Second win for Myriad as Federal Circuit stands firm on gene patent ruling

Managing IP is part of Legal Benchmarking Limited, 1-2 Paris Gardens, London, SE1 8ND

Copyright © Legal Benchmarking Limited and its affiliated companies 2025

Accessibility | Terms of Use | Privacy Policy | Modern Slavery Statement

Second win for Myriad as Federal Circuit stands firm on gene patent ruling

solated-dna-molecule-on-white-background-45.jpg

Biotech company Myriad, which owns US patents covering the isolation and detection of the BRCA1 and BRCA2 genes, has won a second victory at the US Court of Appeals for the Federal Circuit

In the long-running dispute, a number of parties including the Association for Molecular Pathology argued that Myriad’s claims covered matter that was not eligible for patent protection.

In today’s majority opinion, Judge Alan Lourie affirmed that the district court had declaratory judgment jurisdiction as at least one plaintiff (Harry Ostrer) had standing to challenge the validity of the patents.

The Federal Circuit also again reversed the district court’s finding that Myriad’s composition claims to isolated DNA molecules cover patent-ineligible products of nature saying “each of the claimed molecules represents a nonnaturally occurring composition of matter”

In addition, the court reversed the finding that Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates of transformed cells is directed to a patent-ineligible scientific principle.

But it affirmed the district court’s decision that Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible, saying “such claims include no transformative steps and cover only patent-ineligible abstract, mental steps”.

Judge Kimberly Moore, who reportedly asked probing questions in the oral hearing, wrote a concurring opinion.

But Judge William Bryson wrote an opinion in which he dissented from the court’s holding that Myriad’s BRCA gene claims and its claims to gene fragments are patent-eligible.

“In my view, those claims are not directed to patentable subject matter, and the court’s decision, if sustained, will likely have broad consequences, such as preempting methods for whole-genome sequencing, even though Myriad’s contribution to the field is not remotely consonant with such effects,” wrote Bryson.

The Federal Circuit first ruled in the Myriad case in July last year, after which an appeal to the Supreme Court was filed. The case was remanded back to the Federal Circuit following the Supreme Court’s decision in Mayo v Prometheus in March this year.

The list of attorneys acting for the parties and amicus curiae extends to five pages of the opinion. One of them was Dan Ravicher of the Public Patent Foundation, who was profiled as one of the 50 most influential people in IP last month.

Managing IP also has a page devoted to the Myriad case.

more from across site and SHARED ros bottom lb

More from across our site

News of EasyGroup failing in its trademark infringement claim against ‘Easihire’ and Amgen winning a key appeal at the UPC were also among the top talking points
Submit your nominations to this year's WIBL EMEA Awards by February 16 2026
Edward Russavage and Maria Crusey at Wolf Greenfield say that OpenAI MDL could broaden discovery and reshape how clients navigate AI copyright disputes
The UPC has increased some fees by as much as 32%, but firms and their clients had been getting a good deal so far
Meryl Koh, equity director and litigator at Drew & Napier in Singapore, discusses an uptick in cross-border litigation and why collaboration across practice areas is becoming crucial
The firm says new role will be at the forefront of how it delivers value and will help bridge the gap between lawyers, clients and tech
Qantm IP’s CEO and AI programme lead discuss the business’s investment and M&A plans, and reveal their tech ambitions
Controversial plans were scrapped by the Commission earlier this year after the Parliament had previously backed them
Lawyers at Spoor & Fisher provide an overview of how South Africa is navigating copyright and consent requirements to improve access to works for blind and visually impaired people
Gillian Tan explains how she balances TM portfolio management with fast-moving deals, and why ‘CCP’ is a good acronym to live by
Gift this article