Myriad gene patent survives challenge in Australia

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

Myriad gene patent survives challenge in Australia

In a Federal Court ruling, Justice John Nicholas held that isolated genetic material is patentable in Australia

Cancer Voices of Australia had challenged Myriad Genetics’ patent on the isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, arguing that the subject matter was not patentable. Section 18(1)(a) of the Patents Act states that invention must be of “a manner of manufacture within the meaning of section 6 of the Statute of Monopolies” in order to be patentable. Cancer Voices claimed that the isolated DNA and RNA were naturally occurring and thus not patentable.

Justice Nicholas disagreed, noting that the controlling case, National Research Development Corporation vs Commissioner of Patents (the NDRC case), held that this criteria is satisfied if the invention consists of an “artificially created state of affairs”, is discernible over time, and has economic significance. Even if the material is naturally occurring as Cancer Voices asserted, the endeavour required in isolating the genetic material can be understood as an artificially created state.

The other criteria of discernibility and economic significance were not at issue. Cancer Voices did not assert that the invention was not new or lacked inventive step.

The United States Supreme Court has agreed to review the patentability of the same BRCA1 as well as the BRCA2 sequences patented by Myriad, after the Court of Appeals for the Federal Circuit held that the isolated sequences were patentable under section 101. The Supreme Court is expected to issue its ruling by the end of the year.

more from across site and SHARED ros bottom lb

More from across our site

Attorneys explain why there are early signs that the US Supreme Court could rule in favour of ISP Cox in a copyright dispute
A swathe of UPC-related hires suggests firms are taking the forum seriously, as questions over the transitional stage begin
A win for Nintendo in China and King & Spalding hiring a prominent patent litigator were also among the top talking points
Rebecca Newman at Addleshaw Goddard, who live-reported on the seminal dispute, unpicks the trials and tribulations of the case and considers its impact
Attorneys predict how Lululemon’s trade dress and design patent suit against Costco could play out
Lawyers at Linklaters analyse some of the key UPC trends so far, and look ahead to life beyond the transition period
David Rodrigues, who previously worked at an IP boutique, said he may become more involved in transactional work at his new firm
Indian smartphone maker Lava must pay $2.3 million as a security deposit for past sales, as its dispute with Dolby over audio coding SEPs plays out
Powell Gilbert’s opening in Düsseldorf, complete with a new partner hire, continues this summer’s trend of UPC-related lateral movement
IP leaders at Brandsmiths and Bird & Bird, who were on opposing sides at the UK Supreme Court in Iconix v Dream Pairs, unpick the landmark case and its ramifications
Gift this article