Court Opinion

ID: 4310114
Source: CourtListenerOpinion
Date Created: 2018-09-06 15:00:41.896181+00
Date Added: 2024-06-11T14:43:34.205566
License: Public Domain

NOTE: This disposition is nonprecedential.

  United States Court of Appeals
      for the Federal Circuit
                ______________________

      SUPERNUS PHARMACEUTICALS, INC.,
               Plaintiff-Appellee

                           v.

       TWI PHARMACEUTICALS, INC., TWI
        INTERNATIONAL LLC, DBA TWI
           PHARMACEUTICALS USA,
              Defendants-Appellants
             ______________________

                      2017-2513
                ______________________

    Appeal from the United States District Court for the
District of New Jersey in No. 1:15-cv-00369-RMB-JS,
Judge Renee Marie Bumb.
                ______________________

              Decided: September 6, 2018
                ______________________

   NICHOLAS F. GIOVE, Haug Partners LLP, New York,
NY, argued for plaintiff-appellee. Also represented by
EDGAR HAUG, KEVIN GEORGEK, JONATHAN HERSTOFF,
ANDREW SCOTT ROPER, CAMILLE YVETTE TURNER; WILLIAM
CHARLES BATON, CHARLES M. LIZZA, Saul Ewing Arnstein
& Lehr LLP, Newark, NJ.

   DONALD J. MIZERK, Husch Blackwell LLP, Chicago, IL,
                 SUPERNUS PHARMS., INC. v. TWI PHARMS., INC.
2

argued for defendants-appellants. Also represented by
PHILIP DALE SEGREST, JR., DUSTIN L. TAYLOR.
                ______________________

Before O’MALLEY, CLEVENGER, and STOLL, Circuit Judges.
O’MALLEY, Circuit Judge.
     TWi Pharmaceuticals, Inc. (“TWi”) appeals from a de-
cision of the United States District Court for the District
of New Jersey holding, after bench trial, that Supernus
Pharmaceuticals, Inc.’s (“Supernus”) U.S. Patent Nos.
7,722,898 (“the ’898 patent”), 7,910,131 (“the ’131 pa-
tent”), and 8,821,930 (“the ’930 patent) (collectively, “the
asserted patents”) are not invalid and would be infringed.
Supernus Pharms., Inc. v. TWi Pharms., Inc., 265 F.
Supp. 3d 490 (D.N.J. 2017). For the following reasons, we
affirm.
                     I. BACKGROUND
                 A. The Asserted Patents
    This case involves a formulation of active ingredient,
oxcarbazepine, which treats partial epilepsy seizures in
adults and children over the age of six. Supernus is the
holder of New Drug Application No. 202810 for an ox-
carbazepine extended-release tablet, which is prescribed
and sold in the United States under the trade name
Oxtellar XR®. The asserted patents are listed in the
FDA’s Approved Drug Products with Therapeutic Equiva-
lence Evaluations, commonly known as the “Orange
Book,” as covering Oxtellar XR®.
    Supernus is the assignee of the asserted patents,
which claim priority from provisional application No.
60/794,837. All three asserted patents share a common
SUPERNUS PHARMAS., INC. v. TWI PHARMAS., INC.              3

specification, 1 the same inventors, and substantially the
same claim limitations at issue on appeal.
     In the common specification, the background of the
invention explains that twice daily, immediate release
formulations of oxcarbazepine were known in the art and
were disadvantageous because they require multiple daily
administrations and can result in increased side effects.
’898 patent, col. 1, ll. 30–33. For these reasons, sustained
release formulations were preferred, but were purportedly
difficult to achieve because oxcarbazepine is poorly solu-
ble in water. Id. at col. 1, ll. 33–35, 41–53.
    The common specification explains that the asserted
patents purport to solve these problems by “provid[ing]
controlled-release oxcarbazepine formulations for once-a-
day administration,” and “enhanc[ing] the bioavailability
of oxcarbazepine and its derivatives.” Id. at col. 3, ll. 54–
60. The asserted patents purport to achieve these objec-
tives by (1) using matrix polymers that comprise a homo-
geneous matrix structure, and (2) “incorporat[ing] a
combination of solubility-enhancing excipients and/or
release-promoting agents into the formulations to en-
hance the bioavailability of oxcarbazepine and its deriva-
tives.” Id. at col. 5, ll. 53–55, col. 3, ll. 54–60.
    Representative claim 1 of the ’898 patent recites:
    1. A pharmaceutical formulation for once-a-day
    administration of oxcarbazepine comprising a ho-
    mogeneous matrix comprising:
        (a) oxcarbazepine;
        (b) a matrix-forming polymer selected
        from the group consisting of cellulosic pol-
        ymers, alginates, gums, cross-linked poly-

