In a landmark case about gene patents, the High Court of Australia has unanimously held that an isolated nucleic acid, coding for a BRCA1 protein with variations that indicate susceptibility to breast and ovarian cancer, is not a “patentable invention” within the meaning of Australia’s Patent Act (Act). The highly anticipated decision overturns a decision of the Full Federal Court of Australia, made only a year before, which had unanimously held that the invention was patentable.
The High Court decision (given by the 7 Judges in 3 separate judgments) in D’Arcy v Myriad Genetics Inc concerns a patent granted to Myriad for an isolated nucleic acid which has one or more specific mutations in the BRCA1 gene used in genetic testing. In BRCA1 testing, the patient’s DNA is extracted and tested for specific mutations indicative of a predisposition to breast cancer and ovarian cancer. In practice, the patent if enforced by Myriad would have prevented isolation and testing of the BRCA1 gene without a licence from Myriad. The case was brought by Yvonne D’Arcy, a breast cancer survivor, who first challenged the patent in the Federal Court in 2010. Under the Act, any person can apply to the court to have a standard patent revoked on specified grounds. According to Ms D’Arcy’s lawyers, the patent, if enforced, would have significant implications for access to genetic testing, cancer research and treatment development.
The High Court decision means that the law in Australia on patentability of genetic material is now broadly in line with the position in the United States. However, it is at odds with other jurisdictions such as Europe where it has been held that isolated nucleic acid is capable of being patentable subject matter.
Analysis of the High Court decision
Section 18(1)(a) of the Act provides that an invention is patentable if, among other requirements, it is “a manner of manufacture within the meaning of section 6 of the Statute of Monopolies”. The High Court held that the requirements for patentability imposed by this section should not depend on a strict application of a formula expressed in the NRDC case, the key authority on the meaning of the phrase “manner of manufacture”. In the NRDC case, the High Court construed “manner of manufacture” to require “an ‘artificially created state of affairs’, leading to ‘an economically useful result'”.
The High Court in Myriad emphasised that satisfaction of the NRDC “formula” does not automatically mandate a finding of inherent patentability. Other considerations may also be taken into account. These include:
- alignment with the purposes of Act (i.e. striking the correct balance of policy considerations in patent law)
- the coherence of the law relating to inherent patentability
- Australia’s obligations under international law, and developments in patent laws in other countries
- whether the decision as to the patentability of the Myriad invention would involve law-making that should be done by the legislature
The Court placed particular emphasis on the fact that the invention as claimed (an essential element being the information stored in the isolated nucleic acid) is the same information as that contained in the DNA in its native cellular environment. Although the isolated product is extracted by human action, the High Court held it is not something “made” because it is the same whether inside or outside of the body. Rather, the Court said, the end product is something “discerned”.
Having regard to the relevant factors, the High Court held that an isolated nucleic acid, coding for BRCA1 protein with specific mutations, is not a “manner of manufacture” and accordingly, not a patentable invention under the Act.
The High Court considered that the Myriad patent claims were at the boundary of the concept of manner of manufacture and to uphold the patent (and therefore, as the Court saw it, extend the current scope of what constitutes a manner of manufacture) was not an appropriate decision for the judiciary.
The decision will have some significant implications for other Australian patents covering genetic material. It will be interesting to see whether the decision prompts a parliamentary response.
Post Script: Following the Myriad decision, IP Australia’s Commissioner of Patents has proposed an examination practice for public consultation and is now inviting comments from interested parties by Friday 30 October 2015. For more information, see here.