Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc.

United States Court of Appeals
for the Federal Circuit
______________________
BAYER HEALTHCARE PHARMACEUTICALS, INC.
AND BAYER SCHERING PHARMA AG,
Plaintiffs-Appellees,
v.
WATSON PHARMACEUTICALS, INC.
AND WATSON LABORATORIES, INC.,
Defendants-Appellants,
AND
SANDOZ INC.,
Defendant-Appellant.
______________________
2012-1397, -1398, -1400
______________________
Appeal from the United States District Court for the
District of Nevada in Nos. 07-CV-1472 and 08-CV-0995,
Judge Kent J. Dawson.
-------------------------------------------------
BAYER SCHERING PHARMA AG AND
BAYER HEALTHCARE PHARMACEUTICALS, INC.,
Plaintiffs-Appellees,
v.
2 BAYER HEALTHCARE PHARMA v. WATSON PHARMA
LUPIN, LTD. AND LUPIN PHARMACEUTICALS,
INC.,
Defendants-Appellants.
______________________
2012-1424
______________________
Appeal from the United States District Court for the
District of Nevada in No. 10-CV-1166, Judge Kent J.
Dawson.
______________________
Decided: April 16, 2013
______________________
ADAM K. MORTARA, Bartlit Beck Herman Palenchar &
Scott, LLP, of Chicago, Illinois, argued for plaintiffs-
appellees. With him on the brief were PETER B.
BENSINGER, JR. and MATTHEW R. FORD. Of counsel was
PAUL J. SKIERMONT, Skiermont Puckett, LLP, of Dallas,
Texas.
MARK T. JANSEN, Crowell & Moring LLP, of San Fran-
cisco, California, argued for defendants-appellants Wat-
son Pharmaceuticals, Inc., et al. With him on the brief
were CEDRIC C.Y. TAN and KRISTIN M. COOKLIN.
JOSEPH A. HYNDS, Rothwell, Figg, Ernst & Manbeck,
P.C., of Washington, DC, argued for the defendant-
appellant, Sandoz Inc. With him on the brief were
STEVEN LIEBERMAN and LISA N. PHILLIPS.
ROBERT F. GREEN, Leydig, Voit & Mayer, Ltd. of Chi-
cago, Illinois, argued for defendants-appellants, Lupin
Ltd., et al. With him on the brief were CHRISTOPHER T.
BAYER HEALTHCARE PHARMA v. WATSON PHARMA 3
GRIFFITH and KATE M. LESCIOTTO; JAMAICA P. SZELIGA, of
Washington, DC.
______________________
Before LOURIE, SCHALL, and PROST, Circuit Judges.
LOURIE, Circuit Judge.
In these consolidated patent infringement actions, ge-
neric pharmaceutical manufacturers Watson Pharmaceu-
ticals, Inc., Watson Laboratories, Inc., Sandoz, Inc., Lupin
Ltd., and Lupin Pharmaceuticals, Inc. (collectively, the
“Defendants”) appeal from the final judgments of the
United States District Court for the District of Nevada in
favor of Plaintiffs-Appellees Bayer Healthcare Pharma-
ceuticals, Inc. and Bayer Schering Pharma AG (collective-
ly, “Bayer”). In particular, the Defendants challenge the
district court’s entry of summary judgment that asserted
claims 13 and 15 of Bayer’s U.S. Patent RE37,564 (the
“’564 patent”) are not invalid for obviousness in view of
numerous cited prior art references. Bayer Schering
Pharma AG v. Watson Pharm., Inc., Nos. 2:07-cv-01472,
2:08-cv-00995, 2012 WL 1079551 (D. Nev. Mar. 30, 2012)
(“Watson Summary Judgment Order”); Bayer Schering
Pharma AG v. Lupin Ltd., No. 2:10-cv-01166, 2012 WL
1080296 (D. Nev. Mar. 30, 2012) (“Lupin Summary
Judgment Order”). For the reasons that follow, we re-
verse.
