04 November, 2015

Genes Lost - Myriad Genetics Loses in the Australian High Court

The Myriad Genetics saga has been going on for several years now in the Land Down Under, and this writer has been waiting for the Australian High Court decision with bated breath. After a ruling in both the Federal Court and the Full Federal Court (more on which can be found here) in favor of Myriad Genetics, the cause seemed all but lost to the appellant, Yvonne D'Arcy. She was awarded the right to appeal to the High Court of Australia, who handed their judgment down only last month.

Although the case has been discussed on this blog before, some exposition is needed for those who might not be wholly familiar with the matter. The case of D'Arcy v Myriad Genetics dealt with the protein BRCA1; one that is quite relevant as a marker for a potential heightened risk for breast and ovarian cancer should it possess a mutation within it. Myriad Genetics acquired a patent for the sequence's isolation and subsequent analysis (Australian patent no. 686004), which was challenged by Yvonne D'Arcy, a cancer patient herself, in 2013.

What the High Court had to consider was whether the patent can be defined as a 'manner of manufacture' under the Statute of Monopolies 1623; a requirement for patentability under the Australian Patents Act 1990.

Genes are not that important
In a lengthy, multi-opinion decision, the High Court unanimously decided that the disputed claims of the patent were not a 'manner of manufacture', and thus were not patentable. Discussing the science and precedent, the majority still focused on the substance of the patent in in-depth detail. What Myriad Genetics argued, and the preceding judges agreed with, was that the isolation of the genetic sequence, and its analysis, created an artificial state of affairs, changing what is in simplistic terms a natural phenomenon into a man-made substance falling under the definition of a 'manner of manufacture'. The majority disagreed, and saw that "...the information stored in the sequence of nucleotides coding for the mutated or polymorphic BRCA1 polypeptide is the same information as that contained in the DNA of the person from which the nucleic acid was isolated. It is the existence of that information which is an essential element of the invention as claimed. The product is the medium in which that information resides". In the majority's view the isolation of the genetic content retains the very same information as occurs naturally within that person, adding or 'making' nothing new. Myriad Genetics' claims honed on the information within the genetic sequence, and not the chemical changes made to it when isolating, falling foul of a 'manner of manufacture' as a result, attempting to claim what already exists through nature (echoing, and accepting, the position by the US Supreme Court, more on which can be found here).

Ultimately what befell Myriad Genetics' case was the language used in the patent's claims, as stated by the majority: "Although it may be said in a formal sense that the invention as claimed, referring to isolated nucleic acids, embodies a product created by human action, that is not sufficient to support its characterisation as a manner of manufacture. The substance of the invention as claimed and the considerations flowing from its substance militate against that characterisation". As such the High Court allowed the appeal by Ms. D'Arcy.

The complexity and uncertainty around the case is evidenced by the length and multitude of opinions, and even though the decision was unanimous in allowing the appeal, the opinions reflect different approaches in arriving in the same answer. To this writer the focus seems to be very language specific, and had Myriad Genetics differentiated their claims through more specific, composition-heavy language, they could have been successful. Nevertheless, the case was more of a point of principle, as the patent expired only a few months ago, but it does set a precedent for the genetics industry in Australia. The Australian government has given guidance on proper practice in relation to genetic materials and patents, which looks gloomy for the industry, but the consultation does allow for comments and thoughts going forward.

Source: ABC Online 

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