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Roche Molecular Systems, Inc. v. Cepheid

Use of PCR Insufficient to Confer Patent Eligibility For Bacterial Assay

Roche Molecular Systems, Inc. v. Cepheid905 F.3d 1363 (Fed. Cir. Oct. 9, 2018) (O’Malley (concurring), REYNA, Hughes) (N.D. Cal.: Laporte) (3 of 5 stars)

Fed Cir affirms summary judgment of invalidity under § 101. Roche’s patent related to detection of certain tuberculosis bacteria in a sample. One set of claims addressed nucleotide “primers” useful in such detection; the other addressed methods for detecting the bacteria using such primers via polymerase chain reaction (“PCR”).

Roche’s “primer claims”: At Alice/Mayo step one, Roche’s claims are directed to natural phenomena because the man-made “primers” claimed by Roche comprised genetic sequences identical to those found in nature. Per BRCA1, 774 F.3d 755 (Fed. Cir. 2014), such primers are not sufficiently distinct from natural DNA to be patent-eligible. The opinion rejects Roche’s argument that the presence of certain groups at the ends of the molecules conferred patent-eligibility, and notes that the patent-ineligible molecules in BRCA1 had such groups, too. That the claimed primers were linear, while the naturally occurring bacterial chromosome at issue was circular, was also immaterial.

At Alice/Mayo step two, that Roche’s primers were specific to certain nucleotides in bacterial DNA was not an inventive concept sufficient to confer patent-eligibility. This site-specificity arose only because the primers incorporated naturally occurring DNA sequences. “A primer that is otherwise patent-ineligible does not gain subject matter eligibility simply because it can selectively hybridize to a certain position of naturally occurring DNA, because a primer having an identical nucleotide sequence to naturally occurring DNA without further chemical modification is a natural phenomenon.” 905 F.3d at 1370. The opinion notes that, while Roche’s discoveries of these useful nucleotide sequences “are valuable contributions to science and medicine,” per Myriad, 569 U.S. 576 (2013), such discovery without more does not confer patent-eligibility.

Roche’s method claims: At Alice/Mayo step one, the method claims are directed to naturally occurring phenomena because they focus on the naturally occurring relationship between the presence of certain naturally occurring nucleotides, and the presence of the bacteria in a sample. And the claims lack an inventive concept sufficient to confer patent eligibility. The use of PCR to amplify extracted DNA was insufficient. The opinion notes the district court’s unchallenged finding that PCR was a “routine” technique at the time of the patent (1994). While Roche was the first to use PCR to detect bacteria in the claimed manner, Mayo again does not confer patent-eligibility on those grounds. The opinion rejects Roche’s argument that the use of its primers, with PCR, was an inventive act on par with “mak[ing] a specific artificial drug that is effective to treat a [bacterial tuberculosis] infection.” 905 F.3d at 1372–73. Because Roche’s method exploits a “well-established law of nature that ‘complementary nucleotide sequences bind to each other,’” per BRCA1 the claims are not directed to a sufficiently new function to obtain patent eligibility. CellzDirect, 827 F.3d 1042 (Fed. Cir. 2016), is distinguishable because that case involved development of a new laboratory technique that went beyond simply observing or detecting naturally occurring phenomena. Vanda, 887 F.3d 1117 (Fed. Cir. 2018), is also distinguishable, as that case addressed a method of treatment based on a natural phenomenon, not the phenomenon itself.

Concurrence: Judge O’Malley agrees that BRCA1, 774 F.3d 755 (Fed. Cir. 2014), controls this case, but writes to urge the court to revisit that case’s holding, which she views as unduly broad.

KEYWORDS: SUBJECT-MATTER ELIGIBILTY; SECTION 101; NATURAL PHENOMENA