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 Australia.
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 Australia.
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 compositions.
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.