Appeal filed against Federal Court Ruling that Gene Patents are Patentable

On 4 March 2013, a Notice of Appeal was filed by cancer survivor Yvonne D’Arcy against the decision of Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65 (“Cancer Voices”), which held that isolated nucleic acid such as isolated DNA and RNA is patentable subject matter in Australia.  In this post, we take a look at the basis for the appeal.

Cancer Voices

In Cancer Voices, Nicholas J considered that a composition of matter may constitute patentable subject matter if it consists of an artificial state of affairs, that has some discernible effect, and that is of utility in a field of economic endeavour.  The claims in question were Claims 1, 2 and 3 of Australian Patent 686004:

1.            An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1  one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19.

2.            An isolated nucleic acid as clamed in claim 1 which is a DNA coding for a mutant BRCA1 polypeptide, said DNA containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:  1 one or more mutations set forth in Tables 12, 12A and 14.

3.            An isolated nucleic acid as claimed in claim 1 which is a DNA coding for a polymorphic BRCA1 polypeptide, said DNA containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1 one or more polymorphisms set forth in Tables 18 and 19.

These claims were not challenged on the grounds of novelty, inventive step, utility or fair basis.

BRCA Abstract

Fig 6 of Australian Patent 686004

In deciding that the claims to isolated nucleic acids were an artificial state of affairs, Nicholas J considered at [104] that:

“In the context of biological material, an artificial state of affairs may manifest itself in different ways. The physical properties of the naturally occurring material may have changed as a result of it having been isolated. But even if the physical properties of the material have not changed, the removal of the material from its natural environment and its separation from other cellular components may still give rise to what might reasonably be described as an artificial state of affairs.”

Nicholas J then set out three considerations at [107] to [109] which led his Honour to think that  an isolated nucleic acid, which may be assumed to have precisely the same chemical composition and structure as that found in the cells of some human beings, constitutes an artificial state of affairs.  Of particular importance was the consideration at [108] and [109] that:

“Secondly, in the absence of human intervention, naturally occurring nucleic acid does not exist outside the cell, and “isolated” nucleic acid does not exist inside the cell. Isolated nucleic acid is the product of human intervention involving the extraction and purification of the nucleic acid found in the cell. Extraction of nucleic acid requires human intervention that necessarily results in the rupture of the cell membrane and the physical destruction of the cell itself. And purification of the extracted nucleic acid requires human intervention that results in the removal of other materials which were also originally present in the cell. It is only after both these steps are performed that the extracted and purified product may be properly described as “isolated” in the sense that word is used in the disputed claims.

Thirdly, as Dann’s Patent demonstrates, the isolation of a particular micro-organism may require immense research and intellectual effort. In that case, it was only as a result of an intensive research effort that the isolated micro-organism in question could be made available for use in the manufacture of the new antibiotic. It was fortuitous for the patentee that it was its employees who were first to isolate the new micro-organism and first to deploy it in the manufacture of the new drug. That will not always be so. It would lead to very odd results if a person whose skill and effort culminated in the isolation of a micro-organism (a fortiori, an isolated DNA sequence) could not be independently rewarded by the grant of a patent because the isolated micro-organism, no matter how practically useful or economically significant, was held to be inherently non-patentable. In my view it would be a mistake, and inconsistent with the purposes of the Act, not to give full effect in such situations to the broad language used by the High Court in NRDC.”

It is these considerations are referred to in the Notice of Appeal.

Notice of Appeal

The Notice sets out a number of grounds of appeal which centre on the finding that an isolated nucleic acid constitutes an artificial state of affairs.  In particular, the grounds are set out below:

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In Cancer Voices it was interesting to see at [103] that the Court was not required to ask whether a composition of matter is a “product of nature” for the purpose of deciding whether or not it constitutes patentable subject matter, that it may be unhelpful to approach the problem in this way, and especially so in the field of biotechnology.  The Court went on to say the established principles do not require the Court to ask whether a micro-organism is “markedly different” to something that already exists in nature for the purpose of deciding whether it constitutes patentable subject matter.

However, it appears from the grounds of the Notice that the Appellant will present arguments that the claimed nucleic acids are the same as those naturally occurring in cells, that the isolated nucleic acids are the mere discovery of products of nature, the detection of mutations and polymorphisms was the mere discovery of phenomena of nature, and that the properties of the isolated nucleic acids had not changed as a result of human intervention.

Degree of Intervention?

A question arising Cancer Voices is whether there is a threshold test to degree to human intervention that is necessary before something can be an artificial state of affairs.  At [102] Nicholas J stated:

“It goes without saying that the relevant state of affairs must be the result of some human intervention. After all, it is the element of human intervention that allows one to both characterise the relevant state of affairs as being artificial and to identify one or more inventors who, one way or another, must have brought such a state of affairs into existence in the first place. The real problem lies in knowing, or rather not knowing, what degree of human intervention is necessary before it can be concluded that the requisite artificial state of affairs exists. It is an especially difficult problem in the present case, not so much because the authorities provide no clear solution to it, but because the problem has an almost metaphysical dimension to it.”

In the case of isolated nucleic acids which may be assumed to have precisely the same chemical composition and structure as that found in cells, the steps associated with ‘isolation’ (such as extraction and purification of nucleic acid) appear to meet the required degree of intervention.  An implication from Cancer Voices is that the degree of intervention may be different for different subject matter.

The Notice of Appeal asserts the primary Judge erred in holding that the fact of human intervention, per se, in the process of isolation was relevant to the question of whether the claimed isolated nucleic acid constituted patentable subject matter.  We may therefore have some consideration in the Appeal of whether only intervention itself of some kind is required, or whether there are degrees of intervention and a threshold requirement that must be met.

The Age reports that the Appeal is expected to be heard on 17 April 2013.

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