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