The High Court of Australia today heard the long anticipated appeal from the unanimous decision of a 5-judge bench of the Full Federal Court to allow Myriad’s claims to isolated nucleic acids1.
The question before the High Court is whether the invention claimed in claims 1-3 of Australian Patent No. 686004,2 owned by Myriad Genetics, is a manner of manufacture within the meaning of s 6 of the Statute of Monopolies, as required by section 18(1)(a) of the Patents Act 1990. The test for “manner of manufacture” was defined by the High Court in NRDC,3 and requires that the claimed invention involve an artificially created state of affairs in a field of economic utility.
Today’s hearing follows yesterday’s decision by the High Court to deny leave to the Institute of Patent and Trade Mark Attorneys (IPTA) to be heard as amicus curiae. IPTA made submissions to the Court on the basis that section 51(xviii) of the Constitution is broad enough to cover isolated nucleic acids, and that in the absence of explicit exclusions the Patents Act should be interpreted to “occupy the full permissible landscape given by section 51(xviii) of the Constitution”.4
The Commonwealth, through the Attorney-General, also sought to intervene in the event that the High Court granted IPTA leave to be heard. Whilst explicitly stating that the Commonwealth makes no submissions on the ultimate question of whether isolated nucleic acid is patentable, the Attorney-General was critical of IPTA’s submissions, noting that the question before the Court “can be decided fully and completely on the proper construction of the Patents Act without the need to examine the reach of the grant of power under s 51(xviii) of the Constitution”.5 Further that the “Court should not resolve the appeal by deciding a constitutional question in circumstances where this not necessary of the matter”.6
The decision of the High Court to deny IPTA leave to be heard meant that the Court only heard from the original two parties today and no new arguments were heard.
In today’s hearing, counsel for the Appellant, Mr Catterns QC, argued that, while the isolation of the BRCA1 gene by Myriad may be a “fine and laborious piece of science”, claims to isolated nucleic acids without any limitation to a useful application are claims to products of nature, which Mr Catterns submitted is the “antithesis of an artificially created state of affairs” and therefore excluded from patentability.
The Appellant’s arguments relied heavily on the reasoning of the US Supreme Court in AMP v Myriad Genetics7, asserting that the isolated nucleic acids are in substance identical to the corresponding sequences in nature. Contrary to Myriad’s submissions that isolated nucleic acids are chemically, structurally and functionally different from the naturally occurring nucleic acids and have new applications which do not apply to the sequences as found in nature,8 Mr Catterns argued that the isolated polynucleotide sequences code for the same polypeptides as encoded by the gene as found in nature and are therefore, in substance, the same.
Following the Appellant’s submissions, counsel for Myriad, Mr Shavin QC, argued that claims 1-3 of the Myriad patent are not to genetic information, rather they are claims to a new chemical entity and that there is “no jurisprudential basis or normative principle upon which claims to isolated nucleic acids should be treated differently from any other technology”.9
Myriad’s arguments centered on the notion that the isolated nucleic acids have utility in isolated form that they do not possess in their native form inside a cell. Accordingly, Mr Shavin argued that an isolated nucleic acid is “different from nature in the critical sense that it has utility”. The Court accepted that utility is inextricably linked to what is isolated, however the Court also noted the utility needs to be linked to the artificiality in order to define patentable subject matter. In light of the fact that the sequence of nucleic acids is substantially unaltered by the isolation process, the Court did not appear to consider that the utility was sufficiently linked to the artificiality of the isolated material.
While Mr Shavin cautioned the Court against “carving out” from the principles of NRDC, it may not be necessary for the Court to do so in order to find that the claims at issue do not relate to an artificially created state of affairs. Further, the day’s proceedings suggest that the Court’s consideration will be confined to claims to isolated nucleic acids, leaving aside any broader question of patentability of isolated biological material.
The decision, expected later this year, will be keenly awaited.
1 D’Arcy v Myriad Genetics Inc. [2014] FCAFC 115.
2 Due to expire on 11 August 2015.
3 National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252; endorsed by the High Court in Apotex Pty Ltd v Sanofi Aventis [2013] HCA 50.
4 IPTA Submissions at [34].
5 Attorney-General’s Submissions at [6].
6 Ibid at [10].
7 Association for Molecular Pathology v Myriad Genetics 569 US 12-398 (2013)
8 First Respondent’s Submissions at [48]-[50].
9 Ibid at [45]