The Full Federal Court has unanimously upheld a previous Federal Court decision that allowed patents to be granted for the isolation of specific gene sequences. In D’Arcy v Myriad Genetics Inc  FCAFC 115, five judges unanimously upheld the previous single judge decision in Cancer Voices Australia v Myriad Inc  FCA 65.
The Court stated in their reasoning that the judgment was “not about whether, for policy or moral or social reasons, patents for gene sequences should be excluded from patentability…. It is not a matter for the court, but for Parliament to decide.” However, the case is certain to reignite debate about the positives and negatives of allowing corporations to hold patents for genetic material.
As previously discussed on TimeBase, the case revolved around Myriad Genetic’s patent for naturally occurring nucleic acid (either DNA or RNA) that has been “isolated” – which is in this case, BRCA1, a human breast or ovarian cancer disposing gene. Under Australian law, patents cannot be granted over naturally occurring things, and require “human intervention that creates an artificial state of affairs”. Essentially, the case revolved around how to characterise the process. The Court summed it up at [162-3] by saying:
[T]he appellant submitted that isolated nucleic acid is not materially different to cellular nucleic acid and that naturally occurring DNA and RNA even in isolated form are products of nature that cannot form the basis of a valid patent.
The respondents contended that the claims were to a product that consists of an artificial state of affairs providing a new and useful effect that is of economic significance that is, that the product is a manner of manufacture within the meaning of NRDC [National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252]. The respondents contended that isolated nucleic acid differs from nucleic acid found in a human cell chemically, structurally and functionally.
The Court ultimately sided with the respondents. They used the principles in NRDC (“that it is sufficient for a product to result in ‘an artificially created state of affairs’, leading to ‘an economically useful result’”, [at 208], to conclude that:
“The isolated nucleic acid, including cDNA, has resulted in an artificially created state of affairs for economic benefit. The claimed product is properly the subject of letters patent. [at 218]”
The decision runs contrary to the way the US Supreme Court decided a similar version of the case in America.
Companies like Myriad Genetics (and Genetic Technologies, who hold the licence to conduct tests in Australia), argue that the patents are necessary to drive continued research and innovation. Law firm Jones Day, who represented Myriad in Australia, told The Sydney Morning Herald in a statement:
“Myriad invested hundreds of millions of dollars in research and development, patient and physician education, insurance reimbursement and operational excellence in laboratory operations which has resulted in a gold standard test, BRCAnalysis, for the testing of predisposition to hereditary breast and ovarian cancer risk at an affordable cost.”
Without a guarantee that any advances would be patentable, companies may be more reluctant to engage in the work in the first place.
Bernadette Hawkins, a patent and trademark attorney at Cullens, told the Sydney Morning Herald:
“This decision is also certainly not going to stifle research and innovation in this field, in fact, I wonder if we will see more US companies starting to try to commercialise things here.”
However, others argue that allowing these kinds of patents stifle innovation and could make testing prohibitively expensive for patients. Maurice Blackburn lawyer Rebecca Gilsenan told The Guardian that:
“[The patenting of this material] places limits on genetic testing, genetic research and the development of treatments and cures for genetically associated disease… Gene patents are of great concern to the medical research community and to the medical profession. Gene patents stifle innovation.”
Adjunct Professor at Murdoch University Luigi Palombi told The Conversation that:
“anyone who comes along and reproduces that biological material, no matter how they do it, or anyone who wants to use that material in some other way, even if it’s in a gene therapy, can’t do it without the permission of Myriad Genetics… We know Myriad hasn’t been terribly useful in giving permission. That’s why the case started in the United States in the first place, because over there women are paying over US$4,000 to have their genes tested.”
He was also strongly critical of the Federal Court’s reliance on the reasoning in NRDC, saying
“If you apply black letter law and you apply a very extreme interpretation of a near 60-year-old decision that had nothing to do with biotechnology, that’s what we’ve got.”
Cancer survivor Yvonne D’Arcy, on whose behalf the case was begun by Maurice Blackburn, was reported by the government to be “devastated” by the result. Ms Gilsenan told The Guardian that they would seek leave to appeal to the High Court.
TimeBase is an independent, privately owned Australian legal publisher specialising in the online delivery of accurate, comprehensive and innovative legislation research tools including LawOne and unique Point-in-Time Products.
D’Arcy v Myriad Genetics Inc  FCAFC 115
FREE legislation news, delivered weekly.
Sign up now.#WeLoveLegislation Tweets
NEW information resources - great for training.