    1   For ease of reference, all citations to the common
specification will refer to the ’898 patent.
                  SUPERNUS PHARMS., INC. v. TWI PHARMS., INC.
4

        acrylic acid, carageenan, polyvinyl pyrrol-
        idone, polyethylene oxides, and polyvinyl
        alcohol;
        (c) at least one agent that enhances the
        solubility of oxcarbazepine selected from
        the group consisting of surface active
        agents, complexing agents, cyclodextrins,
        pH modifying agents, and hydration pro-
        moting agents; and
        (d) at least one release promoting agent
        comprising a polymer having pH-
        dependent solubility selected from the
        group consisting of cellulose acetate
        phthalate, cellulose acetate succinate,
        methylcellulose     phthalate,    ethylhy-
        droxycellulose phthalate, polyvinylacetate
        phthalate, polyvinylbutyrate acetate, vinyl
        acetate-maleic anhydride copolymer, sty-
        rene-maleic mono-ester copolymer, and
        Eudragit L100-55 (Methacrylic Acid-Ethyl
        Acrylate Copolymer (1:1)), and methyl
        acrylate-methacrylic acid copolymers.
Id. at col. 12, l. 51–col. 13, l. 6 (emphases added).
                   B. Procedural History
     On December 30, 2013, TWi filed Abbreviated New
Drug Application No. 206576 with the FDA seeking
regulatory approval to market extended-release oxcarba-
zepine oral tablets in 150 mg, 300 mg, and 600 mg dosag-
es (the “proposed tablets”) and certifying that the asserted
patents are invalid and/or would not be infringed. Super-
nus sued TWi for infringement of the asserted patents,
and TWi counterclaimed for invalidity. On October 7,
2015, the district court held a Markman hearing, during
which it construed claim term “at least one agent that
enhances the solubility of oxcarbazepine” (hereinafter, the
SUPERNUS PHARMAS., INC. v. TWI PHARMAS., INC.             5

“solubility agent limitation”) as “an agent, other than
oxcarbazepine, that enhances the solubility of oxcarbaze-
pine, which agent cannot also serve as the sole matrix-
forming polymer in 1(b) or the sole release promoting
agent in 1(d) in claim 1,” and claim term “homogeneous
matrix” as a “matrix in which the ingredients or constitu-
ents are uniformly dispersed.”
     After the Markman hearing in this litigation, the dis-
trict court decided a related case, Supernus Pharms., Inc.
v. Actavis Inc., No. 13-cv-4740-RMB-JS, 2016 WL 527838
(D.N.J. Feb. 5, 2016) (“Actavis”), which involved the same
plaintiff and asserted patents from this litigation, but
different defendants and accused products. In that case,
the district court concluded that the asserted patents are
not invalid and would be infringed.
    After its decision in Actavis, the district court held a
four-day bench trial in this litigation from April 3–6,
2017. The parties submitted post-trial briefs. In a deci-
sion dated August 15, 2017, the district court concluded
that the asserted patents are not invalid and would be
infringed by TWi’s proposed tablets. In particular, the
district court found that TWi’s proposed tablets satisfied
the “homogeneous matrix” and the solubility agent limita-
tions under its constructions of those terms, and that the
common specification and prosecution histories of the
asserted patents demonstrate that the “homogeneous
matrix” limitation is not indefinite and does not lack
adequate written description support. In making these
determinations, the district court, at times, referenced its
decision in Actavis.
   TWi appeals. We have jurisdiction pursuant to 28
U.S.C. § 1295(a)(1).
                      II. DISCUSSION
    “On appeal from a bench trial, we review a district
court’s conclusions of law de novo and its findings of fact
                  SUPERNUS PHARMS., INC. v. TWI PHARMS., INC.
6

