Nalpropion Pharmaceuticals v. Actavis Laboratories Fl, Inc.
934 F.3d 1344
| Fed. Cir. | 2019Background
- Nalpropion (successor to Orexigen/Takeda) markets Contrave® (extended‑release naltrexone + bupropion) and asserted three Orange‑Book patents: the ’195 (specific SR dosages + USP 2 dissolution profile), the ’111 (composition: SR bupropion + SR naltrexone in a single fixed oral dosage), and the ’626 (methods of treating obesity using bupropion and naltrexone; dependent claims require co‑administration and single dosage form).
- Actavis filed an ANDA to market a generic Contrave product; Nalpropion sued for infringement; Actavis counterclaimed invalidity for written description (’195 claim 11) and obviousness (’111 claim 1; ’626 claims 26, 31).
- Claim 11 of the ’195 patent recites daily ~32 mg naltrexone + ~360 mg bupropion (each as SR, dosed twice daily) and a naltrexone in‑vitro dissolution profile measured by USP Apparatus 2 (paddle) at 100 rpm in water at 37°C (specific % release at 1, 2, and 8 hours).
- The specification reports dissolution data in Example Tables; some data were measured with USP Apparatus 1 (basket) and Table 10 (tri‑layer example) does not state which apparatus was used. Actavis argued USP 1 data do not provide written description support for the USP 2‑measured limits in claim 11.
- For obviousness, Actavis relied on prior art (Jain and Anderson for bupropion weight‑loss data; O’Malley, Dante, Atkinson, Bernstein for naltrexone and combinations) arguing a skilled artisan would be motivated to combine bupropion and naltrexone with a reasonable expectation of success.
Issues
| Issue | Nalpropion's Argument | Actavis's Argument | Held |
|---|---|---|---|
| Whether claim 11 of the ’195 patent satisfies the written description requirement (USP 2 dissolution profile) | Specification (Tables 5 and 10) and expert testimony show inventors possessed the claimed SR formulations; USP 1 and USP 2 are substantially equivalent for written description purposes | Tables report dissolution using USP 1 (or are silent); USP 1 and USP 2 produce different results so the specification does not disclose the claimed USP 2 profile | Affirmed: district court did not clearly err; claim 11 has adequate written description (USP methods treated as substantially equivalent on the facts) |
| Whether claim 1 of the ’111 patent and claims 26 & 31 of the ’626 patent are invalid for obviousness in view of O’Malley, Jain (and other prior art) | Prior art does not teach or motivate combining the two drugs for weight‑loss; bupropion had modest efficacy and safety concerns; naltrexone not clearly known to produce weight loss; secondary considerations support nonobviousness | Prior art discloses weight‑loss effects of both drugs (Jain, Anderson, Atkinson, Dante); O’Malley and Dante teach combining naltrexone and bupropion for related uses; skilled artisan would be motivated to combine with reasonable expectation of success | Reversed: claims 1, 26, and 31 are obvious in view of O’Malley and Jain; district court’s nonobviousness finding reversed |
| Miscellaneous: Nalpropion’s motion to strike Actavis’s reply brief | Motion to strike asserted procedural fault | Actavis opposed | Motion denied as moot by the court |
Key Cases Cited
- Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir.) (en banc) (written description is a factual inquiry: specification must reasonably convey possession of the claimed invention)
- Alcon Research Ltd. v. Barr Labs., Inc., 745 F.3d 1180 (Fed. Cir.) (written description reviewed for clear error on underlying facts)
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (combining familiar elements yielding predictable results is likely obvious)
- Anderson v. City of Bessemer City, 470 U.S. 564 (1985) (appellate courts defer to district court factfinding when two permissible views exist)
- Lockwood v. Am. Airlines, Inc., 107 F.3d 1565 (Fed. Cir.) (written description does not permit claims that are merely obvious variants of the specification)
- Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286 (Fed. Cir.) (motivation to combine need not mirror FDA‑approval rationales)
- Arctic Cat Inc. v. Bombardier Recreational Prods. Inc., 876 F.3d 1350 (Fed. Cir.) (motivation to combine assessed from a range of real‑world facts)