101 F. Supp. 3d 833
D. Minnesota2015Background
- PPG filed suit seeking declaratory judgment that the Canine EIC ‘297 Patent is invalid as a natural law and, alternatively, for obviousness; it also alleges unfair competition and tort claims.
- The ‘297 Patent covers eight claims directed to detecting a DNM1 gene mutation (767T) linked to Canine Exercise-Induced Collapse (EIC) in dogs.
- The patent claims involve sampling a dog’s nucleic acid and applying various well-known detection methods to determine if the dog is homozygous for the T767 allele.
- The invention is framed as identifying a natural biomarker associated with EIC; the patent examiner identified the natural law as the distinguishing feature.
- The court applies Mayo two-step analysis (step 1: directed to a patent-ineligible concept; step 2: absence of an inventive concept) to assess § 101 eligibility.
- The court grants partial summary judgment for PPG, holding the ‘297 Patent is invalid as directed to a natural law with no patent-eligible inventive concept.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Is the '297 Patent directed to a natural law? | PPG argues the claims identify a natural biomarker (767T) linked to EIC. | Canine EIC contends the claims are narrowly drawn and not a broad natural law. | Yes; directed to a natural law. |
| Do the claims contain an inventive concept under Mayo step two? | Some claims describe detailed detection steps beyond a mere natural law. | Even detailed steps are routine and conventional. | No inventive concept; invalid. |
| Do detailed detection steps save the claims from Mayo step two? | Claims two–six provide specific, technologically detailed detection methods. | Those steps are still well-known techniques in genetics. | No; still fails Mayo step two. |
| Would narrowing the scope or limit of the claims save them from invalidity? | Limited to a single mutation-disease link, akin to a narrow BRCA claim. | Narrowness does not alter that the claims center on a natural law. | Still invalid as to all claims. |
| Should the court delay for claim construction or discovery before § 101 ruling? | Claim construction could affect eligibility. | No disputed facts; § 101 analysis can proceed at summary judgment. | Proceed; no delay warranted. |
Key Cases Cited
- Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012) (two-step framework for natural laws and patent eligibility)
- Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014) (abstract idea prohibition and need for inventive concept)
- Myriad Genetics, Inc. v. Ass'n for Molecular Pathology, 133 S. Ct. 2107 (2013) (natural law/genetic patenting; cDNA patentable, natural DNA not)
- BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation (In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation), 774 F.3d 755 (Fed. Cir. 2014) (detailed hybridization/amplification claims found not inventive concepts)
- CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366 (Fed. Cir. 2011) (Mayo step-one analysis considerations; claim assessment guidance)
- Fort Props., Inc. v. American Master Lease LLC, 671 F.3d 1317 (Fed. Cir. 2012) (patent eligibility framework and expectations for transformation of natural laws)