Isolated naturally occurring DNA or RNA sequences can be patentable under Australian law.
The Federal Court has clarified the position of so-called "gene patents" under Australian law. Cancer Voices Australia v Myriad Genetics Inc  FCA 65 is the first Australian decision to consider the patentability of isolated naturally occurring DNA or RNA sequences. The case confirms that, when isolated from their natural environment, these sequences can be patentable under Australian law. The case provides welcome certainty, although public debate is likely to continue.
The BRCA1 gene and the patent
Whether genetic material ought to be patentable has long been the subject of debate both in Australia and overseas. This case related to certain claims of an Australian patent owned by US based molecular diagnostics company Myriad Genetics Inc. Myriad's patent relates to the BRCA1 gene, which is what is known as a breast and ovarian cancer disposing gene. A mutation of the BRCA 1 gene results in an increased risk of breast and ovarian cancer and the gene is therefore useful in diagnostic testing. The claims in dispute related to "naturally occurring" nucleic acid (either DNA or RNA) that has been "isolated" from the cellular environment in which it naturally exists.
Cancer Voices Australia (a national network of cancer advocacy groups) and breast cancer survivor Yvonne D'Arcy challenged the validity of the claims relating to the isolated genetic material, on the sole basis that the isolated genetic material was not proper subject matter for a patent. The applicants did not rely on any of the other available grounds for challenging the validity of a patent.
Isolated DNA and RNA
While "human beings and biological processes for their production" are not patentable, the Patents Act does not include any specific prohibition on the grant of a patent for an isolated DNA or RNA sequence. The applicants did not argue that DNA or RNA were biological processes for the production of human beings. Instead, they argued that the isolated genetic sequences did not satisfy the "manner of manufacture" requirement for patentable subject matter. This requirement distinguishes patentable inventions from "mere discoveries", which are not patentable under Australian patent law.
The respondents argued that each of the disputed claims was valid because the isolated nucleic acid found in human cells differs from the isolated nucleic acid claimed in the patent. In particular, they argued that the process of isolating, at least, DNA sequences necessarily involved breaking covalent bonds. Although not accepting this general proposition, Justice Nicholas accepted that the isolated genetic material was different from that genetic material existing in its context in the human body, holding that "naturally occurring DNA and RNA are not within the scope of any of the disputed claims and could never, at least not until they had been isolated, result in the infringement of any such claim."
The "manner of manufacture" requirement
According to section 18(1)(a) of the Patents Act, to be patentable an invention must be a "manner of manufacture". The term "manner of manufacture" is a reference to an old English statute and is not defined in the Patents Act. Australian courts have resisted giving the term a precise definition in order to allow the law to adapt to advances in technology.
The leading authority on the meaning of "manner of manufacture" is the NRDC1decision in which the High Court held that a new method for using known chemicals to eradicate weeds from crops was a "manner of manufacture" because:
- it resulted in an artificially created state of affairs; and
- its effect had economic significance.
As there was no dispute in this case as to economic significance, the only issue for Justice Nicholas to decide was whether the isolation of the nucleic acid described in the claims was "an artificially created state of affairs".
Justice Nicholas held that an isolated nucleic acid constitutes an "artificially created state of affairs in the sense those words should be understood in the present context". This was so because the nucleic acid is not found in the body in its isolated form, and because the naturally occurring nucleic acid does not exist outside the body without human intervention. He identified the following key considerations:
- the High Court deliberately used expansive language in the NRDC case, so as not to fetter changing understandings of technology;
- "isolated" nucleic acid is the product of human intervention which involves the extraction and purification of the nucleic acid found inside the cell; and
- the isolation of a particular DNA sequence can require immense research and intellectual effort and failing to acknowledge the result of this effort and expense as a manner of manufacture would lead to "very odd results".
Justice Nicholas considered his finding consistent with decisions of the Australian Patents Office on the patentability of isolated DNA and with European Union law which specifically provides that an element isolated from the body, including the sequence or partial sequence of a gene, "may constitute a patentable invention, even if the structure of that element is identical to that of a natural element". He also noted that the equivalent litigation to the Myriad Genetics case in the US is on appeal to the Supreme Court, and is, in any event, not directly relevant because of differences in US law.
Recent amendments to the Patents Act
Although they were not authoritative in relation to his decision, Justice Nicholas gave consideration to the recent law reform and parliamentary enquiries and reports relating to gene patenting. Justice Nicholas noted widely expressed views that it would not now be appropriate from a social, political or economic perspective to pass laws making genetic material unpatentable on a per se basis.
Justice Nicholas also reviewed the history of recent amendments to the Patents Act (including the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth)). Section 119C of the Patents Act now provides a defence to patent infringement for "experimental use". This overcomes one argument commonly advanced against the patentability of isolated DNA sequences, specifically "the impact that patents for such materials may have on future research into previously undiscovered genetic mutations and research and the development of new diagnostic and therapeutic technologies that may only take place using patented biological materials."
He also noted the new section 7A in the Patents Act, imposing a more onerous requirement for a patented invention to be "useful". It is considered that this requirement may have an impact on attempts to patent certain shorter genetic sequences called expressed sequence tags or ESTs, the patentability of which has been the subject of particular debate.
While this case does clarify the law in Australia relating to the patentability of naturally occurring genetic material, it is important to note two limitations on the case's influence.
First, the case was argued solely on the question of whether isolated "naturally occurring" genetic material can be subject matter for a patent. None of the other requirements for patentability were addressed. Every time a patent application seeks to claim isolated genetic material, it will remain subject to all of the other requirements for patentability.
In particular, the case did not address whether the isolated DNA or RNA was sufficiently inventive to warrant patentability. All patents remain subject to the (often onerous requirement) of "inventive step" or "non-obviousness", and those requirements will continue to impose restraints on patentability.
Secondly, only the claims of the patent relating to the genetic material itself were challenged. As the patent had other claims covering diagnostic methods, Myriad would still have had a patent monopoly in relation to its methods even if the challenge had been successful. The ethical question of whether naturally occurring genetic material ought to be patentable per se may therefore be proven to be somewhat limited in its practical consequence.
A similar past question, now clearly resolved in the affirmative in Australia, was whether methods of treatment for the human body are patentable. When that question was unresolved, patent claims were often creatively drafted to avoid this potential difficulty, with the result that the ethical question involved was, largely, rendered theoretical.
The same considerations apply in relation to genetic material as patent subject matter; in the context of the Australian patent system overall, this clarification seems unlikely to have an impact on access to medical treatment.
It remains to be seen whether the applicants seek to appeal this decision. Whether or not an appeal occurs, the debate is likely to continue, with Cancer Voices Australia now calling upon the public to sign a petition to the Australian Parliament.
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1 National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252.
Clayton Utz communications are intended to provide commentary and general information. They should not be relied upon as legal advice. Formal legal advice should be sought in particular transactions or on matters of interest arising from this bulletin. Persons listed may not be admitted in all states and territories.