United States District Court, D. Delaware
INDIVIOR INC., INDIVIOR UK LIMITED, and MONOSOL RX, LLC Plaintiffs;
MYLAN TECHNOLOGIES INC., MYLAN PHARMACEUTICALS INC. and MYLAN N.V., Defendants. RECKITT BENCKISER PHARMACEUTICALS INC., RB PHARMACEUTICALS LIMITED, and MONOSOL RX, LLC Plaintiffs;
ALVOGEN PINE BROOK INC. Defendant.
W. Bourke, Dana K. Severance, Daniel M. Attaway, WOMBLE BOND
DICKINSON (US) LLP, Wilmington, DE; Daniel A. Ladow, James P.
Bollinger, Timothy P. Heaton, J. Magnus Essunger, Sujatha
Vathyam, Katherine Harihar, TROUTMAN SANDERS LLP, New York,
NY; Charanjit Brahma, Craig Crockett, TROUTMAN SANDERS LLP,
San Francisco, CA; Daniel Sharpe, TROUTMAN SANDERS LLP,
Washington, DC; Jeffrey B. Elikan, Jeffrey H. Lerner, Erica
N. Anderson, R. Jason Fowler, Nicholas F. Lenning, COVINGTON
& BURLING LLP, Washington, DC; James F. Hibey, STEPTOE
& JOHNSON LLP, Washington, DC; Cassandra A. Adams,
STEPTOE & JOHNSON LLP, New York, NY. Attorneys for
Dominick T. Gattuso, HEYMAN ENERIO GATTUSO & HIRZEL LLP,
Wilmington, DE; Steven H. Sklar, Gregory C. Bays, David M.
Airan, J. Karl Gross, Nicole E. Kopinski, LEYDIG, VOIT &
MAYER, LTD., Chicago, IL. Attorneys for Defendant.
ANDREWS, U.S. DISTRICT JUDGE.
brought separate patent infringement actions against Mylan
Technologies Inc., Mylan Pharmaceuticals Inc., and Mylan
N.V., and Alvogen Pine Brook Inc., in 2015. (No. 15-0477-RGA,
D.I. 1, D.I. 48; No. 15-1016-RGA, D.I. 1, D.I.
The two cases were consolidated. (D.I. 140). On September 26,
2017, Plaintiffs and the Mylan Defendants entered into a
Settlement Agreement, leaving Alvogen as the sole remaining
defendant. (D.I. 242).
filed Abbreviated New Drug Application ("ANDA") No.
205954, seeking approval for a generic version of the 2
mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg dosage
strengths of Plaintiffs' Suboxone® sublingual film.
(D.I. 211-1 at 5-6). Suboxone® sublingual film is
indicated for maintenance treatment of opioid dependence.
(Id. at 2). Since its FDA approval for certain
dosage strengths in 2010, Suboxone® sublingual film has
been exclusively manufactured in the United States by
Plaintiff MonoSol and exclusively sold in the United States
by Plaintiff Indivior Inc. (Id.). Approval of additional
dosage strengths followed in 2012. (Id.).
issue in this case is the process for drying the sublingual
Court held a bench trial September 26-27, 2017. Plaintiffs
assert that Alvogen's ANDA submission constitutes
infringement of claim 24 of U.S. Patent No. 8, 900, 497
("the '497 patent"), and claims 62, 63, 65, 69,
71, and 73 of U.S. Patent No. 8, 603, 514 ("the '514
patent). (Trial Transcript ("Tr.") 9:24-10:4; D.I.
235 at 1-2).,  Alvogen does not argue that the asserted
claims are invalid. (Tr. 5:4-15).
claim 1 of the '497 patent reads as follows:
1. A process for making a film having a substantially uniform
distribution of components, comprising the steps of:
(a) forming a flowable polymer matrix comprising an edible
polymer, a solvent and a desired amount of at least one
active, said matrix having a substantially uniform
distribution of said at least one active;
(b) casting said flowable polymer matrix;
(c) rapidly evaporating at least a portion of said solvent
upon initiation of drying to form a
visco-elastic film within about the first 4.0
minutes to maintain said substantially uniform distribution
of said at least one active by locking-in or substantially
preventing migration of said at least one active within said
(d) further drying said visco-elastic film to form a
self-supporting edible film having a substantially uniform
distribution of said at least one active component; and
wherein said substantially uniform distribution of said at
least one active component is measured by substantially
equally sized individual unit doses which do not vary by more
than 10% of said desired amount of said at least one active.
