US Supreme Court remands Myriad patent ruling

In light of its decision in Prometheus v Mayo, the US Supreme Court has remanded the Myriad Genetics patent case to the US Court of Appeals for the Federal Circuit.

On March 26 the court set aside the ruling that Myriad can patent two human genes, BRCA1 and BRCA2, which account for most forms of breast and ovarian cancer. The patents allow Myriad exclusively to perform genetic tests that could help to determine future treatment of the cancerous genes.

In a separate case the week before, the Supreme Court invalidated two patents held by Prometheus Laboratories, a therapeutics and diagnostics company owned by Nestlé. The patents covered blood-monitoring medical tests that could help decide the correct dosage of a drug to give to a particular patient.

Myriad’s DNA claims to a product are different from Prometheus’s claims to a method. The Myriad claims are directed to a product derived from, but different in chemical structure to, the DNA as it exists in nature.

The fact that the DNA carries the same information as the native DNA does not change the fact that, as isolated, the DNA is a new chemical entity with new uses, said James Haley, a partner at Ropes & Gray LLP in New York. He added that while the DNA existed in nature, it had never been previously identified or employed outside of the body for a useful purpose.

“As such, the isolated DNA is novel,” he said. “These facts suggest that the Supreme Court’s rationale in Prometheus v Mayo—that to be patent-eligible, a claim must do more than recite a law of nature and, say, apply it using conventional steps—should not apply to Myriad’s DNA claims.”

Edward Reines, of Weil Gotshal & Manges LLP in Silicon Valley, added: “Prometheus suggests that the High Court will not look kindly on the Myriad composition claims. There is nothing in Prometheus itself that requires the rejection of the Myriad gene patents, but it creates an unfriendly climate for such claims.”