Australia: High Court unanimously rejects patenting of isolated DNA in breast cancer gene case

The High Court of Australia today unanimously allowed an appeal from the Full Federal Court, holding that isolated nucleic acid (such as DNA or RNA) corresponding to forms of the BRCA1 gene associated with increased cancer risk is not a 'patentable invention' within the meaning of Australia's Patents Act 1990 (Cth) (Act). The decision in D'Arcy v Myriad Genetics Inc [2015] HCA 35 was much anticipated, with potentially wide-ranging implications for access to certain types of genetic material by the scientific and research community. We summarise the High Court's decision below.

Myriad case history

The Myriad proceedings were a test case, brought by cancer survivor Yvonne D'Arcy to determine whether isolated nucleic acid (that is, nucleic acid extracted from human cells or synthesised in a laboratory) having a nucleotide sequence corresponding to naturally occurring genetic material is a 'patentable invention' under the Act. The nucleic acids at issue in this case involve mutations (or 'polymorphisms') of the BRCA1 gene associated with susceptibility to breast and ovarian cancer.

The Primary Judge and the Full Federal Court found that isolated nucleic acid was a patentable invention and, therefore, the disputed claims of the patent were valid. Ms D'Arcy was granted special leave to appeal to the High Court, which today overturned the decision of the Full Federal Court and invalidated Myriad's disputed claims to isolated nucleic acid.

Claimed subject matter

While the Myriad patent included 30 claims, only claims 1 to 3 (disputed claims) were at issue before the High Court. Each of the disputed claims was for a product, claim 1 being directed to 'an isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide' and having one or more mutations identified in Myriad's patent specification. Claims 2 and 3 were expressed in similar terms. None of claims 1 to 3 was restricted to any particular application of the claimed nucleic acids (eg, use in screening tests for cancer susceptibility).

Ms D'Arcy challenged the disputed claims on the basis that their subject matter was not a 'manner of manufacture' as that term is used in s 18(1)(a) of the Act and, therefore, that none of the disputed claims was directed to a patentable invention. For the purposes of the appeal, Ms D'Arcy accepted that, if eligible to be patented, the claimed subject matter was new, useful, and involved an inventive step.

Ms D'Arcy's case

Ms D'Arcy submitted that Myriad was, in effect, seeking a monopoly over naturally occurring genetic information, without regard to the technical processes required to isolate the claimed nucleic acids. On the basis that an 'isolated nucleic acid' is no more than a naturally occurring product 'in a different place', Ms D'Arcy argued that it could not be regarded as a 'manner of manufacture' within the meaning of the Act.

Ms D'Arcy also submitted that public policy considerations weighed against patenting of isolated nucleic acid, which would restrict access to genetic materials for research purposes, particularly as the disputed claims were not limited to any particular application.

Those arguments were unsuccessful before the Primary Judge and the Full Federal Court, which emphasized that Myriad's claims were directed to chemical compounds which are structurally and functionally different to the nucleic acids found inside human cells. On that basis, the Full Federal Court held that the claims were directed to an "artificially created state of affairs of economic utility", and so eligible to be patented under the principles established by the seminal NRDC case. ¹

Reasoning in the High Court

Allowing Ms D'Arcy's appeal, the judges of the High Court held that merely to characterise the subject matter of the disputed claims as chemical compounds was to elevate form over substance. They noted that Myriad's claims focused not on the structure or function of the claimed compounds, but on the information they convey, which information underlies the utility of the claimed nucleic acids in cancer screening. Importantly, their Honours noted that the information was not "made" by any human action, but merely "discerned".

Consistently with the principles established by the NRDC case, the High Court accepted that, in assessing patentability, it is relevant to ask whether claims are directed to a product or process that has been made by human intervention and has economic utility. However, the High Court explained that that alone is not a sufficient test, and may represent an overly narrow approach, where a new application or extension of patent eligibility is at issue. In such cases, additional factors must be considered, including whether the claims may have a "chilling effect" on innovation. Their Honours considered that the latter was true of Myriad's claims, because use of the generic term "isolated nucleic acid" meant that the boundaries of the claimed monopoly were elusive.

According to the judges of the High Court, it will also be relevant to consider whether finding subject matter to be patent-eligible would involve the Court engaging in law-making activities that are more appropriately left to the legislature. This factor was influential in the judgment of the High Court, which considered that to affirm the patentability of isolated nucleic acid would require the Court to consider questions of public policy and conflicting interests which Parliament is better equipped to address.

Future implications

Today's decision may not be the final word concerning the patentability of genetic materials in Australia:

• First, the High Court noted that it is for the legislature to determine whether the balance of public policy considerations favours the extension of the scope of patent-eligible subject matter and it is therefore possible that this issue may be revisited by the Commonwealth Parliament in the light of today's judgment.
• Secondly, as the High Court noted, this case was not concerned with gene patenting broadly, but rather with the validity of specific claims directed to certain isolated nucleic acids. Their Honours considered those claims to lie "at the boundaries" of patent eligibility. Exactly where those boundaries are to be drawn will only be elucidated through subsequent cases concerning the patent eligibility of genetic materials under the Act.

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