Tony Conaghan

Patentability of isolated DNA in Australia: a win for patentees, a question mark for researchers, a lightning rod for public opinion and now on appeal

Tony Conaghan

12 March 2013

Patents

The landmark decision in Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65 from 15 February 2013 represents the first judicial pronouncement in Australia that confirms the patentability of isolated genetic material, to the collective sigh of relief of DNA patentees.


The emotive background to this case evolved out of consideration of patent claims directed towards the BRCA1 and genes that are commonly mutated in hereditary cases of breast and / or ovarian cancer. Until recently, it has been virtually unquestioned that genes, in isolated and purified form with some identified purpose / utility, constitute patentable subject matter. It has long been accepted practice for gene patents to be granted by IP Australia as well as by the US Patent and Trademark Office. Challenges to gene patents have frequently been on other terms within the context of infringement proceedings.

 

In CVA v Myriad, the Australian courts had its first opportunity to consider the validity of gene patents on first principles, with a great deal of public attention.

 

The key reasons for judgment

 

Scientific expert evidence on DNA

 

In paragraphs 9 to 45 of the reasons for judgment, Nicholas J took great care to provide a full background of how DNA works, along with its relatives coding DNA (cDNA), RNA and the mechanics of transcription and translation during gene expression. In doing so, Nicholas J made observations about how DNA may be isolated from its in situ environment within a cell.1 Namely, that a sample must be broken down into individual cells, the cell membranes destroyed, the proteins associated with the DNA degraded and separated from the DNA, and RNA broken down to result in a DNA pellet that is capable of being sequenced. These findings would be important in relation to the disputed patent.

 

The Myriad Genetics’ patent

 

The patent itself, entitled ‘In vivo mutations and polymorphisms in the 17q-linked breast and ovarian cancer susceptibility gene’, had three disputed claims directed towards isolated DNA, RNA and cDNA encoding for the BRCA1 gene with one or more of specific mutations. Nicholas J found that, ‘each of the disputed claims is to a chemical composition’.2 In doing so, Nicholas J rejected a notion that covalent bonds in the DNA itself had to be broken in order to be isolated.  While this may in fact occur, the claims in the patent did not require this to be the case.

 

Crucially, Nicholas J observed the following, presumably in an effort to ameliorate the concerns of the applicants and the public in general:3

 

First, the disputed claims are not to genetic information per se. They claim tangible materials.  Much emphasis was placed by the applicants upon the informational character of DNA as a storehouse of genetic information. But the disputed claims are not to information as such. They could never be infringed by someone who merely reproduced a DNA sequence in written or digitised form.

 

Secondly, because each of the claims is to an isolated chemical composition, naturally occurring DNA and RNA as they exist in cell are not within the scope of any of the disputed claims and could never, at least not until they had been isolated, result in the infringement of any such claim.

 

Australian patent law and the NRDC case


Nicholas J was at pains to set out the requirements for patentability under Australian law, principally with respect to the precedent set by the High Court in National Research Development Corporation v Commissioner of Patents.4 At [88], Nicholas J found that, ‘It is apparent from this passage that a product that consists of an artificially created state of affairs which has economic significance will constitute a “manner of manufacture”.  In relation to a process, the product is the state of affairs in which an effect may be observed.’

 

In doing so, Nicholas J provided the foundation for rejecting any suggestion that the Court was bound to consider whether a manner of manufacture was a ‘product of nature’, or ‘markedly different’, which would be the case in the US.5

 

Applicability of the ‘product of nature’ doctrine

 

In considering a line of authorities from 1903, the Court traced the ‘product of nature’ doctrine through its application to inventions. That is, the difference between a mere discovery and an invention. Nicholas J cited NRDC’s pronouncement:6

 

The truth is that the distinction between discovery and invention is not precise enough to be other than misleading in this area of discussion. There may indeed be a discovery without invention—either because the discovery is of some piece of abstract information without any suggestion of a practical application of it to a useful end, or because its application lies outside the realm of “manufacture”.

 

Having noted the Australian Court’s view of the ‘product of nature’ doctrine, Nicholas J disposed of the applicants’ arguments in relation to alleged supporting precedent in Australian cases and observed:7

 

Whether or not a composition of matter (including a micro-organism) is a “manner of manufacture” must be decided in accordance with the principles set out in the NRDC case. It follows (leaving aside any relevant statutory exception) 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.

 

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.