for clear error.” Vanda Pharms. Inc. v. W.-Ward Pharms.
Int’l Ltd., 887 F.3d 1117, 1123 (Fed. Cir. 2018). TWi
contends that the district court erred because it gave its
decision in Actavis de facto preclusive effect in this case.
TWi also argues that the district court erred in concluding
that the proposed tablets would infringe the solubility
agent and “homogeneous matrix” limitations, and that the
asserted patents are not invalid as indefinite or for lack of
written description. For the following reasons, we con-
clude that the district court did not err in any of these
respects.
                              A
    First, the district court did not give its decision in Ac-
tavis de facto preclusive effect in this case. The district
court explicitly stated in its post-trial decision that its
decision in Actavis has “some relevance to this action,”
but that its “findings of fact and conclusions of law set
forth [in this post-trial decision] are based upon the
evidence and argument presented in this litigation.”
Supernus, 265 F. Supp. 3d at 497 n.6. The district court
adhered to this position throughout its analysis. TWi
disagrees and contends that the district court improperly
relied on its decision in Actavis in three ways, each of
which we address below.
    TWi argues that the district court relied on its find-
ings and conclusions from Actavis when it referenced the
case in making its invalidity determinations. But, as
Supernus points out, the district court made express
findings based on the record presented in this litigation
and relied on Actavis only to the extent that the records
were similar or the parties had agreed to be bound by a
subsidiary conclusion from Actavis. Id. at 519 n.13 (“The
Court comes to this conclusion [of no invalidity] exclusive-
ly on the basis of the record developed in this litigation.”);
id. at 521 (“Based upon the record in this litigation, the
Court sees no reason to deviate from this finding” in
SUPERNUS PHARMAS., INC. v. TWI PHARMAS., INC.              7

Actavis “that the term ‘homogeneous matrix’ had ade-
quate written description.”). Thus, the district court did
not err in this regard.
    TWi also argues that the district court improperly re-
lied on results from tests conducted on Oxtellar XR®
tablets by Dr. Bugay, Supernus’s expert, which were
admitted as evidence in Actavis but not in this litigation.
To the contrary, the district court made only a passing
reference to the Oxtellar XR® tests, id. at 506, and based
its infringement determination solely on tests and evi-
dence admitted in this litigation, id. at 510 (“In sum,
based upon TWi’s manufacturing process, the results of
the FDA uniformity testing on the TWi Tablets, and the
Raman chemical imaging of the sample TWi Tablet, the
Court finds that the TWi Tablets comprise a homogeneous
matrix, as construed by this Court and as understood by a
person of ordinary skill in the art.”). We find that the
district court did not rely on evidence not of record in this
case.
     Finally, TWi argues that the district court relied on
its reasoning from Actavis even though the arguments
and evidence presented in this case were different from
that of the Actavis case. Indeed, had the district court
attributed any failures of proof in the Actavis litigation to
TWi, that would be error. But, as noted above, the dis-
trict court referenced Actavis only to the extent that the
records in the two cases were the same. For these rea-
sons, the district court did not err in referencing Actavis
in its decision in this case. The Actavis decision also does
not color our decision-making on appeal.
                             B
     Second, TWi argues that Supernus’s admissions in
the common specification preclude a finding that the
accused agent satisfies the solubility agent limitation. As
described above, the asserted patents require both a
release promoting agent and a solubility agent. TWi
                 SUPERNUS PHARMS., INC. v. TWI PHARMS., INC.
8

argues that the accused agent cannot satisfy the solubility
agent limitation because the common specification, at
Table 1, characterizes a formulation that contains the
accused agent, but not a release-promoting agent, as a
“non-enhanced” formulation. ’898 patent, col. 9, ll. 10–33.
TWi contends that the specification defines “non-
enhanced” formulations as formulations that contain
neither a release promoter nor a solubility agent, and
“enhanced” formulations as formulations that contain a
release promotor, solubility agent, or both. In other
words, TWi contends that the accused agent cannot
satisfy the solubility agent limitation because the common
specification admits that a formulation containing the
accused agent is a “non-enhanced” formulation, i.e. is a
formulation that contains neither a solubility agent nor a
release promoting agent.
    TWi’s argument turns on how the common specifica-
tion defines “enhanced” and “non-enhanced” formulations.
In support of its alleged definitions of the terms, TWi
points to language from the common specification stating
that “improvements were made to the formulations by
incorporating solubility enhancers and/or release-
promoting excipients (such formulation[s] are referred to
as enhanced formulations).” Id. at col. 4, ll. 1–4 (emphasis
added). TWi believes that the term “and/or” in this
statement means “and” or “or,” whereas Supernus con-
tends that “and/or” means solely “and.” The district court
found that, in the context of the specification, “and/or”
means solely “and.”
    We agree with the district court. We read “enhanced”
formulations, in the context of the common specification,
to require both a “combination of solubility and release
promoters.” Id. at col. 4, ll. 14–16. Indeed, as Supernus
notes, even “[TWi]’s own citation to a legal style manual”
describes “and/or” “as a ‘grammatical abomination’ that
can mean ‘and,’ ‘or,’ or ‘and/or.’” See Oral Arg. at 19:08–
25,
SUPERNUS PHARMAS., INC. v. TWI PHARMAS., INC.              9

