Court Opinion

ID: 4099048
Source: CourtListenerOpinion
Date Created: 2016-11-17 16:01:31.436122+00
Date Added: 2024-06-11T14:22:14.203133
License: Public Domain

NOTE: This disposition is nonprecedential.

  United States Court of Appeals
      for the Federal Circuit
                 ______________________

          ROXANE LABORATORIES, INC.,
               Plaintiff-Appellant

                           v.

  CAMBER PHARMACEUTICALS INC., INVAGEN
         PHARMACEUTICALS INC.,
            Defendants-Appellees
           ______________________

                       2016-1028
                 ______________________

    Appeal from the United States District Court for the
District of New Jersey in No. 2:14-cv-04042-SRC-CLW,
Judge Stanley R. Chesler.
                ______________________

              Decided: November 17, 2016
                ______________________

    KENNETH G. SCHULER, Latham & Watkins LLP, Chica-
go, IL, argued for plaintiff-appellant. Also represented by
MARC NATHAN ZUBICK; GREGORY SOBOLSKI, San Francisco,
CA; ROBERT J. GAJARSA, Washington, DC.

   ROBERT S. SILVER, Caesar, Rivise, Bernstein, Cohen &
Pokotilow, Ltd., Philadelphia, PA, argued for defendants-
appellees. Also represented by SALVATORE GUERRIERO, PEI-
RU WEY.
2                   ROXANE LABS., INC.   v. CAMBER PHARM. INC.

                  ______________________

    Before LOURIE, MAYER, and O’MALLEY, Circuit Judges.
LOURIE, Circuit Judge.
     Roxane Laboratories, Inc. (“Roxane”) appeals from a
stipulated judgment of noninfringement following the
decision of the United States District Court for the Dis-
trict of New Jersey construing the claims of U.S. Patent
8,563,032 (“the ’032 patent”). See Roxane Labs., Inc. v.
Camber Pharm. Inc., No. 14-4042, 2015 WL 4393785
(D.N.J. July 15, 2015) (claim construction order); Roxane
Labs., Inc. v. Camber Pharm. Inc., No. 14-4042, ECF No.
247 (D.N.J. Sept. 9, 2015) (final judgment). Roxane also
challenges an earlier decision of the United States Dis-
trict Court for the Southern District of Ohio transferring
this infringement action to the District of New Jersey.
See Roxane Labs., Inc. v. Camber Pharm., Inc., No. 2:14-
cv-232, 2014 WL 2812867 (S.D. Ohio June 23, 2014).
Because the district courts did not err in transferring the
case and in construing the claims, we affirm.
                        BACKGROUND
    Calcium acetate is used to treat patients suffering
from end-stage kidney failure who have abnormally high
serum phosphorous levels. When taken orally, calcium
acetate binds to phosphorous in foods and prevents its
absorption through the gastrointestinal tract. Roxane
owns the ’032 patent, directed to a capsule formulation of
calcium acetate granules, with each capsule containing a
dose of 667 mg calcium acetate on an anhydrous basis.
      Pharmaceutical capsules for human use are available
in a variety of sizes, including size 5 (the smallest), 4, 3, 2,
1, 0, 00, and 000 (the largest). The claims of the ’032
patent require that the calcium acetate granules be
contained within “a pharmaceutically acceptable capsule
. . . that is size 00 or less.” ’032 patent col. 6 ll. 35–41.
ROXANE LABS., INC.   v. CAMBER PHARM. INC.               3

