Soft Gel Technologies, Inc. v. Jarrow Formulas, Inc.
16-1814
Fed. Cir.Jul 26, 2017Background
- Soft Gel Technologies owns three related patents (’072, ’583, ’826) claiming CoQ10 dissolved in a monoterpene (limited to d‑limonene) and formulations/soft gel capsules containing that solution.
- Motoyama (1982) discloses dissolving CoQ10 in oils and specifically reports high solubility in the monoterpene carvone and encapsulating the solution with improved bioavailability.
- Khan ’786 and Nazzal (dissertation) disclose using essential (volatile) oils (e.g., lemon, peppermint, spearmint) with CoQ10 and recommend studying interactions of CoQ10 with specific oil components such as limonene and carvone; they also describe self‑emulsifying systems.
- Fenaroli and IARC disclose that lemon oil is largely limonene and that d‑limonene predominates in citrus oils.
- The USPTO Board combined Motoyama, Khan/Nazzal, Fenaroli, and IARC to find claims obvious; Soft Gel appealed arguing errors in (1) factual finding that d‑limonene is lemon oil’s main constituent, (2) that Khan teaches away, and (3) lack of reasonable expectation of success.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether d‑limonene is the main constituent of lemon oil | Soft Gel: record shows some lemon oils have low limonene; Board’s finding is erroneous | Jarrow/Board: IARC and Fenaroli show ~88–90% limonene; Lota data still supports limonene as principal constituent | Court: Affirmed Board; references support finding that d‑limonene is main constituent |
| Whether Khan ’786 teaches away from using lemon oil/d‑limonene | Soft Gel: Khan discloses difficulties dissolving CoQ10 and shows inconsistent behavior with emulsifiers, teaching away | Jarrow/Board: Khan actually teaches using essential oils (including lemon) to improve CoQ10 availability; results show lemon performed best | Court: Khan does not teach away; Board’s conclusion sustained |
| Whether a person of ordinary skill would have a reasonable expectation of success using d‑limonene | Soft Gel: Motoyama/Nazzal/Khan don’t name d‑limonene; follow‑up studies by Khan show uncertainty, so no reasonable expectation | Jarrow/Board: Nazzal recommends testing limonene; Motoyama lists terpenes; lemon oil’s main component is d‑limonene — a skilled artisan would expect success | Court: Affirmed — reasonable expectation of success existed; later confirmatory studies don’t negate obviousness |
| Whether Board’s reference to “limonene” vs. amended claims specifying “d‑limonene” was reversible error | Soft Gel: substitution of limonene for d‑limonene was material error | Jarrow/Board: IARC/Fenaroli show lemon oil is predominately d‑limonene; substitution harmless | Court: Harmless error; affirmed obviousness |
Key Cases Cited
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (establishes framework for obviousness analysis requiring an apparent reason to combine and consideration of skill in the art)
- Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286 (reasonable expectation of success standard in chemical/pharmaceutical obviousness)
- In re Merck & Co., 800 F.2d 1091 (cannot establish nonobviousness by attacking references individually when rejection is based on combination)
- Noelle v. Lederman, 355 F.3d 1343 (obviousness requires reasonable expectation, not absolute predictability)
AFFIRMED