Australia: Appeal lodged in gene patents decision

Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65

On 15 February 2013, Justice Nicholas of the Federal Court of Australia delivered the first Australian decision regarding the validity of gene patents.

At issue was whether a valid patent may be granted for a claim that covers the composition of isolated nucleic acid, being DNA or RNA, from a naturally occurring sequence.¹ Significantly, Justice Nicholas determined that a valid patent can be granted for such a claim.

Maurice Blackburn, solicitors for Ms D'Arcy, one of the applicants in the case before Justice Nicholas, lodged an appeal against the decision on 4 March 2013. The other applicant, Cancer Voices, is not an applicant in the appeal.

Background

Myriad Genetics Inc. (Myriad) is the owner of a patent (686004) involving a particular gene (BRCA1), which is a human breast and ovarian cancer disposing gene. Mutations of BRCA1 are indicative of a predisposition to breast cancer and ovarian cancer. Myriad's patent claims isolated DNA or RNA sequences. Naturally occurring DNA and RNA as they exist in cells are not within the scope of Myriad's patent.

Ms D'Arcy and Cancer Voices Australia (the national network of state Cancer Voices organisations representing Australians affected by cancer) brought an application challenging the claims in the Myriad patent solely on the basis that they include non-patentable subject matter.² They argued that naturally occurring DNA and RNA, even in isolated form, are products of nature that cannot form the basis of a valid patent.³

Myriad contended that each of the disputed claims are valid because the patent claims a product that consists of an artificial state of affairs, providing a new and useful effect that is of economic significance.⁴ In response, the applicants accepted that what was claimed in the patent was of "economic significance" but maintained that the claims related to non-patentable subject matter.

Issue

The issue of the patentability of isolated DNA or RNA sequences turned on whether the substance is a "manner of manufacture" within s 18(1)(a) of the Patents Act 1990 (Cth) (the Act).

Decision

Justice Nicholas held that each of the disputed claims is to a manner of manufacture as required under the Act.⁵ His Honour found that the patent's claims extended only to DNA and RNA which have been extracted from cells obtained from the human body and purged of other biological materials with which they were associated ⁶ - that is, an artificial state of affairs.⁷

Reasoning

Applying the principles set out in the case of National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252, Justice Nicholas identified that the critical issue in the case is whether isolated nucleic acid constitutes an artificial state of affairs, in circumstances where isolated nucleic acid has precisely the same chemical composition and structure as that found in the cells of some human beings.⁸

Justice Nicholas' concluded that isolated nucleic acid constitutes an artificial state of affairs for three reasons: ⁹

1. The concept of the "manner of manufacture" had a "broad sweep" and the High Court had been deliberate in its use of very expansive language when explaining that concept as one involving the creation of an artificial state of affairs.¹⁰
2. Isolation of nucleic acid is the result of human intervention involving the extraction and purification of the nucleic acid found in the cell.¹¹
3. Isolation may require immense research and intellectual effort and it would be an odd result if that skill and effort could not be rewarded because the isolated DNA sequence was inherently non-patentable no matter how practically or economically significant.¹²

Justice Nicholas was fortified in his decision as the Act does not exclude the grant of a patent for isolated DNA or RNA sequences and the decision was said to reflect the longstanding practice of the Australian Patent Office to grant patents for these substances.¹³

Conclusion

The appeal from Justice Nicholas' judgment will be heard later this year. By that time, the Supreme Court of the United States may well have ruled upon a similar challenge to the validity of Myriad's US Patent including claims to isolated DNA.

Footnotes:

¹ Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65 [1].
² Ibid [8].
³ Ibid [6].
⁴ Ibid [7].
⁵ Ibid [137].
⁶ Ibid [136].
⁷ Ibid [106].
⁸ Ibid.
⁹ Ibid.
¹⁰Ibid [107].
¹¹Ibid [108].
¹²Ibid [108]-[109].
¹³Ibid [112], [114].

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