The Australian Patent Office has reversed its current
examination practice in Arrowhead
Research Corporation  APO 70 by confirming that
gene-based pharmaceuticals, namely interfering RNA (iRNA)
compositions, do represent patentable subject matter in
In October 2015, the High Court of Australia ruled in the
Myriad decision" that isolated naturally-occurring gene
sequences did not represent patent eligible subject matter in
On the basis of the Myriad decision, the Patent Office revised
its examination guidelines to render isolated naturally-occurring
genes patent ineligible. The focus of the Australian High Court on
"genetic information" also resulted in the Patent Office
adopting a view that artificially created genes, which arguably
embody the same "genetic information" as
naturally-occurring genes, are also not patent eligible. This
practice resulted in the rejection of claims defining
artificially-created gene-based pharmaceuticals, such as iRNA
Issues and findings
Australian patent application 2013207601 included claims
defining double-stranded iRNA compositions capable of treating
inflammation by attenuating the expression of spleen tyrosine
kinase. As the sequence of nucleotides in the defined iRNA
compositions was the same as that which occurs in the genome, the
Examiner initially rejected the iRNA composition claims on the
basis that they encompassed genetic information that occurs in
nature. In particular, the Examiner took the view that the defined
sequence of nucleotides was solely responsible for how the
invention worked and therefore the "substance of the
claims" was directed to genetic information which occurred in
nature and had not been "made".
In their hearing submissions, the Applicant adduced evidence in
the form of an expert declaration that supported their position
that the manner in which the iRNA compositions worked is not solely
dependent on the sequence of nucleotides in the iRNA. Critical to
the invention was the structure of the double-stranded RNA, which
does not exist in nature. On this basis, the Delegate of the Patent
Office considered that the substance of the defined invention
related to a pharmaceutical composition that had been
"made" rather than naturally-occurring genetic
information. For this reason, the claims directed to the iRNA
compositions were considered patent eligible.
This decision clarifies and confirms the limited impact of the
Myriad decision and leaves the door open for patents covering other
artificially-created genes, such as cDNA, that are currently
considered ineligible for patentability in Australia.
Shelston IP represented Arrowhead Research Corporation in this
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
Shelston IP ranked one of Australia's
leading Intellectual Property firms in 2015.
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This case set a new benchmark in Australia for future patent infringement damages claims against generic manufacturers.
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