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US Appeals Court Overturns Roche Win in Illumina NIPT Suit

This story has been updated to include comments from Arti Rai of Duke University.

NEW YORK – A US appellate court has revived a patent infringement suit brought by Illumina against Roche over non-invasive prenatal testing (NIPT) technology.

In a 2-1 decision issued Tuesday, a three-judge panel of the US Court of Appeals for the Federal Circuit reversed the US District Court for the Northern District of California December 2018 order that had thrown out Illumina's case. The decision suggested the trial court erred when it ruled that Illumina's patents were invalid and unenforceable because their claims were not directed to patent-eligible subject matter. The case was remanded, or sent back, to the lower court.

"Because we conclude the claims are directed to patent-eligible subject matter, we reverse," Circuit Judge Alan Lourie wrote in the majority opinion, joined by Judge Kimberly Moore. The majority noted, "This is not a diagnostic case. And it is not a method of treatment case. It is a method of preparation case," specifically, a method for preparing a fraction of cell-free DNA that is enriched in fetal DNA.

However, in a dissenting opinion, Circuit Judge Jimmie Reyna wrote, "I conclude that the claims are directed to a natural phenomenon. The patents' only claimed advance is the discovery of that natural phenomenon. The claims, the written description, and the legal precedent applicable to this case all support the conclusion that the patents are ineligible."

Illumina did not immediately responded to request for comment while Roche declined to comment. 

Illumina had originally filed suit in May 2018, alleging that Roche subsidiary Ariosa Diagnostics infringed two US patents numbered 9,580,751 and 9,738,931 through its Harmony cell-free DNA-based NIPT. Illumina holds an exclusive license to both patents though an agreement with Sequenom, which describe processes to separate fetal and maternal DNA in a blood sample.

The 2018 case was one in a string of lawsuits between Illumina or Sequenom on one side and Roche and Ariosa on the other. Ariosa was acquired by Roche in 2014. In 2015, the Federal Circuit invalidated a Sequenom patent due to it covering ineligible subject matter related to a natural phenomenon; the US Supreme Court denied Sequenom's petition to review the decision.

More recently, in January of 2018, a jury awarded Illumina $26.7 million in damages for Ariosa's infringement of three other patents covering both NGS and microarray-based NIPT. Roche appealed that decision and the Federal Circuit court hear oral arguments in November 2019. Illumina also won a judgment from a UK court in June 2019 for patent infringement; two years prior, the same court determined that Ariosa had infringed five NIPT patents licensed by Illumina.

Lourie noted that while it was clear the inventors of the '751 and '931 patents had discovered a natural phenomenon, which the US Supreme Court has held to be ineligible, "the focus of the dispute in this case is whether the claims of the patents are 'directed to' the natural phenomenon, i.e., whether they claim the discovered natural phenomenon itself versus eligible subject matter that exploits the discovery of the natural phenomenon." 

The patent's process steps "change the composition of the mixture, resulting in a DNA fraction that is different from the naturally occurring fraction in the mother's blood," Lourie wrote.

The case will now pick up again in the District Court; however, it's unclear what comes next.

"This may be an attempt by the Federal Circuit to create mechanisms for diagnostic patent applicants to thread the needle of patent eligibility," Arti Rai, an expert on the legal concept of patent eligibility at Duke University School of Law who briefly reviewed the decision, said. She added that the Supreme Court has decided not to further address the topic and a bipartisan attempt to change patent eligibility through legislation has stalled.