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Roche Molecular Sys. v. Cepheid

United States Court of Appeals for the Federal Circuit

October 9, 2018, Decided

2017-1690

Opinion

 [***1222]  [*1365]   Reyna, Circuit Judge.

Appellant Roche Molecular Systems, Inc. ("Roche") owns 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." The United States District Court for the Northern District of California found that the asserted claims of the '723 patent are directed to patent-ineligible subject matter and are therefore invalid under 35 U.S.C. § 101. Roche appeals from a grant of summary judgment [**2]  of invalidity. We affirm.

I. The '723 Patent

The '723 patent is directed to methods for detecting the pathogenic bacterium Mycobacterium tuberculosis ("M. tuberculosis" or "MTB"). '723 patent col. 2 ll. 50-54. MTB infection is a major cause of tuberculosis. Id. col. 1 ll. 13-30. In 1994, before the priority date of the '723 patent, the general method of MTB detection in a tuberculosis patient was known as sputum examination by the acid-fast bacilli smear. For this test, a biological sample taken from a patient is subjected to cell culture in a process that can take three to eight weeks. Id. col. 2 ll. 9-11. This test has limitations: it can identify the presence of bacterial cells in a biological sample, but cannot identify the cells as MTB. There is a need to know whether the MTB from a patient is resistant to antibiotics. The standard of care for MTB treatment at the time involved a regimen of antibiotics, with rifampin being a first-line anti-tuberculosis drug. Id. col. 1 ll. 31-33. Tuberculosis outbreaks, however, still resulted because of delays in diagnosis and reporting of rifampin-resistant tuberculosis due to the inability to rapidly identify MTB strains that are resistant to rifampin and put a patient on an appropriate [**3]  alternative therapy. Id. col. 1 ll. 61-65.

Prior to the '723 patent, scientists in the field had been working on diagnostic tests for faster detection of MTB, particularly rifampin-resistant MTB strains. Id. col. 2 ll. 18-46. It was speculated that "[g]enotypic detection of multi-drug resistant MTB [strains] directly from clinical specimens is theoretically the fastest and most direct step toward determining effective therapy for patients." Id. col. 2 ll. 39-42. It was known in the art that rifampin has a unique site of action on a particular gene that encodes the β subunit of bacterial RNA polymerase ("the rpoB gene"). Id. col. 1 ll. 31-42. The rpoB gene is present in MTB and other bacterial species, and its deoxyribonucleic acid ("DNA") sequences were known to be highly conserved, with little variation from one bacterial species to another. In 1994, single site mutations in the rpoB gene that confer rifampin resistance in some bacteria, such as Escherichia coli ("E. coli"), were well characterized, making rpoB a prime candidate for studying rifampin resistance in MTB. Id. col. 1 ll. 42-52.

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905 F.3d 1363 *; 2018 U.S. App. LEXIS 28411 **; 128 U.S.P.Q.2D (BNA) 1221 ***; 2018 WL 4868033

ROCHE MOLECULAR SYSTEMS, INC., Plaintiff-Appellant v. CEPHEID, Defendant-Appellee

Subsequent History: As Amended October 11, 2018.

Prior History:  [**1] Appeal from the United States District Court for the Northern District of California in No. 3:14-cv-03228-EDL, Magistrate Judge Elizabeth D. Laporte.

Roche Molecular Sys. v. Cepheid, 2017 U.S. Dist. LEXIS 113280 (N.D. Cal., Jan. 17, 2017)

Disposition: AFFIRMED.

CORE TERMS

primers, nucleotide, sequence, patent, naturally occurring, detecting, subject matter, rpoB, signature, patent-ineligible, eligible, strands, amplification, biological sample, natural phenomena, hydroxyl group, isolated, patent-eligible, tuberculosis, hybridize, cDNA, ineligible, invention, chemical, genetic, district court, occurring, bind, position-specific, chromosome

Civil Procedure, Appeals, Standards of Review, De Novo Review, Patent Law, Jurisdiction & Review, Summary Judgment Review, Standards of Review, Utility Patents, Process Patents, Principles & Results, Utility Requirement, Chemical Compounds, Subject Matter