Merck Sharp & Dohme B v. v. Warner Chilcott Company, LLC , 711 F. App'x 633 ( 2017 )

NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
MERCK SHARP & DOHME B.V.,
Plaintiff-Appellant
v.
WARNER CHILCOTT COMPANY, LLC,
Defendant-Appellee
WARNER CHILCOTT (US), LLC,
Defendant
______________________
2016-2583
______________________
Appeal from the United States District Court for the
District of Delaware in No. 1:13-cv-02088-GMS, Judge
Gregory M. Sleet.
______________________
Decided: October 19, 2017
______________________
RAYMOND N. NIMROD, Quinn Emanuel Urquhart &
Sullivan, LLP, New York, NY, argued for plaintiff-
appellant. Also represented by GREGORY BONIFIELD,
CATHERINE MATTES, MATTHEW A. TRAUPMAN; PHILIP
CHARLES STERNHELL, Washington, DC.
2 MERCK SHARP & DOHME B.V. v. WARNER CHILCOTT COMPANY,
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GEORGE C. LOMBARDI, Winston & Strawn LLP, Chica-
go, IL, argued for defendant-appellee. Also represented
by TYLER JOHANNES, KURT A. MATHAS, BRIAN J. NISBET,
MICHAEL KEENAN NUTTER, ZACHARY L. SORMAN, KEVIN E.
WARNER; STEFFEN NATHANAEL JOHNSON, Washington,
DC.
______________________
Before DYK, LINN, and HUGHES, Circuit Judges.
HUGHES, Circuit Judge.
Merck Sharp & Dohme B.V. appeals from the district
court’s determination that claims 4 and 11 of U.S. Patent
No. 5,989,581 are invalid as obvious. Because a person of
ordinary skill would not have found it obvious to modify
the prior art of record to arrive at the claimed invention,
we reverse.
I
The ’581 patent relates to a vaginal ring used for con-
traception, and its commercial embodiment is sold under
the brand name NuvaRing®. Warner Chilcott is seeking
to introduce a generic version of NuvaRing®, and con-
cedes that its generic product would infringe the ’581
patent if the claims are found valid.
A vaginal ring is a small, flexible drug-delivery device
used for contraception. The ring is inserted in the vagina
for 21 days, where it releases a constant daily dose of
progestin and estrogen. For this appeal, the relevant
progestogenic and estrogenic compounds are etonogestrel
(ETO) and ethinyl estradiol (EE), respectively.
One challenge in the design of vaginal rings is ensur-
ing that both progestin and estrogen are released at a
stable rate. Earlier prior art designs combined ETO and
EE in a single compartment, but could not properly
control the release rate for each compound simultaneous-
ly. The ’581 patent purports to solve this problem by
MERCK SHARP & DOHME B.V. v. WARNER CHILCOTT COMPANY, 3
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providing a vaginal ring made of a polymer that is super-
saturated with ETO. 1 The ’581 patent explains that,
under certain conditions, ETO can remain in a supersatu-
rated state for long periods of time.
Claims 4 and 11 are at issue. Claim 4 is dependent
from claim 1. Claims 1 and 4, in relevant part, state:
1. A drug delivery system comprising at least one
compartment which comprises
a thermoplastic polymer core . . . said core com-
prising a mixture of a steroidal progestogenic
compound and a steroidal estrogenic compound in
a ratio by weight that allows a direct release of
both said progestogenic compound and said estro-
genic compound in physiologically required
amounts,
said progestogenic compound being initially dis-
solved in said polymer core material in a degree of
supersaturation of 1 to about 6 times of the
amount by weight necessary for obtaining satura-
tion concentration of said progestogenic compound
in said polymer core material at 25° C,
said estrogenic compound being dissolved in said
polymer core material in a concentration lower
than that of said progestogenic compound . . . .
4. A drug delivery system according to claim 1,
wherein the amount of progestogenic compound
dissolved in the thermoplastic core material is 2 to
5 times the amount necessary for obtaining satu-
ration concentration.
1 Supersaturation refers to a solution that contains
more dissolved material than could be dissolved by the
solvent under normal circumstances.
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’581 patent at col. 7, l. 30–col. 8, l. 4. Claim 11 depends
from claim 5. Claims 5 and 11, in relevant part, state:
5. A drug delivery system in a substantially ring-
shaped form and suitable for vaginal administra-
tion comprising at least one compartment which
comprises
a thermoplastic polymer core . . . said core com-
prising a mixture of a progestogenic steroidal
compound and an estrogenic steroidal compound
in a ratio by weight of 10 parts of the progestogen-
ic compound to 1.5–5 parts of the estrogenic com-
pound . . . .