 

Isolated DNA as an artificially created state of affairs

 

In finding that the disputed claims in question were directed towards a manner of manufacture, Nicholas J made three points:8

  1. The NRDC case was deliberately broad in its characterisation of creating an artificial state of affairs.
  2. Isolated nucleic acid did not exist inside a cell, and only existed outside a cell with the benefit of considerable human intervention. Conversely, naturally occurring nucleic acid did not exist outside.
  3. Isolating micro-organisms and DNA may require enormous resources and time, and this should not be forgotten.

 

In making these comments, Nicholas J specifically rejected the notion that chemical composition of the claimed invention as an artificial state of affairs had to be different to its naturally occurring form. That is, it was sufficient that it was an artificial state of affairs, albeit with nearly identical chemical composition.9

 

Parallel patent litigation in the US

 

The proceedings in CVA v Myriad were filed after the US District Court decision in Association For Molecular Pathology et al v. United States Patent and Trademark Office et al.  Justice Sweet invalided the claims for the isolated DNA owned by Myriad, very similar to the Australian patent the subject of CVA v Myraid. Justice Sweet relied on the US development of the ‘product of nature’ doctrine to reject the isolated nature of the DNA as giving rise to patentable subject matter:10

 

In light of DNA’s unique qualities as a physical embodiment of information, none of the structural and functional differences cited by Myriad between native BRCA1/2 DNA and the isolated BRCA1/2 claimed in the patents-in-suit render the claimed DNA “markedly different”. This conclusion is driven by the overriding importance of DNA’s nucleotide sequence to both its natural biological function as well as the utility associated with DNA in its isolated form. The preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition claims are directed to unpatentable products of nature.

 

However, this decision was overturned on appeal by the United States Court of Appeals for the Federal Circuit, which itself was affirmed by the Appeals Court. However, on 30 November 2012, the Supreme Court agreed to hear a challenge to two Myriad patents, which has yet to be decided.

 

Conclusion:  where next for gene patents in Australia?

 

Clearly, the subject matter of CVA v Myriad was, and continues to be, a sensitive topic for the public in general, and for cancer sufferers and their families in particular. At the heart of it lies competing policy considerations: the monopoly rights granted by a patent with its correlative incentive for innovation versus the public interest in accessibility to information and ‘ownership’ of their own biological processes. Indeed, both the Australian and US Courts noted the long standing practice of granting patents with claims for isolated DNA, and the potential for a great upheaval should isolated DNA not be deemed patentable.

 

In Australia, the NRDC case test has, for the time being, allowed gene patents directed at isolated genetic material to remain valid. In Nicholas J’s view, there was sufficient human intervention to lead to an artificially created state of affairs, even if the DNA is chemically identical inside and outside the cell. The fact that the information function of the DNA remained the same was irrelevant. Accordingly, Myriad’s BRCA1 gene patent stands. Despite emotional media statements made following the judgment, Nicholas J has attempted to provide an assurance that under current law, a patent cannot be granted over a person’s DNA as it exists inside their body. Further, as pointed out by Nicholas J, the recent Raising the Bar Act amendments, coming into effect on 15 April 2013, will allow research use exemptions regarding patented DNA, though presumably not for diagnostic testing itself.

 

The most recent US decision, subject to a current appeal to the Supreme Court, has likewise found in favour of Myriad and its BRCA1 patent. This is not to say that Myriad has universal support in the US judiciary: a minority judgment of the Appeals Court forcefully criticised the majority decision, finding that the changes inherent in the isolation process did not change the functional portion of the DNA and therefore did not render it an invention.

 

As of 4 March 2013, the lawyers for the applicants have filed an appeal against the Federal Court decision on behalf of the applicants.  Regardless of the passage of this Appeal, it is by no means assured that a similar challenge will not eventuate in the future, particularly if the US Supreme Court later overturns the Myriad patents.  However, for the time being, Australian isolated DNA patents will continue to be valid as a manner of manufacture in the absence of legislative intervention.

 

 

1 Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65 at [46] – [54]
2 Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65 at [72]
3 Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65 at [76] – [77]
4 (1959) 102 CLR 252
5 Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65 at [103]
6 Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65 at [92], citing NRDC case at 263-264
7 Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65 at [102]
8 Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65 at [107] – [109]
9 Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65 at [105]
10 Association For Molecular Pathology et al v. United States Patent and Trademark Office et al at 125