BACKGROUND
This case concerns pharmaceutical formulations and
dosing regimens for 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—a stepwise, hor-
mone-directed process in which an ovarian follicle con-
taining an immature oocyte (i.e., an egg cell) grows and
4 BAYER HEALTHCARE PHARMA v. WATSON PHARMA
develops for approximately the first two weeks of an
ovarian cycle, culminating in the release of a fertile oocyte
at ovulation. The synthetic progestin and estrogen pro-
vided in a COC suppress production of the natural hor-
mones that drive folliculogenesis, thus inhibiting
ovulation and reducing the incidence of pregnancy in COC
users. The contraceptive effects depend on the continued
presence of the inhibitory synthetic hormones; folliculo-
genesis will commence if the synthetic progestin and
estrogen are withdrawn but can be abrogated if the hor-
mones are reintroduced before ovulation occurs.
To maintain synthetic hormone concentrations suffi-
cient for sustained follicular suppression, COCs are
typically taken once daily, and since their introduction,
most COCs have been provided in 28-day, 28-pill packs
that align with the approximate length of a natural
ovarian cycle. Early COCs relied on a 21/7 dosing regi-
men in which each monthly pill pack would include twen-
ty-one active pills containing synthetic progestin and
estrogen followed by seven placebo pills containing no
hormones. The seven-day placebo period, also known as
the pill-free interval, was originally included because it
(i) triggered a “withdrawal bleed” that mimicked natural
menstrual bleeding and was presumed to improve ac-
ceptance among COC users, and (ii) provided a regular
break from synthetic hormone exposure that was thought
to mitigate potential side effects. The 21/7 regimen
persists in most COCs on the market today.
In addition to maintaining a pill-free interval, another
strategy to reduce side effects has been to reduce the
hormone dose provided in each pill. For example, the first
COCs provided relatively high daily doses of synthetic
estrogen, up to approximately 150 µg per active pill.
Deleterious side effects of COC use, including thrombo-
embolism, nausea, and bloating, have been most strongly
associated with synthetic estrogen exposure, so the estro-
gen dose in particular has been progressively reduced
BAYER HEALTHCARE PHARMA v. WATSON PHARMA 5
over time. The first COC containing the synthetic estro-
gen ethinylestradiol (“EE”) at only 20 µg per pill was
approved for sale in the United States in 1976.
In the early 1990s, Bayer began developing a low-dose
COC containing 20 µg EE and the synthetic progestin
drospirenone (“DRSP”) to be administered with a reduced
pill-free interval. Lowering EE dosage to 20 µg per pill
limits undesirable side effects, but it also results in weak-
er ovarian suppression compared to higher-dose COCs.
As such, some ovarian activity and follicular maturation
can persist in users of low-dose COCs, and any intake
errors (i.e., missed pills), especially those that effectively
lengthen the unregulated pill-free interval, could result in
“escape” ovulation and unintended pregnancy. ’564
patent col. 2 l. 38 – col. 3 l. 6. To address the risk of
escape ovulation for users of low-dose COCs, Bayer im-
plemented 23/5 and 24/4 dosing regimens, reducing the
pill-free interval to five or four days, respectively, and
increasing the number of active pills per cycle accordingly.
Bayer demonstrated that shortening the pill-free interval
to four or five days improved the contraceptive efficacy of
low-dose COC formulations. Accordingly, Bayer filed its
first patent application directed to such low-dose, extend-
ed-regimen COCs on December 22, 1993, and that appli-
cation eventually led to the ’564 patent. 1 The ’564 patent
includes 15 claims reciting various COC preparations;
claims 13 and 15 read as follows:
1 The December 1993 application was a foreign pri-
ority application filed in Germany. Bayer filed its first
corresponding U.S. application in June 1994 and obtained
U.S. Patent 5,824,667 (the “’667 patent”) as a continua-
tion of that first U.S. application on October 20, 1998.
The asserted ’564 patent, issued on February 26, 2002,
arose as a reissue of the ’667 patent.
