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Oct. 7 — Myriad Genetics sustained another patent setback Oct. 7 when the High Court of Australia held that an isolated nucleic acid coding for a BRCA1 associated with breast and ovarian cancer isn't a “patentable invention” under the country's patent laws (D'Arcy v. Myriad Genetics, HCA, No.  HCA 35, 10/7/15).
The decision makes Myriad's isolated DNA claims unpatentable in both the U.S. and Australia.
Information Is Essential Stored Element
The U.S. Supreme Court in 2013 found Myriad's U.S. claims for isolated DNA for the BRCA1 and BRCA2 genes to be patent ineligible under the judicial exception of laws of nature in Association for Molecular Pathology v Myriad Genetics Inc.
Myriad spokespeople and panelists at biotechnology conferences frequently have noted, however, that Myriad's claims are patentable in Europe and Japan by legislation and that the Full Federal Court of Australia, openly criticizing the U.S. Supreme Court's decision, had in 2014 found Myriad's claims to be patentable.
But the High Court of Australia reversed the lower court, finding that, “Although it may be said in a formal sense that the invention as claimed, referring to isolated nucleic acids, embodies a product created by human action,” it is the existence of the information stored in the relevant isolated DNA sequences that is an essential element of the invention as claimed and that renders the invention unpatentable.
Kevin Noonan of McDonnell, Boehnen, Hulbert & Berghoff, LLP, Chicago, told Bloomberg BNA in an Oct. 7 e-mail, “The decision of the Australian High Court continues the trend (beginning in the U.S. Supreme Court in Myriad) of a lay court interpreting literally technical terms outside their proper context. Once again, the court reduced the claimed nucleic acid to patent ineligible ‘information' instead of considering the isolated DNA as a chemical compound.”
In addition, Noonan wrote, the High Court didn't recognize the distinction between genomic DNA isolated from a cell and cDNA synthesized in a test tube. “The significance of this decision in a post-Human Genome Project world is limited with regard to DNA but raises issues regarding patent eligibility for other ‘natural products' having importance inter alia for new drug development,” Noonan said.
Daniel J. Wise of Carpmaels & Ransford LLP, London, wrote in an e-mail, “I'm surprised the Australian courts have ended up going down a similar route as the U.S. Supreme Court on this issue because it complicates the traditional approach (which we still follow in Europe) of isolated natural products being patentable subject-matter. It will be interesting to see if Australian patent law runs into the same problems that the USPTO [U.S. Patent and Trademark Office] has had recently in devising consistent guidelines on which type of naturally-derived materials can be patented.”
A Myriad spokesman said in an Oct. 7 e-mail to Bloomberg BNA, “We are disappointed with the decision by the High Court of Australia. The High Court's decision comes at a critical time when we're entering the golden era of personalized medicine. In order for personalized medicine to become a reality, strong patent protection is essential because it provides the research-based companies like Myriad with an incentive to continue to invest in R&D [research and development]. Myriad invested more than $1 billion over 25 years to develop its world-class hereditary cancer testing business, and the company has tested more than two million patients to date. We remain committed to what we do best, developing innovative and high-quality molecular diagnostic tests that save and improve the lives of patients.”
Yvonne D'Arcy, a two-time cancer survivor, and Cancer Voices Australia had challenged the validity of claims in Myriad's Australian patent titled “In vivo mutations and polymorphisms in the 17q-linked breast and ovarian cancer susceptibility gene,” owned by Myriad and licensed to Genetic Technologies in Australia. They asserted that claims 1-3 of the patent are invalid because DNA that is isolated from the body isn't materially different from DNA in the body and is, therefore, unpatentable.
Under Section 18(1)(a) of the Australia Patents Act 1990 (Cth), for an invention to be patentable, it must be “a manner of manufacture” within the meaning of section 6 of the Statute of Monopolies, which specifies that such claims must be novel, inventive and useful.
The claims at issue concern a nucleic acid coding for a BRCA1 protein, and with one or more specified variations from the norm in its nucleotide sequence, isolated from its cellular environment. Those specified variations, characterized as mutations or polymorphisms, are indicative of susceptibility to breast cancer and ovarian cancer.
In February 2013, the Federal Court of Australia dismissed the case, saying that the isolated gene sequences, even though they contain the same information as sequences in the body, became “manufactured” by being isolated. On appeal, the full court held that an isolated nucleic acid was chemically, structurally and functionally different from a nucleic acid inside a human cell. The invention was a manner of manufacture because an isolated nucleic acid with the characteristics specified in claims 1 to 3 resulted in an artificially created state of affairs for economic benefit, the full court concluded.
The High Court held that an isolated nucleic acid, coding for the BRCA1 protein, with specified variations, isn't “a manner of manufacture.”
“Although the isolation of nucleic acid comprising the BRCA1 gene is a man-made process, it does not involve any element of inventiveness. It is no more than the application of a recognized diagnostic technique to a known purpose of examining fragments of human DNA,” the court wrote.
The court focused on the information of the relevant sequences stored in both the DNA in the body and in the isolated DNA, just as the U.S. Supreme Court did in its Myriad decision.
Justice Michelle Marjorie Gordon wrote in a separate and concurring opinion that none of the asserted chemical, structural and functional differences identified by the Full Federal Court of Australia play any part in the definition of the invention as claimed.
“To put it in functional terms, the fact that the isolated DNA has one or more of the characteristics of the code is the function. The fact that isolated nucleic acids cannot produce the natural polypeptide is irrelevant. Production of natural polypeptide is not a characteristic of claims 1-3,” Gordon wrote. “To put it in structural terms, the relevant structural attribute is that the product (the isolated DNA from a patient) contains an identical coding sequence to the coding sequence in the patient. The fact that, as a consequence of isolation of the nucleic acid from the cell, other parts of the cell and the DNA are removed in that process is irrelevant.”
Gordon and other justices also considered Myriad's argument that making the claims unpatentable would put Australia out of step with some of its trading partners including the European Union and the U.S. “That issue, if it is to be addressed, is a matter for the legislature. It is no basis to extend Section 18(1) of the Act to claims 1-3,” Gordon wrote.
Although the court referenced decisions that the U.S. Supreme Court relied on in Myriad, its analysis focused solely on Australia case law and statutes. In a footnote, the High Court wrote, “It is important to notice that the claims made in the patents in suit in the United States of America considered in Association for Molecular Pathology v Myriad Genetics Inc. 186 L Ed 2d 124 (2013) were claims to the particular genetic sequences and therefore radically different from the disputed claims in this appeal.”
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