D'Arcy v Myriad Genetics Inc & Anor - [2015] HCATrans 12

[2015] HCATrans 012

IN THE HIGH COURT OF AUSTRALIA

Office of the Registry
Sydney No S251 of 2014

B e t w e e n -
YVONNE D’ARCY
Applicant
and
MYRIAD GENETICS INC
First Respondent
GENETIC TECHNOLOGIES LIMITED ABN 17 009 212 328
Second Respondent
Application for special leave to appeal

FRENCH CJ
BELL J

TRANSCRIPT OF PROCEEDINGS

AT SYDNEY ON FRIDAY, 13 FEBRUARY 2015, AT 9.31 AM

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

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

FRENCH CJ: Yes, Mr Catterns.

MR CATTERNS: May it please the Court. Your Honours, our submission is that the normative principle is that a naturally occurring human gene – or a sequence of natural DNA – is not a patentable invention. It is not within the broad concept of “manner of manufacture” that was explained and developed in the NRDC Case. We submit it is hard to imagine a more important question in patent law.

Your Honours, the case largely turned on the question whether – or the fact that the claim is to the isolated gene or parts of it that we all agree can be as short as 15 nucleotides long, coding for five amino acids. Your Honours, our submission is that the isolated DNA – or it could be RNA – of claims 1 to 3 is, in every relevant sense, identical. Your Honours, what is relevant is that the claim sequences of nucleic acid code for the same natural polypeptide. It is the mutated polypeptide that possesses one of the various mutations that we see, for example, in table 12 where a single change in the code leads either to a stop or the wrong amino acid with potentially disastrous results.

FRENCH CJ: Is the artificiality of the state of affairs said to be the isolation of the exons and the detachment of the covalent bonds?

MR CATTERNS: Your Honour, the Full Court placed a lot of emphasis on the covalent bonds upholding a ‑ ‑ ‑

FRENCH CJ: They are just an attraction. They are not a thing.

MR CATTERNS: Well, exactly, your Honour. They might be – let us agree you have to, so to speak, sniff it out in the test tube in a line of DNA that may be dozens or hundreds of nucleotides long. There will be a break in the covalent bonds where they are separated from the sugar or the phosphate at either end. But the 15 that would constitute an infringement can well be in the middle of that and that is why his Honour, Justice Nicholas in his Honour’s reasons at paragraphs 105 and 106, put aside this as being a relevant consideration. The Full Court –…

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 12
Decision Date

CaseChat Overview and Summary

The High Court of Australia considered an appeal concerning the patentability of isolated human DNA sequences. The appellant, D'Arcy, sought to challenge the validity of Myriad Genetics Inc's Australian patent over isolated nucleic acid sequences encoding the BRCA1 gene, which is associated with an increased risk of breast and ovarian cancer. The dispute centred on whether these isolated DNA sequences were mere discoveries or inventions eligible for patent protection under Australian law.

The primary legal issue before the High Court was whether isolated nucleic acid sequences, which occur naturally in the human body, could be considered "inventions" for the purposes of the *Patents Act 1990* (Cth). Specifically, the Court had to determine if the isolation and identification of these naturally occurring sequences constituted a manner of manufacture within the meaning of section 6 of the *Statute of Monopolies* (as incorporated into Australian patent law).

The High Court, by majority, held that isolated human gene sequences were not patentable subject matter. The Court reasoned that the mere isolation of a naturally occurring substance, without further modification or application, did not transform it into an "invention" in the sense of a "manner of manufacture." The Court distinguished between a discovery of something that exists in nature and the creation of something new through human ingenuity. While acknowledging the utility of the isolated sequences, the Court found that their isolation did not involve sufficient inventive step to qualify as patentable.

The High Court allowed the appeal, setting aside the earlier decisions of the Federal Court and the Patent Office. Consequently, Myriad Genetics Inc's patent was declared invalid.

Orders