IP Law Daily Patent to detect tuberculosis causing infection ineligible as directed to natural phenomenon
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Tuesday, October 9, 2018

Patent to detect tuberculosis causing infection ineligible as directed to natural phenomenon

By Brian Craig, J.D.

Roche Molecular Systems, Inc.’s patent addressing methods for detecting the pathogenic bacterium Mycobacterium tuberculosis MTB infection, a major cause of tuberculosis, was directed to patent-ineligible subject matter, the Federal Circuit has held. Because the asserted claims were directed to a natural phenomenon and lacked any inventive concept that transformed them into patent-eligible subject matter, the Federal Circuit affirmed a district court’s judgment declaring the patent invalid. The Federal Circuit held that being the first to discover a previously unknown naturally occurring phenomenon or a law of nature alone was not enough to confer patent eligibility (Roche Molecular Systems, Inc. v. Cepheid, October 9, 2018, Reyna, J.).

Roche Molecular Systems, Inc. ("Roche") owned U.S. Patent No. 5,643,723 ("the ’723 patent"), titled "Detection of a Genetic Locus Encoding Resistance to Rifampin in Microbacterial Cultures and in Clinical Specimens." Cepheid made and sold "Xpert MTB/RIF Assay," an assay that can detect MTB in a biological sample and can identify rifampin-resistant MTB. Roche brought a patent infringement case against Cepheid asserting that Cepheid’s product infringed the ’723 patent. The federal district court in San Francisco decided that the asserted claims of the ’723 patent were directed to patent-ineligible subject matter and were therefore invalid under 35 U.S.C. §101. Roche appealed to the Federal Circuit.

The only issues on appeal were whether the primer claims and the method claims of the ’723 patent were patent-ineligible. The court recognized that laws of nature, natural phenomena, and abstract ideas were not patent-eligible subject matter, citing Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014).

Primer claims. The appeals court first examined whether the primer claims in the patent covered patent eligible subject matter. Roche argued that at step one of the Alice/Mayo test, the primer claims were patent-eligible because they were directed to artificial, man-made primers that were different from naturally occurring DNA. The court recognized it was well established that primers were short, single stranded nucleic acid molecules that bind to their complementary nucleotide sequence. The Federal Circuit previously held that primers necessarily contain the identical sequence of the nucleotide sequence directly opposite to the DNA strand to which they are designed to bind. In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litig., 774 F.3d 755, 760 (Fed. Cir. 2014) ("BRCA1 "). Here, the court found that the primers were indistinguishable from their corresponding nucleotide sequences on the naturally occurring DNA. Therefore, the primer claims were ineligible.

Method claims. The court then addressed whether the method claims of the ’723 patent were patent eligible. At Alice/Mayo step one, the plain language of the asserted method claims, viewed in light of the written description, demonstrated that they were directed to naturally occurring phenomena. The method claims disclosed a diagnostic test based on the observation that the presence of the 11 position-specific signature nucleotides of the naturally occurring MTB rpoB gene indicated the presence of MTB in a biological sample. The court held that the method claims did not contain an inventive concept that transformed the 11 position specific signature nucleotides of the MTB rpoB gene into patent-eligible subject matter. While it may be true that Roche inventors were the first to use PCR to detect MTB in a biological sample, being the first to discover a previously unknown naturally occurring phenomenon or a law of nature alone was not enough to confer patent eligibility. Many groundbreaking, innovative, and brilliant discoveries have been held patent-ineligible. Because the asserted method claims of the ’723 patent were directed to a natural phenomenon and lacked any inventive concept that transformed them into patent-eligible subject matter, the court held that the method claims were ineligible.

Concurring opinion. While Circuit Judge Kathleen M. O’Malley agreed with the majority that the decision in BRCA1 compelled the conclusion that the primer and method claims of the ’723 patent were not eligible for patent protection, Judge O’Malley wrote a concurring opinion arguing that the court should revisit the holding in BRCA1, at least with respect to the primer claims. Specifically, the concurring opinion stated that the holding in BRCA1 was unduly broad for two reasons: (1) the question raised in BRCA1 was narrower than the holding in that case; and, (2) the court’s interpretation of the nature and function of DNA primers lacked the benefit of certain arguments and evidence that the patent owner presents in the present case. The concurring opinion recommended that the court engage in en banc review of BRCA1.

This case is No. 2017-1690.

Attorneys: Stephen S. Rabinowitz (Hughes Hubbard & Reed LLP) for Roche Molecular Systems, Inc. Erik R. Puknys (Finnegan, Henderson, Farabow, Garrett & Dunner, LLP) and Grant L. Kim (Morrison & Foerster LLP) for Cepheid.

Companies: Roche Molecular Systems, Inc.; Cepheid

MainStory: TopStory Patent FedCirNews

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