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Australian High Court Rules Against Myriad's BRCA1 Patent Claims

NEW YORK (GenomeWeb) – The High Court of Australia has ruled that a nucleic acid isolated from the body encoding a BRCA1 protein and harboring variations that confer increased risk of breast and ovarian cancer is not a patentable invention as defined by the country's laws.

The decision in D'Arcy v Myriad Genetics impacts three patent claims held by diagnostics firm Myriad related to its BRCA genetic test. "An isolated nucleic acid, coding for the BRCA1 protein, with specified variations, is not a manner of manufacture," the high court said. "While the invention claimed might be, in a formal sense, a product of human action, it was the existence of the information stored in the relevant sequences that was an essential element of the invention as claimed."

In a statement, Myriad expressed disappointment over the court's decision. "The High Court’s decision comes at a critical time when we’re entering the golden era of personalized medicine," the company said. "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." 

The case began when plaintiffs Cancer Voices Australia and Yvonne D'Arcy challenged the validity of claims in Myriad's Australian patent, entitled "In vivo mutations and polymorphisms in the 17q-linked breast and ovarian cancer susceptibility gene." They argued that this patent, held by Myriad, 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 February 2013, the Federal Court of Australia dismissed the case. Federal Court Justice John Nicholas reasoned that the isolated gene sequences, even though they contain the same information as sequences in the body, become a manufactured object by the process of isolation. 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.

The plaintiffs appealed this decision to the full Federal Court, but in September 2014 the court upheld the earlier decision. "The isolated nucleic acid, including cDNA, has resulted in an artificially created state of affairs for economic benefit," the judges held. "The claimed product is properly the subject of letters patent."

Still, 69-year-old D'Arcy, a two-time cancer survivor, appealed this decision with the High Court, which unanimously held that the claimed invention "did not fall within the concept of a manner of manufacture."

The Australian decision follows the US Supreme Court's ruling in 2013 in Association for Molecular Pathology v Myriad, which invalidated several patent claims underlying Myriad's BRCA test. The justices reasoned that DNA segments isolated from the body are patent-ineligible, but also ruled that cDNA is patent-eligible when the sequence is different from that found in nature.

According to Myriad, it has invested more than $1 billion over 25 years to build its hereditary cancer testing business, of which BRCA testing has long been the center piece. During this time, the firm's patents allowed it to be the only provider of commercial BRCA testing. The company said it has tested more than 2 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," the company said in a statement. Myriad executives recently outlined a five-year growth strategy with analysts. By fiscal year 2020, Myriad anticipates its annual revenues could more than double, to $1.5 billion — 46 percent coming from its hereditary cancer testing business and the remaining coming from a number of new tests.