SUPERNUS PHARMACEUTICALS, INC. v. AJANTA PHARMA LIMITED

UNITED STATES DISTRICT COURT

DISTRICT OF NEW JERSEY

NOT FOR PUBLICATION

SUPERNUS PHARMACEUTICALS,

INC,,

Civ. No. 21-6964 (GC)

Plaintiff,

V. OPINION

AJANTA PHARMA LIMITED and

AJANTA PHARMA USA INC.,

Defendants.

SUPERNUS PHARMACEUTICALS,

INC., .

Civ. No. 21-14628 (GC)

Plaintiff,

V. OPINION

TORRENT PHARMACEUTICALS LTD.

and TORRENT PHARMA INC.,

Defendants.

CASTNER, District Judge

THIS MATTER comes before the Court on the Joint Claim Construction and Prehearing

Statement regarding U.S. Patent Nos. 8,298,580 (filed Dec. 17, 2010) (“the ’580 Patent”),

8,663,683 (filed Aug. 27, 2012) (“the ’683 Patent”), 8,877,248 (filed July 14, 2014) (“the °248

Patent”), 8,992,989 (filed Sept. 29, 2014) (the °989 Patent”), 9,549,940 (filed Sept. 8, 2016) (“the

"940 Patent”), 9,622,983 (filed Sept. 8, 2016) (“the °983 Patent”), and 10,314,790 (filed March 30,

2017) (the °790 Patent”) (collectively, the “patents in suit”) submitted by Plaintiff Supernus

Pharmaceuticals, Inc. (“Plaintiff”) and Defendants Ajanta Pharma Ltd. and Ajanta Pharma USA

Inc. (“Ajanta”), and Torrent Pharmaceuticals Ltd. and Torrent Pharma Inc. (“Torrent”)

(collectively, “Defendants”) pursuant to L. Pat. R. 4.3. (ECF No. 61.) On May 9, 2022, Plaintiff

and Defendants filed opening briefs. (ECF Nos. 67, 68.) Plaintiff submitted the Expert

Declaration of Mansoor A. Khan, R.Ph., Ph.D., with its opening brief. (See generally Opening

Declaration of Mansoor A. Khan (“Opening Khan Decl.”), ECF No. 68-2.) On July 1, 2022,

Plaintiff and Defendants filed responsive briefs. (ECF Nos. 76, 77.) Plaintiff submitted another

Declaration of Mansoor A. Khan, P.Ph., Ph.D., with its responsive brief. (See generally

Responsive Declaration of Mansoor A. Khan (“Responsive Khan Decl.”}, ECF No. 77-1.)

The parties dispute five claim terms that appear in the patents in suit, (See Joint Prehr’g

Stmt. Ex. A, ECF No. 61.) On July 21, 2022, pursuant to L. Pat. R. 4.6, the Court held a Markman

hearing to construe the claim terms. (ECF No. 78.) The claim terms are construed below.

BACKGROUND

A. Procedural Background

This case arises out of Defendants’ filing of Abbreviated New Drug Applications

(“ANDAs”) with the Food and Drug Administration (“FDA”) to seek approval to market a generic

version of the pharmaceutical product Trokendi XR® (hereinafter, “Trokendi”), (Joint Prehr’g

Stmt. {.) Plaintiff, the pharmaceutical company that holds the New Drug Application ((NDA”)

for Trokendi, alleges that Defendants’ ANDAs infringe on the seven patents in suit, as well as

three additional Trokendi patents, United States Patent Nos. 8,298,576 (“the *576 Patent”),

8,889,191 (“the °191 Patent”), and 9,555,004 (“the °004 Patent”), (collectively, the “Trokendi

patents”). (id. at 1; Compl. 4 1, 54-133, ECF No. 1.)!

To market and sell Trokendi, Plaintiff listed the Trokendi patents in the FDA’s Approved

Drug Products with Therapeutic Equivalence Applications, commonly known as the Orange Book.

See 21 U.S.C. § 355(b)(1), (c)(2); (Compl. | 28.) Thereafter, Defendants filed their ANDAs with

the FDA to market generic versions of Trokendi. See 21 U.S.C. § 355G)(1); (Compl. ff] 39-42.)

Accordingly, pursuant to 21 U.S.C. § 355()(S)(B)Gii), Plaintiff initiated this suit against

Defendants because Defendants requested to market the generic version of Trokendi prior to the

expiration of the Trokendi patents, (Compl. ۤ 54-133.)

B. The Patents in Suit

All seven of the patents in suit are called “Sustained-Release Formulations of Topiramate,”

and they share the same specification.” (’580 Patent col, 1 1. 1-2, Compl. Ex. B, ECF No. 1-2;

Patent col. 1 1. 1-2, Compl. Ex. C, ECF No. 1-3; ’248 Patent col. 1 1. 1-2, Compl. Ex. D,

ECF No. 1-4; °989 Patent col. 1 1. 1-2, Ex. F, ECF No. 1-6; °940 Patent col. 1 1. 1-2, Compl. Ex.

