D’Arcy v Myriad: Australia’s High Court deals blow to natural product patents
Australia’s highest court has said that naturally occurring nucleic acid molecules are not patentable, overturning a lower court ruling.
The decision, handed down today, October 7, by the High Court of Australia, centres on a patent dispute between breast cancer survivor Yvonne D’Arcy and US molecular diagnostic company Myriad Genetics.
D’Arcy was seeking to revoke one of Myriad’s patents related to the BRCA1 gene—mutations of which are associated with the development of breast and ovarian cancer—based on a lack of “manner of manufacture”.
In Australia, patentable subject matter is defined as “matter of manufacture”.
In September last year, the full Federal Court of Australia upheld Myriad’s patent, ruling that isolated fragments of DNA or RNA can be a “manner of manufacture” and are therefore patent eligible.
The federal court ruled that isolating a DNA sequence from the gene’s surrounding genetic material involves “structural and functional changes” that create a new composition, meaning it can be patented.
But today’s ruling has overturned that decision. The court found that while the discovery of the gene was a product of human action, to consider it an invention stretched Australia’s patent law.
The ruling is in line with that of the US Supreme Court in 2013.
The high court said there was a real risk that the “chilling effect of the claims” covering use of any isolation process in relation to the BRCA1 gene would lead to an “exorbitant and unwarranted” de facto monopoly on all methods of isolating nucleic acids containing the sequences coding for the BRCA1 protein.
It added that “such a result would be at odds with the purposes of the patent system”.
Tania Obranovic, special counsel at Watermark Intellectual Asset Management, an Australian firm of patent and trademark attorneys, wrote in a blog post that the decision is a blow to patentability.
“Unless another case concerning the question of the issue of the patentability of natural products is brought before the high court, or the Australian parliament enacts legislation to clarify the issue, the fact is that the patentability of natural products in Australia has been dealt a significant blow, one that could now be potentially used to retrospectively invalidate currently granted patents which claim natural products.”
She added that the uncertainty which this now creates for the Australian biotechnology and pharmaceutical sectors is concerning and could undermine future investment and innovation.
Speaking to The Australian, 69-year-old D’Arcy said she was “thrilled” with the result.
“It’s been such a long, hard fight and it means so much to so many people.”
A spokesperson for Myriad said it was disappointed with the decision.
“The decision comes at a critical time when we’re entering the golden era of personalised medicine. In order for personalised 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 research and development.”
