While the question of patentability of isolated gene sequences
awaits resolution at the U.S. Supreme Court, the Australian Federal
Court today upheld Myriad Genetics' patent on methods for
screening for cancer-predisposing mutations in the BRCA1 gene.
Cancer Voices Australia v. Myriad Genetics Inc.,
NSD643/2010, Federal Court of Australia (Sydney). The result is a
significant win for Myriad and its Australian licensee Genetics
Technologies Ltd., and provides long-awaited certainty for holders
of patents directed to isolated gene sequences and for the
Australian biotech industry as a whole.
Echoing the arguments made by petitioner Association for
Molecular Pathology (AMP) in its recently filed Supreme Court brief
in Association for Molecular Pathology v. Myriad Genetics,
Inc. ("Myriad"), applicants Cancer Voices
Australia and Yvonne D'Arcy, a Brisbane resident diagnosed with
breast cancer, argued that Myriad's patent was not
patent-eligible because it claims naturally occurring subject
matter—DNA that is not materially different from DNA found in
The Federal Court disagreed, finding that because the claimed
nucleic acid is "isolated" from native DNA, the claimed
nucleic acid is patentable under Australian patent law. The court
found that isolated nucleic acid does not exist outside the cell in
the absence of human intervention, and thus consists of an
"artificially created state of affairs" as required for
patent-eligibility. Specifically, the court held that "even if
the physical properties of the material have not changed, the
removal of the material from its natural environment and its
separation from other cellular components may still give rise to
what might reasonably be described as an artificial state of
affairs." Although based on Australian case law, the
court's reasoning closely paralleled the reasoning of the
Federal Circuit in Myriad, which focused on the fact that
isolated DNA must be chemically cleaved from native DNA, and thus
has "markedly different" characteristics than native
The Australian Federal Court also referenced the fact that the
Australian Parliament recently had rejected proposals to amend the
Patent Act to exclude claims directed to DNA and RNA, evincing
Parliament's intent not to limit their patent-eligibility. The
court noted that this decision was in line with the law of the UK
and U.S., specifically pointing out Myriad's success in its
appeal at the Federal Circuit.
The fate of that Federal Circuit decision, however, is uncertain
as it currently is under review by the U.S. Supreme Court.
Petitioner AMP filed its brief in the Supreme Court on January 24,
and respondent Myriad's brief will be filed March 7. More than
20 amicus curiae briefs have been filed, including a brief by the
United States arguing that isolated DNA sequences that have not
been otherwise modified are not patent-eligible. Oral argument will
be held April 15, 2013, with a decision expected before July.
Because of the generality of this update, the information
provided herein may not be applicable in all situations and should
not be acted upon without specific legal advice based on particular
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