United States: Federal Circuit Affirms Section 101 Ineligibility Determination Of Genetic Diagnostic Methodology Patent

The Federal Circuit recently affirmed a decision from the District Court for the Northern District of California granting appellee Cepheid's summary judgment motion against appellant Roche Molecular Systems ("Roche") and held that Roche's patent was directed to patent ineligible subject matter under 35 U.S.C. § 101. 

Roche owns U.S. Patent No. 5,643,723 ("the '723 patent"), which claims methods for detecting Mycobacterium tuberculosis (MTB)—a pathogenic bacterium, the infection of which causes tuberculosis. Previous MTB detection methods fell short in detecting MTB strains that are resistant to certain antibiotics, including rifampin, which is the standard of care for MTB treatment. Rifampin was known to have a unique site of action on a gene that encodes the β subunit of the rpoB gene, a gene that is naturally present in MTB. Roche scientists sequenced the rpoB gene in MTB and discovered that it contains 11 position-specific signature nucleotides that do not appear in the rpoB gene in other bacteria. From these 11 signature nucleotides, Roche inventors developed a diagnostic test to detect whether a sample of patient deoxyribonucleic acid (DNA) contained MTB, and if so, whether the MTB strain was resistant to rifampin treatment. The test utilized polymerase chain reaction (PCR) to amplify the rpoB gene, which if present would be marked by a set of primers at the gene's beginning and end.

The '723 patent contains two varieties of claims: (1) "primer claims," covering the primers used in PCR to hybridize to an rpoB gene of MTB at a site that includes one of the 11 signature nucleotides; and (2) "method claims" for detecting MTB based on PCR amplification of the rpoB gene. Roche believed that Cepheid, which manufactures and sells the Xpert MTB/RIF Assay for detecting MTB and rifampin resistance, was infringing both types of claims and filed suit. Cepheid responded by moving for summary judgment that all of the '723 patent's claims are invalid as patent-ineligible subject matter under 35 U.S.C. § 101. 

The district court granted Cepheid's motion and noted that the primer claims "have genetic sequences identical to those found in nature" and are "indistinguishable from those held to be directed to nonpatentable subject matter."  The district court further determined that the method claims were patent-ineligible natural phenomena because "the use of newly developed, non-patentable primers...using the well-known routine process of PCR in a conventional way does not transform the claimed methods."  Roche appealed this decision to the Federal Circuit. 

Section 101 delineates patent-eligible subject matter and states that "[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent."  Over time, the judiciary recognized three critical exceptions to § 101 that are patent-ineligible subject matter: natural phenomena, laws of nature and abstract ideas. Moreover, in Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Supreme Court articulated a two-step test to determine whether a patent claims eligible subject matter or runs afoul of the three § 101 eligibility exceptions. 566 U.S. 66 (2012). At step one, courts ask whether a claim is directed towards an abstract idea, law of nature, or a natural phenomenon. Then, if a claim is directed towards one of the three ineligible exceptions, step two involves a determination of whether the claim has an inventive concept that transforms the claimed ineligible concept into a patent-eligible application. 

While Roche argued that the claimed primers are artificial, and thus the claims are not directed to a natural phenomenon, the Federal Circuit determined—citing In re BRCA, 1774 F.3d 755 (Fed. Cir. 2014)—that primers are structurally identical to DNA strand ends found in nature. This is because the primer will always have the same nucleotide sequence of the DNA strand opposite of which the primer binds, as the sequences are complementary. As support for this, the Federal Circuit relied on Roche's own acknowledgement that "the claimed primers include DNAs with the same nucleotide sequence as portions of the MTB rpoB gene."  Accordingly, the Federal Circuit determined that, because the primer is found in nature, it is patent ineligible. 

The Federal Circuit also found unavailing Roche's argument that the claimed primers' ability to hybridize to the 11 signature nucleotides "transforms" them from naturally occurring phenomena into patent-eligible subject matter. The Federal Circuit found that there was no chemical modification to the primers and that the 11 signature nucleotides were likewise naturally occurring. As such, no transformation took place to render the previously patent-ineligible claims eligible. 

As to the method claims, the Federal Circuit conducted a comparable analysis and came to much the same result. At Mayo step one, the court found that a method for detecting MTB based on PCR amplification of the rpoB gene is a phenomenon that occurs already in nature. The only human, non-natural action taken in the method claims is the recognition of a relationship between the 11 signature nucleotides and the presence of MTB. Likewise, the Federal Circuit held that no inventive concept existed at Mayo step two—PCR amplification was routine in 1994 when the '723 patent was filed, and an observer detecting a chemical relationship was merely a mental determination, not a new and useful improvement. Notably, the court emphasized that just because Roche inventors were the first to utilize PCR to detect MTB, that fact alone cannot transform a naturally occurring phenomenon into patent-eligible subject matter. Accordingly, the Federal Circuit affirmed the district court's ineligibility determination. 

Practice Tip:  Section 101 continues to be difficult legal terrain to navigate for determining subject matter eligibility, particularly in the life sciences. Importantly, in this case, the Federal Circuit left open the possibility of patent eligibility for primers that have been altered, such that their nucleotide sequences are not found in nature. This keeps with the Supreme Court's decision in Diamond v. Chakrabarty, that a newly created bacteria "with markedly different characteristic from any found in nature," was patent eligible. 447 U.S. 303, 310 (1980). 

Roche Molecular Sys., Inc. v. Cepheid, No. 2017-1690, 2018 U.S. App. LEXIS 28411 (Fed. Cir. Oct. 9, 2018)

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