In Roche Molecular Systems, Inc., v. Cepheid, [2017-1690] (October 9, 2018), the Federal Circuit affirmed summary judgment of invalidity of claims of\u00a0U.S. Patent No. 5,643,723 as directed to patent ineligible subject matter.<\/p>\n
The \u2019723 patent is directed to methods for detecting\u00a0the pathogenic bacterium Mycobacterium tuberculosis.\u00a0 The \u2019723 patent provides two types of claims: (1) composition-of-matter\u00a0claims for the primers used in the PCR,\u00a0which could hybridize to the rpoB gene of MTB at a site\u00a0that includes at least one of the eleven signature nucleotides\u00a0(\u201cthe primer claims\u201d); and (2) process claims for\u00a0methods for detecting MTB that include amplifying target\u00a0sequences by PCR and detecting amplification products,
\nwhich, if present, indicate the presence of MTB (\u201cthe\u00a0method claims\u201d).<\/p>\n
As to the primer claims, the Federal Circuit held that In re BRCA1 foreclosed Roche\u2019s arguments for patentability. There, the Federal Circuit\u00a0examined the subject matter eligibility of similar\u00a0primer claims and held that those primers were not distinguishable
\nfrom the isolated DNA found patentineligible\u00a0in Myriad\u201d and thus are not patent-eligible.\u00a0 Primers necessarily contain the identical sequence of\u00a0the nucleotide sequence directly opposite to the DNA\u00a0strand to which they are designed to bind.\u00a0 The subject\u00a0matter eligibility inquiry of primer claims hinges on\u00a0comparing a claimed primer to its corresponding DNA\u00a0segment on the chromosome\u2014not the whole chromosome.<\/p>\n
As to the method claims, the Federal Circuit said that\u00a0the claims disclose a\u00a0diagnostic test based on the observation that the presence\u00a0of the eleven position-specific signature nucleotides of the\u00a0naturally occurring MTB\u00a0rpoB gene indicates the presence
\nof MTB in a biological sample.\u00a0 The method claims are directed\u00a0to a relationship between the eleven naturally\u00a0occurring position-specific signature nucleotides and the
\npresence of MTB in a sample. In other words, the method\u00a0claims assert that if an investigator detects a signature\u00a0nucleotide from a sample, she knows the sample contains\u00a0MTB. This relationship between the signature nucleotides\u00a0and MTB is a phenomenon that exists in nature\u00a0apart from any human action, meaning the method claims\u00a0are directed to a natural phenomenon, which itself is\u00a0ineligible for patenting.<\/p>\n","protected":false},"excerpt":{"rendered":"
In Roche Molecular Systems, Inc., v. Cepheid, [2017-1690] (October 9, 2018), the Federal Circuit affirmed summary judgment of invalidity of claims of\u00a0U.S. Patent No. 5,643,723 as directed to patent ineligible subject matter. The \u2019723 patent is directed to methods for … Continue reading