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 2026

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

Shwetasree Majumder, managing partner of Fidus Law Chambers, discusses fighting gender bias and why her firm is building a strong AI and tech expertise
Hady Khawand, founder of AÏP Genius, discusses creating an AI-powered IP platform, and why, with the law evolving faster than ever, adaptability is key
UK firm Shakespeare Martineau, which secured victory for the Triton shower brand at the Court of Appeal, explains how it navigated a tricky test regarding patent claim scopes
The firm’s managing partner said the city is an ‘exciting hub of ideas and innovation’
In our latest podcast, Deborah Hampton talks through her hopes for the year, INTA’s patent focus, London 2026, and her love of music
Tech leads at three IP service groups discuss why firms need to move away from off-the-shelf AI products and adopt custom solutions
IP firms say they have been educating some clients on AI use, with ‘knowledge-sharing’ becoming more prevalent
As the US patent system tilts further toward favouring patent owners, firms with a strong patentee focus can get ahead of the game
Amanda Yang and Rachel Tan at Rouse and Landy Jiang at Lusheng Law Firm provide an overview of the draft amendments to China’s trademark law
News of EIP launching an AI platform and a trade secret blow for TCS in the US were also among the top talking points
Gift this article