In the recent decision of Meat & Livestock Australia Limited v Cargill, Inc [2018] FCA 51, the Federal Court has upheld MLA's appeal against a patent application for identifying desirable cattle traits but also dismissed suggestions that the potential patent claims will have a "chilling effect" on future research in the livestock industry in Australia.
Meat and Livestock Australia (MLA) has successfully challenged (at least, for the time being) the application by US industry giant, Cargill (and associate, Branhaven LLC) to patent fifteen method claims for identifying a trait of a bovine animal from a nucleic acid sample of the animal. The patent was granted by the Patents Office in May 2016.
The Cargill invention
It sounds like a mouthful, and ultimately it's intended to influence those juicy steaks that go into our mouths at the dinner table: Australian patent application number 2010202253 titled “Compositions, methods and systems for inferring bovine traits”.
The field of Cargill's invention relates generally to gene association analyses, specifically to single nucleotide polymorphisms (SNPs)and correlated traits in cattle. Among other things, the invention is described as "methods, systems, and compositions... that allow the identification and selection of cattle with superior genetic potential for desirable characteristics... for managing, selecting and mating, breeding, and cloning cattle... to collect, record and store such data by individual animal identification..."
Since Gregor Mendel's ground-breaking experiments on genetic inheritance in peas in the 1860s, animal breeders and researchers have been interested in how variation in the genetic blueprint of an animal is associated with variation in the traits expressed by an animal and how these variations influence the way the animal looks and performs. By measuring the phenotype (traits) of an individual, and its relatives including its siblings and offspring, it is possible to obtain information on the breeding value of an animal or how well its offspring will perform compared to other individuals in the population.
Ultimately, Cargill's invention would allow it to identify and select superior cattle based on traits which include, but are not limited to, marbling, tenderness, quality grade, quality yield, muscle content, fat thickness, feed efficiency, red meat yield, average daily weight gain, disease resistance, protein content, milk production, hide quality, stress susceptibility and response, temperament, digestive capacity, pattern of fat deposition, ribeye area, fertility, ovulation rate, conception rate, fertility, heat tolerance, environmental adaptability, and so on.
Naturally, the commercial impact of the patent would be significant and MLA has been 'playing for (cattle) stations'.
Opposing Cargill's patent, MLA asserted the application in substance:
is to the mere discovery of a naturally occurring correlation between naturally occurring SNPs and naturally occurring traits;
does not give rise to anything that is man-made or an artificially created state of affairs that has economic utility;
does not fall within the boundaries of existing patentable subject matter, and in light of other matters such as the chilling effect of the grant of such claims and the desire for cohesion of the law both within Australia and with the US, such boundaries should not be extended to encompass such claims; and
in any event is not patentable because on the face of the specification all that is claimed is the use of standard techniques in a manner for which the known properties of those techniques make them suitable.
The Court's findings
In a pithy judgment that would shade many textbooks for its ability to summarise and explain scientific principles of genetics, his Honour Beech J found that Cargill's patent application, in its present form, is deficient in its clarity, failed adequately to define the subject invention and did not adequately identify whether it has industrial use.
However, the Court has not made any final orders dismissing the patent application and it gave a clear indication as to how it thinks the application should be amended.
“I will not, however make any final orders until Branhaven has been given the opportunity to consider whether to apply or amend any of the claims to address the concerns I have expressed in these reasons”
Implications
First, it's not over. MLA has had a provisional win - but Cargill has an opportunity to address the deficiencies in its application as highlighted by the Court.
Secondly, his Honour drew on the principles set out in the recent landmark decision in D'Arcy v Myriad Genetics Inc (2015) 258 CLR 334 (where the High Court ruled that the BRCA1 gene mutation linked to breast cancer could not be patented in Australia) and found that Cargill's claims were not directed to “naturally occurring genetic information per se”.
Instead, it would appear the Court has accepted that the methods proposed by the Cargill application are indeed capable of patenting. The implications are obvious: if the application is amended to address the identified deficiencies, Cargill stands to assert significant commercial control over methods and systems for identification and selection of cattle with superior genetic potential for desirable characteristics. The Australian cattle industry will be watching closely for Cargill's next move.