Roche, Illumina to Settle Decade-Long Fight Over Prenatal Tests

(Bloomberg) -- Roche Holding AG and Illumina Inc. are on the verge of settling a nearly decade-long battle over a blood test that replaced a painful and sometimes dangerous test used to determine fetal abnormalities.

The companies “anticipate that a settlement will be signed by May 26,” Illumina lawyer Edward Reines of Weil Gotshal said in a court filing late Friday. The agreement was reached just as the Supreme Court was set to consider whether to wade into a debate over whether the technology underlying the tests could be patented.

The tests separate the smaller strands of fetal DNA from the longer strands of a mother’s DNA to identify abnormalities. It replaced amniocentesis -- an invasive and often painful procedure that involves inserting a needle into the uterus to obtain a sample of the amniotic fluid that surrounds the fetus. The procedure has caused miscarriages in rare instances.

Roche’s Ariosa, which makes the Harmony prenatal tests, had claimed patents owned by the Sequenom unit of Laboratory Corp. of America Holdings and licensed to Illumina, simply covered natural phenomena.

The U.S. Court of Appeals for the Federal Circuit, in a 2-1 decision last year, revived Sequenom’s patents, ruling that they didn’t cover the discovery of the difference between the length of DNA strands, but for a process to increase the amount of fetal DNA cells in a sample so they could be distinguished from the mother’s cells.

Ariosa had filed a long-shot bid asking the Supreme Court to take a look at a ruling. Justices were scheduled to consider Ariosa’s petition at a conference Friday before the two sides asked that the case be dismissed.

Elizabeth Baxter, a spokeswoman for Roche Diagnostics, said the company had no comment on “ongoing litigation.” Officials with Illumina didn’t respond to a query seeking comment.

Dismissal of the case leaves intact one of the rare instances in which the nation’s top patent court upheld patents on diagnostic tests following a 2012 decision by the Supreme Court that some tests merely cover the natural correlation between the body and a medical condition and a 2013 ruling that limited the ability to patent human genetic sequences.

In both decisions, the high court warned that giving exclusive rights in these areas would hinder critical medical research. The biotechnology industry has argued that the rulings instead take away needed incentives to investigate ways doctors can identify and treat diseases based on an individual’s genetic makeup.

“Fetal DNA’s size distribution is dictated by nature, not by humans,” Ariosa said. The Federal Circuit ruling “creates a roadmap for patent drafters to evade” those earlier rulings and will “encourage applicants to exploit artificial distinctions between isolated DNA claims and methods for isolating the DNA.”

Illumina, which licenses the patents from Sequenom, said the patents involve a specific series of steps that result in a composition that’s different from what occurs naturally and solves the problem of identifying the fetal DNA within the much larger amount of maternal DNA.

“The claims are not directed at a natural phenomenon,” Illumina said. “They apply knowledge of a phenomenon to create a novel human-engineered process for producing a novel substance that overcomes a barrier to non-invasive fetal genetic testing.”

The cases are Ariosa Diagnostics, Inc. v. Illumina Inc., 20-892, Supreme Court and Verinata Health Inc. v. Ariosa Diagnostics Inc., 12-5501, U.S. District Court for the Northern District of California (San Francisco).

©2021 Bloomberg L.P.