Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc., 713 F.3d 1369

Consolidated actions where Bayer asserts claims 13 and 15 of the ’564 patent against generic challengers Watson, Sandoz, Lupin in the Nevada district court.
District court granted Bayer summary judgment that claims 13 and 15 are not invalid for obviousness in view of prior art; final judgments issued against defendants; FDA restrictions on approval pending patent expiry.
The ’564 patent covers low-dose combined oral contraceptives with 20 µg ethinylestradiol and 2.5–3.0 mg drospirenone in a 23/5 or 24/4 dosing regimen (28-day pack with 5 or 4 placebo days).
Prior art in the record includes AU’094 and EP’607 disclosing EE/DRSP regimens and 24/4 or 23/5 dosing; other references discuss missed-pill risks and shortened pill-free intervals.
Defendants conceded infringement under 35 U.S.C. § 271(e)(2) but challenged validity under obviousness; the appellate court reversed the district court, finding the claims obvious.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Are claims 13 and 15 obvious in view of AU’094, EP’607 and cited references?	Bayer contends prior art teaches all claim elements with motivation to combine.	Defendants argue the references teach away or lack motivation/expectation of success; district court misapplied references.	Yes; claims invalid for obviousness.

KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (U.S. 2007) (obviousness requires reason to combine with reasonable expectation of success)
Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352 (Fed. Cir. 2011) (need for motivation and expectation of success in combining art)
In re Fulton, 391 F.3d 1195 (Fed. Cir. 2004) (prior art combination need not be the preferred or most desirable)
Dow Jones & Co. v. Ablaise Ltd., 606 F.3d 1338 (Fed. Cir. 2010) (skepticism evidence must address actual invention)