The sole issue before us is whether the district court
erred in granting summary judgment in favor of Bayer
and holding that asserted claims 13 and 15 of the ’564
patent are not invalid for obviousness in light of the
presented prior art.
We agree with the Defendants that the district court
erred in holding the claims not invalid. 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.” 35 U.S.C. § 103(a)
(2006). 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.
“[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.” In re Fulton,
391 F.3d 1195, 1200 (Fed. Cir. 2004). Just because one of
several references indicated a preference for using 24/4 or
23/5 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.
Copying in an ANDA context was quickly disposed of:
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. Purdue Pharma Prods. L.P. v.
Par Pharm., Inc., 377 F. App’x 978, 983 (Fed. Cir. 2010).
concerning Bayer’s U.S. Patent RE37,564
Subject matter: combined oral contraceptive (“COC”) products. First introduced in 1960, COCs, better known as birth control pills, deliver synthetic hormones that regulate the natural ovarian cycle and prevent pregnancy. Specifically, COCs comprise a progestin and an estrogen that together inhibit folliculogenesis