D'Arcy v Myriad Genetics Inc & Anor - [2015] HCATrans 147

[2015] HCATrans 147

IN THE HIGH COURT OF AUSTRALIA

Office of the Registry
Sydney No S28 of 2015

B e t w e e n -
YVONNE D’ARCY
Appellant
and
MYRIAD GENETICS INC
First Respondent
GENETIC TECHNOLOGIES LIMITED ABN 17 009 212 328
Second Respondent

FRENCH CJ
KIEFEL J
BELL J
GAGELER J
KEANE J
NETTLE J
GORDON J

TRANSCRIPT OF PROCEEDINGS

AT CANBERRA ON WEDNESDAY, 17 JUNE 2015, AT 10.17 AM

(Continued from 16/6/15)

FRENCH CJ: Yes, Mr Shavin.

MR SHAVIN: If the Court pleases. I foreshadowed to the Court last night that there were two substantive matters I would seek to take the Court to fairly briefly. The first is to identify some matters that are raised by the decision of this Court in Apotex v Sanofi‑Aventis, and to two matters that arise from that. In the bundle, it is tab 6, and the print that has been circulated is of the Australian Law Report version 304 ALR 1. If I could first take the Court very briefly to two passages from your Honour the Chief Justice’s reasons, and the first is at paragraph [44] on page 50. The part of this paragraph which we would seek to refresh the Court’s memory is your Honour’s statement that:

An important constraint is that a propounded development of legal principle involving large questions of public policy and reconciliation of interests in tension is, for the most part, best left to the legislature. On the other hand, a qualification or exception to a general principle may have become anomalous to such an extent that its removal would enhance the logical and/or normative coherence of the law.

In our respectful submission, the relevance of that statement to the present proceeding is that if this Court was to seek to make some form of exemption or limitation upon the statement of principle articulated by the Court in NRDC, it is important that it be framed in a way that has a coherence with the rest of those reasons and some normative principle underlying it. As we sought to develop yesterday and will conclude with today, when one considers each of the options available, in our respectful submission it is not really practicable to play with the conclusion that was developed at page 277 of the NRDC Case.

FRENCH CJ: It may be that NRDC does not provide us with an answer. It was not addressing this problem, and I suppose the question then is if it is not able to be dealt with as a matter of coherence, which was the approach that I took in Apotex v Sanofi, do the concepts of instrumentalism versus “proprietarianism”, which I mentioned in, I think, the following paragraph, [45], have any part to play in determining the basis upon which we make, if there be a choice, the common law choice?

MR SHAVIN: Yes, but with a danger. If one is to establish a…

Grounds of appeal

[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.

[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.

[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.

Consideration

[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.

[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.

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Details

Case: [2015] HCATrans 147
Decision Date

CaseChat Overview and Summary

The High Court of Australia considered an appeal from the Full Federal Court concerning the patentability of isolated human genes. The applicants, D'Arcy and others, sought to challenge the validity of Myriad Genetics Inc's Australian patent over the BRCA1 gene, which is associated with an increased risk of breast and ovarian cancer. The core of the dispute revolved around whether isolated DNA sequences, which are naturally occurring and have been isolated from the human body, could be considered "inventions" or "artificially created or manipulated substances" for the purposes of the *Patents Act 1990* (Cth).

The central legal question before the High Court was whether isolated nucleic acid sequences, specifically the BRCA1 gene, were patentable subject matter under Australian patent law. This required the Court to determine whether such sequences, despite being isolated from their natural state, could be classified as "manner of manufacture" under section 6 of the *Statute of Monopolies* (as incorporated into the *Patents Act*), or whether they were merely discoveries of naturally occurring phenomena. The Court also had to consider whether the claims in Myriad's patent were directed to a physical product or to information.

The High Court, by majority, held that isolated nucleic acid sequences, including the BRCA1 gene, were not patentable subject matter. The majority reasoned that these sequences, even when isolated, were essentially the same as the DNA as it exists in the human body and were therefore discoveries of naturally occurring substances, not inventions. The Court distinguished between a discovery of a natural phenomenon and an invention, emphasizing that patent law is intended to protect human ingenuity and innovation, not the identification of pre-existing natural materials. The Court found that the claims were directed to the gene itself, not to a new or useful application or manipulation of it.

Consequently, the High Court allowed the appeal, finding that the patent claims were invalid for lacking patentable subject matter. The Court ordered that the patent be revoked.

Orders