Merck & Cie v. Gnosis S.P.A.
808 F.3d 829
| Fed. Cir. | 2015Background
- Merck owns U.S. Patent No. 6,011,040 claiming methods of preventing or treating diseases associated with elevated homocysteine by administering the natural stereoisomer L-5-MTHF (and related dependent limitations). The PTAB instituted inter partes review and canceled several claims; remaining dependent claims 8, 9, 11, 12, 14, 15, and 19–22 were contested.
- Prior art relied on by the Board: Serfontein (EP application) teaching use of folate or a "suitable active metabolite of folate" plus B‑vitamins to lower homocysteine; Marazza (U.S. patent) identifying L-5-MTHF as a chirally pure natural metabolite and methods for obtaining it; Ubbink (1993 study) showing folic acid (and B‑vitamins) lowers homocysteine in patients with certain enzyme deficiencies (e.g., thermolabile MTHFR).
- PTAB concluded a person of ordinary skill would be motivated to combine Serfontein and Marazza to use L‑5‑MTHF to lower homocysteine, and to further combine Ubbink to apply that method to enzyme‑deficiency patients; PTAB also found certain claims anticipated and construed claims to allow mixtures of enantiomers.
- Merck argued the prior art taught away (instability of 5‑MTHF, possible increases in homocysteine, poor polyglutamation) and presented objective indicia of non‑obviousness (commercial success, licensing, copying, praise, long‑felt need, unexpected results). PTAB rejected these contentions for lack of adequate nexus or persuasive weight.
- The Federal Circuit majority affirmed PTAB’s obviousness determination, finding the Board’s factual findings supported by substantial evidence and that the combination rendered the claims obvious under 35 U.S.C. § 103. Judge Newman dissented, arguing the Court should review PTAB findings under a preponderance/clear‑error standard (not substantial evidence) given the AIA’s altered burden and finality and that the record did not support a reasonable expectation of success nor overcome objective indicia.
Issues
| Issue | Merck's Argument | Gnosis/PTAB's Argument | Held |
|---|---|---|---|
| Whether claims are obvious in light of Serfontein + Marazza (+ Ubbink) | Prior art teaches away; instability, adverse data, and poor polyglutamation undermine motivation and expectation of success | Serfontein suggests using a suitable folate metabolite; Marazza identifies L‑5‑MTHF; a skilled artisan would be motivated to combine and would reasonably expect success given the art as a whole | Affirmed: PTAB’s finding of motivation to combine and implied reasonable expectation of success supported by substantial evidence; claims obvious under §103 |
| Whether objective indicia (commercial success, licensing, copying, praise) establish non‑obviousness | Products (especially Deplin® and Pamlab products) show commercial success and nexus to claimed invention; licensing and praise support non‑obviousness | Commercial products contain additional components and other patents; nexus to the novel claim features is weak or ambiguous | Affirmed: PTAB reasonably afforded little weight to objective indicia for lack of adequate nexus and persuasive weight |
| Whether PTAB erred by not expressly finding a reasonable expectation of success | Merck: lack of explicit finding undermines KSR/Kubin requirements | PTAB: addressed expectation via teaching‑away analysis; found no teaching away and thus implied expectation of success | Affirmed: implicit finding sufficient where PTAB rejected teaching‑away arguments and substantial evidence supports outcome |
| Review standard on appeal for PTAB factfinding (raised in dissent) | Dissent (Merck aligned): AIA places burden on petitioner to prove invalidity by preponderance; appellate review should ensure PTAB findings are supported by a preponderance (clear‑error), not merely substantial evidence | Majority: appellate review follows existing framework—factual findings reviewed for substantial evidence; legal conclusion reviewed de novo | Majority: applied substantial evidence review and affirmed PTAB; dissent argued for closer review but was not the holding |
Key Cases Cited
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (obviousness requires motivation to combine and a reasonable expectation of success; ‘obvious to try’ limited by predictability)
- Graham v. John Deere Co., 383 U.S. 1 (1966) (framework for obviousness inquiry: scope/content of prior art, differences, skill level, and secondary considerations)
- In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009) (obviousness is law based on underlying factual findings)
- In re Cuozzo Speed Techs., LLC, 793 F.3d 1268 (Fed. Cir. 2015) (standards of review for PTAB decisions)
- In re Gartside, 203 F.3d 1305 (Fed. Cir. 2000) (factual findings of the Board reviewed for substantial evidence)