Genetic Veterinary Scis., Inc. v. Laboklin GMBH & Co.
314 F. Supp. 3d 727
E.D. Va.2018Background
- Patent at issue: U.S. Patent No. 9,157,114 claiming an in vitro genotyping method to detect a T→G point mutation at position 972 in the SUV39H2 gene associated with Hereditary Nasal Parakeratosis (HNPK) in Labrador Retrievers.
- Plaintiff (Paw Print Genetics) sought declaratory judgment that Claims 1–3 of the '114 patent are invalid under 35 U.S.C. § 101; parties stipulated Plaintiff's test practices Claims 1–3.
- Claim 1 recites: (a) obtain biological sample, (b) genotype SUV39H2, (c) detect the T→G substitution at position 972; Claims 2–3 recite conventional genotyping techniques and specific primer-based PCR variation.
- Trial evidence: inventor and experts agreed the mutation and its inheritance are natural phenomena; the genotyping steps are routine, well-known laboratory techniques.
- Procedural posture: jury trial; after close of evidence Plaintiff moved for JMOL on invalidity under Alice; court granted JMOL finding claims patent-ineligible.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Claims 1–3 are directed to patent-ineligible natural phenomenon under § 101/Alice step 1 | The claims merely claim the discovery of a naturally occurring mutation and routine lab steps; thus directed to a natural phenomenon | The claims are patent-eligible because they recite a method (not mere observation) and apply the discovery using specific laboratory techniques | Held: Claims 1–3 are directed to a natural phenomenon; paragraphs (a)–(c) amount to identifying the mutation, not a patent-eligible method |
| Whether the claimed methods add an "inventive concept" under Alice step 2 | The claimed additional elements (PCR, sequencing, primers, etc.) are conventional and do not transform the natural discovery into patent-eligible subject matter | The claims are akin to Vanda/CellzDirect where application of a discovery produced a patent-eligible practical application or technique | Held: Claims 2–3 only recite well-known, routine genotyping techniques; no inventive concept; claims fail Alice step 2 |
| Whether Claim 3's primer-pair limitation supplies novelty/inventiveness | PPG: primer usage is conventional and old; does not supply patentability | Univ. of Bern: primer-pair directed to particular sequence positions renders claim inventive | Held: Primer-pair technique was decades-old and routine; does not provide the requisite inventive concept |
| Relief: whether JMOL appropriate after close of evidence | PPG: evidence compels judgment of invalidity as a matter of law | Defs: disputes of fact preclude JMOL | Held: Court granted JMOL for Plaintiff, finding no reasonable juror could find claims patent-eligible |
Key Cases Cited
- Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014) (two-step framework for patent-eligibility under § 101)
- Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012) (laws of nature are not patentable; inventive-concept inquiry)
- Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) (natural phenomena and naturally occurring DNA are not patentable)
- Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015) (claims directed to detection of natural phenomenon using conventional techniques are ineligible)
- Vanda Pharms., Inc. v. West-Ward Pharms. Int'l Ltd., 887 F.3d 1117 (Fed. Cir. 2018) (distinguishable: claims applied genetic correlation to a specific treatment regimen)
- Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016) (claims to new, useful laboratory techniques may be patent-eligible and are distinguishable from claims that merely identify natural phenomena)