Two recent Australian Patent Office decisions have provided clarity as to the patentability of isolated nucleic acid sequences following the High Court’s decision in D’Arcy v Myriad Genetics1 (‘Myriad’). The first decision is perhaps not such a surprise, however the second decision represents a clear contradiction in Patent Office practice following Myriad until now. The outcome of both decisions is greater certainty, at least for those in the life sciences industry seeking patent protection in Australia.
The October 2015 High Court Myriad decision has been covered extensively.2 While isolated DNA is different on a chemical and structural level to DNA as it naturally exists, the key point from the High Court’s decision was the determination that the substance of a patent claim directed to an isolated mutant ‘breast cancer gene’ was the information embodied in the claimed molecule. That information was deemed to be naturally occurring. Consequently, the Court found claims directed to the isolated mutant gene were not eligible for patent protection in Australia.
Subsequent to Myriad, the Australian Patent Office issued updated examination practice guidelines for considering eligibility of patent claims directed to isolated nucleic acid sequences. The guidelines set out several questions which enables examiners to make a call on whether a claim directed to an isolated nucleic acid is patent eligible. These questions include an assessment of:
- the ‘substance’ of a claim (not merely its form),
- whether that substance is ‘made’ or ‘artificial’, and
- whether the claimed invention has economic utility.
Notably, the guidelines state that certain subject matter is to be clearly excluded from patent eligibility. This includes isolated, naturally occurring nucleic acid molecules, whether DNA or RNA, human or non-human, or coding or non-coding. Further, relevant to the second case below is the statement in the guidelines that claims to isolated interfering/inhibitory nucleic acids (which merely replicate genetic information of a naturally occurring organism) are also to be excluded from patent protection.
Cargill Incorporated v Dow AgroSciences LLC  APO 43 (‘Cargill’)
This decision concerns Cargill Incorporated’s opposition to Dow Agrosciences’ patent application which broadly relates to the production of oil in genetically engineered canola.
Claim 31 of the opposed application is directed to an isolated DNA sequence coding for an enzyme derived from a fungus. Expressing the fungus-derived gene in canola causes a modification to the oil which provides a health benefit. Although claim 31 was not opposed by Cargill, the hearing officer invited both parties to provide submissions in light of the High Court’s findings in Myriad. Only Dow provided submissions.
Although not expressly stated, the unique feature of claim 31 was that the ‘information’ embodied in the isolated fungal nucleic acid had been altered from that which normally exists (codon optimised for those technically inclined) such that, when the gene is expressed in an oil producing plant, the corresponding gene product is more efficiently produced, albeit that the gene product itself is not different from that which naturally exists.
The hearing officer concludes at paragraphs  to  that the ‘substance’ of claim directed to the altered fungal gene is different from the mutant breast cancer gene in Myriad. Specifically, the officer’s view was that the genetic information embodied in the isolated fungal nucleic acid had been modified, and that its economic utility in oil production in genetically engineered canola was clear.
Accordingly, claim 31 was considered to comprise patent eligible subject matter.
Arrowhead Research Corporation  APO 70 (‘Arrowhead’)
Arrowhead concerns a patent application which relates to interfering RNA (or iRNA) compositions. The outcome of using iRNA compositions is specific targeting and modification of gene expression. In Arrowhead’s application, the iRNA compositions were directed to treating inflammatory conditions such as allergic conjunctivitis, ocular inflammation, dermatitis, rhinitis, and asthma by way of controlled gene expression.
Prosecution of Arrowhead’s application had stalled given the examiner’s insistence that the claims directed to iRNA compositions were not patent eligible. Specifically, it was the examiner’s view that RNA interference is only possible because the sequence of nucleotides is the same to that which occurs in the genome.
The attorney for the applicant exercised the option of requesting an ex parte hearing on the matter which provides the option of having an independent assessment of any outstanding objections.
Bearing in mind that Patent Office examination guidelines have, until now, provided that iRNA molecules are to be excluded from patent protection, the key points as argued by Arrowhead’s attorney was that the claimed iRNA molecules do not normally exist in nature, and the manner in which iRNA-mediated gene silencing works is not solely dependent on the sequence of nucleotides in an iRNA molecule. Further distinguishing the claims from patent ineligible subject matter was the fact that it was a ‘composition’ that was claimed rather than an isolated RNA molecule per se.
The hearing officer concludes at para  that based on a consideration of how RNAi-mediated gene silencing works, the substance of the claims was more than genetic information alone, and the claimed compositions were products having economic utility.
Accordingly, the claims directed to compositions comprising iRNA molecules were found to be patent eligible.
The above decisions not only provide clarity for those prosecuting nucleic acid-based product claims in Australia, but also support for arguing against patent eligibility objections raised against such claims during examination. Clearly, if a claim directed to a nucleic acid molecule provides more than genetic information alone (by modification or otherwise), there is now greater opportunity for arguing in support of patent eligibility and obtaining a broader scope of protection.
This is good news for those in the life sciences industry seeking patent protection in Australia.
The Arrowhead decision also highlights that an ex parte hearing can be a useful strategy for prosecuting Australian standard patent applications where examination hurdles have been insurmountable as a result of a dispute between the applicant and an examiner.