NEW YORK (GenomeWeb News) – The Federal Court of Australia has dismissed a case in which a group of cancer patients were challenging the viability of a patent held by Myriad Genetics covering mutations in the BRCA1 gene linked to increased risk of hereditary breast and ovarian cancer.
Under Australian patent law, human beings and the biological processes involved in the creation of human beings are not patentable, but any "manner of manufacture," claims that are novel, inventive and useful, are patentable.
"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," wrote Federal Court Justice John Nicholas in dismissing the case, Cancer Voices Australia v Myriad. "However, the disputed claims do not cover naturally occurring DNA and RNA as they exist inside such cells."
The plaintiffs, Cancer Voices Australia and Yvonne D'Arcy, represented by law firm Maurice Blackburn, are challenging the validity of Myriad's Australian patent, entitled "In vivo mutations and polymorphisms in the 17q-linked breast and ovarian cancer susceptibility gene." The patent covers "an isolated polynucleotide comprising all, or a portion of the BRCA1 locus or of a mutated BRCA1 locus, preferably at least eight bases and not more than about 100 kb in length."
The plaintiffs argued that this patent, held by Myriad Genetics, Centre de Recherche de Chul in Canada, and the Cancer Institute in Japan and licensed to Genetic Technologies, is invalid because DNA and RNA isolated from the body are not materially different from DNA or RNA occurring inside the body, and as such, isolated gene sequences are products of nature that cannot form the basis of a valid patent.
In Nicholas' decision, however, he states that in his view isolated gene sequences, even though they may contain the same information as DNA sequences in the body, become a manufactured object by the process of isolation.
"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 wrote.
"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," he further wrote.
The Australian court's dismissal of this case is occurring as a similar lawsuit is ongoing against Myriad in the US. In Association for Molecular Pathology et al. v. USPTO, slated to come before the US Supreme Court on April 15, researchers and patients represented by the American Civil Liberties Union and the Public Patent Foundation are challenging BRCA patents held by the University of Utah and exclusively licensed to Myriad. The plaintiffs allege that Myriad's patents are invalid because they claim gene sequences in the body, which are naturally occurring substances and cannot be patented under US law.
Legal experts have been cautious in not drawing broad conclusions about how the court decision in Australia might impact the case in the US, since the laws describing patentable subject matter differ markedly between the two countries. In the US, there are also a number of past cases, mainly Mayo v. Prometheus and Bilski v. Kappos, that will likely have significant bearing on how the Supreme Court decides.
In Mayo v. Prometheus, a case that invalidated method patents held by Prometheus Labs, the Supreme Court emphasized that "an application of a law of nature … to a known structure or process may [deserve] patent protection," but in order to transform a law of nature into something worthy of a patent, the applicant "must do more than simply state the law of nature while adding the words 'apply it.'"
Moreover, in Bilski v. Kappos, a case challenging the patentability of a business method, the Supreme Court invalidated the patent as an abstract idea, but held that the so-called machine-or-transformation test is not the sole test of patent eligibility under the criteria laid out under Patent Act 35 USC Section 101.
Plaintiffs in the Australian case have said they are watching closely how the Supreme Court in the US decides with regard to Myriad's patents on isolated gene sequences.