http://oralarguments.cafc.uscourts.gov/default.aspx?fl=20
17-2513.mp3 (quoting Bryan A. Garner, The Redbook: A
Manual on Legal Style § 1.81(d) (2d ed. 2006)) (emphasis
added).
     Here, the common specification indicates that the use
of “and/or” must mean solely “and” because the common
specification identifies both agents as essential to enhanc-
ing the bioavailability of oxcarbazepine. Id. at col. 4, ll.
21–31. In particular, the common specification emphasiz-
es that, “[w]hen a formulation containing both the enteric
polymer[, a type of release-promoting agent,] and solubil-
izer is exposed to an aqueous media . . . the enteric poly-
mer dissolves rapidly leaving a porous structure, resulting
in increased contact surface between the aqueous medium
and the poorly soluble drug.” Id. at col. 4, ll. 22–27. “This
increased surface area,” according to the common specifi-
cation, in turn, “enhances the efficiency of the solubil-
izer(s), and hence, the overall solubility and release rate
of the drug is enhanced to a point where it impacts the
availability of the drug for systemic absorption.” Id. at
col. 4, ll. 27–31. In this way, the common specification
describes the presence of both a solubility agent and a
release-promoting agent as essential to formulating an
“enhanced” formulation.
     Accordingly, “non-enhanced” formulations can include
formulations that do not contain either a solubility agent
or a release promoter. Applied to Table 1, the “non-
enhanced” formulation containing the accused agent does
not preclude a finding that the accused agent is a solubili-
ty agent. This is because it is entirely possible that the
formulation is “non-enhanced” solely because it lacks a
release-promoting agent and not because it lacks a solu-
bility agent. Thus, the district court did not err in finding
that this statement in the specification does not amount
to an admission of noninfringement, nor did it err in
ultimately concluding, based on expert testimony, that
                 SUPERNUS PHARMS., INC. v. TWI PHARMS., INC.
10

the accused agent infringes the solubility agent limita-
tion.
    TWi also contends that the district court failed to ap-
ply its own construction of the solubility agent limitation
which the district court agreed implicitly required that
the solubility agent enhance solubility by more than a de
minimis amount. While the district court did not use the
magic words “de minimis,” we conclude that it made the
necessary findings to support a conclusion of infringement
of the limitation as construed. Specifically, the district
court found, consistent with expert testimony, that the
patents do not require any specific amount of enhance-
ment and that the accused agent enhanced solubility by a
statistically significant amount. That TWi disagrees with
the district court’s assessment that a statistically signifi-
cant increase satisfies the claim limitation as construed is
not grounds for error. Thus, we conclude that the district
court did not err in this respect. We have considered
TWi’s remaining noninfringement arguments regarding
the solubility agent limitation and find them unpersua-
sive.
                             C
    TWi also argues that the district court erred in find-
ing that the proposed tablets infringe the “homogeneous
matrix” limitation. Specifically, it contends that the
district court changed its construction of “homogeneous
matrix” from a “matrix in which the ingredients or con-
stituents are uniformly dispersed,” as construed in the
district court’s Markman order, to “no localization of
constituents,” as stated in its post-trial decision.
    We conclude that district court did not change the
construction of the term in its post-trial decision, but
rather clarified what was already inherent in its construc-
tion, as permitted. See Cordis Corp. v. Boston Sci. Corp.,
658 F.3d 1347 (Fed. Cir. 2011). In fact, the district court
remained consistent in its use of the term throughout the
SUPERNUS PHARMAS., INC. v. TWI PHARMAS., INC.              11

