Since the High Court’s watershed decision in D’Arcy v Myriad Genetics Inc ( HCA 35; (“Myriad”) regarding the patent eligibility in Australia of DNA isolated from humans, the body of case law regarding nucleic acid-based inventions has been steadily evolving. This evolution is necessary since the High Court made plain that the decision in Myriad was not a blanket ban on the patentability of inventions derived from nature. Rather than draw an immovable line between what is, and what is not, a manner of manufacture, or generate a precise formulation, the High Court provided a general framework within which to assess whether such inventions satisfy s 18(1)(a) of the Patents Act 1990 (“the Act”) relating to manner of manufacture. The Court upheld a case-by-case approach having regard to the substance of the invention, and not simply the form of the claim under consideration.
The decision from the Australian Patent Office in Academisch Ziekenhuis Leiden and BioMarin Technologies B.V. ( APO 49) has applied the principles established in Myriad and subsequent cases (Meat & Livestock Australia Limited v Cargill, Inc ( FCA 51); Arrowhead Research Corporation ( APO 70); Cargill Incorporated v Dow AgroSciences LLC ( APO 43) to further expand patent eligibility of nucleic acid-based inventions under Australian practice. The present decision sets out with clarity for applicants and their counsel the approach taken by the Australian Patent Office to determine what is patentable subject matter for nucleic acid-based inventions.
The invention under consideration broadly relates to a therapeutic invention for the treatment of Duchenne muscular dystrophy (DMD) or Becker muscular dystrophy (BMD), both common types of childhood forms of muscular dystrophy. DMD is a severe and fatal form of muscular dystrophy. BMD is milder with sufferers remaining ambulatory until later in life and having a near normal life expectancy.
DMD and BMD are genetic disorders in which the gene that codes for the dystrophin protein is mutated. In a non-diseased individual, the dystrophin protein maintains fibre stability during contraction. The genetic mutation in DMD results in the absence of a functional dystrophin protein whereas the BMD dystrophin gene mutation permits synthesis of a partially functional dystrophin protein. This divergence accounts for the difference in severity between the diseases. The problematic mutation is the presence of exon 44 that consequently causes a disruption to production of the dystrophin protein.
The claims under consideration encompass short forms of nucleic acids (oligonucleotides) that convert the mutated dystrophin gene to a form that can produce the partially functional dystrophin protein characterised by BMD, which will prolong the viability of the muscles. The invention provides a method of treating DMD or BMD by inducing skipping of exon 44 of the dystrophin gene, which results in an increase in the partially functional dystrophin protein and/or a decrease in the production of an aberrant or less functional protein. The oligonucleotides claimed were of a specific length, had a sequence complementary to exon 44, and included a modification in the form of a nucleotide analogue that is a locked nucleic acid. The locked nucleic acid modification was included to increase the stability of the oligonucleotide, and thereby increase the functional efficiency of the oligonucleotide.
Delegate Lim reviewed prevailing authority from the High Court and application of this authority in subsequent decisions to apply the following approach for determining the patent eligibility of the subject matter of the claims (at paragraphs 93 and 94):
…to determine what is the substance of the claimed invention, and whether or not that substance has been “made”. I note that the substance of the claimed invention is not necessarily the subject matter of the claim as defined by the words of the claim.
In determining the substance of the invention, I am to consider:
- how the invention works;
- the nature and contribution of the nucleotide sequence to the working of the invention;
- the nature and contribution of the other claimed features to the working of the invention;
- the nature of the contribution to the art; and
- whether the nature and contribution of the features of the invention claimed as a whole, on balance, weigh towards being characterised as genetic information, or a chemical compound.
Using the above approach, Delegate Lim ruled in favour of the Applicant and thus overturned the Examiner’s objection that the claimed invention is not a manner of manufacture in accordance with s18(1)(a).
The crux of the Examiner’s objection was that the substance of the invention was genetic information that the claimed oligonucleotide encodes, and the “…invention is considered to have a natural counterpart, as the oligonucleotide is the complement of the natural dystrophin gene, and as discussed above, the claim is considered to be genetic information and not a product.” The Examiner completely disregarded inclusion of the non-natural modification of the oligonucleotide.
In response, the Applicant argued that the claimed oligonucleotide is a non-naturally occurring product for use in therapy and is thus patentable subject matter.
Saliently, Delegate Lim rejected the premise that where a claim encompasses an artificially made chemical compound incorporating a nucleic acid, the substance of the claimed invention is not genetic information and consequently is a manner of manufacture. Conversely, according to the delegate it also does not follow as a matter of course that where the subject matter of a claim is a pharmaceutical composition, the substance of the claimed invention is not genetic information and consequently is a manner of manufacture. Ultimately, “consideration must be given to the true nature of the claim, and not simply the form of the claim.”
Whilst acknowledging that the claimed oligonucleotide uses the information embodied in a specific nucleotide sequence and, in some forms, the information corresponds to that contained in genomic DNA, Delegate Lim determined via a thorough review of the specification as a whole and applying the above approach that for the present case, the manner in which the information is used in the working of invention and the result of that use weighs towards the substance of the claimed invention being a chemical compound, and thus a product that is patentable.
Furthermore, the structural features of length and presence of LNA of the claimed oligonucleotide are significant to the working of the invention, and weigh towards the substance of the claimed invention being a chemical compound.
Consequently, Delegate Lim concluded that the substance of the claimed invention is an artificially made compound and thus is a manner of manufacture in accordance with s 18(1)(a) of the Act.
A further point of note in the decision is the Delegate’s particular statement that “no single consideration is conclusive in determining the substance of the claimed invention. Some considerations may be more significant than others.”
This decision is notable not only for expanding the scope of nucleic-acid based inventions, but also the clarity with which the decision was reached. The decision by Delegate Lim provides a further ray of hope that nucleic acid-based inventions can be patentable subject matter in Australia. It is also noteworthy that Delegate Lim analysed the facts of the case de novo to reach the above conclusion and was not partisan to either the Examiner’s view, nor the Applicant’s arguments.