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. RECKITT BENCKISER PHARMACEUTICALS INC., RB PHARMACEUTICALS LIMITED, and MONOSOL RX, LLC, Plaintiffs,
PAR PHARMACEUTICAL, INC. and INTELGENX TECHNOLOGIES CORP., Defendants. RECKITT BENCKISER PHARMACEUTICALS INC., RB PHARMACEUTICALS LIMITED, and MONOSOL RX, LLC, Plaintiffs,
WATSON LABORATORIES, INC. and ACTA VIS LABORATORIES UT, 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, Timothy C. Bickham, STEPTOE & JOHNSON LLP,
Washington, DC; David L. Hecht, 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 Stall, GOODWIN PROCTOR LLP, Washington, DC Attorneys for
Defendants Dr. Reddy's Laboratories S.A. and Dr.
Reddy's Laboratories, Inc.
J. Fineman, Katharine L. Mowery, RICHARDS, LAYTON &
FINGER, P.A., Wilmington, DE; Daniel G. Brown, LATHAM &
WATKINS LLP, New York, NY; Jennifer Koh, B. Thomas Watson,
LATHAM & WATKINS LLP, San Diego, CA; Emily C. Melvin,
Brenda L. Danek, LATHAM & WATKINS LLP, Chicago, IL; Terry
Kearney, Michelle Woodhouse, Jie Wang, LATHAM & WATKINS
LLP, Menlo Park, CA; B. Thomas Watson, LATHAM & WATKINS
LLP, San Diego, CA. Attorneys for Defendants Par
Pharmaceutical, Inc. and IntelGenx Technologies Corp.
C. Phillips, Jr., Megan C. Haney, PHILLIPS, GOLDMAN &
SPENCE, P.A., Wilmington, DE; George C. Lombardi, Michael K.
Nutter, WINSTON & STRAWN LLP, Chicago, IL; Stephen
Smerek, David P. Dalke, Jason C. Hamilton, WINSTON &
STRAWN LLP, Los Angeles, CA. Attorneys for Defendants Watson
Laboratories, Inc. and Actavis Laboratories UT, 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"),
Defendant Watson Laboratories, Inc. ("Watson"), and
Defendants Par Pharmaceutical, Inc. and IntelGenx
Technologies Corporation (collectively, "Par").
This opinion addresses allegations of infringement and
invalidity with respect to U.S. Patent Nos. 8, 603, 514
("the '514 patent") and 8, 900, 497 ("the
Court held a four-day bench trial relating to these patents.
(D.I. 299; D.I. 300; D.I. 301; D.I. 302). The parties filed
proposed findings of fact (D.I. 275), post-trial briefing
with respect to infringement (D.I. 279; D.I. 285; C.A. No.
14-1574, D.I. 184; C.A. No. 14-1573, D.I. 203; D.I. 295), and
post-trial briefing with respect to invalidity (D.I. 278;
D.I. 288; D.I. 293). I have also considered letters submitted
regarding Medicines Co. v. Mylan, Inc., 853 F.3d
1296 (Fed. Cir. 2017). (D.I. 309; D.I. 310). 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).
Reckitt Benckiser Pharmaceuticals, Inc. 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 No. 15). 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 Reckitt
Benckiser Pharmaceuticals, Inc. (D.I. 228-2, Admitted Fact
'514 patent, entitled "Uniform Films for Rapid
Dissolve Dosage Form Incorporating Taste-Masking
Compositions, " issued on December 10, 2013. (D.I.
228-2, Admitted Fact No. 21). The '514 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. 23).
'497 patent, entitled "Process for Making a Film
Having a Substantially Uniform Distribution of Components,
" issued on December 2, 2014. (D.I. 228-2, Admitted Fact
No. 27). Plaintiff MonoSol owns the '514 and '497
patents and Plaintiff Reckitt Benckiser Pharmaceuticals, Inc.
is an exclusive licensee of the '514 and '497
patents. (D.I. 228-2, Admitted Fact Nos. 22, 28).
are asserting claims 62-65, 69, 71, and 73 of the '514
patent against DRL. (D.I. 228-2, Admitted Fact No. 91; D.I.
279 at 1 n.1). Claim 62 of the '514 patent is an
independent claim. Claims 63, 64, 65, 69, 71, and 73 all
depend from claim 62. (D.I. 228-2, Admitted Fact No. 92). The
'514 patent was separately tried against Watson and Par.
(C.A. No. 13-1674, D.I. 446).
asserted independent claim of the '514 patent reads as
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.
(JTX-2, claim 62) (emphases added).
are asserting claim 24 of the '497 patent against all
Defendants. (D.I. 228-2, Admitted Fact Nos. 30, 64, 95).
Claim 24 of the '497 patent depends from claim 1. (D.I.
228-2, Admitted Fact No. 96). Claims 1 and 24 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 visco-elastic film;
(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.
(JTX-3, claim 1) (emphases added).
24. The process of claim 1, wherein said active is in the
form of a particle.
(JTX-3, claim 24).
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., 160F.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). 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 % 988 F.2d 1165, 1178 (Fed. Cir. 1993).
