Federal Circuit, December 17, 2014, 2014-1361, 1366

In University of Utah, the U.S. Court of Appeals for the Federal Circuit (CAFC) revisited several of the Patents at issue in the Supreme Court’s opinion in Association for Molecular Pathology v. Myriad, 133 S. Ct. 2107 (2013). In Association for Molecular Pathology, the Supreme Court held that “isolated DNA” is not patent-eligible under 35 U.S.C. § 101 if the same sequence exists as all or part of a naturally-occurring DNA.

After the Supreme Court’s opinion in Association for Molecular Pathology, Ambry Genetics began selling kits for predicting susceptibility to certain cancers (breast- and ovarian cancer), based on detection of BRCA1 and BRCA2 genes. On July 9, 2013, in Utah, the University of Utah sued Ambry Genetics in district court, requesting a preliminary injunction preventing Ambry’s continued sale of the kits. The district court denied the injunction, finding that University of Utah’s asserted product and method claims were likely patent-ineligible under § 101. University of Utah appealed.

University of Utah’s product claims were directed to pairs of synthetic, single-stranded DNA primers, useable in polymerase chain reactions (PCR) to amplify BRCA1 and BRCA2 genes. University of Utah argued that these primers were distinguishable from the “isolated DNA” found patent-ineligible in Association for Molecular Pathology because: they were synthetically produced (not isolated); they were single-stranded (and thus different from the double-stranded DNA which normally occurs in humans); and they had a new function (in PCR). The Federal Circuit found each argument unavailing. First, the court stated that producing something synthetically does not render it patent-eligible, if its structure is the same as what occurs in nature. Second, the court concluded that single-stranded DNA is simply DNA separated from its naturally-occurring environment, which the Supreme Court held in Association for Molecular Pathology to be patent-ineligible. Third, the primers’ use in PCR were found to rely upon the same function the DNA sequence had in nature – to hybridize to complementary DNA. All the asserted primer claims were therefore held patent-ineligible.

The method claims fared no better. Ambry had argued that these claims – which related to the comparing of BRCA1 and BRCA2 gene sequences from patients against wild-type sequences – simply recited natural laws, and were patent-ineligible under Mayo v. Prometheus, 132 S.Ct. 1289 (2012). Without addressing this argument, the court held that the method claims – because they encompassed the detection of any BRCA1/BRCA2 mutation for any purpose – did not recite significantly more than a patent-ineligible “abstract idea.” Citing Alice Corp. v. CLS Bank Int'l, 134 S. Ct. 2347, 2354 (2014), the court concluded that even though the comparing step was achieved using a specific technique – hybridization probes – this could not supply an inventive concept because the same hybridization techniques were routine and conventional at the time of the invention.