proceedings below. During the claim construction pro-
ceedings in this litigation, Supernus raised concerns that
TWi may attempt to avoid infringement by arguing that
the asserted patents require complete uniformity, which
Supernus contends is unattainable. In response to Su-
pernus’s concerns, the district court stated that, in its
view, the asserted patents do not require any specific
degree of uniformity, just some degree of uniformity. J.A.
2405 (“[A] homogeneous matrix comprising A, B, C and D
means that there is a uniform dispersion of A, B, C and D
whatever that rate, whatever that proportion, whatever
that degree is. The fact that it may vary a little here or
there is of no moment.”).
     The district court later reiterated in its post-trial de-
cision that this proposition is inherent in its construction
of the term. Because the parties had agreed to adopt the
district court’s construction of the term “homogeneous
matrix” from the Actavis matter, the district court began
by incorporating its reasoning for this construction from
its decision in that case, Supernus, 265 F. Supp. 3d at
498, including its reasoning that “everyone understands .
. . that you don’t get this perfect uniformity ever; it’s
impossible,” Actavis, 2016 WL 527838 at *7. The district
court then considered the prosecution histories and found,
based on a specific office action, that “[t]he term was not
added to describe the degree of uniformity or homogeneity
of the Supernus invention or to distinguish the degree of
uniformity of Supernus’s invention from that of prior art
formulations.” Supernus, 265 F. Supp. 3d at 501 (empha-
sis added). Rather, the district court stated, the term
“was added to the claims to distinguish Supernus’s inven-
tion, which has all four matrix components in the tablet
core, from the prior art references, which contained cer-
tain matrix constituents solely in the coating, which the
Patent Examiner viewed to be part of the matrix.” Id.
Thus, the district court clarified that inherent in its
construction of “homogeneous matrix” is this understand-
                 SUPERNUS PHARMS., INC. v. TWI PHARMS., INC.
12

ing that, where the degree of uniformity is irrelevant,
“uniformly dispersed” necessarily implicates an absence of
localization. Id. at 524–25.
     This is similar to our decision in Cordis Corp. v. Bos-
ton Sci. Corp., 658 F.3d 1347 (Fed. Cir. 2011). There, the
district court construed the claim term “undulating” to
mean “rising and falling in waves, thus having at least a
crest and a trough.” Id. at 1355. When the district court
entered a judgment of noninfringement as a matter of
law, it clarified that “waves” implies a change in direction.
Id. Cordis argued that the district court’s characteriza-
tion of “waves” improperly narrowed the construction. Id.
On appeal, we found that the district court did not err,
but merely “clarified what was inherent in the construc-
tion,” because “the terms ‘crest’ and ‘trough,’ as used in
district court’s claim construction, implicate changes of
direction, with the curve extending beyond the point of
inflection.” Id. at 1356. Similarly, here, the district court
merely clarified what was inherent in its construction
because uniform dispersal, in the context of the district
court’s finding that “homogenous matrix” does not require
any specific degree of uniformity, necessarily implicates
an absence of localization. Thus, the district court did not
err.
                             D
     Finally, TWi argues that the district court erred in
finding that the “homogeneous matrix” limitation was not
indefinite and did not lack written description support.
But the specification, prosecution history, and expert
testimony support the district court’s conclusions. See,
e.g., ’898 patent, col. 5, ll. 53–59; Supernus, 265 F. Supp.
3d at 520–21 (stating during prosecution that “one of
ordinary skill in the art would appreciate that the formu-
lations derived according to the protocol set forth in the
Examples would necessarily comprise a homogeneous
SUPERNUS PHARMAS., INC. v. TWI PHARMAS., INC.           13

matrix.”). Thus, we conclude that the district court did
not err.
                     III. CONCLUSION
     For the reasons stated above, we affirm the district
court’s conclusion that the asserted patents are not inva-
lid and would be infringed by TWi’s proposed tablets. 2
                       AFFIRMED
                          COSTS
    No costs.

    2   Prior to oral argument in this case, Supernus
moved to modify the district court’s protective order
pursuant to Federal Circuit Rule 11(e).           Supernus
Pharms., Inc. v. TWi Pharms., Inc., No. 17-2513, ECF No.
34, 35. TWi opposed the motion. Id. at ECF No. 38, 39.
In an order dated July 20, 2018, this court reserved ruling
on this motion pending a decision on the merits. Id. at
ECF No. 74. Having affirmed the district court’s decision
without reference to the information that was the subject
of the motion, we deny the motion as moot.