Background
In 2015, Australia’s highest court considered whether an isolated nucleic acid is patentable subject matter in Australia [i].
The decision related to Myriad’s Australian patent No. 686004, which was litigated in many countries around the world. The patent included claims directed to isolated nucleic acid sequences encoding mutant or polymorphic BRCA1 polypeptides, indicative of susceptibility to breast cancer.
The High Court unanimously held that claims to isolated nucleic acid sequences were not patentable subject matter because they did not constitute a “manner of manufacture”, which is the test for patentable subject matter in Australia. The court found that the “substance of the invention” resided in the information embodied in the sequence of nucleotides of the molecule. They concluded that if this corresponded to a sequence of nucleotides existing in a human being, then such claims merely define genetic information that is not considered to be “made” or changed by human intervention.
IP Australia Practice
IP Australia follows the Myriad decision and considers that the act of isolation, purification, or synthesis of a nucleic acid molecule (for example, creating cDNA), is not enough to confer patentability, in circumstances where the genetic information in the man-made molecule corresponds to that in the genome of an organism. In contrast, where the information in a nucleic acid does not have a counterpart in the genome of an organism, the genetic information can be considered “made” or artificial, and therefore represents patentable subject matter in Australia. Of course, such claims must also satisfy the requirements of novelty and inventive step. In addition, they need to be useful, and sufficiently enabled, such that a skilled person can perform the invention across the scope of the claims.
IP Australia sets out in its Manual of Practice and Procedure the key principles that determine the patentability of claims directed to nucleic acids or genetic information. The questions to be asked are:
- What is the substance of the claim; and
- Is the substance of the claim “made”?
These principles have been applied in several decisions of courts and the patent office[ii]. In practice, as DNA and RNA are both carriers of genetic information, any claim to a sequence of nucleotides that reproduces genomic DNA is likely to be found to be in substance directed to genetic information. This is likely to be the case, even when the claimed nucleic acid molecule represents a lesser part of the full-length nucleic acid molecule, for example a fragment or primer. Objections are usually taken against antisense oligonucleotides on the same basis, namely that they “correspond” to a naturally occurring target sequence.
Options for Claims to Patentable Subject Matter
The Myriad decision does not preclude patentability of claims directed to probes, vectors, expression cassettes, microarrays, methods of production, methods of diagnosis and methods of treatment. Therefore, including these types of claims in Australian patent applications is generally recommended. Note that both Swiss-style and method of treatment claims are in principle allowable in Australia.
In terms of achieving product claims, in some cases it may be possible to argue that the nucleic acid does not correspond to a naturally occurring sequence. In other cases, including additional elements not naturally associated with the target or gene sequence may address examiners’ objections. For example, some nucleic acid molecules include non-naturally occurring regulatory sequences, spacer sequences, repeat sequences or stem and loop structures, which may be sufficient for the molecule to be considered “made”. Likewise, some nucleic acid molecules include modifications, such as modifications to phosphothioate linkages or sugar rings, that may fundamentally alter the substance of the claims.
Conclusion
Australian patent law does not specifically exclude nucleic acid molecules from patentability. Rather, the High Court has provided a framework for assessing whether such inventions satisfy the Australian patentability requirement for a “manner of manufacture”. This is assessed on a case-by-case basis, having regard to the substance of the invention, as well as the form of the claim.
If you would like to discuss patent protection options in Australia, or have questions about the above, please feel free to contact the team at MBIP. Our experienced team of attorneys would be glad to assist.
[i] D’Arcy v Myriad Genetics Inc. (2015) HCA 35
[ii] Meat & Livestock Australia Limited v Cargill, Inc. (2018) FCA; Sequenom, Inc. v Ariosa Diagnostics, Inc. (2019) FCA 1011; Arrowhead Research Corporation [2016] APO 70; Cargill Incorporated v Dow AgroSciences LLC (2016) APO 43; Academisch Ziekenhuis Leiden and BioMarin Technologies B.V. [2018] APO 49
