Eurand, Inc. v. Mylan Pharmaceuticals Inc.
676 F.3d 1063
| Fed. Cir. | 2012Background
- Cephalon owns the '793 and '372 patents covering Amrix cyclobenzaprine extended-release formulations and methods.
- District of Delaware held the patents invalid as obvious and entered judgment for Mylan/Par.
- This court reverses and vacates the obviousness judgment because the district court failed to account for the lack of a known PK/PD relationship.
- Best mode defense was upheld; the district court’s best mode analysis was affirmed.
- The appeal from the injunction pending Cephalon’s appeal was dismissed as premature, with the injunction remaining in place for a short period.
- The claims require a therapeutically effective 24-hour PK profile; the record shows no known PK/PD relationship for cyclobenzaprine at the time of invention, and there were long-felt needs and failed attempts by others indicating nonobviousness.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Obviousness based on bioequivalence | Cephalon argued lack of known PK/PD relation negates obviousness from bioeq. | Mylan/Par argued bioequivalence supports obviousness via routine optimization. | District court erred; bioequivalence cannot alone establish obviousness here. |
| Best mode disclosure | Cephalon argued best mode disclosed; the dew-point details were routine. | Mylan/Par claimed missing dew-point specifics constitute best mode failure. | Best mode defense affirmed; district court’s best mode ruling upheld. |
| Injunction pending appeal | Cephalon sought to maintain injunction to recapture product during appeal. | Mylan challenged injunction as premature and inappropriate. | Appeal from injunction dismissed as premature; injunction to remain temporarily in place. |
Key Cases Cited
- Graham v. John Deere Co., 383 U.S. 1 (U.S. 1966) (multifactor obviousness framework; objective considerations relevant to nonobviousness)
- KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (U.S. 2007) (flexible, expansive approach to obviousness; avoid hindsight bias)
- Microsoft Corp. v. i4i Ltd., 131 S. Ct. 223 (2011) (Supreme Court 2011) (standard of proof for invalidity is clear and convincing; burden placement clarified)
- Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530 (Fed. Cir. 1983) (objective evidence must be considered in obviousness analysis; not just prior art)
- In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009) (rejects hindsight-based obviousness where prior art lacks a finite path to claimed invention)
- Procter & Gamble Co. v. Teva Pharms. USA Inc., 566 F.3d 989 (Fed. Cir. 2009) (reasonable expectation of success required for prima facie obviousness)
- Graham v. John Deere Co. (duplicate), 383 U.S. 1 (U.S. 1966) (reiterated as authority for comprehensive obviousness framework)