905 F.3d 1363
Fed. Cir.2018Background
- Roche owns U.S. Patent No. 5,643,723 claiming (a) short DNA primers that hybridize to one of eleven MTB-specific "signature" nucleotides in the rpoB gene, and (b) PCR-based methods that amplify rpoB from clinical samples and infer MTB presence from detection of amplification product.
- By the priority date (1994) PCR was a well-known, routine technique; rpoB sequences and some rifampin-resistance mutations were known in the art.
- Roche’s inventors identified eleven naturally occurring, position-specific MTB signature nucleotides and designed complementary primers to detect them and to assess rifampin resistance faster than culture-based tests.
- Cepheid accused of infringement; it moved for summary judgment that the asserted primer and method claims are patent-ineligible under 35 U.S.C. § 101. The district court granted summary judgment for Cepheid.
- The Federal Circuit affirmed: (1) primer claims are directed to naturally occurring DNA sequences and thus ineligible under Myriad/BRCA1; (2) method claims are directed to a natural phenomenon (the correlation between signature nucleotides and MTB) and add only conventional PCR and a detection/mental step, lacking an inventive concept under Alice/Mayo.
Issues
| Issue | Plaintiff's Argument (Roche) | Defendant's Argument (Cepheid) | Held |
|---|---|---|---|
| Primer claims §101 eligibility | Primers are man-made, chemically/structurally distinct (3' end and 3'-OH) and not naturally occurring; therefore eligible. | Primers have nucleotide sequences identical to natural DNA segments and are indistinguishable from the primers held ineligible in BRCA1/Myriad. | Primer claims are directed to a natural phenomenon and are patent-ineligible. |
| Method claims §101 eligibility | The methods apply PCR to detect MTB using specific primers and are not routine uses; limited scope to 11 signature nucleotides avoids preemption and is inventive. | Claims are directed to the natural correlation between signature nucleotides and MTB and merely apply routine, well-known PCR and a detection/mental step. | Method claims are directed to a natural phenomenon and, at step two, add only conventional techniques and a mental step, so lack an inventive concept and are ineligible. |
| Effect of BRCA1/Myriad precedent | Roche attempted to distinguish by chemical/structural features (circular bacterial chromosome, primer length/type). | BRCA1 and Myriad control: identical sequences and synthetic replication do not confer eligibility; structural/chemical distinctions offered do not change the §101 analysis here. | BRCA1/Myriad foreclose eligibility; primers identical to natural sequences remain ineligible absent structural alterations. |
| Factual disputes over primer structure (concurring view) | Roche (and concurrence) argued record evidence raises genuine factual disputes about structural/functional differences (RNA vs DNA, length, 3'-OH at nonnatural location) that might affect eligibility. | Cepheid argued BRCA1 settled the legal rule; structural distinctions asserted do not overcome precedent. | Majority: BRCA1 controls and resolves §101 as a matter of law; concurrence urges reconsideration en banc because of factual record that could affect BRCA1’s breadth. |
Key Cases Cited
- Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013) (isolated natural DNA sequences are products of nature and not patent-eligible; cDNA may be eligible).
- Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012) (claims applying natural correlations with only conventional steps lack an inventive concept).
- Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014) (two-step test for determining patent eligibility under §101).
- In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litig., 774 F.3d 755 (Fed. Cir. 2014) (primers with sequences identical to natural DNA held patent-ineligible; controlling precedent here).
- Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015) (declining eligibility for methods that detect natural biological phenomena using conventional techniques).
- CellzDirect, Inc. v. Sequel Labs., Inc., 827 F.3d 1042 (Fed. Cir. 2016) (distinguished: claims that created a new, nonconventional laboratory technique based on a discovery of natural phenomenon can be eligible).
- Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018) (method-of-treatment claims applying a natural relationship can be eligible where the claim is directed to a novel, practical application).
- Diamond v. Chakrabarty, 447 U.S. 303 (1980) (compositions with markedly different characteristics from anything found in nature may be patent-eligible).