   Claim 1, the only independent claim, is representative
and reads as follows:
    1. A calcium acetate capsule formulation com-
    prising flowable granules comprised of a pharma-
    ceutically acceptable amount of calcium acetate
    along with other pharmaceutically acceptable ad-
    juvants, wherein said granules are filled into and
    contained within a pharmaceutically acceptable
    capsule such that 667 mg of said calcium acetate
    on an anhydrous basis are present in said capsule
    that is size 00 or less.
Id. (emphasis added).
     Camber Pharmaceuticals, Inc. and InvaGen Pharma-
ceuticals, Inc. (collectively, “the Appellees”) manufacture
and sell calcium acetate products in elongated size 00
(“size 00el”) capsules. A size 00el capsule has the same
diameter as a standard size 00 capsule, but has a greater
length and a larger fill volume.
    In March 2014, Roxane sued the Appellees in the
United States District Court for the Southern District of
Ohio, alleging infringement of the ’032 patent. On the
Appellees’ motion, in June 2014, the district court in Ohio
transferred the action to the District of New Jersey pur-
suant to 28 U.S.C. § 1404(a). Applying Sixth Circuit law,
the district court in Ohio found that the convenience of
the parties and witnesses as a whole and the balance of
public and private interests favored the transfer of venue
to New Jersey. Roxane, 2014 WL 2812867, at *3–5.
    In July 2015, the district court in New Jersey issued
an order construing the claim limitation “size 00 or less.”
The court examined the intrinsic record of the ’032 patent
and concluded that the meaning of “‘size 00 or less’ is
unambiguous,” that “nothing in the patent . . . suggests
that the applicants understood ‘size 00’ to mean a family
of capsule sizes” that included both standard and elongat-
4                  ROXANE LABS., INC.   v. CAMBER PHARM. INC.

ed size 00 capsules, and that the intrinsic record consist-
ently indicated that “size 00” refers to a single capsule
size with a specific weight and fill capacity. Roxane, 2015
WL 4393785, at *4–5. The district court therefore con-
cluded that “size 00 or less” means “precisely size 00 or
less,” which excludes capsules of size 00el. Id. at *6.
    In light of that construction and the undisputed fact
that the Appellees’ products use size 00el capsules, which
are larger than standard size 00 capsules, Roxane stipu-
lated to a judgment of noninfringement. The district
court then entered final judgment under Federal Rule of
Civil Procedure 54(b). Roxane timely appealed to this
court. We have jurisdiction under 28 U.S.C. § 1295(a)(1).
                        DISCUSSION
                              I
    We first consider whether the district court in Ohio
erred in transferring the case to the District of New
Jersey. In reviewing a district court’s decision on a mo-
tion to transfer under 28 U.S.C. § 1404(a), we apply the
law of the regional circuit in which the district court
deciding the motion sits, here, the Sixth Circuit. Storage
Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 836 (Fed. Cir.
2003). The Sixth Circuit recognizes that district courts
have “broad discretion” to determine “when party ‘conven-
ience’ or ‘the interest of justice’ make[s] a transfer appro-
priate.” Reese v. CNH Am. LLC, 574 F.3d 315, 320 (6th
Cir. 2009) (quoting 28 U.S.C. § 1404(a)). Applying Sixth
Circuit law, we reverse a district court’s ruling on a
motion to transfer “[o]nly when the district court clearly
abuse[s] its discretion in balancing these considerations.”
Id. (second alteration in original) (internal quotation
marks omitted).
    Roxane argues that the district court abused its dis-
cretion in transferring the action, and that the court made
two legal errors: (1) that the court afforded no weight to
ROXANE LABS., INC.   v. CAMBER PHARM. INC.                5

Roxane’s choice of forum; and (2) that the court consid-
ered the convenience of employee witnesses as the most
important factor. According to Roxane, a plaintiff’s choice
of forum controls unless the factors of convenience strong-
ly favor transfer. Roxane contends that those factors did
not strongly favor transfer in this case.
    The Appellees respond that it was within the broad
discretion of the district court to transfer the action. The
Appellees argue that the district court properly weighed
the relevant factors, including Roxane’s choice of forum,
the location of the complained-of activity, the location of
and ease of access to sources of proof, and the convenience
of all parties in the lawsuit, and correctly found that the
balance of those factors as a whole favored the transfer.
     We agree with the Appellees that the district court
did not abuse its discretion in transferring the case. The
court recognized that Roxane’s choice to litigate in Ohio is
“[t]he most significant factor weighing against transfer.”
Roxane, 2014 WL 2812867, at *5. Nevertheless, the court
found that other factors, including the location of the
complained-of activity, greatly weighed in favor of trans-
fer. As the district court found, the Appellees’ operations
and employees are located in New Jersey or nearby New
York; all documentary evidence relating to the marketing
and sales of the accused products was located in either
New Jersey or New York; and the accused products were
designed and developed in New Jersey. Id. at *3–4. The
district court conducted a fact-specific analysis of all of
the relevant factors and ultimately found that those
factors on balance favored transfer. On this record, we
discern no clear abuse of discretion in the district court’s
decision to transfer the case to the District of New Jersey.
                               II
    We next consider whether the district court in New
Jersey erred in construing the claim limitation “size 00 or
less.” “The proper construction of a patent’s claims is an
6                  ROXANE LABS., INC.   v. CAMBER PHARM. INC.

