FRENCH CJ, KIEFEL, BELL, GAGELER, KEANE, NETTLE AND GORDON JJ
YVONNE D'ARCY APPELLANT
AND
MYRIAD GENETICS INC & ANOR RESPONDENTS
D'Arcy v Myriad Genetics Inc [2015] HCA 35
7 October 2015
S28/2015
ORDER
1.Appeal allowed.
2.Set aside paragraph 1 of the order of the Full Court of the Federal Court of Australia made on 5 September 2014 and, in its place, order that:
(a)the appeal be allowed; and
(b)paragraph 1 of the order of Nicholas J made on 15 February 2013 be set aside and, in its place, order that claims 1, 2 and 3 of Australian Patent No 686004 be revoked.
On appeal from the Federal Court of Australia
Representation
D K Catterns QC with P K Cashman for the appellant (instructed by Maurice Blackburn Lawyers)
D Shavin QC with C Dimitriadis SC for the first respondent (instructed by Jones Day)
Submitting appearance for the second respondent
Notice: This copy of the Court's Reasons for Judgment is subject to formal revision prior to publication in the Commonwealth Law Reports.
CATCHWORDS
D'Arcy v Myriad Genetics Inc
Intellectual property – Patents – Patents Act1990 (Cth) – Patentable subject matter – Patent claimed isolated nucleic acid coding for BRCA1 protein with specified mutations or polymorphisms indicative of susceptibility to cancer – Whether invention claimed is a patentable invention under s 18(1)(a) of Patents Act1990 (Cth) – Whether invention claimed is a "manner of manufacture" within meaning of s 6 of Statute of Monopolies – Whether sufficient that invention claimed is artificially created state of affairs of economic significance – Utility of "artificially created state of affairs" criterion – Factors relevant to whether new class of claim falls within concept of manner of manufacture.
Words and phrases – "artificially created state of affairs", "isolated nucleic acid", "manner of manufacture", "naturally occurring", "patentable invention", "product of nature".
Patents Act 1990 (Cth), ss 18(1)(a), 40(2)(b). Statute of Monopolies (21 Jac I c 3), s 6.
FRENCH CJ, KIEFEL, BELL AND KEANE JJ.
Introduction
A human gene which codes for the production of a protein called BRCA1 may bear variations from the norm, characterised as mutations or polymorphisms, which are associated with susceptibility to breast and ovarian cancers[1]. Like all genes, it is a functional unit of the deoxyribonucleic acid ("DNA") molecule found in the nucleus of the human cell. By a biochemical process within the cell involving ribonucleic acid ("RNA"), a gene gives rise to the production of the protein molecule or "polypeptide", which is defined by, or is an "expression" of, the sequence of components of the gene known as nucleotides. That sequence comprises "the genetic code"[2]. The BRCA1 gene is one of approximately 25,000 genes in the human DNA molecule, which consists of about 3.2 billion linked nucleotides. The isolation of any of a class of molecules bearing a sequence of nucleotides coding for a BRCA1 polypeptide is said by the first respondent, Myriad Genetics Inc ("Myriad"), to give rise to a patentable invention…
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.
Continue reading D'Arcy v Myriad Genetics Inc
Sign in free to access the full text
Details
AGLC
D'Arcy v Myriad Genetics Inc [2015] HCA 35
Case
[2015] HCA 35
Decision Date
CaseChat Overview and Summary
The High Court of Australia considered an appeal by D'Arcy against Myriad Genetics Inc concerning the patentability of isolated nucleic acid sequences that indicate a susceptibility to cancer. The dispute centred on whether these isolated DNA sequences, which code for the BRCA1 protein and contain specific mutations or polymorphisms, constituted a patentable invention under the *Patents Act 1990* (Cth).
The core legal issue before the High Court was whether the claimed invention, specifically isolated nucleic acid sequences coding for the BRCA1 protein with mutations indicative of cancer susceptibility, was a "manner of manufacture" within the meaning of s 6 of the *Statute of Monopolies*. This required the Court to determine whether the "artificially created state of affairs" criterion, as established in previous case law, was satisfied, and what factors were relevant to assessing whether a new class of claim fell within this concept.