6 BAYER HEALTHCARE PHARMA v. WATSON PHARMA
13. A combination product for oral contraception,
comprising
(a) 23 or 24 daily dosage units, each containing
0.020 mg of ethinylestradiol, and 2.5 to 3.0 mg
of drospirenone, and
(b) 5 or 4, respectively, active ingredient-free pla-
cebo pills or other indications to show that the
daily administration of the 23 or 24 dosage
units, respectively, is to be followed by 5 or 4,
respectively, pill-free or placebo pill days,
wherein each of the dosage units containing dro-
spirenone contains the same amount of dro-
spirenone.
....
15. A combination preparation of claim 13, which
comprises 24 dosage units and 4 placebo pills or
other indications to show that no dosage unit or
placebo pill is administered during the last 4 days
of the menstrual cycle.
’564 patent col. 6 l. 57 – col. 8 l. 4. Bayer markets a COC
product that embodies claims 13 and 15 under the brand
name YAZ®. That product includes four placebo pills and
twenty-four active pills each containing 20 µg EE and 3
mg DRSP. Bayer received final approval to market YAZ®
in the United States on March 16, 2006.
The Defendants filed Abbreviated New Drug Applica-
tions (“ANDAs”) with the U.S. Food and Drug Admin-
istration (“FDA”) seeking approval to market generic
versions of YAZ®. Those ANDA filings included Para-
graph IV certifications asserting that the ’564 patent is
invalid. See 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (2006). Bayer
responded by bringing patent infringement actions alleg-
BAYER HEALTHCARE PHARMA v. WATSON PHARMA 7
ing that the Defendants’ ANDA filings infringed claims 13
and 15 of the ’564 patent under 35 U.S.C. § 271(e)(2). 2
Before the district court, the Defendants conceded
that their ANDAs infringed the ’564 patent under
§ 271(e)(2). Bayer Schering Pharma AG v. Watson
Pharm., Inc., No. 2:07-cv-01472, 2011 WL 1235154, at *1
(D. Nev. Mar. 31, 2011); Bayer Schering Pharma AG v.
Lupin Ltd., No. 2:10-cv-01166, slip op. at 2 (D. Nev. July
22, 2011), ECF No. 86. The Defendants responded and
counterclaimed, however, that the asserted claims of the
’564 patent were invalid for obviousness in view of nu-
merous prior art references. Each side moved for sum-
mary judgment on the obviousness issue, and the district
court granted Bayer’s motions, holding that the asserted
claims of the ’564 patent were not invalid in view of the
cited prior art. Watson Summary Judgment Order, 2012
WL 1079551, at *16–23; Lupin Summary Judgment
Order, 2012 WL 1080296, at *14–21. The district court
thereafter entered final judgment against the Defendants,
Bayer Schering Pharma AG v. Watson Pharm., Inc., No.
2:07-cv-01472 (D. Nev. May 29, 2012), ECF No. 354
(Partial Final Judgment); Bayer Schering Pharma AG v.
Lupin Ltd., No. 2:10-cv-01166, (D. Nev. Apr. 11, 2012),
ECF No. 107 (Judgment in a Civil Case), and issued
orders pursuant to 35 U.S.C. § 271(e)(4)(A) prohibiting
the FDA from approving the Defendants’ ANDAs before
the ’564 patent expires on June 30, 2014, Bayer Schering
Pharma AG v. Watson Pharm., Inc., Nos. 2:07-cv-01472,
2 Bayer filed suit against Watson on November 5,
2007, and against Sandoz on August 1, 2008. The district
court consolidated those actions on November 4, 2008.
Bayer Schering Pharma AG v. Watson Pharm., Inc., Nos.
2:07-cv-01472, 2:08-cv-00995 (D. Nev. Nov. 4, 2008), ECF
No. 43 (Order to Consolidate Related Cases). Bayer
initiated parallel infringement proceedings against Lupin
on July 15, 2010.
8 BAYER HEALTHCARE PHARMA v. WATSON PHARMA
2:08-cv-00995, 2013 WL 592890 (D. Nev. Feb. 11, 2013);
Bayer Schering Pharma AG v. Lupin Ltd., No. 2:10-cv-
01166, 2013 WL 592017 (D. Nev. Feb. 11, 2013).