11. A drug delivery system according to claim 5,
wherein the core material comprises 0.55 to 0.8%
by weight of etonogestrel and 0.12 to 0.18% by
weight of ethinyl estradiol.
Id. at col. 8, l. 5–col. 8, l. 49.
Importantly, claims 4 and 11 both require at least a
single-compartment that includes a progestogenic steroi-
dal compound and an estrogenic steroidal compound.
Claim 4, for example, requires direct release of “physiolog-
ically required amounts” of both compounds from one
compartment. Id. at col. 7, ll. 30–37. Claim 11 likewise
requires “at least one compartment” to include a “mixture
of a progestogenic steroidal compound and an estrogenic
steroidal compound” in specific ratios and concentrations.
Id. at col. 8, ll. 5–20.
In the proceedings below, Warner Chilcott argued
that the asserted claims are anticipated or rendered
obvious by International Patent Application WO 97/02015
(PCT ’015). Like the ’581 patent, PCT ’015 also discloses
a vaginal ring that prevents contraception by releasing
ETO and EE. PCT ’015, however, relies on a two-
compartment design, in which a first compartment in-
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cludes ETO only, and a second compartment includes
ETO and EE.
PCT ’015 criticizes one-compartment vaginal rings,
stating that
These above-mentioned one-compartment rings
have the disadvantage that, when loaded with
more than one active substance, release patterns
of these substances cannot be adjusted inde-
pendently. Such devices usually show sub-
optimum release patterns for the different sub-
stances, whereas it is generally preferred that all
substances are released in a controlled rate and
during a similar duration of time. As a conse-
quence the release ratio of the active substances
undergoes a change after a period of time.
J.A. 3039.
After a four-day bench trial, the district court found
that PCT ’015 renders obvious the ’581 patent claims.
Specifically, the court reasoned that “a person of ordinary
skill would have been motivated to optimize PCT ’015
such that the second compartment released physiological-
ly required amounts of ETO and EE.” J.A. 19–20. The
district court also found that PCT ’015 discloses target
release rates for ETO and EE, and that “it would have
been obvious for a person of skill to derive the claimed
ratios of progestin and estrogen” from the target release
rates. J.A. 21. Accordingly, the district court held that
claims 4 and 11 are invalid as obvious.
Merck appeals the district court’s judgment of invalid-
ity. We have jurisdiction under 28 U.S.C. § 1295(a).
II
Obviousness is a question of law that we review de
novo, and any underlying factual questions are reviewed
for clear error. Honeywell Int’l v. United States, 609 F.3d
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1292, 1297 (Fed. Cir. 2010) (citations omitted). The
underlying factual issues include the scope and content of
the prior art, the difference between the prior art and
claims at issue, level of ordinary skill in the art, and any
secondary considerations of non-obviousness. Graham v.
John Deere Co., 383 U.S. 1, 17–18 (1966).
“[A] patent composed of several elements is not proved
obvious merely by demonstrating that each of its elements
was, independently, known in the prior art.” KSR Int’l
Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Even if all
elements of the claim were known, we still must resolve
whether a person of ordinary skill in the art would have
found it obvious to combine these elements or modify
them in a way that meets the claim. In making this
inquiry, we have cautioned that “[t]he inventor’s own path
itself never leads to a conclusion of obviousness; that is
hindsight.” Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d
1280, 1296 (Fed. Cir. 2012). Thus, it is improper to com-
bine references “like separate pieces of a simple jigsaw
puzzle” without “explain[ing] what reason or motivation
one of ordinary skill in the art at the time of the invention
would have had to place these pieces together.” InTouch
Techs., Inc. v. VGO Commc’ns, Inc., 751 F.3d 1327, 1349
(Fed. Cir. 2014).
We start with Claim 4 of the ’581 patent, which re-
quires a physiologically effective amount of progestogenic
and estrogenic steroid compounds to be released from one
compartment. PCT ’015 discloses a two-compartment
ring where the first compartment is loaded with ETO
only, and the second chamber is loaded with ETO and EE.
The purpose of this design is to better control the release
profile by delivering the two compounds through separate
compartments. PCT ’015 explains that “one-compartment
rings have the disadvantage that, when loaded with more
than one active substance, release patterns of these
substances cannot be adjusted independently. Such
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devices usually show sub-optimum release patterns for
the different substances . . . .” J.A. 3039.
