The Cyberlaw Clinic contributed to an amicus brief recently filed in the United States Supreme Court, in the case of Medtronic, Inc. v. Mark A. Barry, M.D., No. 19-414. The case is on petition for writ of certiorari to the United States Court of Appeals for the Federal Circuit; the brief urges the Supreme Court to grant cert and hear the case. The Clinic collaborated with the R Street Institute, a nonprofit, nonpartisan, public policy research organization, on the brief. The case presents two questions relating to patent validity that will have a significant impact on pharmaceutical prices and disclosure of medical devices, and the brief argues that the Federal Circuit’s ruling — which is the subject of Medtronic’s cert petition — will exacerbate the existing problem of high medical treatment costs.
The Federal Circuit ruled that respondent, Mark Barry, had a valid patent on a spinal surgery technique. Barry practiced his surgical method more than one year prior to the patent application date, which would ordinarily put the invention in “public use” and prevent Barry from obtaining a patent. But, the court held that the public use bar did not apply, because Barry had not yet determined that the surgical method worked for its intended purpose before the critical date for filing the patent. This “intended purpose” was determined from after-the-fact testimony from Barry, not listed anywhere on the patent. Thus, surgeries that Barry performed using the patented surgical method fell within the “experimental use” exception and did not adversely impact Barry’s patent application. Additionally, the court determined that Barry had no burden of persuasion to prove experimental use before patenting the technique.
Among other things, the brief advances the argument that the Federal Circuit’s ruling will enable patent holders to extend their patent terms beyond statutorily prescribed periods. First, the ruling that the public use bar does not trigger until the invention works for a subjective intended purpose could be exploited by drug makers looking to extend their patent terms during the FDA approval and testing phase. Second, creating a lower burden for experimental uses could allow medical treatment developers to commercialize their products before patenting them. Both are contrary to Congressional intent and may have negative impacts on the public interest by raising drug prices and reducing disclosure of medical treatments.
Cyberlaw Clinic students Natalie Morrissey and James Delacenserie worked with R Street’s Charles Duan and the Clinic’s Managing Director, Chris Bavitz, on the brief.