issue of Federal Circuit law.” Absolute Software, Inc. v.
Stealth Signal, Inc., 659 F.3d 1121, 1129 (Fed. Cir. 2011).
We review a district court’s ultimate claim constructions
de novo and any underlying factual determinations in-
volving extrinsic evidence for clear error. Teva Pharm.
U.S.A., Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841–42 (2015).
Here, because the district court relied only on the intrin-
sic record to construe “size 00 or less,” we review the
district court’s construction de novo. See Shire Dev., LLC
v. Watson Pharm., Inc., 787 F.3d 1359, 1364, 1368 (Fed.
Cir. 2015) (citing Teva, 135 S. Ct. at 840–42).
     The words of a claim “are generally given their ordi-
nary and customary meaning” as understood by a person
of ordinary skill in the art at the time of the invention.
Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir.
2005) (en banc). Because that meaning is “often not
immediately apparent, and because patentees frequently
use terms idiosyncratically,” the court looks to the intrin-
sic record, including “the words of the claims themselves,
the remainder of the specification, [and] the prosecution
history,” as well as to extrinsic evidence when appro-
priate, to construe a disputed claim term. Id. at 1314,
1319. “[W]hile extrinsic evidence can shed useful light on
the relevant art, we have explained that it is less signifi-
cant than the intrinsic record in determining the legally
operative meaning of claim language.” Id. at 1317 (quota-
tion marks omitted); see also id. at 1318 (“We have viewed
extrinsic evidence in general as less reliable than the
patent and its prosecution history in determining how to
read claim terms, for several reasons.”).
    Roxane argues that the district court erred in constru-
ing the claims as excluding size 00el capsules. According
to Roxane, “size 00” refers to either non-elongated or
elongated size 00. Roxane maintains that capsule “size”
only designates capsule diameter, not length or volume.
Roxane argues, moreover, that nowhere in the intrinsic
record did the patentee redefine “size 00” as an indicator
ROXANE LABS., INC.   v. CAMBER PHARM. INC.                7

of anything other than capsule diameter, and that the
patentee did not discuss elongated capsules or consider
them as constituting a separate size. Appellant’s Br. 45.
Roxane additionally asserts that the district court ignored
the “pharmaceutically acceptable” claim language, which
imposes a requirement for ease-of-swallowability that is
primarily determined by capsule diameter. Lastly, Rox-
ane contends that its proposed construction is supported
by extrinsic evidence.
    The Appellees respond that the district court correctly
construed “size 00” as designating a capsule of one specific
size—i.e., one specific diameter, length, and fill volume—
not a family of capsules. The Appellees argue that all
descriptions of “size 00” in the written description and
prosecution history of the ’032 patent are limited to one
specific capsule size—standard size 00, and that nothing
in the intrinsic record suggests that the applicants in-
tended a broader meaning of “size 00” to encompass size
00el. The Appellees additionally argue that the declara-
tion filed by coinventor Dr. Uraizee (“the Uraizee declara-
tion”), as well as the two capsule size charts in the
prosecution history, resolve any remaining doubt on the
meaning of “size 00.”
    We agree with the district court and the Appellees
that “size 00” in the ’032 patent means standard, non-
elongated size 00, and that the limitation “size 00 or less”
thus excludes the larger elongated size 00 capsules from
the scope of the claims. The main dispute in this appeal
is whether “size 00” in the ’032 patent refers to a capsule
of a specific diameter, length, and fill volume, or to a
family of capsules with the same diameter but varying
lengths and fill volumes. We agree with the district court
that the intrinsic record of the ’032 patent unambiguously
indicates that the former, not the latter, is the proper
construction.
8                  ROXANE LABS., INC.   v. CAMBER PHARM. INC.

