United States: Federal Court Of Australia Declined To follow U.S. Supreme Court In Myriad

Recently, the Federal Court of Australia found that isolated DNA is patent eligible, contrary to the holding in Ass'n for Molecular Pathology v. Myriad Genetics, Inc. Persuaded by the Federal Circuit's reasoning, the Federal Court found structural and functional differences between isolated DNA and genomic DNA, concluding the former is patent eligible in Australia.

I. U.S. Supreme Court

In 2013, the U.S. Supreme Court held that complementary DNA ("cDNA") was patent eligible under 35 U.S.C. § 101 because such DNA contained no intronic sequence, distinguishing it from natural or genomic DNA. Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2119 (2013). The Court distinguished cDNA from a naturally occurring DNA segment isolated from the total genomic DNA ("isolated DNA"). The Court found isolated DNA segments "are not patent eligible under § 101 simply because they have been isolated from the surrounding genetic material." Id. at 2120. The Court's distinction between patent eligible cDNA and patent ineligible isolated DNA reversed in part the Federal Circuit's holding that both isolated DNA and cDNA were patent eligible as "markedly different" from genomic DNA. Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office, 653 F.3d 1329, 1353 (Fed. Cir. 2011). Judge Lourie, writing for the Federal Circuit's majority, focused on the structural differences between isolated and genomic DNA in finding isolated DNA patent eligible. Id.

II. Federal Court of Australia

In September 2014, the Federal Court of Australia considered the patentability of isolated nucleic acid sequences (DNA or RNA). D'Arcy v Myriad Genetics Inc. [2014] FCAFC 115. The Federal Court found both cDNA and isolated DNA patent eligible. Id. at 165. In so finding, the Federal Court declined to apply the Supreme Court's reasoning, and instead found the reasoning of the Federal Circuit more in line with Australian law. Id.

The Federal Court reviewed claim 1 of Australian Patent No. 686004 concerning BRCA1. Id. at 115. Directed to both isolated DNA and cDNA, claim 1 recited "[a]n isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1 one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A, and 14 and the polymorphisms set forth in Tables 18 and 19." Id. at 145. This claim was similar to those in the U.S. case. Id.

Like the Federal Circuit, the Federal Court found significant structural differences between isolated DNA and genomic DNA. In particular, the Federal Court discussed that isolated DNA has been removed from "cellular components that enable it to function in vivo." Id. at 154. While genomic DNA exists in a dynamic environment without "hav[ing] an obvious or single outcome," isolated DNA is inert and cannot produce a polypeptide product without the aid of cellular machinery. Id. at 156. These structural differences led to significant functional difference. While genomic DNA functioned within the cellular environment, the fragmented state of isolated DNA made it useful for genetic testing. Id. at 161.

In addition, the Federal Court noted that Australia's Parliament had a chance to draft an exception for DNA segments when it considered a 2010 bill regarding such an exception. However, Parliament declined to do so. Id. at 153. As such, the structural and functional differences between isolated and genomic DNA led the Federal Court to find isolated DNA patent eligible, contrary to the U.S. Supreme Court's decision in Myriad.

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