Bayer Healthcare Pharma., Inc. v. Watson Pharma., Inc.

Case Name: Bayer Healthcare Pharma., Inc. v. Watson Pharma., Inc., 713 F.3d 1369 (Fed. Cir. Apr. 16, 2013) (Circuit Judges Lourie, Schall, and Prost presiding; Opinion by Lourie) (Appeal from D. Nev., Dawson, J.)

Drug Product and Patent(s)-in-Suit:YAZ^® (estrogen ethinylestradiol / progestin drospirenone); U.S. Patent No. RE37,564 (“the ’564 patent”)

Nature of the Case and Issue(s) Presented: Defendants stipulated to infringement; the only issue remaining concerned the validity of the ’564 patent. Both parties moved for summary judgment on the issue of obviousness. The district court granted Bayer’s motion that the ’564 patent was non-obvious.

On appeal, the defendants argued that the ’564 patent was obvious in light of a combination of one prior art reference with any one of five different prior art references. Defendants argued that all of the claimed limitations were known in the art, and one of skill would have been motivated to combine those references to render the ’564 patent obvious.

Bayer argued that two prior art references, AU’094 and EP’607, were directed to narrow subpopulations of patients primarily in need of hormone-replacement therapy, so those references would not have been combined by a person of ordinary skill seeking to develop a combined oral contraceptive before the priority date of the patent-in-suit. Furthermore, according to Bayer, the prior art as a whole taught away from the claimed combined oral contraceptive preparations at that time in view of the entrenched use of traditional 21/7 dosing and the perceived risks from increasing total synthetic hormone administration by shortening the pill-free interval. Finally, Bayer defended the district court’s reliance on its evidence of unexpected results, expert skepticism, industry praise, and copying as secondary indicia of non-obviousness. The Federal Circuit rejected Bayer’s arguments and held that the ’564 patent was invalid.

Why Watson Prevailed: First, the Federal Circuit disagreed that the prior art references were limited to hormonal replacement therapy. The court found that those references discussed both hormonal replacement and contraceptive applications. Second, the Federal Circuit disagreed that the prior art taught away from the claimed invention because, as a whole, the references did not explicitly state that a reduced pill-free interval was not warranted or desired. The Federal Circuit reasoned, “[j]ust because one of several references indicated a preference for using 24/4 or 23/5 dosing regimens in tandem with higher-dose [combined oral contraceptives] does not mean the same missed-pill rationale could not also motivate applying the shorter pill-free interval to similarly improve other [combined oral contraceptive] preparations.” Finally, the Federal Circuit rejected Bayer’s evidence of secondary considerations finding that the evidence did not show anything more than common sense results from using a reduced pill-free interval.