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Australian Court Upholds Myriad's BRCA1 Gene Patent

NEW YORK (GenomeWeb) – The Federal Court of Australia today upheld an earlier judgment that Myriad Genetics could patent mutations in the BRCA1 gene that are linked to an increased risk of hereditary breast and ovarian cancer.

The decision by the court leaves intact its ruling in February 2013 that isolated gene sequences, even if they contain the same information as DNA sequences in the body, become a manufactured object as a result of the isolation process, conferring on them an "artificial state," and making them patentable.

After the court dismissed the case, Cancer Voices Australia v Myriad, last year, the plaintiffs appealed the decision back to the court. A different set of judges was involved in today's dismissal.

Those judges said today that "the isolation of the nucleic acid also leads to an economically useful result — in this case, the treatment of breast and ovarian cancer," and agreed with the earlier court's ruling that "[i]t is not the chemical change alone, but that change combined with the different and beneficial utility, which leads [the court] to conclude that small isolated DNA fragments are patentable subject matter.'"

It further added today, "The isolated nucleic acid, including cDNA, has resulted in an artificially created state of affairs for economic benefit. The claimed product is properly the subject of letters patent."

In an email to GenomeWeb Daily News, a spokesman for Myriad said, "We are satisfied with the court's decision, which is consistent with the law and the weight of the evidence."

The case centered on Myriad's Australian patent, entitled "In vivo mutations and polymorphisms in the 17q-linked breast and ovarian cancer susceptibility gene," that covers "an isolated polynucleotide comprising all, or a portion of the BRCA1 locus or of a mutated BRCA1 locus, preferably at eight bases and not more than about 100kb in length."

The plaintiffs in the lawsuit, Cancer Voices Australia and Yvonne D'Arcy, argued that Myriad's patent was invalid because DNA and RNA isolated from the body are not materially different from DNA or RNA occurring inside the body, and so isolated gene sequences are products of nature which could not be patented.

In last year's ruling, the court said, "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."

Furthermore, "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."

In appealing the original 2013 decision, the plaintiffs argued that, among other things, while isolating nucleic acid requires human intervention, the act of doing so does not make its isolation an artificial event as the nucleic acid sequence is not changed. Rather, someone is merely taking the nucleic acid out of the cell.

The court today said, however, that in an earlier case, National Research Development Corporation v Commissioner of Patents, the High Court of Australia ruled that artificiality applies to products. "In order to determine whether an invention claimed is a relevant product, the question is whether it consists of an artificially created state of affairs, not whether it produces or fails to produce an artificial effect." (Emphasis is by the court).

It also noted that Australia has no statutory or jurisprudential limitation of patentability to exclude products of nature. "To the contrary, the [High Court] has specifically rejected such an approach. A mere discovery is not patentable and an idea is not patentable, but a 'manner of manufacture,' as that term has been developed, is" patentable, the court said.

Its judgment runs in opposition to a decision last year by the US Supreme Court, which found that while synthetic genes are patentable, human genes are not. The Australian court today noted several points on which it differed with SCOTUS, including SCOTUS's emphasis on the similarity "'of the location and order of the nucleotides'' that exist within the nucleic acid in nature before Myriad found them.

The US court's focus on the similarity, the Federal Court of Australia said, was "misplaced. It is the chemical changes in the isolated nucleic acid which are of critical importance, as this is what distinguishes the product as artificial and economically useful. The fact that, hypothetically, if the isolated DNA sequence were replaced into the cell it would express the same proteins is irrelevant.

"The US Supreme Court accepted that cDNA is patentable [but] rejected the isolated nucleic acid claim … because it accepted wrongly, with respect, that the isolated nucleic acid is a 'product of nature,'" the Australian court said.

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