D'Arcy v Myriad Genetics Inc & Anor - [2015] HCATrans 146

[2015] HCATrans 146

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 TUESDAY, 16 JUNE 2015, AT 10.15 AM

MR D.K. CATTERNS, QC: May it please the Court, I appear with my learned friend, MR P.K. CASHMAN, for the appellant. (instructed by Maurice Blackburn Lawyers)

MR D. SHAVIN, QC: May it please the Court, I appear with my learned friend, MR C. DIMITRIADIS, SC, for the first respondent. (instructed by Jones Day)

FRENCH CJ: There is a submitting appearance for the second respondent. Yes, Mr Catterns.

MR CATTERNS: May it please the Court. Your Honours, before I go to the propositions and the three pages that we have handed the Court, may I just mention a couple of them in advance, which are in those propositions. Your Honours, in short, our submission is that a product of nature is not patentable. It is not a manner of manufacture within section 18(1)(a) of the Patents Act. The Full Court erred, we submit, in holding that the High Court in the NRDC Case had expressly rejected that exception.

Your Honours, although the three claims in issue here refer to isolated – that is the nub of the case, really – nucleic acids, ranging from the whole of the coding sequence of the natural gene – that is the natural mutated gene possessing the mutations that are referred to in the claim ranging from that whole gene coding sequence, we readily accept it does not refer to the introns – down to a sequence of 15 nucleotides. The fact of isolation, we submit, as a matter of substance does not – and I will address the Court as to why that is an appropriate way of looking at it – take the claim sequences out of the exclusion.

Your Honours, at bottom we think this is a – we submit this is a matter of properly construing the claims or perhaps appreciating the level of discourse at which they are written which is it is about the possession of all or part of the coding sequence of the gene – the natural gene possessing the natural mutations or polymorphisms.

FRENCH CJ: Perhaps underlying the “product of nature” terminology, which may or may not be useful, is the question what is it that is done to make the invention – when you look at the integers and particularly, the existence of the mutations or polymorphism which are an accident of the particular person from whose body you have taken the sample.

MR CATTERNS: Yes, your Honour, exactly. I agree, with respect. I will take the Court in a minute…

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 146
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 applicant, D'Arcy, sought to challenge the validity of Myriad Genetics Inc's patent over the BRCA1 gene, which is associated with an increased risk of breast and ovarian cancer. D'Arcy argued that the gene, being a product of nature, was not a patentable invention under Australian law.

The central legal question before the High Court was whether isolated DNA sequences, specifically the BRCA1 gene, constituted a manner of manufacture for the purposes of section 6 of the Statute of Monopolies, and therefore were eligible for patent protection. This involved determining whether such sequences, once isolated from the human body, were sufficiently distinct from their natural state to be considered an invention.

The High Court, by majority, held that isolated DNA sequences, including the BRCA1 gene, were not patentable inventions. The Court reasoned that these sequences were essentially discoveries of naturally occurring substances and did not involve a "manner of manufacture" in the sense contemplated by patent law. The majority distinguished between the discovery of a gene and the creation of a new and useful product or process, concluding that the isolation of a gene, while scientifically significant, did not transform it into an invention. The Court affirmed that patent law is intended to protect human ingenuity and the creation of new things, not the mere discovery of what already exists in nature.

The High Court allowed the appeal, setting aside the decision of the Full Federal Court and declaring the patent invalid.

Orders