Methods of Genetic Testing Still Patentable

9 February 2018

This afternoon the Federal Court handed down its highly anticipated decision in Meat & Livestock Australia Limited v Cargill, Inc [2018] FCA 51. The matter has attracted substantial media attention in Australia and generated debate about whether patents claiming methods which use genetic information should be allowed.

The principal claims of the application in suit involve method claims for identifying a trait of a bovine subject from a nucleic acid sample. In particular, the invention made use of single nucleotide polymorphisms (SNPs).

In its decision, the Federal Court rejected Meat & Livestock Australia's (MLA) principal grounds of opposition to the grant of the patent, the result being that the application may proceed to grant subject to amendments to address issues of clarity and definition.

MLA's principal ground of opposition was that the claims of the patent did not satisfy the "manner of manufacture" requirement, that is, the patent application did not claim patentable subject matter.

MLA had argued that the invention was merely the discovery and use of naturally occurring polymorphisms (ie, SNPs) in nucleotide sequences that are associated with naturally occurring traits. His Honour rejected that argument and found that the principal claims were not simply directed to the SNPs or their association with the trait per se. The Federal Court distinguished the High Court's decision in D'Arcy v Myriad Genetics Inc [2015] HCA 35 (Myriad), which found that claims to certain isolated nucleic acids were not patentable subject matter. It was noted that all members of the High Court in Myriad were concerned with what in substance was claimed. In this case, the Court found that the invention as claimed involved the practical application of a naturally occurring phenomenon to a particular use.

Of note, MLA also argued that the patent, if granted, would have a chilling effect on future research in the livestock industry in Australia and would be contrary to the interests of the Australian public. The Court found that there was no cogent evidence to support that contention. Further, the Court noted that the breadth of the claims in a separate patent, of which MLA was a co-owner, hardly sat well with MLA's "chilling effect" argument.

The decision provides assurances that claims directed to the application of genetic material to a particular use continue to be patentable in Australia.

K&L Gates acted for Branhaven LLC, the successful applicant for the patent.

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