## Facts

- Orexo owned U.S. Patent No. 8,940,330 covering a sublingual buprenorphine/naloxone tablet for opioid dependence with buprenorphine adsorbed onto citric-acid carrier particles in a specified microstructure.
- Actavis filed an ANDA seeking approval to market a generic version and certified under Paragraph IV that the patent was invalid and/or not infringed, triggering Hatch–Waxman litigation under 35 U.S.C. § 271(e)(2)(A).
- In the District of Delaware, Actavis argued the asserted claims were obvious because the prior art disclosed buprenorphine/naloxone sublingual formulations and the use of citric acid as an excipient and bioavailability enhancer.
- The district court held claims 1, 3–6, and 8–10 invalid for obviousness, reasoning the invention was an “obvious to try” combination of known elements and treating the reported ~66% bioavailability increase as a difference in degree.
- Orexo appealed, relying in part on the claimed microstructure and evidence of unexpected results and other objective indicia of nonobviousness.

## Issues

1. Whether claims 1, 3–6, and 8–10 of the ’330 patent were obvious under 35 U.S.C. § 103 based on prior art disclosing buprenorphine/naloxone sublingual products and citric acid use in such formulations.
2. Whether the district court erred by discounting objective indicia of nonobviousness, including substantial bioavailability improvement and related evidence tied to the claimed formulation.

## Decision

- The Federal Circuit reversed the judgment of invalidity.
- The court held Actavis failed to prove obviousness by clear and convincing evidence.
- The court concluded the record did not support a finding that the prior art suggested the claimed selection and arrangement—buprenorphine adsorbed onto citric-acid carrier particles in the claimed microstructure—with a reasonable expectation of success.
- The court treated the reported ~66% bioavailability increase as significant evidence of unexpected results supporting nonobviousness.

## Legal Principles

- Obviousness requires more than showing that each claim component was individually known; the analysis must address whether the prior art would have suggested the claimed combination and arrangement with a reasonable expectation of success.
- A court may not establish obviousness by disaggregating a claim into known elements without a supported rationale for combining them in the specific claimed manner.
- Objective indicia of nonobviousness (including unexpected results and other secondary considerations) are part of the § 103 analysis and must be weighed with the prior-art evidence.
- Patent invalidity for obviousness must be proven by clear and convincing evidence.

## Conclusion

The Federal Circuit reversed the district court’s obviousness ruling because the prior art did not adequately support a motivation and reasonable expectation to create the claimed citric-acid carrier microstructure, and the substantial bioavailability improvement provided strong evidence of nonobviousness under the clear-and-convincing standard.


Orexo AB v. Actavis Elizabeth LLC, 903 F.3d 1265 (Fed. Cir. 2018)