“[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.” Here, just because one of several references indicated a preference for using shortened 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.”
Background / Facts: This case concerns pharmaceutical formulations and dosing regimens for combined oral contraceptive products (“COCs”, better known as birth control pills). Early COCs relied on a 21/7 dosing regimen in which each monthly pill pack would include twenty-one active pills containing synthetic progestin and estrogen followed by seven placebo pills containing no hormones. In the early 1990s, Bayer began developing a low-dose COC to be administered with a reduced pill-free interval. Bayer demonstrated that shortening the pill-free interval to four or five days improved the contraceptive efficacy of low-dose COC formulations. In this regard, the claims recite a combination product for oral contraception, comprising “(a) 23 or 24 daily dosage units, each containing [a low dose of hormones] … and (b) 5 or 4, respectively, active ingredient-free placebo pills.” It is not disputed that the cited prior art references disclose each of these limitations individually.
Issue(s): Whether a person of ordinary skill in the art would have been motivated to combine these teachings to derive the claimed subject matter with a reasonable expectation of success.
Holding(s): Yes. The court found that the prior art additionally “demonstrates that missed-pill ovulation was a recognized concern with traditional 21/7 COCs, particularly for those on the market by 1993 that – like the claimed COC preparations – relied on low-dose [hormones]. … 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 implement such a shortened pill-free interval for use with known low-dose COCs, as recited in the asserted claims.” Bayer’s argument that that the prior art taught away from the claimed COC preparations, focusing on statements in one of the references 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, “do not overcome the express teachings of multiple references, including [the cited one], that a shorter pill-free interval would improve COC efficacy.” Although one particular reference “may have suggested condensing the pill-free interval while concurrently increasing the hormone dose for at-risk patients, … 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.”