The Defendants now appeal. We have jurisdiction
under 28 U.S.C. § 1295(a)(1). 3
DISCUSSION
Summary judgment is appropriate “if the movant
shows that there is no genuine dispute as to any material
fact and the movant is entitled to judgment as a matter of
law.” Fed. R. Civ. P. 56(a). We apply regional circuit law,
in this case the law of the Ninth Circuit, when reviewing
a district court’s grant or denial of a motion for summary
judgment. Teva Pharm. Indus. v. AstraZeneca Pharm.
LP, 661 F.3d 1378, 1381 (Fed. Cir. 2011). The Ninth
3 Bayer has suggested that we lack jurisdiction to
entertain this appeal. Appellees’ Br. 3–4. Specifically,
Bayer contends that it has unresolved claims for damages
relating to alleged at-risk launches of infringing generic
products by Watson and/or Sandoz that preclude appel-
late jurisdiction under 28 U.S.C. § 1292(c)(2). We need
not address that argument, however, because our jurisdic-
tion over this appeal does not depend on § 1292(c)(2). The
district court granted summary judgment against the
Defendants on their invalidity counterclaims and, pursu-
ant to Federal Rule of Civil Procedure 54(b), entered
partial final judgment that the ’564 patent was not inva-
lid for obviousness. Bayer Schering Pharma AG v. Watson
Pharm., Inc., No. 2:07-cv-01472 (D. Nev. May 29, 2012),
ECF No. 354 (Partial Final Judgment). The district court
did not abuse its discretion in applying Rule 54(b), and its
judgment in that part of the case is final. See Sun Pharm.
Indus. v. Eli Lilly & Co., 611 F.3d 1381, 1384 (Fed. Cir.
2010). We therefore have jurisdiction to review the dis-
trict court’s partial final judgment under 28 U.S.C.
§ 1295(a)(1).
BAYER HEALTHCARE PHARMA v. WATSON PHARMA 9
Circuit reviews summary judgment rulings without
deference, “asking ‘whether there are any genuine issues
of material fact’ while ‘[v]iewing the evidence in the light
most favorable to the nonmoving party.’” Dealertrack,
Inc. v. Huber, 674 F.3d 1315, 1320 (Fed. Cir. 2012) (quot-
ing Burke v. Cnty. of Alameda, 586 F.3d 725, 730–31 (9th
Cir. 2009)). Obviousness is a question of law premised on
underlying issues of fact. KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 427 (2007).
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.
The Defendants rely on six prior art references: Aus-
tralian Patent Application 55094/90, published November
22, 1990 (“AU’094”); European Patent Application Publi-
cation 0 253 607, published April 29, 1992 (“EP’607”);
B.G. Molloy et al., “Missed Pill” conception: fact or fic-
tion?, 290 Brit. Med. J. 1474 (1985) (“Molloy”); John
Guillebaud, The forgotten pill—and the paramount im-
portance of the pill-free week, 12 Brit. J. Fam. Plan. 35
(1987) (“Guillebaud”); B-M. Landgren & E. Diczfalusy,
Hormonal Consequences of Missing the Pill During the
First Two Days of Three Consecutive Artificial Cycles, 29
Contraception 437 (1984) (“Landgren”); and N.D.
Goldstuck et al., Use and misuse of oral contraceptives by
adolescents attending a free-standing clinic, 3 Advances in
Contraception 335 (1987) (“Goldstuck”). According to the
Defendants, the combination of AU’094 with any of
EP’607, Molloy, Guillebaud, Landgren, or Goldstuck
would have rendered the asserted claims of the ’564
patent obvious at the time of invention. In particular, the
Defendants argue that AU’094 discloses a COC combining
20–40 µg EE and 1–10 mg DRSP per active pill—dosage
ranges that encompass those recited in claims 13 and 15
of the ’564 patent. The Defendants further contend that
10 BAYER HEALTHCARE PHARMA v. WATSON PHARMA
EP’607, Molloy, Guillebaud, Landgren, and Goldstuck
each disclose 23/5 and/or 24/4 dosing regimens and that
those references provided motivation to combine such
regimens with the low-dose COCs disclosed in AU’094 by
identifying the problem of missed-pill conceptions and
suggesting a shortened pill-free interval as a solution.
