20 CASE REPORT


LSIPR Newsletter 02:13


AUSTRALIA: THE MYRIAD CASE


The Federal Court in Australia has ruled in Cancer Voices Australia v. Myriad Genetics that isolated genetic material is patentable in Australia. Karen Sinclair explains the relevant issues.


What are the issues at stake in the case?


Te most significant aspect of this case is that it is the first time an Australian judicial authority has decided whether genetic subject matter is patent-eligible. Although it has long been the case that IP Australia has granted patents on isolated genes, genetic sequences, DNA, RNA, proteins and the like, this practice has been based on a precedent set by a late 1950s Australian High Court decision (known as the NRDC case) handed down long before anyone even really understood genetic technologies, let alone how they might be commercially utilised.


Tere was widespread concern that a decision in favour of the applicant to remove genetic subject matter from patent-eligibility might


hobble the highly innovative Australian life sciences industry, commercially isolate Australia as a destination for new medical treatments, set Australia apart from accepted IP standards in other parts of the world, and open the floodgates to an extension of the decision to other essentially chemical subject matters such as microbially derived drugs or medically effective drugs isolated or extracted from the environment.


What did the court office decide?


A single judge of the Federal Court decided that the decision in NRDC (National Research Development Corporation v Commissioner of Patents [1959] HCA 67; 102 CLR 252) remains good law, and that since the isolated genetic sequences claimed in the Myriad patent


Life Sciences IP Review


were an ‘artificially created state of affairs’, they constitute patent-eligible subject matter. Nicholas J highlighted the very sweeping scope allowed to him under this precedent stating that, even if ‘an isolated nucleic acid ... may be assumed to have precisely the same chemical composition and structure as that found in the cells of some human beings’, in the absence of human intervention, naturally occurring


Case: Cancer Voices Australia v Myriad Genetics Inc


Court: Federal Court of Australia, Sydney Judge: Justice John Nicholas


Decision: Case dismissed, isolated DNA ruled patentable


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