The medical diagnostics industry has found an ally in its quest to restore patent eligibility for groundbreaking discoveries, even those involving natural phenomena.
Judge Kathleen O’Malley of the U.S. Court of Appeals for the Federal Circuit called on the full court to review its case law Tuesday even while voting to affirm the latest invalidation, this time on a Roche patent for quickly diagnosing drug-resistant tuberculosis.
Judge Jimmie Reyna wrote for a unanimous panel that Roche’s patent is ineligible for protection, in part because the process uses DNA “primers”—single strands of DNA that pair up with a gene from the tuberculosis bacteria and make it easier to detect.
His decision turned on the 2014 opinion In re BRCA1- and BRCA2-based Hereditary Cancer Test Patent Litigation, known as BRCA1. That was one of the first Federal Circuit opinions to interpret the U.S. Supreme Court’s Association for Molecular Pathology v. Myriad Genetics decision on patenting naturally occurring DNA.
“BRCA1 forecloses Roche’s arguments,” Reyna wrote, because it held that DNA primers are “structurally identical to the ends of DNA strands found in nature.”
O’Malley signed onto Reyna’s opinion, but argued in a concurrence that BRCA1 has sent the Federal Circuit down the wrong path.
She argued that BRCA1 was decided too much by reaching the merits—that the only question properly before the court was whether the accused infringer had raised “a substantial question of patentability” to defeat a preliminary injunction.
Second, she argued that while primers might have the same gene sequence as naturally occurring DNA, that doesn’t necessarily make them structurally identical. “As the record in this case reveals, a finding that the two have identical sequences does [not] entirely resolve the question of whether they are structurally identical because structure is not defined solely by nucleotide sequence,” she wrote.
O’Malley has a track record when calling for en banc review. She was one of the judges who persuaded the court to reconsider the scope of appellate review of PTAB decisions. A few years back her call to reconsider the law of willfulness led to a Supreme Court decision largely adopting her position.
Absent further review, Erik Puknys of Finnegan, Henderson, Farabow, Garrett & Dunner had the winning argument for Cepheid. Hughes Hubbard & Reed represented Roche.
Roche Molecular wasn’t the only Section 101 opinion from the court Tuesday.
A three-judge panel led by Judge Kara Stoll partially reversed U.S. District Judge Leonard Stark and ruled that some patent claims on tabbed three-dimensional spreadsheets are patent-eligible. Benjamin Foster, then of Ahmad, Zavitsanos, Anaipakos, Alavi & Mensing, had the winning argument in Data Engine Technologies v. Google. King & Spalding represented Google.
Stoll characterized the ruling as an extension of Core Wireless Licensing v. LG Electronics, a Federal Circuit decision earlier this year that supported the patent eligibility of some graphical user interfaces.
Correction: A previous version of this article attributed the winning argument to the wrong attorney and law firm. Erik Puknys of Finnegan, Henderson, Farabow, Garrett & Dunner argued the appeal for Cepheid. We regret the error.