Finally, the Defendants contend that the district court
erred by misapplying and misinterpreting the cited refer-
ences and by crediting legally insufficient evidence as
secondary indicia of nonobviousness.
In response, Bayer argues that AU’094 and EP’607
were directed to narrow subpopulations of patients pri-
marily in need of hormone-replacement therapy, so those
references would not have been combined by a person of
ordinary skill seeking to develop a COC in 1993. Fur-
thermore, according to Bayer, the prior art as a whole
taught away from the claimed COC 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 defends the district court’s
reliance on its evidence of unexpected results, expert
skepticism, industry praise, and copying as secondary
indicia of nonobviousness.
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 as-
serted claims are invalid under § 103.
BAYER HEALTHCARE PHARMA v. WATSON PHARMA 11
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
DRSP per active pill, and (3) a 23/5 or 24/4 dosing regi-
men. ’564 patent col. 6 l. 57 – col. 8 l. 4. Nor is it disput-
ed that the cited prior art references disclose each of those
limitations. For example, EP’607 discloses a combination
dosage form that can provide hormonal replacement
therapy and contraceptive protection, using a “preferred
administration cycle [of] 24 days of the combination
dosage form and 4 days of no dosage form.” EP’607 col. 1
ll. 3–18; see also id. col. 3 ll. 46–57 (describing 24/4 and
23/5 dosage regimens as “preferred”). In addition, the
disclosed active dosage form includes an estrogen and a
progestin; EP’607 lists EE (8–30 µg per dose) among three
estrogen choices and describes several suitable progestins,
but DRSP is not disclosed. Id. col. 2 l. 35 – col. 3 l. 25.
AU’094, however, discloses DRSP as an additional proges-
tin suitable for use “alone or in combination with estro-
gens in contraceptive preparations.” AU’094 at 1.
Furthermore, AU’094 indicates that EE is a preferred
estrogen complement to DRSP for COC use and suggests
using daily doses of 20–40 µg EE with 1–10 mg DRSP. Id.
at 4–5. AU’094 even refers expressly to EP’607, stating
that the disclosed EE/DRSP preparations can be used
“analogously” to the EP’607 combinations and expressly
incorporating the disclosure of EP’607 by reference. Id. at
5–6. In sum, EP’607 and AU’094 disclose all three limita-
tions required by the asserted claims. AU’094 discloses
COC preparations that encompass the claimed doses of
EE and DRSP, and EP’607 discloses similar COCs, also
comprising the claimed dose of EE, administered via the
claimed 24/4 and 23/5 regimens.
With every limitation of the asserted claims thus dis-
closed 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
12 BAYER HEALTHCARE PHARMA v. WATSON PHARMA
those teachings to derive the claimed subject matter with
a reasonable expectation of success. See, e.g., Unigene
Labs., Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir.
2011) (“Obviousness requires more than a mere showing
that the prior art includes separate references covering
each separate limitation in a claim under examination.
Rather, obviousness requires the additional showing that
a person of ordinary skill at the time of the invention
would have selected and combined those prior art ele-
ments . . . .”) (citing KSR, 550 U.S. at 418, 421); see also
Watson Summary Judgment Order, 2012 WL 1079551, at
*18 (“What was not known based on the prior art was the
desirability of using the claimed drospirenone and EE
doses together with the claimed monthly regimen.”).
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 develop-
ment, 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. See, e.g., Molloy at 1475
(“The demonstration of ovarian folliculogenesis . . . on the
seventh pill free day, means that during the early days of
the subsequent pill cycle, some women harbour signifi-
cantly developed follicles, ready to [ovulate] if oestrogen
suppression were to fail because of a missed pill.”); Guil-
lebaud at 35 (stating “that it is precisely because of this
seven day break that most pregnancies occur, and that
the pill omissions of greatest concern are those that lead
to a lengthening of the pill-free interval”) (quotation
omitted); Landgren at 444 (“These data seem to suggest
that ovulation is more likely to occur when the pill is
omitted during the first days of the artificial cycle. Hence,
the prolongation of the pill-free week by two or more days
is likely to increase the risk of ‘escape’ ovulation.”). In
BAYER HEALTHCARE PHARMA v. WATSON PHARMA 13
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). J.A. 2032–35.
