Patent Watch: Bayer Schering Pharma AG v. Watson Pharm., Inc.

by BakerHostetler

[Secondary consideration] evidence of copying in the ANDA context is not probative of nonobviousness because a showing of bioequivalence is required for FDA approval.

On April 16, 2013, in Bayer Schering Pharma AG v. Watson Pharm., Inc., the U.S. Court of Appeals for the Federal Circuit (Lourie,* Schall, Prost) reversed the district court's summary judgment that U.S. Reissue Patent No. 37,564 (reissue of U.S. Patent 5,824,667), which related to combined oral contraceptive (COC) pharmaceuticals such as Bayer's YAZ® product, was not invalid for obviousness under 35 U.S.C. § 103. The Federal Circuit stated:

A claim is invalid for obviousness "if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art." In this case, the cited prior art references set forth every limitation required by the asserted claims and provide express motivation to combine those teachings to derive the claimed COC products. Accordingly, the asserted claims are invalid under § 103. There is no dispute that claims 13 and 15 of the '564 patent require a COC product defined by the following limitations: (1) 20 µg EE per active pill, (2) 2.5-3.0 mg [drospirenone or] DRSP per active pill, and (3) a 23/5 or 24/4 dosing regimen. Nor is it disputed that the cited prior art references disclose each of those limitations. . . . With every limitation of the asserted claims thus disclosed in the cited references, the question, as the district court recognized, becomes whether a person of ordinary skill in the art would have been motivated to combine those teachings to derive the claimed subject matter with a reasonable expectation of success.

The prior art before us provides that motivation. In addition to AU'094's express reference to EP'607, several of the cited references highlight evidence that the unregu¬lated ovarian activity that occurs during a seven-day pill-free interval can achieve significant follicular development, and those references also express concern that inadvertently extending the traditional pill-free interval via one or more missed pills could lead to escape ovulation and unintended pregnancy. In addition, Bayer's expert acknowledged that one of skill in the art at the time of the invention would have expected an even greater risk of such "missed pill" ovulation for users of low-dose COCs (i.e., those containing 20 µg EE per active pill). The evidence thus demonstrates that missed-pill ovulation was a recognized concern with traditional 21/7COCs, particularly for those on the market by 1993 that -- like the claimed COC preparations -- relied on low-doseEE. As the Supreme Court has stated, "any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed." Furthermore, the references in this case go beyond just illuminating a known problem; they also expressly propose the claimed solution: "To reduce the risk of missed pill conception a 28 day pack containing 23 pills and 5 blanks could be substituted for the current 21 day pack. This would still permit a withdrawal bleed without the risk of significant follicular development." Accordingly, the prior art's direct recommendations to use 24/4 and 23/5 dosing regimens to minimize the risks of escape ovulation would have motivated one of ordinary skill in the art to imple¬ment such a shortened pill-free interval for use with known low-dose COCs, as recited in the asserted claims. . . .

In addition, Bayer argues that the prior art taught away from the claimed COC preparations, focusing on statements in Guillebaud as indicating that the "conventional wisdom" in the field favored 21/7 dosing for most patients and as suggesting that a reduced pill-free interval should be used together with higher-dose COCs for patients perceived to be at risk of escape ovulation. Those statements, however, do not overcome the express teachings of multiple references, including Guillebaud, that a shorter pill-free interval would improve COC efficacy. Furthermore, Guillebaud may have suggested condensing the pill-free interval while concurrently increasing the hormone dose for at-risk patients, but those two measures are never described as mutually dependent, and each could be expected to reduce missed-pill ovulation risks with or without the other. "[A] finding that the prior art as a whole suggests the desirability of a particular combination need not be supported by a finding that the prior art suggests that the combination claimed . . . is the preferred, or most desirable, combination." Just because one of several references indicated a preference for using 24/4 or23/5 dosing regimens in tandem with higher-dose COCs does not mean the same missed-pill rationale could not also motivate applying the shorter pill-free interval to similarly improve other COC preparations.

Finally, Bayer's evidence of secondary indicia of non-obviousness, including alleged unexpected results, expert skepticism, industry praise, and copying by others, is legally insufficient. To demonstrate unexpected results, Bayer relies on data showing that 23/5 administration results in reduced follicular activity compared to 21/7 dosing of the same COC formulation. But those data merely confirm that administering additional active pills results in additional follicular suppression, which would have been a matter of "common sense," as even Bayer's expert agreed. As evidence of expert skepticism, Bayer cites an FDA request for clinical safety data and data demonstrating efficacy benefits sufficient to justify the added synthetic hormone exposure required for the proposed 24/4 dosing regimen. That request in no way indicates that FDA experts would have been surprised to receive such data. Rather, the cited request reflects attention to the FDA's normal duties ensuring the safety and efficacy of new drugs by requiring actual data to corroborate statements in a new drug application. . . . Lastly, we reject Bayer's contention that copying of its COC preparations by the Defendants and other generic manufacturers supports its validity position. Such evidence of copying in the ANDA context is not probative of nonobviousness because a showing of bioequivalence is required for FDA approval.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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