FEDERAL COURT OF AUSTRALIA
D’Arcy v Myriad Genetics Inc [2014] FCAFC 115
SUMMARY
ALLSOP CJ, DOWSETT, KENNY, BENNETT & MIDDLETON JJ
5 SEPTEMBER 2014
SYDNEY
SUMMARY
1 In accordance with the practice of the Federal Court in some cases of public interest, importance or complexity, the following summary has been prepared to accompany the publication of the Court’s reasons for judgment. This summary is intended to assist in understanding the outcome of this proceeding and is by no means a complete statement of the conclusions reached by the Court. The only authoritative statement of the Court’s reasons is that contained in the published reasons for judgment which will be available on the internet at http://www.fedcourt.gov.au together with this summary.
2 The first respondent (Myriad) is the current owner of an Australian patent which contains claims directed to an isolated nucleic acid coding for a mutant or polymorphic protein by reference to a table prepared based on extensive epidemiological research.
3 The appellant (Ms D’Arcy) challenges the validity of the patent on the basis that the claims are not to an invention within the meaning of the Patents Act 1990 (Cth) (the Act), in that they are not claims to a manner of manufacture and are not to subject matter that is properly the subject of a patent under the Act. Ms D’Arcy submits that isolated nucleic acid is not materially different to cellular nucleic acid and that naturally occurring DNA and RNA, even in isolated form, are products of nature that cannot form the bases of a valid patent.
4 The primary judge upheld the validity of the claims.
5 The relevant principles are set out by the High Court in National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 (NRDC), recently affirmed in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (2013) 304 ALR 1. Not only are we bound by those principles, we also, with respect, agree with them. In particular, and of relevance to this decision:
• If a new use of a product consists in taking advantage of a hitherto unknown or unsuspected property of that product, there may be invention for the purposes of validity.
• Expressions such as “the work of nature” or “the laws of nature” are unhelpful when dealing with claims of a kind in this case.
• One may distinguish between discovery of a piece of abstract information without suggestion of a practical application to a useful end, on the one hand, and a useful result produced by doing something which has not been done by that procedure before, on the other.
6 In our view, the analysis should focus on the differences in structure and function effected by the intervention of man and not on the similarities. The isolated nucleic acid the subject of the claims has resulted in an artificially created state of affairs of economic benefit and is properly the subject of letters patent. The claims are to an invention within the meaning of s 18(1) of the Act.
7 We note that the Supreme Court of the United States came to a decision that an isolated naturally occurring DNA segment fell within a “products of nature” exception (Association for Molecular Pathology v Myriad Genetics, Inc, 596 US 12-398 (2013)). With respect, this approach is inapposite in an Australian patent law context. We find the reasoning of the majority in the corresponding decision in the US Court of Appeals for the Federal Circuit persuasive and in accordance with the approach in NRDC (Association for Molecular Pathology v United States Patent and Trademark Office and Myriad Genetics, Inc, 689 F.3d 1903 (2012)).
8 Accordingly, we do not accept the basis on which Ms D’Arcy argued that the patent is invalid.