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
uses the CL02 and CL03 dryers where the sole source of heat
is hot air coming from air nozzles over the liner.
DRL's proposed ANDA manufacturing process (hereinafter,
"ANDA process") is extensively controlled to
achieve drug content uniformity.
DRL's ANDA process is designed to avoid the
"rippling effect." 4. The extent of bottom drying
employed by DRL is conventional.
General testimony that DRL's method is unconventional is
conclusory and not credible.
There is insufficient evidence for me to conclude that
DRL's ANDA process utilizes unconventional drying.
does not infringe the "drying" limitation of the
'497 patent or the "dried" limitation of the
About four minutes after "drying, " the majority of
the wet matrix is still water.
Prud'homme's testimony that a visco-elastic solid
results after about four minutes of drying is given little to
does not infringe the visco-elastic solid film limitation of
the '497 patent.
DRL's AND As report drug content uniformity measurements
across the 12 mg/3 mg, 8 mg/2 mg, 4 mg/1 mg, and 2 mg/0.5 mg
'514 and the '497 patents do not require that
Plaintiffs use the "three sigma rule" standard to
Plaintiffs establish that DRL infringes the drug content
uniformity limitation of the asserted claims of both patents.
DRL's polymer matrix is specified to range between 5, 000
to 20, 000 centipoise for the 12 mg/3 mg, 8 mg/2 mg, 4 mg/1
mg, and 2 mg/0.5 mg dosage strengths.
Davies offers credible testimony as to whether DRL's ANDA
process is "sufficient to provide little to no
aggregation of the active within the film."
Plaintiffs establish that DRL infringes the viscosity
limitation of the asserted claims of the'514 patent
does not infringe any asserted claim of the '497 and
Conclusions of Law
argues that it does not infringe the "dried"
limitation of the asserted claims of the '514 patent or
the "drying" limitation of the asserted claim of
the '497 patent. I construed "dried" in the
'514 patent to mean "dried without solely employing
conventional convection air drying from the top." (C.A.
No. 15-1016, D.I. 87 at 5). I further clarified this
construction as follows:
"[D]ried without solely employing conventional
convection air drying from the top" is meant to exclude
drying techniques that are associated with the problem of the
"rippling effect." This problem takes place when
the initial drying of the upper surface of the film leads to
the trapping of moisture inside the film, causing the top
surface to be ripped open and reformed when the moisture
trapped inside later evaporates. This does not necessarily
exclude techniques where the only direct sources of air are
from the top. This also should not be understood to require
techniques to use direct sources of air from the bottom.
(Id. at 5-6). "Drying" in the '497
patent is construed similarly. (Id. at 8-9). DRL
argues that their ANDA process is "conventional"
because (1) the drying method used by DRL was ordinary and
commonplace in the web coating industry as of 2001, (2)
DRL's ANDA products are dried solely using top air, and
(3) no bottom air or heat is used during the drying of
conventional coating and drying equipment, a POSA could
control the temperature, line speed, air velocity, and the
direction of air nozzles. (See, e.g., Tr. 785:6-10,
784:17-24, 785:1-5, 799:18-21). It would be conventional to
adjust these settings in order to produce a desired product.
(Tr. 1066:19-22, 784:17-785:10). Dr. Gogolin opines that it
was conventional for an operator in 2001 to control a top air
impingement dryer to prevent defects like rippling. (Tr.
1344:1-14). I agree with Plaintiffs that merely employing a
conventional oven does not necessarily mean that a drying
technique is conventional.
uses the CL02 and CL03 dryers where the sole source of heat
is hot air coming from air nozzles over the liner. (Tr.
1353:20-1354:2, 1360:16-1361:4). In both the CL02 and CL03,
there are no air nozzles below the liner. (D.I. 228-2,
Admitted Fact No. 121). DRL's ANDA process is extensively
controlled. (See, e.g., Tr. 577:7-14). DRL's
ANDAs state, "The most critical aspect during coating
and drying for this product is to achieve content uniformity
in the master roll." (JTX-59 at 32). To meet that
objective, DRL's ANDA process regularly monitors the oven
temperature, fan speeds, supply dampers, and exhaust dampers
in each zone. (JTX-59 at 32).
evidence shows that DRL's ANDA process is designed to
avoid the "rippling effect." To avoid rippling,
DRL's drying parameters are such that lower temperatures
and air velocities are employed at the beginning and higher
temperatures and air velocities are used toward the end of
the drying process. (Tr. 982:1-983:3). DRL's ANDAs
suggest that their films did not have visual defects. (JTX-12
at 11). DRL's technique employs low airflow at the
surface of the web during the initial drying phase, such that
the amount of heat transfer from the bottom web approaches
the amount of heat transfer from the top. (Tr.
830:12-831:4). This is consistent with a technique that is
associated with minimizing the rippling effect. This is not
dispositive because my construction left open the possibility
as to whether conventional convection air drying techniques
could also avoid the "rippling effect." Whether a
technique causes rippling is only a factor as to whether a
technique constitutes conventional convection air drying.
argue that DRL's ANDA process is unconventional because
it employs bottom drying. I am not persuaded that the extent
of DRL's bottom drying is unconventional. No measurements
were taken of the temperature of the metal rollers. (Tr.