(emphasis added). Dependent claim 24 of the '497 patent
covers, "The process of claim 1, wherein said active is
in the form of a particle."
claim 62 and dependent claims 63, 65, 69, 71, and 73 of the
'514 patent read as follows:
62. A drug delivery composition comprising:
(i) a cast film comprising a flowable water-soluble or water
swellable film-forming matrix comprising one or more
substantially water soluble or water swellable polymers; and
a desired amount of at least one active; wherein said matrix
has a viscosity sufficient to aid in substantially
maintaining non-self-aggregating uniformity of the active in
(ii) a particulate active substantially uniformly stationed
in the matrix; and
(iii) a taste-masking agent selected from the group
consisting of flavors, sweeteners, flavor enhancers, and
combinations thereof to provide taste-masking of the active;
wherein the particulate active has a particle size of 200
microns or less and said flowable water-soluble or water
swellable film-forming matrix is capable of being
dried without loss of substantial uniformity in the
stationing of said particulate active therein; and wherein
the uniformity subsequent to casting and drying of the matrix
is measured by substantially equally sized individual unit
doses which do not vary by more than 10% of said desired
amount of said at least one active.
63. The drug delivery composition of claim 62, wherein the
particulate active has a particle size of 150 microns or
65. The drug delivery composition of claim 62, wherein said
variation of drug content is less than 5% by weight per film
69. The drug delivery composition of claim 62, wherein said
taste-masking agent is present in the amount of about 0.1-30%
by weight of the drug delivery composition.
71. The drug delivery composition of claim 62, wherein said
active is selected from the group consisting of antimicrobial
agents, non-steroidal antiinflammatory drugs, anti-tussives,
decongestants, antihistamines, expectorants, anti-diarrheals,
Fh antagonists, proton pump inhibitors, general non-selective
CNS depressants, general non-selective CNS stimulants,
selective CNS functional modifiers, anti-parkinsonism drugs,
narcotics, analgesics, erectile dysfunction therapies,
anti-pyretics, psychopharmacological drugs and combinations
73. The drug delivery composition of claim 62, wherein said
active is an opiate or opiate derivative.
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).
"Literal 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). 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).
jurisdictional purposes, 35 U.S.C. § 271(e)(2)(A)
defines filing an ANDA application for a drug covered by a
patent as an act of infringement. 35 U.S.C. §
271(e)(2)(A); see also Glaxo, Inc. v. Novopharm,
Ltd., 110 F.3d 1562, 1569 (Fed. Cir. 1997)
("[Section] 271(e)(2) provided patentees with a defined
act of infringement sufficient to create case or controversy
jurisdiction to enable a court to promptly resolve any
dispute concerning infringement and validity.").
INFRINGEMENT OF THE '514 AND '497 PATENTS
Findings of Fact
Alvogen's proposed commercial manufacturing process for
its ANDA product (hereinafter, "ANDA process") is
designed to avoid the "rippling effect." 2. There
is insufficient evidence for me to conclude that
Alvogen's ANDA process uses unconventional drying.
extent of bottom drying employed by Alvogen is conventional.
bars used in Alvogen's ANDA process do not substantially
dry films from the bottom, alone or in conjunction with any
other bottom heat sources.
Contact between the web and lower plenum of the oven in
Alvogen's ANDA process does not substantially dry films
from the bottom, alone or in conjunction with any other
bottom heat sources.
flow underneath the web in Alvogen's ANDA process does
not substantially dry films from the bottom, alone or in
conjunction with any other bottom heat sources.
There exist two plausible explanations for films produced
using Alvogen's exhibit batch process and commercial
process having equal moisture contents.
Alvogen does not infringe the "drying" limitation
of the '497 patent or the "dried" limitation of
the ' 514 patent.
Prud'homme's testimony that a viscoelastic solid
results after about four minutes of drying is given little
Fassihi's visual evidence demonstrating that
Alvogen's mix remains a liquid after four ...