The district court concluded that it would have been
obvious to modify the two-compartment ring so that
pharmaceutically required amounts of both ETO and EE
are delivered from one compartment. In doing so, the
district court found that “PCT ’015 discloses a two-
compartment ring in which the second compartment:
(1) is loaded with both ETO and EE; (2) has a higher
concentration of ETO than EE; and (3) comprises 97% of
the ring.” J.A. 19. The district court reasoned that a
person of ordinary skill in the art would have optimized
the second compartment to release physiologically re-
quired amounts of ETO and EE. Thus, there would be
“little reason to keep the first compartment in place.” J.A.
20.
The problem, however, is that PCT ’015 does not ac-
tually disclose a ring with a second compartment that
comprises 97% of the ring, and includes a higher concen-
tration of ETO than EE in the second compartment.
Instead, PCT ’015 provides a broad range of values for the
relative size of each compartment as well as concentra-
tions of each compound. For example, PCT ’015 states
that the “[r]atios of the lengths of the first and second
compartment are contemplated to be between 30:1 and
1:30, but usually are between 15:1 and 1:1, and preferably
are about 2:1.” J.A. 3041. Thus, the second compartment
can occupy anywhere from 3% to 97% of the ring. Else-
where, PCT ’015 explains that “the second compartment
is loaded with 0.05-3% w/w” of ETO and “0.05-5% w/w” of
EE. J.A. 3042.
To arrive at the hypothetical ring that the district
court relied on for obviousness, the person of ordinary
skill must make the second compartment 97% of the total
ring, which is outside of the usual or preferred range
disclosed in PCT ’015. And the person of ordinary skill
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must also pick a concentration of ETO from the high end
of the disclosed range, but conversely select a concentra-
tion of EE from the low end of the range. Nothing in PCT
’015 suggests picking these values out of the innumerable
possible combinations of ETO concentrations, EE concen-
trations, and compartment length ratios. Instead, the
only way to arrive at the hypothetical ring is by using the
’581 patent as a roadmap to piece together various ele-
ments of PCT ’015. That represents an improper reliance
on hindsight.
The district court’s reliance on hindsight is further
underscored by the prior art’s criticism of the one-
compartment solution. PCT ’015 expressly states that one
compartment rings are undesirable because it is difficult
to control the release rates for both compounds. Yet the
district court found that a person of ordinary skill would
be motivated to use a single compartment to reduce
manufacturing costs. J.A. 20. In some instances, a
person of ordinary skill may have “good reason to pursue
the known options” based on “design need or market
pressure.” KSR, 550 U.S. at 421. But a person of ordi-
nary skill in the art would pursue “identified, predictable
solutions,” not designs that were seemingly inoperable.
See id. Here, PCT ’015 expressly warns that a one-
compartment ring has sub-optimal release patterns. The
’581 patent purportedly solved this problem by supersatu-
rating the ring with a progestogenic compound, a tech-
nique not taught in the prior art of record. Because PCT
’015 criticizes the use of one compartment to deliver both
compounds, the person of ordinary skill would not be
motivated to modify PCT ’015 to make a one-compartment
ring.
Claim 11, unlike claim 4, does not require a physiolog-
ically required amount of progestogenic and estrogenic
steroid compounds to be delivered from one compartment.
Claim 11, however, requires one compartment to have
specific concentrations for each compound. To show that
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PCT ’015 discloses such concentrations, Warner Chilcott
relies on the target drug release rates disclosed in
PCT ’015, and argues that it would have been obvious to
calculate the relative concentrations for each compound
based on those release rates.
The dosage rates disclosed in PCT ’015, however, ap-
ply to a two-compartment ring. Thus, an ordinary artisan
would need to calculate the relative concentrations for a
two-compartment ring, and apply those concentrations to
a single compartment. But again, PCT ’015 warns that
release rates for single compartment rings are difficult to
control. Indeed, PCT ’015 explains that its design can
achieve consistent release rates because there are two
compartments. See, e.g., J.A. 3040 at ll. 7–23 (describing
how a ring-shaped device containing two separate com-
partments fulfills the requirement of a good release
pattern). Therefore, an ordinary artisan would not dis-
card the two-compartment design but still expect the ring
to deliver a controlled dose of both compounds.
Because it was not obvious to load the claimed con-
centrations of progestogenic compounds and estrogenic
compounds in one compartment, we reverse the district
court’s finding of invalidity.
REVERSED AND REMANDED