A recent Patent Office decision in Arrowhead Research Corporation  APO 701 (“Arrowhead”) has confirmed that nucleic acids can still be patented in Australia.
Following the High Court of Australia’s ruling in D’Arcy v Myriad Genetics Inc  HCA 352 (“Myriad”), the Australian Patent Office has been broadly objecting to claims that encompass isolated nucleic acids. This practice has frustrated applicants and their attorneys who consider many of the objections to be reactionary, and not consistent with the facts and principles set out in Myriad. In a very recent decision, the Patent Office has confirmed that nucleic acids remain patentable subject matter in Australia by allowing claims directed to interfering RNA compositions.
In Myriad, the High Court clearly stated that it would not be concerning itself with “gene patents” generally, but with the disputed claims specifically (at ). Those claims defined isolated nucleic acids per se that were useful in the detection of breast cancer. While acknowledging that the claims defined a product created by human action, the High Court considered that the “substance” of the claims was information, which could not be the subject of a valid claim.
Australian Patent Application No. 2013207601 included claims directed to interfering RNA compositions that are capable of reducing the expression of spleen tyrosine kinase. Following several failed attempts to convince the examiner that the claims defined patentable subject matter, the Applicant requested a hearing.
In determining the “substance” of the claimed invention, the Delegate in Arrowhead gave consideration to the description of the specification, observing that the manner in which the invention worked was not solely dependent on the sequence of nucleotides in the interfering RNA (at ). The Delegate found that the informational, structural and chemical content of the interfering RNA molecules were all essential elements of the claimed invention, and as a result, the substance of the invention encompassed all of those elements, not merely the genetic information conveyed by the molecule (at ).
The decision in Arrowhead confirms that nucleic acid molecules, particularly those with direct therapeutic utility, can be patented in Australia.