A judge of the Federal Court of Australia held that naturally-occurring DNA and RNA sequences isolated from the human body may be patented under Australian law. Cancer Voices Australia v. Myriad Genetics Inc. [2013] FCA 65 (Austr. Fed. Ct. Feb. 15, 2013). The case involved a challenge to Myriad Genetics’s Australian Patent No. 686004 on the isolated BRCA1 gene and corresponding RNA, whose presence in humans indicates a predisposition to breast and ovarian cancer. Notably, Myriad’s US patent on the BRCA1 gene is currently the subject of a patent validity challenge in the U.S. Supreme Court.
BASIS OF THE PATENT CHALLENGE. As explained by the court, Myriad’s patent claims related to “isolated” nucleic acids, which the court defined as “naturally occurring nucleic acid found in the cells of the human body, whether it be DNA or RNA, [that] has been removed from the cellular environment in which it naturally exists and separated from other cellular components also found there.” The challengers contended that Myriad had claimed an unpatentable “product of nature” because the patent did not indicate a substantial difference between the sequences of the claimed isolated nucleotides and the sequences of the same molecules as they exist in human cells. Their argument was that naturally occurring DNA and RNA, even in isolated form, cannot form the basis of a valid patent. The court disagreed.
“PRODUCT OF NATURE” INQUIRY FOUND “UNHELPFUL.” The court acknowledged that some patent authorities, including the U.S. Supreme Court, hold that “products of nature” are not capable of being patented. However, the court opined that, “in the field of biotechnology in which micro-organisms play a critical role in the development, manufacture and use of diagnostic and therapeutic products and techniques,” it is especially “unhelpful” to view the question of patentability in terms of whether the claimed invention is a “product of nature.” Indeed, Australian jurisprudence recognizes “a clear distinction … between the discovery of one of nature’s laws” –which is not patentable– “and of its application to some new and useful purpose”–which may constitute patentable subject matter.
“MANNER OF MANUFACTURE.” According to the court, the relevant inquiry for determining the patentability of Myriad’s claimed invention was whether the claims were directed to a “manner of manufacture” within the meaning of the applicable statute. Citing Re GEC’s Application (1943) 60 RPC 1, and National Research Development Corporation v Commissioner of Patents [1959] HCA 67 (1959), the court explained that “a product that consists of an artificially created state of affairs which has economic significance will constitute a ‘manner of manufacture.'” In the court’s view, this judicially-created definition “does 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.” The court determined that the prerequisite of patentability–an “altered state of affairs” –may exist even if the isolated nucleotide sequences are identical to those that exist in nature. The court explained 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.
In my opinion the patentability of the isolated nucleic acids referred to in the disputed claims does not turn upon what changes have been made to the chemical composition of such substances as a result of them having been isolated. In particular, the question of whether these substances constitute patentable subject matter does not depend upon the type of chemical bond that may have been broken in the process of isolating them. It is inevitable that some bonds will be broken in the course of isolating nucleic acids, but it is not apparent from the evidence that these will necessarily include covalent bonds.
The court elaborated on the notion that isolation of a naturally-occurring gene by itself is sufficient to constitute a manner of manufacture:
[I]n 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.
CONCLUSION. The court found that its interpretation of the applicable law was supported by recent legislative history, the practice of the Australian Patent Office, and by a 2004 report of the Australian Law Reform Commission regarding gene patents. Accordingly, the court overruled the objections to Myriad’s patent and concluded:
There is no doubt that naturally occurring DNA and RNA as they exist inside the cells of the human body cannot be the subject of a valid patent. However, the disputed claims do not cover naturally occurring DNA and RNA as they exist inside such cells. The disputed claims extend only to naturally occurring DNA and RNA which have been extracted from cells obtained from the human body and purged of other biological materials with which they were associated.
by Shawn N. Sullivan, February 28, 2013.
