Supercow* (*Patent pending?)

In 2015, in D'Arcy v Myriad Genetics Inc, the High Court held that isolated nucleic acid sequences are not patentable subject matter in Australia. Following this landmark case, there has been extensive commentary on the implications of this case, including the potential impact on the validity of other patents directed to genetic based products, methods and processes.

In Meat & Livestock Australia Limited v Cargill, Inc [2018] FCA 51 (9 February 2018), Justice Beach of the Federal Court of Australia held that patent claims directed to providing methods for selecting, breeding and cloning cattle utilising genetic information were patentable.

Cargill and Branhaven's patent application

When breeding cattle, farmers naturally want to breed only those animals that are likely to pass on certain preferred traits to their offspring, such as a high milk yield for dairy cattle, or a fast growth rate and high meat quality for cattle destined for your local steakhouse.

The Cargill case concerned a patent application filed by Cargill, Inc and Branhaven LLC (collectively, Branhaven). The patent application (the Branhaven application) focused on methods that identified genetic differences between cattle and associated those differences with certain traits (such as marbling of meat, growth rate, and the like) in order to select, breed and clone cattle with the preferred traits. In particular, the Branhaven application focussed on single nucleotide polymorphisms (SNPs). An SNP is a DNA sequence variation in which a single nucleotide, at a specific location in the DNA sequence, differs - either between different members of that species, or between paired chromosomes in a single member of the species. SNPs can act as biological markers to locate genes that may be associated with certain traits in the species.

Meat & Livestock Australia Limited and Dairy Australia Limited (collectively, MLA) opposed the Branhaven application in the Australian Patent Office, but the opposition was largely unsuccessful. MLA appealed the decision to the Federal Court.

Was this technology something that could be patented?

MLA's principal attack was that the invention in each claim of the Branhaven application was not a "manner of manufacture" as required under the Patents Act 1990 - that is, the inventions claimed were not patentable subject matter. MLA relied heavily on Myriad and argued that each claim in the Branhaven application:

• was directed to the mere discovery of a naturally occurring correlation between naturally occurring SNPs and naturally occurring traits;
• did not give rise to anything that is man-made or an artificially created state of affairs that has economic utility;
• did not fall within the boundaries of existing patentable subject matter (which for public policy reasons, MLA argued, should not be extended to encompass such claims); and
• simply amounted to the use of standard techniques in a manner for which the known properties of those techniques make them suitable.

From the outset, Justice Beach distinguished this case from Myriad for all but one of the 15 claims of the Branhaven application. Justice Beach said this case principally concerned method claims rather than product claims to nucleic acid molecules. This was in contrast to the claims the High Court considered in Myriad. He noted that there had been no suggestion in Myriad that claims to methods involving the practical application of nucleic acids could be dismissed as being directed to genetic information only.

Claim 1 of the Branhaven application referred 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 went on to specify claimed locations for the relevant SNPs. Justice Beach considered that claim 1 involved the practical application of a naturally occurring phenomenon to a particular use, i.e. the process of identifying the trait.

Justice Beach stated:

"It [the claimed invention] is not just the mere identification or discernment of the naturally occurring phenomenon, contrary to MLA’s assertions. The claimed method involves human interaction and the creation of an artificially created state of affairs. It requires the taking of a nucleic acid sample of the bovine subject through an appropriate procedure. It requires the identification in that sample of at least three SNPs that meet the requirements of the claim, which involves analysing the sample to identify SNPs present that are associated with the trait. It involves the creation of an artificially created state of affairs of economic significance through human interaction."

In referring to the creation of an artificial state of affairs of economic significance, Justice Beach applied the principles in NRDC v Commissioner of Patents [1959] 102 CLR 252, the seminal High Court decision on patentable subject matter, which was also considered in detail in Myriad.

Justice Beach held that the claims of the Branhaven application (other than claim 13 - see below) were directed to novel and inventive methods and processes which were within the "plain vanilla concept of manner of manufacture as outlined in NRDC and Myriad".

In Myriad, the High Court identified a number of "other factors" (such as the potential chilling effect on innovation, the coherence of the law, and conflicting private and public interests) which warranted consideration where a claimed invention is on the border of what is currently considered patentable subject matter. Because the claims were within the established boundaries of what is patentable subject matter, Justice Beach decided that regard did not need to be had in this case to those "other factors". Even if he was wrong about this, Justice Beach said, he would still have found the inventions the subject of the Branhaven application to be patentable subject matter in light of those "other factors". In particular:

• there was "no cogent evidence" to support MLA's contention that there would be a "chilling effect" on livestock research in Australia if the Brahaven patent were granted - indeed, there were a number of other granted patents in the area (ironically, the inventors of one of these granted patents were two expert witnesses called by MLA) which clearly had not curtailed the research which resulted in the inventions the subject of the Branhaven application; and
• MLA's arguments in relation to the desirability of achieving coherency with foreign law were based on decisions in the United States, based on the law as it stands in that country, rather than presenting any comprehensive survey of the position internationally.

There was only one claim which did not satisfy the manner of manufacture requirement. Claim 13 claimed an “isolated polynucleotide identified according to the method of claim 8”. As Branhaven had not formally appealed the Patent Office decision in respect of claim 13, there was strictly speaking no need for Justice Beach to make a finding on this claim. However, he did indicate that he agreed that claim 13 was not patentable subject matter in light of Myriad.

Is a cloned cow a "manner of manufacture"?

Claim 11 of the Branhaven application claimed a bovine (eg. cow) resulting from a cloning method that was claimed separately. As a cloned cow is genetically identical to the one it originated from, MLA suggested a cloned cow is "mere genetic information on a grander scale" and that, as such, Myriad was directly applicable - it could not, MLA argued, be patentable subject matter.

While acknowledging this submission had a "superficial allure", Justice Beach rejected it, as a cloned cow is an artificial object of economic significance which is produced for its own sake, not merely as a receptacle for its informational content. This leads to the interesting result - in theory at least - that an isolated naturally occurring DNA sequence is not patentable, but a cloned animal produced by means of the claimed techniques (and, axiomatically, containing the relevant DNA sequences) may be patented.

Other grounds and outcome

The case also considered other grounds for patentability, including novelty and inventive step. As noted above, Justice Beach was satisfied that the claimed invention was novel and inventive. With the exception of claim 13, MLA's only success in the appeal was Justice Beach's finding that some of the claims of the Branhaven application lacked clarity, did not adequately define the invention and, in some respects, lacked "utility" (ie. carrying out the method in the form claimed would not produce a useful result). Justice Beach indicated that these deficiencies could likely be overcome by amendments to the claims.

Conclusion

Branhaven has now had an opportunity to file amended claims to address the clarity and related issues identified by Justice Beach. In his decision, Justice Beach gave some guidance as to the nature of the amendments that will be necessary. So it would appear likely that the patent (with the exception of claim 13) will proceed to grant in the near future.

This decision by Justice Beach confirms the relatively narrow compass of the outcome in Myriad. It is clear that Australia is still a jurisdiction that provides extensive patent protection for genetic technologies. In particular, the decision confirms that patent protection is available for genetic based methods and processes where naturally occurring genetic information is identified, analysed and applied to practical and useful effect. Of course, such processes also have to satisfy the stringent requirements of novelty and inventiveness, before being eligible for a patent.