D'Arcy v Myriad Genetics Inc: High Court Reverses Breast Cancer Gene Patentability

Wednesday 7 October 2015 @ 11.48 a.m. | IP & Media | Legal Research

In D'Arcy v Myriad Genetics Inc & Anor [2015] HCA 35, the High Court of Australia has today (7 October 2015), in a unanimous decision, allowed an appeal from the decision of the Full Court of the Federal Court of Australia in D'Arcy v Myriad Genetics Inc [2014] FCAFC 115 (5 September 2014).

The High Court decision found that:

“. . . an isolated nucleic acid, coding for a BRCA1 protein, with specific variations from the norm that are indicative of susceptibility to breast cancer and ovarian cancer,”

was not a "patentable invention" within the meaning of section 18(1)(a) of the Patents Act 1990 (Cth) (the Patents Act).

Background to the Case

Myriad Genetics owns Australian Patent Number 686004, being a patent over the invention of certain methods of detecting the gene BRCA1 and of using components and mutations of that gene in the diagnosis of predisposition to breast cancer and ovarian cancer. Ms Yvonne D’Arcy challenged the patent on the ground that the claim involved naturally occurring nucleic acids that was merely isolated by Myriad without the necessary “manner of manufacture” as prescribed in section 18(1)(a) of the Patents Act.

The Basic Science

The term "nucleic acid" includes two kinds of molecules, deoxyribonucleic acid (DNA) and ribonucleic acid (RNA), which are found inside a human cell. A gene is a functional unit of DNA which encodes a particular protein produced by the cell. The protein produced depends on the sequence of nucleotides. The BRCA1 gene codes for the production of a protein called BRCA1.

The Dispute

Myriad Genetics filed a patent containing 30 claims, of these, claims 1 to 3 related to a nucleic acid coding for a BRCA1 protein, and with one or more specified variations from the norm in its nucleotide sequence, isolated from its cellular environment. Those specified variations, characterised as mutations or polymorphisms, are indicative of susceptibility to breast cancer and ovarian cancer.

The dispute arose because section 18(1)(a) of the Patents Act requires that, for an invention to be patentable, it must be "a manner of manufacture" within the meaning of section 6 of the Statute of Monopolies. Yvonne D’Arcy and Cancer Voices Australia initiated proceedings in the Federal Court of Australia which challenged the validity of claims 1 to 3 on the basis that the invention claimed did not meet the requirement of section 18(1)(a) of the Patents Act (see Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65 (15 February 2013)).

In the Federal Court

Justice Nicholas, the primary judge dismissed the challenge by Yvonne D’Arcy and Cancer Voices Australia, holding that the invention fell within the concept of a "manner of manufacture". On appeal, the Full Federal Court dismissed an appeal from the decision of Justice Nicholas holding that an isolated nucleic acid was chemically, structurally and functionally different from a nucleic acid inside a human cell. As a result the invention was a manner of manufacture because an isolated nucleic acid with the characteristics specified in claims 1 to 3 of Myriad Genetics claims resulted in an artificially created state of affairs for economic benefit.

In the High Court

Yvonne D’Arcy appealed to the High Court of Australia and was granted of special leave to appeal.

The High Court unanimously allowed the appeal, holding that the invention claimed did not fall within the concept of a manner of manufacture. The Court held that, having regard to the relevant factors, an isolated nucleic acid, coding for the BRCA1 protein, with specified variations, is not a manner of manufacture. While the invention claimed might be, in a formal sense, a product of human action, it was the existence of the information stored in the relevant sequences that was an essential element of the invention as claimed.

Further, several members of the Court considered that to attribute patentability to the invention as claimed would involve an extension of the concept of a manner of manufacture which was not appropriate for judicial determination.

See paragraphs [94] and [95] of the joint judgment of Chief Justice French and Justices Kiefel, Bell and Keane JJ:

[94] Although it may be said in a formal sense that the invention as claimed, referring to isolated nucleic acids, embodies a product created by human action, that is not sufficient to support its characterisation as a manner of manufacture. The substance of the invention as claimed and the considerations flowing from its substance militate against that characterisation. To include it within the scope of a "manner of manufacture" involves an extension of that concept, which is not appropriate for judicial determination. Further, to include this class of claim within that concept would not contribute to coherence in the law as was the case in Apotex. Nor do Australia's international obligations and the differently framed patent laws of other jurisdictions, which were referred to earlier in these reasons, support the conclusion that this class of claim should fall within the concept.

[95] The invention as claimed in Claims 1 to 3 does not meet the requirement of section 18(1)(a) and the appeal should be allowed.

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Sources:

  • D'Arcy v Myriad Genetics Inc [2015] HCA 35 (7 October 2015)
  • D’Arcy v Myriad Genetics Inc [2014] FCAFC 115
  • Cancer Voices Australia v Myriad Genetics Inc (includes Corrigendum dated 25 February 2013) [2013] FCA 65 (15 February 2013) 

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