Overlooked in the hubbub surrounding the U.S. Supreme Court hearings over the Affordable Care Act this week were a pair of patent decisions that could have similarly huge implications.
The Supremes issued a unanimous decision last week on March 20 to strike down a pair of patents covering medical testing methods in Mayo v. Prometheus, ruling that medical tests relying on the relationship between drug dosages and treatment are non-patentable because they describe "laws of nature."
The impact of that decision is already being felt. On Monday, March 26, the high court issued another decision in Molecular Pathology v. Myriad Genetics, vacating an appeals court ruling and remanding the case to the U.S. Court of Appeals for the Federal Circuit "for further consideration" in light of Mayo v. Prometheus, according to court documents.
The issue in Myriad is whether the company’s patents covering isolated DNA sequences and methods for analyzing genetic mutations linked to increased risk of breast and ovarian cancer are valid. The Federal Circuit ruled in August 2011 that the patents were valid, a decision the Supremes vacated this week.
David Dykeman, a shareholder and patent attorney with Greenberg Traurig, said the decisions could inject tremendous confusion into the biotech and personalized medicine sectors.
"The Prometheus ruling creates uncertainty for diagnostics and personal genomics patents," Dykeman told MassDevice.com. "Prometheus casts a real cloud over whether diagnostics companies can protect their technology with patents."
But much depends on how the legal system reads the Supreme Court’s language in Prometheus, Dykeman said.
"The significance of the Supreme Court’s Prometheus decision for medical device and life science companies depends on how broadly the lower courts interpret the Supreme Court’s guidance," he told us. "Any patent applications claiming ‘laws of nature’ could be affected."
At issue are thousands of patents covering the diagnostics space, which Dykeman says "may be in jeopardy of being invalidated."
"There is clearly uncertainty over patent claims related to diagnostic methods and personalized medicine," he said. "One of the challenges with the Supreme Court’s Prometheus opinion is that the Supreme Court specifically stated that the two Prometheus patents are not patentable, but did not offer much guidance on what type of diagnostics claims could be patentable."
The judgment means there’s work ahead for the legal teams of companies playing in the diagnostics and personalized medicine spaces.
"The first thing companies should do in light of the Supreme Court rulings is review their patent portfolio to assess its strength and file new patent applications to cover any gaps," Dykeman said. "Companies should consider amending the claims of any pending patent applications to increase their likelihood of patentability."