​Accelerated breeding won’t come for free

Accelerated breeding won’t come for free


Beef Cattle
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Op Ed: Lawyer's perspective on the genome patent case

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SYDNEY lawyer Peter Noble, who has extensive experience in the beef industry including owning an abattoir and serving as chairman of the Australian Meat Processing Corporation, provides a comprehensive insight into the cattle genome patent application. 

“ON February 9, the Federal Court of Australia published a 949-paragraph decision in Meat and Livestock Australia (MLA) v Cargill Inc and Branhaven.

The matter has attracted substantial media attention in Australia and generated debate about whether patents claiming methods which use genetic information should be allowed.

MLA  prosecuted the matter contending, colloquially, the grant of a patent would result in ownership of the genome.

The assertion was that ownership of a genome should not, as a matter of public policy and therefore as a matter of law, be capable of being owned by anyone.

Consequently, any attempt at securing a patent should fail.

The defendants agreed with the public policy position but asserted they did not seek to own a genome. The defendants asserted, and established, the principle claims of the patent subject of the proceedings involve the ownership and therefore patentability of methodologies for identifying traits of a bovine genome from a nucleic acid sampling.

In particular, the invention deployed the use of single nucleotide polymorphism (SNPs), pronounced in shorthand snips. SNPs technology, at its essence, allows for the acceleration of breeding outcomes.

The question is can such technology be patented.

That was the contest and subject to the defendants being entitled to amend their claim to better clarify and define it, the defendants will be permitted to establish the patent.

The case is important for a number of reasons.

First, it confirms the public policy notion that certain things as they occur in nature, for example genomes, cannot be owned and therefore patented. On this there was, in spite of MLA’s public posturing, no contest.

Secondly it upheld that methods of genome manipulation were capable of being owned and patented.

Manipulation of genetics is, after all something cattle breeders have done for millennia: That is, they breed in or out, certain genetically determined characteristics.

The SNP technology is about just that.

As indicated, it seeks to accelerate and render more certain the reference in or out of desired and undesired genetically determined characteristics.

MLA’s principle ground of opposition was that the claims of the patent did not satisfy the manner of manufacture requirement, that is, the patent did not claim patentable subject matter.

MLA had argued that the invention was merely the discovery and use of naturally occurring polymorphisms (SNPs) in nucleotide sequences that are associated with naturally occurring traits.

His Honour rejected that argument and found that the principle claims were not simply directed to the SNPs or their association with the trait per se.

Of note, MLA also argued that the patent, if granted, would have a chilling effect on the 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 evidence to support that contention.

Further, the Court noted that the breadth of the claims in a similar patent, of which MLA was a co-owner, hardly sat well with MLA’s chilling effect argument.

Contextually this debate (as with all patents) must be considered as a contest between principles in collision.

As a matter of principle inventors should be entitled to reward for effort.

As a matter of principle, the public interest is served by rendering the fruits of an invention available to the public at affordable cost.

This collision is a perennial in the field of medical research.

On the first principle, the inventors commenced research in or around 2002 with the research and development gaining momentum in around 2004. The best estimate is that research cost around $100 million.

Whilst the MLA contended the invention is not patentable, the technology is in present use and comes at a cost to users however there has been no return to the inventors: its present use will be in breach of patentable rights once the patent is registered. Sixteen years later the patent is as yet unregistered.

There is a public interest in allowing a return on such investment to facilitate privately funded research and development.

On the second principle there is a public interest in not allowing, even the inventors and their financiers as risk takers, to reap a reward at the expense of the public good (access to the new technology) for too long or at too high a cost.  

In the litigation the MLA contended:

  • the practical application of a naturally occurring phenomenon to a particular use was not patentable: The Court found it was.
  • the invention lacked novelty: The Court found it was novel.
  • the invention lacked an inventive step: The Court found it did.
  • the invention lacked utility: The Court found it had utility.
  • the invention was insufficient: The Court found it was capable (subject to clarification) of being sufficient.
  • the patentable matter was not fairly based on the invention: The Court found (subject to clarification) that it was.  

The Court has afforded the defendants an opportunity, as indicated, to amend their claim to better clarify and define it.

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

Finally, anyone who maintains our superior court Justices are paid too much should read this decision.

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