558:19-559:19). The CL02 and CL03 dryers use a conventional
exhaust system, which suggests that any bottom drying is at
most a conventional amount. (D.I. 228-2, Admitted Fact Nos.
122-124; Tr. 1410:18-1411:2, 1352:2-19, 1356:8-21,
1358:9-1359:12, 1353:3-1354:13, 1360:3-15). I think that
DRL's use of "bottom drying" is essentially
that the inside of the oven simply gets hot and as a result,
the bottom of film is incidentally heated. This is a
conventional bottom drying method. (See, e.g.,
JTX-24 at 4:37-42, Fig. 2; Tr. 1367:19-1368:19).
as a whole, this evidence is not enough to persuade me that
DRL's process is unconventional. I am not persuaded that
evidence of a controlled process that does not result in
rippling and that achieves drug content uniformity
automatically amounts to an unconventional process. Watson
raises two good points that apply here. Watson argues that
finding unconventionality based on this kind of evidence
would be using a "results-determinative" approach.
I agree. Finding infringement based on this evidence would
put too much focus on whether drug content uniformity is
achieved, and would gloss over whether the parameters
employed are actually unconventional. This is similar to the
"efficient mixing" issue that the Federal Circuit
addressed in Medicines Co. v. Mylan, Inc., 853 F.3d
1296 (Fed. Cir. 2017). There, the court resisted the
patentee's construction of "efficient mixing"
which sought "to claim all solutions to the identified
'impurities' problem, without describing the entire
range of solutions to that problem.'" Medicines
Co., 853 F.3d at 1307 (citing Ariad Pharms., Inc. v.
Eli Lilly & Co., 598 F.3d 1336, 1352-53 (Fed. Cir.
2010)). If I were to find infringement, I would effectively
be construing the drying limitation to claim all drying
techniques that solve the drug content uniformity problem.
This is not what the patents claim, however.
also argues that finding unconventionality based on this kind
of evidence would read out the uniformity limitation. I
agree. If showing drug content uniformity was effectively all
that was required to meet the drying limitation, there would
be no need for a separate uniformity limitation. See
Bicon, Inc. v. Straumann Co., 441 F.3d 945, 950 (Fed.
Cir. 2006) ("[C]laims are interpreted with an eye toward
giving effect to all terms in the claim."). Thus, on
these facts, Plaintiffs have not met their burden of showing
that the "dried”/"drying" limitations of
the '497 and '514 patents are met.
argues that its drying process does not meet the
visco-elastic solid film limitation of the '497 patent.
Claim 1 of the '497 patent requires "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 visco-elastic film .. . ."
(JTX-3, claim 1). I construed the phrase "to maintain
said substantially uniform distribution of said
[pharmaceutical/at least one active] by locking-in or
substantially preventing migration of said [pharmaceutical/at
least one active]" to mean "to maintain a
distribution of [an active/a pharmaceutical active] by drying
to form a viscoelastic solid film, thereby limiting its
migration such that the individual dosage units do not vary
by more than 10% from the intended amount of the active for
that dosage unit." (D.I. 175 at 8-9).
proposed product would lose about 20% of volatile solvent
(water and alcohol) in about four minutes. (Tr. 693:4-11). As
a result, the majority of the wet matrix is still water. (Tr.
1218:2-16). Rheological testing shows that the DRL's
formulation is at best a visco-elastic liquid after four
minutes of drying. (Tr. 1224:3-22, 1227:17-1235:23,
criticisms of this rheological testing make some points but
are not persuasive. Plaintiffs complain that the tested
sample did not include buprenorphine, but it is unclear that
the inclusion of buprenorphine would be enough to change the
results, that is, to render the sample a visco-elastic solid.
(Tr. 1232:18-1233:3). Plaintiffs complain that the wet
mixture of material was left out in open air to allow
evaporation of solvent. This complaint neglects that after
the dehydrated sample was placed in a petri dish on a balance
to monitor weight loss until it reached the target 16%
volatile weight loss, the sample was then transferred to a
new vial, capped, and sealed to prevent further loss. (Tr.
1199:4-21). Dr. Prud'homme concedes that the measurements
were well done on the solutions DRL used. (Tr. 772:17-773:7).
Dr. Prud'homme concedes that he had no criticisms of the
methodology of the experiment for the ends that were
measured. (Tr. 773:3-7). I think the test was somewhat
representative. Testing can be probative without exactly
duplicating the process being examined. Thus, I attribute
some weight to the rheological tests.
argue that Dr. Prud'homme's testimony demonstrates
that a visco-elastic solid results because the solvent loss
leads to a resulting increase in buprenorphine particle
concentration, which causes a particle network to form.
Specifically, Plaintiffs argue that the citric acid in
DRL's casting dispersion interacts with PEO, causing the
buprenorphine particles to stick to each other to form large
open aggregates of particles through micro-scale chaining and
aggregation. They argue that this finds support from Dr.
Prud'homme's research conducted in 2010 ...