    The written description of the ’032 patent refers to
“size 00” twice. First, it states that “[a]ccording to one
embodiment of the invention, the capsule is a size 00
capsule containing 667 mg of calcium acetate.” ’032
patent col. 3 ll. 29–31. It then describes in Example 1
that “[t]he final blend was then filled into size 00 capsules
using an IMA capsule filling machine wherein the result-
ing filled capsules had a weight of 880 mg and contained
760 mg of the final blend, including a 667 mg dose of
calcium acetate.” Id. col. 5 ll. 53–57.
    The disclosed example thus refers to size 00 capsules
as having the same weight (880 mg) when filled with the
same amount of the final blend (760 mg). As the district
court noted, however, an empty size 00 capsule and an
empty size 00el capsule share the same diameter, but
have different lengths and presumably different weights.
Thus, a size 00 capsule would have a different weight
than a size 00el capsule when both are filled with the
same amount of the final blend. Accordingly, the size-
family definition now advocated by Roxane does not
reconcile with the usage of “size 00” in the written de-
scription.
     Importantly, the prosecution history clearly indicates
that “size 00” refers to standard, non-elongated size 00
capsules. During prosecution, the Examiner rejected the
claims as being obvious over Dennett, which teaches
filling a size 0 capsule with 667 mg of compressed anhy-
drous calcium acetate, in view of Nakai, which teaches
free flowing calcium acetate granules, albeit having a
lower bulk density than that described in the ’032 patent.
J.A. 232–34. The Examiner cited Torpac, a capsule size
chart, to support the rejection. J.A. 239, 241. Notably,
the capsule size chart in Torpac does not list any elongat-
ed capsule sizes, such as size 00el; it only lists standard,
non-elongated capsules, including size 0 and size 00 with
specific fill volumes of 0.68 mL and 0.95 mL, respectively.
J.A. 241. Relying on Torpac, the Examiner maintained
ROXANE LABS., INC.   v. CAMBER PHARM. INC.                  9

that “[i]t’s clear from the metric table that size 00 is about
50% bigger than size 0.” J.A. 233. The Examiner then
reasoned that it would have been obvious to a skilled
artisan to combine the teachings of Dennett, Nakai, and
Torpac to arrive at the claimed capsule formulation. Id.
The Examiner considered “size 00” to be standard size 00,
not elongated size 00.
      We are unpersuaded by Roxane’s argument that the
Examiner’s statement that “size 00 capsules are 50%
bigger than size 0 capsules,” J.A. 286, is evidence that he
referred to size 00el capsules because the volume of size
00el capsules (1.02 mL) is exactly 50% greater than
standard size 0 capsules (0.68 mL). As indicated, the
intrinsic record clearly shows that the Examiner relied
only on Torpac as evidence of capsule sizes and referred to
the fill volume of non-elongated size 00 capsules, 0.95 mL,
in his analysis. See, e.g., J.A. 233 (citing Torpac); J.A. 285
(“Torpac teaches various capsules and their sizes.”); J.A.
292 (“The volume of a size 00 capsule . . . is 0.95 mls.”
(citing Torpac)); see also J.A. 329 (the Board’s opinion
stating that “[a]s the Examiner’s calculation itself shows,
. . . a size 00 capsule holds only 0.95 ml”).
     In response to that rejection and in the subsequent
appeal to the Patent Trial and Appeal Board (“the
Board”), the applicants did not dispute the Examiner’s
understanding of “size 00” as standard size 00. Rather,
the applicants argued that Nakai’s granules, which have
a lower bulk density, cannot be filled into size 00 capsules
to achieve the claimed amount of 667 mg of calcium
acetate on an anhydrous basis. As support, the applicants
submitted a declaration by coinventor Dr. Uraizee. J.A.
221–24. In that declaration, Dr. Uraizee explained that,
although she was able to duplicate the bulk density of
Nakai’s granules, she was unable to fill the claimed
amount of calcium acetate into “size 00 capsules” using
the prior-art granules. J.A. 222. Dr. Uraizee stated that
“[t]he maximum fill we could obtain using these granules
10                  ROXANE LABS., INC.   v. CAMBER PHARM. INC.

