On 7 October 2015, the High Court of Australia (High Court) handed down its unanimous decision in D'Arcy v Myriad Genetics Inc, finding that an isolated nucleic acid coding for specified mutations or polymorphisms of the BRCA1 gene is not patentable subject matter.
This decision overturns the unanimous decision of the Full Federal Court of Australia (Full Court) and Justice Nicholas' decision of Federal Court of Australia at first instance which both found that the isolated gene sequences in question were patentable subject matter.
The decision also brings Australia into alignment with the US Supreme Court’s decision in 2013 that similar patent claims were invalid, as they were claims to a "product of nature" and accordingly, not patentable subject matter.
The claims of the patent relate to isolated nucleic acid coding for specified mutations or polymorphisms of the BRCA1 gene. These variations in the BRCA1 gene can serve as indicators of a woman's risk of developing breast, ovarian and other types of cancer.
Section 18(1)(a) of the Patents Act 1990 (Cth) (Act) requires that, for an invention to be patentable, it must be "a manner of manufacture".
At first instance, Justice Nicholas found that the invention constituted a "manner of manufacture" and held that the patent was valid.
This decision was appealed. However, the Full Court agreed with Justice Nicholas' findings and dismissed the appeal. The Full Court also confirmed that the test for whether an invention was a "manner of manufacture" could be determined in accordance with a two-part test set out in the National Research Development Corporation Case (NRDC Case). That is, an invention constitutes a "manner of manufacture" if it:
- results in an artificial state of affairs; and
- provides a new and useful effect that is of economic significance.
The High Court’s decision
On 13 February 2015, the High Court heard and granted Yvonne D’Arcy’s application for special leave to appeal the Full Court's decision.
The key issue before the High Court was whether the invention claimed constituted a "manner of manufacture" for the purposes of section 18(1)(a) of the Act.
Ms D'Arcy argued that nuclei acids claimed in the invention are not patentable subject matter because they occur naturally in the human body and their isolation does not make them "sufficiently artificial" to constitute a "manner of manufacture".
The respondents, Myriad Genetics Inc and its Australian licensee, argued that the claims satisfied the two-part test set out in the NRDC Case and thus the invention constituted a "manner of manufacture".
While the High Court’s decision allowing the appeal was unanimous, three judgments were delivered. The majority judgment (by French CJ, Kiefel, Bell and Keane JJ) found that the Federal Court's decisions had been based upon an "unduly narrow characterisation" of the test set out in the NRDC Case.
Their Honours held that the NRDC Case did not set a prescriptive 2 two-part test for what constitutes a "manner of manufacture". Rather, the Court should also have regard to "purposive and consequentialist considerations" (that is, policy reasons) with the two factors identified in the NRDC Case forming part of a range of relevant factors to take into consideration. The majority held that other relevant factors to consider were:
- whether according patentability to the invention would be consistent with the purposes of the Act;
- whether according patentability to the invention would enhance or detract from the coherence of the law relating to inherent patentability;
- Australia’s place in the international community of nations; and
- whether according patentability to the invention would involve law-making of a kind which should be done by the legislature.
Having regard to all the relevant factors, the Court held that an isolated nucleic acid, with specified mutations or polymorphisms, is not a "manner of manufacture".
The Court found that while the invention claimed might be a product of human action, it was the existence of the information stored in the relevant sequences (that is, the specified mutations or polymorphisms) that was an essential element of the invention as claimed.
The Court found that to accord patentability to the invention would involve an extension of the concept of a "manner of manufacture" which was not appropriate for judicial determination.