By declaring unpatentable an isolated nucleic acid containing the breast and ovarian cancer susceptibility gene BRCA1, Australia’s High Court used different legal reasoning than the landmark, two-year-old U.S. Supreme Court decision on gene patentability, in order to arrive at a similar conclusion.
The Australian court on October 7 ruled invalid three patents covering a nucleic acid coding for the BRCA1 protein, with mutations linked to breast and ovarian cancer. Like the Supreme Court, Australia’s highest court’s patent ruling concerned the BRCA1 test developed by Myriad Genetics.
In the latest case, the High Court reasoned that even though the test was in a formal sense a product of human action, the essential element of the invention was not—namely the information stored in the nucleic acid sequences. As a result, the Australian court held, the BRCA1 test did not meet Australia’s “manner of manufacture” standard for patentability.
“Although it may be said in a formal sense that the invention as claimed, referring to isolated nucleic acids, embodies a product created by human action, that is not sufficient to support its characterisation as a manner of manufacture,” according to the court’s majority opinion in the case. “The substance of the invention as claimed and the considerations flowing from its substance militate against that characterisation. To include it within the scope of a “manner of manufacture” involves an extension of that concept, which is not appropriate for judicial determination.”
The ruling was a victory for Yvonne D’Arcy, a 69-year-old pensioner from Queensland, Australia, and two-time survivor of breast cancer. In an interview with Australia’s ABC, she said she was motivated by a desire to help women avoid chemotherapy and radiation therapy by making genetic testing more widely available. She began her legal fight in 2010 when a social-justice law firm took the case on her behalf, then pressed on after an Australian Federal Court judge, and the full Federal Court, both ruled in favor of Myriad.
The Australian High Court ruling was arguably as much of a defeat for test developers as the Supreme Court’s landmark AMP v. Myriad decision (2013)—if not more so.
As with AMP v. Myriad, the Australian decision “appears to tighten the boundaries of patentable subject matter,” Lisa Haile, J.D., Ph.D., a partner at the law firm DLA Piper, told GEN.
There is no reason to believe at this time that the decision will be broadly interpreted, Dr. Haile added, given the narrow question addressed by the Australian court of whether isolated genetic material is patentable. In the U.S., she noted, the Supreme Court’s decision had a significant impact because the decision was taken much further than the question of gene patentability.
“At this time in the U.S., almost all ‘naturally occurring’ subject matter—genes, proteins, cells—are patent-ineligible. For Australia, the concern will be whether this decision will be interpreted more broadly beyond just genes,” Dr. Haile said. “We will need to keep any eye on where the Australian Patent Office and the Australian courts take the decision.”
Unlike the American decision, the Australian High Court extended its definition of unpatentable DNA to include composite DNA (cDNA) and other synthetic genetic material.
“Thus, the High Court decision is potentially more far-reaching than the US Supreme Court’s decision,” Mark Egerton, Ph.D., a principal with the Australian law firm Fisher Adams Kelly, said in a commentary posted on the firm’s website.
Ron Rogers, a Myriad spokesman, told GEN the company does not see the Australian decision as hindering its ability to sell its cancer genetic tests, since the company hasn’t sold many in Australia: “It will have no impact on our business.”
However, in a statement, Myriad expressed disappointment in the High Court ruling, which the company said could hinder development of new genetic tests. Myriad said it invested more than $1 billion over 25 years toward its hereditary cancer testing business and the company has tested more than two million patients to date.
“We remain committed to what we do best, developing innovative and high-quality molecular diagnostic tests that save and improve lives,” Myriad stated. “In order for personalized medicine to become a reality, strong patent protection is essential because it provides the research-based companies like Myriad with an incentive to continue to invest in R&D.”