Federal Court of Australia holds methods of genetic testing patentable subject matter

The Federal Court of Australia confirmed that methods of genetic testing remain patentable subject matter. Meat & Livestock Australia Limited v Cargill, Inc [2018] FCA 51 was an appeal to the Federal Court from a pre-grant opposition to Australian patent application number 2010202253. Whilst the standard of such a proceeding is lower than in a corresponding revocation proceeding, it is still indicative of the approach the Federal Court is likely to take to this subject matter.

The Decision

In considering the matter de novo, Beach J. held that the appellant (Meat & Livestock Australia) was successful in establishing three minor grounds of opposition. It seems likely that the Applicant will be able to remedy these grounds by way of amendment. However, the key grounds of opposition, including that the invention did not relate to patentable subject matter, lack of novelty and lack of inventive step were unsuccessful. In an extensive and wide ranging decision of 942 paragraphs, it is the decision in the relation to patentable subject matter which is of most interest.

In D’Arcy v Myriad Genetics Inc (2015) 258 CLR 334 (discussed here) the High Court of Australia held that isolated naturally occurring genetic material was not patentable. However, the Court in D’Arcy was not called on to consider whether methods of genetic testing are patentable subject matter, i.e. a manner of manufacture.

The claims in question in AU 201020253 (with the exception of claim 13), can be summarised as methods of inferring or identifying a trait of a bovine subject comprising testing for single nucleotide polymorphisms. Thus Beach J. needed to consider whether, as a result of the decision in D’Arcy, methods of genetic testing, where the contribution over the art is the sequence tested for, are patentable.

In arriving at his decision, Beach J. utilised the two step test for assessing if the claimed invention should be patentable subject matter that was approved by the majority in D’Arcy: Firstly, were the claims within the established boundaries of a manner of manufacture, and, if not, whether other factors (e.g. policy considerations) led to the subject matter falling outside what should be patentable.

In deciding that methods of genetic testing were within established boundaries of patentable subject matter, Beach J. held:

· The claims are not directed to genetic information. They are methods involving the practical application of the identification of SNPs. (at 453)

· “It is impermissible to disregard the wording of the claims and diminish their formal content under the guise of having regard to the “substance” of what is claimed. There is no suggestion in Myriad that claims to methods involving the practical application of nucleic acids could be dismissed as being in substance just directed to genetic information.” (at 454, existing emphasis)

· There is no separate ‘threshold’, e.g. asking whether a claim is sufficiently artificial in order for the subject matter to be patentable (at 456-461).

Notwithstanding that Beach J. considered that the claims were within the established boundaries, he went on to consider the “other factors” which were alleged to be in favour of not extending the boundaries to include the subject matter, holding:

· An argument for consistency with the decision in Myriad failed. The claims in question were method claims which applied the information, not claims to the information per se (at 487).

· An argument for consistency with foreign law failed. Whilst the US may have rejected claims of a similar nature in Mayo Collaborative Services v Prometheus Laboratories, Inc. 566 US 66 (2012) and Ariosa Diagnostics Inc. v Sequenom, Inc. 788 F3d 1371 (3d Cir 2015), no comprehensive international survey was provided showing this was the global position. Beach J. also had concerns about the clarity of the US approach set down in Mayo.

· There was no cogent evidence of the assertion that the claims would have a substantial chilling effect on future research (at 496). Moreover, the breadth of the claims, although relevant as an “other factor”, is something that arises under other distinct grounds of invalidity such as clarity and sufficiency, and thus is not per se indicative of a lack of patentable subject matter.

Thus the claims directed to methods of genetic testing were held to be patentable subject matter.

Beach J. was also called on to determine if a claims of the following formats were patentable:

13. An isolated polynucleotide identified according to the method of claim 8.

14. An isolated polynucleotide when used in any one of methods 1 to 10…

In rejecting the argument in relation to claim 13 that the words “identified according to the method of claim 8” moved the claim outside the principle set down in D’Arcy, Beach J. stated that to do so would “be a triumph of form over substance” (at 482).

However, claim 14 was interpreted as the product in its use, and was therefore held to be patentable (at 483).

Comment

This decision is probably unsurprising, especially in light of the general feeling of the majority in D’Arcy. Moreover, it remains to be seen what the approach of higher levels of court will be. Nevertheless, it is pleasing to have a decision which clearly states that methods of genetic testing are, at least at present, considered to be patentable.

It is also pleasing that the Federal Courts have chosen not to read a “threshold” test into the test for a method of manufacture, as was suggested by the decisions of Justices Gageler and Nettle in D’Arcy. Applying a “sufficiently artificial” threshold test would potentially have extended the D’Arcy decision beyond information coding molecules to any naturally occurring molecule isolated by a routine means – a result that the majority decision in D’Arcy seemed to be carefully calculated to avoid.

The decision also highlights that, at least at present, there is a distinction between the Australian approach, and the United States approach to claims directed to laws of nature. In Australia, while it is no longer possible to achieve protection for an isolated naturally occurring nucleic acid, it remains possible to claim tests determining the presence of the nucleic acid in relatively broad terms, without the difficulties faced in the United States in light of the Mayo and Ariosa decisions. It is worth noting that a dispute relating to the corresponding Australian patent to that in Ariosa Diagnostics Inc. v Sequenom, Inc. 788 F3d 1371 (3d Cir 2015) is due to be heard by Beach J. in August 2018, so this is not his last word on this subject matter.

We will keep you updated on any developments in this space. If you have any questions please do not hesitate to contact us.

David Nowak - February 2018

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