Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-16-01028/USCOURTS-ca13-16-01028-0/pdf.json

Nature of Suit Code: 830
Nature of Suit: Patent
Cause of Action: 

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NOTE: This disposition is nonprecedential.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, Chicago, 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 defendantsappellees. Also represented by SALVATORE GUERRIERO, PEIRU WEY. 

Case: 16-1028 Document: 45-2 Page: 1 Filed: 11/17/2016
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 District 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 District 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. 

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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 comprising flowable granules comprised of a pharmaceutically acceptable amount of calcium acetate 

along with other pharmaceutically acceptable adjuvants, 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 Pharmaceuticals, 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 pursuant 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 elongatCase: 16-1028 Document: 45-2 Page: 3 Filed: 11/17/2016
4 ROXANE LABS., INC. v. CAMBER PHARM. INC. 

ed size 00 capsules, and that the intrinsic record consistently 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 concluded 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 stipulated 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 motion 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 ‘convenience’ or ‘the interest of justice’ make[s] a transfer appropriate.” 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 discretion in transferring the action, and that the court made 

two legal errors: (1) that the court afforded no weight to 

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ROXANE LABS., INC. v. CAMBER PHARM. INC. 5

Roxane’s choice of forum; and (2) that the court considered 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 strongly 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 transfer. 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 

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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 involving 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 intrinsic 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 ordinary 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 intrinsic record, including “the words of the claims themselves, 

the remainder of the specification, [and] the prosecution 

history,” as well as to extrinsic evidence when appropriate, 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 significant than the intrinsic record in determining the legally 

operative meaning of claim language.” Id. at 1317 (quotation 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 construing 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 

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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, Roxane 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 intended a broader meaning of “size 00” to encompass size 

00el. The Appellees additionally argue that the declaration filed by coinventor Dr. Uraizee (“the Uraizee declaration”), 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, nonelongated 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. 

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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 resulting 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 sizefamily definition now advocated by Roxane does not 

reconcile with the usage of “size 00” in the written description.

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 anhydrous 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 elongated 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

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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 

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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.

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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 Declaration 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 granular 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 containing 667 mg of calcium acetate.” J.A. 329.

Accordingly, the Uraizee declaration and the applicants’ 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 extrinsic 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 

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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 noninfringement.

AFFIRMED

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