Australian High Court Rules Isolated Genes Unpatentable

October 08, 2015
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Whether or not genes are patent-eligible subject matter has been a much-discussed issue over the last several years. The 2013 decision by the U.S. Supreme Court in Ass'n for Molecular Pathology v. Myriad Genetics, Inc. established that that isolated DNA is a product of nature and therefore not patent eligible under Section 101 of Title 35 of the U.S. Code. The patent at issue in the U.S. Myriad case also has corresponding patents in a number of other jurisdictions, including Canada and Australia.

On October 7, 2015, the High Court of Australia (the Australian equivalent to the U.S. Supreme Court) handed down its decision in D'arcy v. Myriad Genetics Inc. & Anor. The High Court held that isolated nucleic acid is not a "patentable invention" within the meaning of the Australian Patents Act.

Myriad's patent included claims 1 to 3, drawn to an isolated nucleic acid coding for a BRCA1 protein, and with one or more specified mutations in its nucleotide sequence. Under the Patents Act, an invention has to be "a manner of manufacture" to be patentable. D'arcy commenced proceedings in the Federal Court of Australia challenging the validity of claims 1 to 3 of the Myriad patent on the basis that the invention claimed did not meet the "manner of manufacture‚¬ requirement. The challenge was dismissed by the Federal Court, which held that the claimed isolated nucleic acid fell within the concept of a "manner of manufacture."An appeal to the Full Court was also dismissed on the basis that an isolated nucleic acid is chemically, structurally and functionally different from a nucleic acid inside a human cell, "resulting in an artificially created state of affairs for economic benefit,"and therefore constituting a "manner of manufacture.‚¬

On ultimate appeal, the High Court reversed the lower court decisions, holding that the claimed isolated nucleic acid sequences did not fall within the concept of a "manner of manufacture"because while the claimed invention might be 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.

The Australian High Court's decision is similar to the U.S. Supreme Court's Myriad decision, but apparently substantially narrower. Whereas the U.S. Myriad decision established a broader exclusion to patentability for "products of nature"and was not limited just to isolated DNA, the Australian decision seems to be limited essentially to the holding that isolated DNA does not inherently constitute patent-eligible subject matter.

A summary of the High Court decision is available here.

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