The evidence thus demonstrates that missed-pill ovu-
lation 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
EE. 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.” KSR, 550 U.S. at 420. Furthermore, the refer-
ences 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 with-
drawal bleed without the risk of significant follicular
development.” Molloy at 1475; see also Goldstuck at 338
(“The suggestion [for 24/4 dosing] is of considerable merit.
This would both maintain a 28-day regimen and help
reduce the pill-free interval in those women who inad-
vertently miss a pill.”); Guillebaud at 43 (“[I]t is prefera-
ble to shorten the pill-free interval, usually to four days,
in women where there is a suspicion of an increased risk
of breakthrough ovulation.”). 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.
Bayer’s arguments do not support a contrary conclu-
sion. Bayer contends that EP’607 and AU’094 “are pri-
marily directed to older women who have reached pre-
menopause and are in need of hormone replacement
14 BAYER HEALTHCARE PHARMA v. WATSON PHARMA
therapy,” and that therefore a “skilled person setting out
to design an oral contraceptive using EE and DRSP would
not have used the 24/4 regimen intended to achieve
effective [hormone-replacement therapy].” Appellees’ Br.
39–40. But those references plainly disclose preparations
with hormone replacement and contraceptive applica-
tions, and the product claims at issue do not distinguish
between target patient populations, whether by age or
otherwise.
In addition, Bayer argues that the prior art taught
away from the claimed COC preparations, focusing on
statements in Guillebaud as indicating that the “conven-
tional wisdom” in the field favored 21/7 dosing for most
patients and as suggesting that a reduced pill-free inter-
val should be used together with higher-dose COCs for
patients perceived to be at risk of escape ovulation. 4
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 in-
creasing 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
4 Bayer also contends that Goldstuck “endorsed”
Guillebaud’s suggestion to use a higher-dose formulation
with a 24/4 or 23/5 regimen and therefore teaches away
on the same basis. Appellees’ Br. 47–48. In citing Guil-
lebaud, however, Goldstuck makes no mention of hormone
dose: “The suggestion that manufacturers make 28-day
packages consisting of 24 active tablets and 4 bran [place-
bo] tablets is of considerable merit [Guillebaud]. This
would both maintain a 28-day regimen and help reduce
the pill-free interval in those women who inadvertently
miss a pill.” Goldstuck at 338. Goldstuck thus offers
little support for Bayer’s position.
BAYER HEALTHCARE PHARMA v. WATSON PHARMA 15
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.” 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.
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.
See Dow Jones & Co. v. Ablaise Ltd., 606 F.3d 1338, 1352
(Fed. Cir. 2010) (rejecting proffered evidence of expert
skepticism that “d[id] not directly address whether there
was actual skepticism concerning the invention”). 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.
16 BAYER HEALTHCARE PHARMA v. WATSON PHARMA
Next, Bayer claims that its invention “was widely
praised by experts in the COC field.” Appellees’ Br. 61.
In making that claim, Bayer relies on journal citations
that reference the findings stated in Bayer’s published
efficacy studies or discuss possible non-contraceptive
indications for 24/4 COC regimens. Another article
describing Bayer’s 24/4 COC regimen as an “innovative
strategy” was authored by the first-named inventor of the
’564 patent. Such bare journal citations and self-
referential commendation fall well short of demonstrating
true industry praise. Furthermore, industry praise of
what was clearly rendered obvious by published refer-
ences is not a persuasive secondary consideration.
Lastly, we reject Bayer’s contention that copying of its
COC preparations by the Defendants and other generic
manufacturers supports its validity position. Such evi-
dence 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).
CONCLUSION
We have considered Bayer’s remaining arguments
and find them unpersuasive. Accordingly, nothing Bayer
has presented overcomes the plain disclosures and ex-
press motivation to combine those disclosures in the prior
art. We therefore conclude that claims 13 and 15 of the
’564 patent are invalid for obviousness in view of the cited
references, and we reverse the judgment of the district
court.
REVERSED