As has been widely reported, the patentability or otherwise of isolated nucleic acids has been a rapidly evolving question through the Australian Courts and Patent Office in recent years.
A recent decision by the Australian Patent Office has given an important indication of how the Office intends to apply the new precedents and its revised guidelines in this area going forward. It also suggests an effective avenue for overcoming objections in this area in some cases.
The context
The High Court of Australia had previously held, just last year, (D’Arcy v Myriad Genetics Inc [2015] HCA 35) that isolated nucleic acids are not patentable subject matter under Australian law. In their decision, the High Court focussed on the “substance” of the claimed invention at issue and, in particular, the sequence information content of isolated nucleic acids. They held that a nucleic acid sequence is genetic information not “made” by humans but is instead naturally-occurring, and that isolation was the only man-made aspect of the invention, which in the High Court’s view was not sufficient to constitute patentable subject matter.
Notwithstanding the above, IP Australia subsequently adopted a somewhat conservative approach to what should be excluded as patent-ineligible subject matter. To this end, updated Examination Guidelines with respect to how the High Court Myriad decision should be practically implemented during patent examination were issued. Pertinent to the present Patent Office decision, now Examiners are to consider the substance of a claim, not merely its form, and whether the substance of the claim has been man made or is artificial in assessing whether a claim is directed to patentable subject matter. Accordingly, claiming nucleic acid molecules that merely replicate or contain a naturally-occurring nucleotide sequence will be held to not constitute patentable subject matter. This exclusion previously extended to isolated interfering/inhibitory nucleic acids as well, even though in many cases such molecules are not found in nature and are generally artificial constructs.
The case
In the recent decision by the Australian Patent Office (Arrowhead Research Corporation [2016] APO 70), a Delegate of the Commissioner of Patents held that composition claims directed to interfering RNAs (iRNAs), a form of double stranded RNA, constitute patentable subject matter. The application (AU2013207601) owned by Arrowhead Research Corporation (Arrowhead) had several composition claims directed to iRNAs comprising a sense strand and an antisense strand that target the mRNA of the spleen tyrosine kinase (Syk).
During prosecution of Arrowhead’s application, the Examiner considered that the claimed composition was not patentable according to those principles set forth in Myriad. To this end, it was the Examiner’s view that the substance of the claimed compositions was genetic information and further that the nucleotide sequence of the iRNA corresponded to that target Syk sequence found in an organism’s genome and as such had not been altered from that which exists in nature. More particularly, the Examiner considered that it was solely the genetic information conveyed by the claimed iRNAs which contributed to their inhibitory function with respect to Syk expression.
Conversely, in the present decision the Delegate held that while the genetic information conveyed by the iRNAs is an important element to the working of the claimed invention, the manner in which the invention works is not solely dependent thereon. In particular, the Delegate considered that the structural and chemical content of the claimed iRNA molecules at least equally contribute to the working of the invention, given that they are integral to the recognition and subsequent processing thereof by a cell’s RNA interference machinery. This is especially in relation to the double-stranded nature of the claimed iRNAs. Consequently, the substance of the invention was found to not only encompass the information content, but also the structural and chemical content, of the iRNA molecules. Accordingly, the Delegate concluded that, unlike claims directed to a nucleic acid per se, the substance of Arrowhead’s claims was a pharmaceutical composition which had been made by man rather than merely genetic information, and as such constituted patentable subject matter.
Conclusion
This decision provides important insight as to how the Patent Office is to apply the High Court’s Myriad decision moving forward. In particular, this decision provides some clarity with respect to the patentability of nucleic acids that arguably do not simply encompass genetic information, but also incorporate other significant elements, such as structural and/or chemical features which have a real effect on the working of the invention.
Importantly, this decision shows that in determining the substance of the invention, an Examiner should give due consideration to how the invention actually works, as described in the specification, and provides applicants with an avenue to rebut allegations of lack of patentable subject matter that appear to be based merely on the presence of nucleic acids in the claims without consideration of differentiating structural and chemical features.