PATENT law experts have weighed in on the legal battle being waged by cattle producers to prevent US interests controlling a gene-based method for improving breeding.
The attempt by Cargill USA and and Branhaven LLC to patent a method of identifying beneficial genetic traits in cattle using DNA analysis - genomics technology - is proving to hold enormous interest in the intellectual property (IP) field.
Meat and Livestock Australia (MLA) has appealed the decision by the Australian Patent Office to accept the grant and the Federal Court of Australia last week found some merit in the MLA argument, namely around the broad nature of the claim.
However, the two companies were given a short period to amend their claim, which IP experts said effectively paved the way for the patent to eventually be granted.
Cargill and Branhaven would then be able to charge cattle breeders a licensing fee to use genomic methods that fall within the scope of the patent, which accounts for more than half the DNA-associated tests currently used in our beef and dairy industries.
One of Australia’s foremost biotechnology IP experts, Dr Grant Shoebridge, from Shelston IP, said the judgement gave an explicit indication as to how the patent application could be amended to render it valid.
“That strongly suggests the patent will ultimately be granted and enforced in Australia,” he said.
He noted Cargill wasn’t represented in the appeal and made the point that if the patent was successful, it may be in the interests of Australia’s beef industry to have Cargill a joint owner.
Firstly, in the event the patent was granted, the co-patentees, Branhaven and Cargill, would need to agree to the terms of licenses issued, he said.
“What should be understood is that having a patent granted doesn’t automatically mean people will have problems in relation to using the technology,” Dr Shoebridge said.
Not only could Cargill prevent the patent being enforced but if it was, it could influence the establishment of reasonable licence fees.
It is, of course, possible for patents to be onsold. Total ownership of the patent by a party with no interest in the betterment of the Australian cattle industry could be a far worse outcome for producers.
If the patent did go to grant, MLA, or anyone else, could also initiate revocation proceedings, Dr Shoebridge said.
“There are many uncertainties at the moment - whether it will be granted, whether there will be further legal proceedings to revoke that, whether it will be enforced and whether the licence fees will be reasonable,” Dr Shoebridge said.
If this patent application was unsuccessful, it was not possible for another party to attempt to patent the same technology because it would longer be new or novel, having been disclosed in this process, Dr Shoebridge said.
Murdoch University’s Luigi Palombi, a well-known patent law expert who has been involved in several gene patent cases, said an outcome might still be a long way off.
“There is no chance the current application will be granted unless amended but an amended version is still no guarantee - it will depend on whether those changes satisfy the next judge,” he said.
“Indeed the next ruling could trigger yet another set of amendments.”
Why others care
THE high level legal battle over a cattle genomics patent is being watched closely by legal and medical experts who believe it will have ramifications far further afield than the beef farm.
Intellectual property expert Dr Grant Shoebridge said the case was the first time the Federal Court of Australia had considered in depth the Myriad Genetics breast cancer High Court decision.
In 2015, the High Court of Australia found isolated naturally-occurring gene sequences were not patentable.
“A number of commentators felt that decision invalidated patenting methods of using gene screening as a diagnosis,” Dr Shoebridge explained.
“What the MLA verses Cargill/Branhaven decision on Friday indicates, however, is the method of using gene sequences to identify beneficial traits in cattle breeding is indeed a patentable subject matter.
“That is a really important development because personalised medicine is a significant emerging field and in Australia we are using genetic screening as diagnostic and prognostic tests.
“This particular case strongly suggests that such tests are patentable subject matter here. In the US, these methods are generally not patent eligible.”