Bayer Pharma Ag v. Watson Laboratories, Inc.
874 F.3d 1316
| Fed. Cir. | 2017Background
- Bayer held U.S. Patent No. 8,613,950 claiming an uncoated oral disintegrating tablet (ODT) of vardenafil that releases drug in the mouth; Bayer markets Staxyn. Watson sought ANDA approval to market a generic and was sued for infringement.
- Claims 9 and 11 (dependent on claim 8) require (9) sorbitol + mannitol and (11) at least one sugar alcohol being sorbitol.
- At a six-day bench trial Watson argued the claimed formulation would have been obvious based on prior-art disclosures motivating: (1) ODTs of ED drugs including vardenafil, (2) use of sorbitol and mannitol, and (3) immediate-release ODTs.
- The district court found Watson failed to prove obviousness by clear and convincing evidence, crediting Bayer’s expert testimony that (a) there was no motivation to make ED ODTs, (b) no reason to add sorbitol to mannitol, and (c) the prior art taught away from immediate-release ODTs due to taste and bioavailability concerns; it also found some objective indicia (copying, unexpected duration) favoring nonobviousness.
- The Federal Circuit held the district court clearly erred in (a) disregarding multiple prior-art references showing ODTs for ED drugs (including vardenafil/sildenafil) and (b) failing to consider prior art disclosing sorbitol+mannitol (e.g., Pharmaburst, Joshi, Norman/Sparks). The court affirmed the factual findings about taste and bioavailability but held those did not teach away.
- Weighing the Graham factors, the Federal Circuit reversed: claims 9 and 11 are obvious; costs awarded to Watson.
Issues
| Issue | Watson's Argument | Bayer's Argument | Held |
|---|---|---|---|
| Motivation to formulate vardenafil as an ODT | Prior art disclosed ODTs for ED drugs and specific ODT proposals for vardenafil/sildenafil; skilled artisan would be motivated | No ED ODTs were on market by 2005; ODTs were rare so no motivation | Court: Prior art expressly taught ODTs for ED drugs; district court clearly erred in ignoring key references -> motivation existed |
| Selection of sorbitol + mannitol excipients | Off-the-shelf Pharmaburst B2 and references (Joshi, Sparks, Norman) disclosed or taught benefits of sorbitol+mannitol | Existing ODTs used only mannitol; no known problems with mannitol alone; Pharmaburst not in approved U.S. products | Court: Prior art disclosed and taught advantages of sorbitol+mannitol; district court clearly erred in finding no motivation |
| Immediate-release limitation (release in mouth) / teaching away | Immediate-release ODTs were known; even if delayed-release might be preferred, prior art did not teach away from immediate-release | Taste bitterness and increased bioavailability (label) would discourage immediate-release; taught away | Court: District court’s taste/bioavailability findings stand, but do not teach away; immediate-release remained a suitable, obvious option |
| Objective indicia (copying, unexpected results) | Watson: objective evidence does not overcome strong prior-art motivation | Bayer: copying and unexpected duration support nonobviousness | Court: District court’s findings on copying and unexpected duration stand and weigh in favor of nonobviousness, but overall obviousness conclusion prevails when balancing all Graham factors |
Key Cases Cited
- In re Kubin, 561 F.3d 1351 (Fed. Cir.) (sets forth Graham-factor framework for obviousness)
- Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir.) (clear-error review of district court fact-findings on obviousness)
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (Sup. Ct.) (motivation-to-combine and that preference for alternatives is not teaching away)
- Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286 (Fed. Cir.) (FDA-approval considerations do not limit obviousness motivation inquiry)
- Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034 (Fed. Cir.) (weighing Graham factors including objective indicia)