United States District Court, D. Delaware
RECKITT BENCKISER PHARMACEUTICALS INC., RB PHARMACEUTICALS LIMITED, and MONOSOL RX, LLC, Plaintiffs,
DR. REDDY'S LABORATORIES S.A., and DR. REDDY'S LABORATORIES, INC., Defendants.
W. Bourke, Dana K. Severance, Daniel M. Attaway, WOMBLE
CARLYLE SANDRIDGE & RICE, LLP, Wilmington, DE. Attorneys
A. Ladow, James M. Bollinger, Timothy P. Heaton, J. Magnus
Essunger, TROUTMAN SANDERS LLP, New York, NY; Charanjit
Brahma, TROUTMAN SANDERS LLP, San Francisco, CA; Robert E.
Browne, Jr., TROUTMAN SANDERS LLP, Chicago, IL; Puja Patel
Lea, TROUTMAN SANDERS LLP, Atlanta, GA; Jeffrey B. Elikan,
Jeffrey Lerner, Erica N. Andersen, Ashley M. Kwon, COVINGTON
& BURLING LLP, Washington, DC. Attorneys for Plaintiffs
Reckitt Benckiser Pharmaceuticals Inc. and RB Pharmaceuticals
F. Hibey, STEPTOE & JOHNSON LLP, Washington, DC;
Cassandra A. Adams, STEPTOE & JOHNSON LLP, New York, NY.
Attorneys for Plaintiff MonoSol Rx, LLC
Richard D. Kirk, Stephen B. Brauerman, Sara E. Bussiere,
BAYARD, P.A., Wilmington, DE; Elaine H. Blais, Robert
Frederickson, III, Molly R. Grammel, Alexandra Lu, Kathryn
Kosinski, GOODWIN PROCTER LLP, Boston, MA; Ira J. Levy,
Robert V. Cerwinsky, GOODWIN PROCTER LLP, New York, NY; John
Coy Stull, GOODWIN PROCTER LLP, Washington, DC. Attorneys for
Defendants Dr. Reddy's Laboratories S.A. and Dr.
Reddy's Laboratories, Inc.
ANDREWS, U.S DISTRICT JUDGE
Reckitt Benckiser Pharmaceuticals, Inc.,  RB
Pharmaceuticals Limited,  and MonoSol Rx, LLC (collectively,
"Plaintiffs") bring this suit against Defendants
Dr. Reddy's Laboratories S.A. and Dr. Reddy's
Laboratories, Inc. (collectively,
"DRL"). This opinion addresses claims of
infringement and invalidity with respect to U.S. Patent No.
8, 017, 150 (the '"150 patent").
Court held a one-day bench trial with respect to this patent
on November 7, 2016. (D.I. 298 ("Tr.")). The
parties filed joint proposed findings of fact (D.I. 273),
post-trial briefing with respect to infringement (D.I. 277;
D.I. 286; D.I. 294), and post-trial briefing with respect to
invalidity (D.I. 276; D.I. 287; D.I. 292). Having considered
the documentary evidence and testimony, I make the following
findings of fact and conclusions of law pursuant to Federal
Rule of Civil Procedure 52(a).
Indivior is the holder of approved New Drug Application No.
22-410 for Suboxone® sublingual film, which is indicated
for maintenance treatment of opioid dependence. (D.I. 228-2,
Admitted Fact Nos. 13-14, 20). The active ingredients of
Suboxone® sublingual film are buprenorphine hydrochloride
and naloxone hydrochloride. (D.I. 228-2, Admitted Fact Nos.
15-18). Suboxone® sublingual film is available in four
dosage strengths (buprenorphine hydrochloride/naloxone
hydrochloride): 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12
mg/3 mg. (D.I. 228-2, Admitted Fact Nos. 16-18). Since the
approval of NDA No. 22-410, Suboxone® Sublingual Film has
been exclusively manufactured in the United States by
Plaintiff MonoSol and exclusively sold in the United States
by Plaintiff Indivior. (D.I. 228-2, Admitted Fact No. 19).
'150 patent, entitled "Polyethylene Oxide-Based
Films and Drug Delivery Systems Made Therefrom, " issued
on September 13, 2011. (D.I. 228-2, Admitted Fact No. 24).
The '150 patent is listed in the FDA's Approved Drug
Products with Therapeutic Equivalences Evaluations (the
"Orange Book") as covering Suboxone® Sublingual
Film. (D.I. 228-2, Admitted Fact No. 26). MonoSol owns the
'150 patent and Indivior is an exclusive licensee of the
' 150 patent. (D.I. 228-2, Admitted Fact No. 25).
are asserting independent claim 1 and dependent claims 4, 5,
8, and 9 of the '150 patent against DRL. (D.I. 273 at p.
110). Claim 1 of the '150 patent reads:
mucosally-adhesive water-soluble film product comprising:
an analgesic opiate pharmaceutical active; and
at least one water-soluble polymer component consisting of
polyethylene oxide in combination with a hydrophilic
the water-soluble polymer component comprises greater than
75% polyethylene oxide and up to 25% hydrophilic cellulosic
the polyethylene oxide comprises one or more low molecular
weight polyethylene oxides and one or more higher molecular
weight polyethylene oxides, the molecular weight of the low
molecular weight polyethylene oxide being in the range 100,
000 to 300, 000 and the molecular weight of the higher
molecular weight polyethylene oxide being in the range 600,
000 to 900, 000; and the polyethylene oxide of low molecular
weight comprises about 60% or more in the polymer component.