The High Court reasoned that while the isolation of nucleic acids involves an artificial process, the resulting product, an isolated DNA sequence, was not fundamentally different in its essential characteristics from the naturally occurring sequence. The Court found that the claims encompassed molecules that, in their essential nature, were products of nature, even if they had been extracted from their natural cellular environment. The Court distinguished between the discovery of a gene and the isolation of a gene, noting that the claims were directed to the isolated gene itself, not a new use or application of it.
The High Court allowed the appeal, setting aside the orders of the Full Court of the Federal Court. The Court ordered that claims 1, 2, and 3 of Australian Patent No 686004 be revoked, finding that the isolated nucleic acid sequences claimed were not patentable subject matter.
Orders
Orders of the court
1. Appeal allowed.
2. Set aside paragraph 1 of the order of the Full Court of the Federal Court of Australia made on 5 September 2014 and, in its place, order that:
(a) the appeal be allowed; and
(b) paragraph 1 of the order of Nicholas J made on 15 February 2013 be set aside and, in its place, order that claims 1, 2 and 3 of Australian Patent No 686004 be revoked.
Background
Background to the litigation
Full text does not contain this section.
Evidence
Evidence Before The Court
Full text does not contain this section.
Decision
Reasons for decision
FRENCH CJ, KIEFEL, BELL AND KEANE JJ
The preceding argument has some similarity to Myriad's submission to the primary judge that Dr Suthers' evidence supported the proposition that there would be at least some breaking of the covalent cells in the sugar phosphate backbone as a result of the isolation process[95]. The primary judge said[96]:"It is not apparent to me that every isolated DNA sequence within the scope of the claims must have had at least some covalent bonds broken as a result of the isolation process. Nor would I imply any such requirement into the claims merely because, in Dr Suther's experience, this is what occurs. To interpret the disputed claims in this way would require me to impose an impermissible gloss upon the words of the claim."Nor, as previously noted, are the claims subject to any process‑based limitation involving the breaking up and physical stitching together of the sequences comprising the isolated nucleic acids which are the products the subject of the claims. The "conceptual" stitching together, which may be regarded as the ordered compilation of information defining the relevant sequence, falls outside the claims entirely. The claims encompass molecules comprising isolated nucleic acids containing coding nucleotides arranged in the same sequence as appears in the DNA from which they were derived, whether or not introns and other non-coding sections have been removed from the relevant stretch of that DNA.[95](2013) 99 IPR 567 at 581 [73].[96](2013) 99 IPR 567 at 581 [74].The primary judge's decision For the primary judge, the issue of patentability turned on[97]:"whether an isolated nucleic acid, which may be assumed to have precisely the same chemical composition and structure as that found in the cells of some human beings, constitutes an artificial state of affairs in the sense those words should be understood in the present context."That approach, as observed earlier, involves application of the verbal formula in NRDC and the apparent assumption, no doubt derived from the way the case was framed before his Honour, that it was a sufficient condition of inherent patentability.[97](2013) 99 IPR 567 at 589 [106]. Approximately one woman in 800 in the general female population has a mutation in the BRCA1 gene sequence that places her at high genetic risk of developing breast cancer and ovarian cancer. In any one year, a variation of unknown clinical significance is identified in approximately 15 per cent of women having tests for unknown variations in the BRCA1 gene. Extracting, isolating and sequencing DNA Myriad extracted, isolated and sequenced the DNA of the BRCA1 gene in what the appellant accepts was a "fine piece of science". However, in doing so, Myriad used well-established processes of DNA extraction, isolation and sequence comparison. DNA is typically obtained from cells removed from a sample of tissue or blood extracted from an individual. A sample will need to be processed before it is tested. It is necessary to break open the cells and expose the DNA. The goal of processing the sample is to remove the DNA from its normal cellular environment without corrupting the information content of the DNA. The DNA sequence of the processed DNA must accurately reflect the sequence of the DNA in the patient's cells for the pathology test to have any medical validity and be relevant for decision-making. These extraction processes are not new.
Ratio Decidendi
Legal Principle Established
Established by:
FRENCH CJ, KIEFEL, BELL AND KEANE JJ