In a recent decision,1 the Federal Court of Australia found that the subject matter of Australian patent application No. 2010202253 was patentable. The patent application concerned a method of using DNA analysis to identify cattle with favourable traits.
A brief overview of this case was reported recently.2 Here we provide further details on this important decision.
Australian Patent Application 2010202253 (the ‘253 application)
The ‘253 application describes an invention providing ‘methods, compositions and systems for managing, selecting, breeding and cloning cattle utilising information regarding genetic diversity among cattle, particularly single nucleotide polymorphisms (SNPs) and the effect or potential effect of nucleotide occurrences of SNPs on important traits.’ 3
Claim 1 of the ‘253 application is directed to:
‘A method for identifying a trait of a bovine subject from a nucleic acid sample of the bovine subject, comprising identifying in the nucleic acid sample an occurrence of at least three single nucleotide polymorphisms (SNPs) wherein the at least three SNPs are associated with the trait, and wherein the at least three SNPs occur in more than one gene:and wherein at least one of the SNPs corresponds to position 300 of any one of SEQ ID NOS: 19473 to 21982, or the SNP is about 500,000 or less nucleotides from position 300 of any one of SEQ ID NOS: 19473 to 21982.’
Grounds for the appeal from the patent office decision
The appeal to the Federal Court of Australia was from an opposition brought by Meat and Livestock Australia (MLA) joined by Dairy Australia, against the US owners of the ‘253 application, Branhaven LLC and Cargill Inc.
The appeal’s principal focus was that the claims of the ‘253 application did not satisfy the requirements for patentable subject matter, i.e. a ‘manner of manufacture’. In particular, it was asserted:
– that the claims were directed to the mere discovery of naturally occurring correlation between naturally occurring SNPs and phenotypic traits, such traits not giving rise to anything that was made, created or provided economic utility; and
– that the claims did not fall within the bounds of ‘patentable subject matter’ as all that was being claimed, was ‘the use of standard techniques known to be suitable for the claimed purposes’. 4
Rejecting these arguments, the Court stated that the claims of the ‘253 application were directed to ‘artificial subject matter being the result of human action, rather than something that exists in nature per se’. 5 As such, the Court considered the claims of the ‘253 application to be directed to patentable subject matter.
The Court distinguished the 2015 High Court decision of Myriad, stating that:
– the claims in Myriad were directed to purely genetic information; and
– the claims in this appeal were not directed purely to genetic information, because where a claim is construed to be to a method comprising a practical application of nucleic acids, such a method should not be regarded as merely being directed to the genetic information employed within that method.6,7
As such, the Court found that, upon proper construction, there was a clear distinction between the circumstances of the Myriad case and those of this appeal.
In addition, the Court found that MLA’s other arguments, namely lack of novelty and lack of inventive step, did not succeed, as the documents relied upon provided no clear disclosure of the claimed method and would not lead a person skilled in the art to the claimed invention.8,9
Clarity, failure to define the invention and lack of utility
MLA had some success on questions of claim construction and associated grounds dealing with lack of clarity and lack of definition.
The Court found that claim 1 as currently drafted was ambiguous and therefore lacked clarity, failed to define the invention and lacked utility. In particular, it was found that the term ‘associated’, when discussing the correlation between SNPs and a trait, required a stipulation of the degree of statistical significance which would establish the requisite association.10 As such, the Court found that this claim failed to adequately define a clear, utile methodology.
However, the Court flagged the possibility of amendment to address these deficiencies, stating:
‘Several integers of the relevant claim(s) will need to be amended to deal with questions of linkage disequilibrium between relevant single nucleotide polymorphisms and also to address questions of statistical significance. And if appropriate amendments are made, then the conclusions of lack of clarity, lack of definition and the residual aspect of lack of utility that I have reservations about fall away.’ 11
The Court ultimately determined that claim 1 and analogous claims were deficient on the grounds of clarity, failure to define the invention and a lack of utility. As such, the appeal was upheld only in respect of these grounds. However all other grounds of the appeal were dismissed.
Final orders of this decision were reserved, pending submissions from the parties in relation to claim amendments to address the deficiencies outlined in the judgement. These submissions are due 2 March 2018.
This decision, handed down by the Federal Court of Australia, differentiates between isolated genetic material (being insufficient to meet the requirements of patentable subject matter as established by the Myriad decision), and methods of using genetic material, which have been found to be patentable under Australian patent law. 12
1. Meat & Livestock Australia Limited v Cargill, Inc  FCA 51
3. Meat & Livestock Australia Limited v Cargill, Inc  FCA 51 (147)
4. Meat & Livestock Australia Limited v Cargill, Inc  FCA 51 (386)
5. Meat & Livestock Australia Limited v Cargill, Inc  FCA 51 (453)
6. D’Arcy v Myriad Genetics  HCA 35
7. Meat & Livestock Australia Limited v Cargill, Inc  FCA 51 (454)
8. Meat & Livestock Australia Limited v Cargill, Inc  FCA 51 (521
9. Meat & Livestock Australia Limited v Cargill, Inc  FCA 51 (777)
10. Meat & Livestock Australia Limited v Cargill, Inc  FCA 51 (298)
11. Meat & Livestock Australia Limited v Cargill, Inc  FCA 51 (15)
12. D’Arcy v Myriad Genetics  HCA 35
This article was written by Dr Benjamin Cleary and Daniel Ash.
If you have any specific enquiries about this article, please contact Paul Jones or Debra Tulloch.