(JTX-1 ('"150 patent"), claim 1).
patent is infringed when a person "without authority
makes, uses, offers to sell, or sells any patented invention,
within the United States ... during the term of the patent..
.." 35 U.S.C. § 271(a). A two-step analysis is
employed in making an infringement determination. See
Markman v. Westview Instruments, Inc., 52 F.3d 967, 976
(Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370
(1996). First, the court must construe the asserted claims to
ascertain their meaning and scope. See Id. The trier
of fact must then compare the properly construed claims with
the accused infringing product. See Id. This second
step is a question of fact. Bai v. L&L Wings,
Inc., 160 F.3d 1350, 1353 (Fed. Cir. 1998).
infringement of a claim exists when every limitation recited
in the claim is found in the accused device." Kahn
v. Gen. Motors Corp., 135 F.3d 1472, 1477 (Fed. Cir.
1998). "If any claim limitation is absent from the
accused device, there is no literal infringement as a matter
of law." Bayer AG v. Elan Pharm. Research
Corp., 212 F.3d 1241, 1247 (Fed. Cir. 2000). If an
accused product does not infringe an independent claim, it
also does not infringe any claim depending thereon. See
Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546,
1553 (Fed. Cir. 1989). However, "[o]ne may infringe an
independent claim and not infringe a claim dependent on that
claim." Monsanto Co. v. Syngenta Seeds, Inc.,
503 F.3d 1352, 1359 (Fed. Cir. 2007) (internal quotation
marks omitted). A product that does not literally infringe a
patent claim may still infringe under the doctrine of
equivalents if the differences between an individual
limitation of the claimed invention and an element of the
accused product are insubstantial. See Warner-
Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S.
17, 39-40 (1997). The patent owner has the burden of proving
infringement by a preponderance of the evidence. See
SmithKline Diagnostics, Inc. v. Helena Labs. Corp., 859
F.2d 878, 889 (Fed. Cir. 1988).
presumption that all patents are valid is the starting point
for any obviousness determination. 35 U.S.C. § 282. A
patent claim is invalid as obvious under 35 U.S.C. § 103
"if the differences between the claimed invention and
the prior art are such that the claimed invention as a whole
would have been obvious before the effective filing date of
the claimed invention to a person having ordinary skill in
the art to which the claimed invention pertains."
Id. § 103(a); see also KSR Int'l Co. v.
Teleflex Inc., 550 U.S. 398, 406-07 (2007). Obviousness
is a question of law that depends on the following factual
inquiries: (1) the scope and content of the prior art; (2)
the differences between the claims and the prior art; (3) the
level of ordinary skill in the relevant art; and (4) any
objective indicia of nonobviousness. See KSR, 550
U.S. at 406; see also Transocean Offshore Deepwater
Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d
1340, 1347 (Fed. Cir. 2012). A court is required to consider
secondary considerations, or objective indicia of
nonobviousness, before reaching an obviousness determination,
as a "check against hindsight bias." See In re
Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent
Litig., 676 F.3d 1063, 1078-79 (Fed. Cir. 2012).
Relevant secondary considerations include commercial success,
long felt but unsolved needs, failure of others, praise,
unexpected results, and copying, among others. Graham v.
John Deere Co. of Kansas City, 383 U.S. 1, 17- 18
(1966); Ruiz v. A.B. Chance Co., 234 F.3d 654,
662-63 (Fed. Cir. 2000); Tex. Instruments, Inc. v. U.S.
Int'l Trade Comm 'n, 988 F.2d 1165, 1178 (Fed.
a party seeking to invalidate a patent as obvious must
demonstrate ... that a skilled artisan would have had reason
to combine the teaching of the prior art references to
achieve the claimed invention, and that the skilled artisan
would have had a reasonable expectation of success from doing
so." In re Cyclobenzaprine Hydrochloride, 676
F.3d at 1068-69. "The Supreme Court has warned, however,
that, while an analysis of any teaching, suggestion, or
motivation to combine known elements is useful to an
obviousness analysis, the overall obviousness inquiry must be
expansive and flexible." Id. at 1069. The
improvement over prior art must be "more than the
predictable use of prior art elements according to their
established functions." KSR, 550 U.S. at 417.
Evidence of obviousness, however, especially when that
evidence is proffered in support of an
"obvious-to-try" theory, is insufficient unless it
indicates that the possible options skilled artisans would
have encountered were "finite, " "small,
" or "easily traversed, " and "that
skilled artisans would have had a reason to select the route
that produced the claimed invention." In re
Cyclobenzaprine Hydrochloride, 676 F.3d at 1072.
Obviousness must be proven by clear and convincing evidence.
Id. at 1078.
Findings of Fact
person of ordinary skill in the art ("POS A") would
understand that only polyethylene oxide ("PEO") and
hydrophobic cellulosic polymers ("HCPs") are
actually claimed by the patent.
specification of the '150 patent identifies polyvinyl
pyrrolidone ("PVP") as an alternative to HCP in a
list of useful "Film-Forming Polymers." 3. Example
EA in the ' 150 patent specification-which is described
as an "example of the present ...