Athena Diagnostics Inc. claimed Mayo used the same technology it licensed to uncover whether patients suffered from “myasthenia gravis.” Fish & Richardson PC and Mayo legal operations director Joe Colaiano defended Mayo in the dispute, which ended before the U.S. Supreme Court in 2020.
Colaiano describes MG as “a neurological disorder that causes muscle weakness, double vision, and slurred speech in those that have it.” Physicians detect the disease by looking for antibodies attacking patients’ neurotransmitters, which leads to successful diagnoses 80% of the time. The two companies’ diagnostic tools identified the other 20% of cases.
Fish & Richardson principal Betsy Flanagan argued the MG test employs a “natural law” that could not be patented since it uses standard technology to detect the correlation between antibody and disease that occurs in nature. “That was the crux of our position in this case,” she said.
Fish & Richardson principal Deanna Reichel said the Athena case was similar to another — Mayo v. Prometheus — heard by the Supreme Court in 2011 and decided for Mayo a year later. The court found a diagnostic tool based on laws of nature could not be patented, she said, in a decision that, while prevailing law, remains controversial.
“A lot of the folks on the other side of the aisle said that this type of decision from the Supreme Court would be the end of the ability to patent medical diagnostics,” Flanagan added. In the Athena case, “they wanted the court to loosen the standard,” she said.
That did not happen. The Supreme Court ruled again in Mayo’s favor by deciding not to hear the case. Thus, the Supreme Court left intact a federal appellate patent court finding that medical diagnostics involving natural law without innovative technology cannot demand a patent. The court’s rulings have not hurt innovation. “We want to make it clear that medical diagnostics very much are still patentable and are receiving patents every single day,” Colaiano said
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