was approximately 600 mg.” Id. Citing Lightfoot, which
also provides a capsule size chart, Dr. Uraizee further
explained that Nakai’s granules had a tapped density of
0.65 g/cc and that “only about 592 mg of granules can be
comfortably filled into the capsule.” Id.
     The Uraizee declaration therefore treated “size 00” as
capsules of one size having a particular fill capacity,
rather than a family of capsules having a range of fill
capacities. Indeed, Roxane conceded to the district court
that Dr. Uraizee only tested one capsule size—standard
size 00, not size 00el. Roxane, 2015 WL 4393785, at *5
n.5. Although Dr. Uraizee cited Lightfoot, which provides
a capsule size chart listing the fill volumes of both size 00
and size 00el capsules, J.A. 303, 1 it appears that she only
used the fill volume of standard size 00, not size 00el, to
calculate the amount of granules (592 mg) that can be
filled into “size 00 capsules,” given the known tapped
density of the granules (0.65 g/cc). 2 She did not perform a
similar calculation as to size 00el capsules, which would,
without doubt, hold a greater amount of calcium acetate
due to the larger fill volume.
    Furthermore, in the Reply Brief filed at the Board,
the applicants emphasized that claim 1 does not cover
capsules that are larger and have more fill capacity than
“size 00.” J.A. 299 (stating that the applicants “have
drafted claim 1 to refer to capsules of size 00 or less, i.e.,

     1   The applicants did not provide a copy of Lightfoot
to the Examiner when filing the Uraizee declaration. It
only submitted a copy of Lightfoot with its Reply Brief
filed at the Board sixteen months later.
     2   In the units used by Dr. Uraizee, 592 mg divided
by 0.65 g/cc gives a fill volume of 0.91 cc, or 0.91 mL,
which corresponds to the fill volume of standard size 00
capsules listed in Lightfoot, not that of size 00el capsules,
which is 1.02 mL. J.A. 303.
ROXANE LABS., INC.   v. CAMBER PHARM. INC.              11

capsules of size 00 or a smaller capsule than size 00.”
(emphasis in original)). In the Examiner’s Answer, the
Examiner maintained that the claims are broader than
what the Uraizee declaration showed. J.A. 292. In reply,
the applicants argued that “although the Uraizee Decla-
ration only tested size 00 capsules it is commensurate
with the claims,” and that “[t]he Uraizee Declaration
showed that only about 592 mg of granules could be
comfortably filled in size 00 capsules using Nakai’s granu-
lar material, which was far short of the claimed fill
amount of 667 mg of flowable granules of calcium acetate
on an anhydrous basis.” J.A. 300 (emphasis added). In
light of the applicants’ arguments, the Board reversed the
Examiner’s rejection and specifically relied on the Uraizee
declaration, finding that it “provides persuasive evidence
to show that Nakai’s process does not produce granules of
calcium acetate that could provide size 00 capsules con-
taining 667 mg of calcium acetate.” J.A. 329.
    Accordingly, the Uraizee declaration and the appli-
cants’ prosecution arguments clearly indicate that size
00el capsules, which have a greater fill volume than the
standard size 00 capsules tested by Dr. Uraizee, are
outside the scope of the claims. In order to overcome the
obviousness rejection, the applicants relied on the Uraizee
declaration and emphatically argued that the claims only
cover size 00 capsules tested by Dr. Uraizee or smaller
capsules. Because the intrinsic record unambiguously
and fully resolves the proper construction of “size 00 or
less,” we agree with the district court that resort to ex-
trinsic evidence is unnecessary and improper.
    We therefore conclude that the district court did not
err in construing “size 00 or less” as meaning standard
size 00 or less, which excludes size 00el.
                         CONCLUSION
   We have considered Roxane’s remaining arguments
but find them to be unpersuasive. For the foregoing
12                 ROXANE LABS., INC.   v. CAMBER PHARM. INC.

reasons, we affirm the decision of the district court for the
Southern District of Ohio to transfer the action to the
District of New Jersey, as well as the decision of the
district court in New Jersey construing “size 00 or less.”
We therefore affirm the stipulated judgment of non-
infringement.
                       AFFIRMED