G, ECF No, 1-7; °983 Patent col. 1 1, 1-2, Compl. Ex. I, ECF No. 1-9; °790 Patent col. 1 1. 1-2,

Compl. Ex. J, ECF No, 1-10; see also Markman H1’g Tr. (“Tr.”) 15:25--16:3, 60:1-60:5, ECF No.

87.)

Topiramate is a pharmaceutical product that has been approved for use as an “antiepileptic

agent” to treat seizures and migraines under the trade name Topamax® (hereinafter, “Topamax”).

' The Torrent and Ajanta Defendants agreed to consolidate their actions on December 17, 2021.

(ECF No, 43.) Unless specified otherwise, citations refer to the docket in the consolidated action,

Supernus Pharmaceuticals, Inc. y. Ajanta Pharma Lid et al., Civ. No. 21-6964 (D.N.J. 2021).

? When citing to the shared specification of the patents in suit, the Court cites to the ’580 Patent.

See Gemalto S.A. v. HTC Corp., 754 F.3d 1364, 1366 & n.2 (Fed, Cir. 2014),

Patent col. 1 1. 16-22.) Topamax is administered in “immediate release dosage form,” which

means that the “topiramate is rapidly absorbed with plasma drug concentrations peaking in

approximately 2 hours.” (Cd, col. 5 1, 23-26.) This type of administration is “associated with a

peak in plasma concentrations of the drug, and the fluctuations associated with the peaks and

valleys of blood plasma levels of the drug are undesirable.” (Ud. col. 1 1. 49-53.)

The Trokendi patents address this problem by providing a “sustained release” of topiramate

where the “sustained release formulation comprises an extended release (XR) component and an

optional immediate release (IR) component.” (/d. col. 2 1, 6-10, 24-27.) With these sustained

release formulations, the Trokendi patents aim to “reduc[e] in the frequency or severity of at least

one side effect associated with the topiramate treatment,” and “provide a sustained release

formulation that can be administered orally once a day” without the associated side effects. (dd.

21. 11-19; Tr. 19:19-20:11.)

I, LEGAL STANDARD

The meaning and scope of patent claims are questions of law to be decided by the court.

Markinan v. Westview Instruments, Inc., 517 U.S. 370, 372 (1996). “It is a bedrock principle of

patent law that the claims ofa patent define the invention to which the patentee is entitled the right

to exclude.” Phillips vy. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (internal citation and

quotation marks omitted). “[T]here is no magic formula or catechism for conducting claim

construction.” /d. at 1324. Instead, the Court is free to attach the appropriate weight to appropriate

sources “in light of the statutes and policies that inform patent law.” fd. (citing Vitronics Corp. v.

Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). “Claim construction begins with the

3 The claims and specification of the patents in suit refer to “extended release” and “XR”

interchangeably, and “immediate release” and “IR” interchangeably. The Court does the same in

this Opinion.

intrinsic evidence of the patent—the claims, the specification, and the prosecution history—and

may require consultation of extrinsic evidence to understand the state of the art during the relevant □

time period.” Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc., 2019 WL 943532, at *2

(D.N.J. Feb. 26, 2019); see also Phillips, 415 F.3d at 1317.

First, the court “looks to the words of the claims themselves, both asserted and nonasserted,

to define the scope of the patented invention.” Vitronics Corp., 90 F.3d at 1582, The “words of a

claim are ‘generally given their ordinary and customary meaning,’” which is “the meaning that the

term would have to a person of ordinary skill in the art in question at the time of the invention, i.e.,

as of the effective filing date of the patent application.” Phillips, 415 F.3d. at 1312-13 (quoting

Vitronics Corp,, 90 F.3d at 1582). -A person of ordinary skill in the art (“/POSA”) “is deemed to

read the claim term not only in the context of the particular claim in which the disputed term

appears, but in the context of the entire patent, including the specification.” Jd. at 1313 (citing

Multiform Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1477 (Fed. Cir. 1998)). Accordingly,

“the claims themselves provide substantial guidance as to the meaning of particular claim terms,”

and a court may look to “the context in which a term is used in the asserted claim” and “other

claims of the patent in question, both asserted and unasserted.” See id. at 1314. “Differences

among claims can also be a useful guide in understanding the meaning of particular claim terms.

For example, the presence of a dependent claim that adds a particular limitation gives rise to a

presumption that the limitation in question is not present in the independent claim.” /d. at 1314—

15 Ginternal citation omitted).

Second, the specification is “always highly relevant to the claim construction analysis.

Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.” Vitronics

Corp., 90 F.3d at 1582; see also Phillips, 415 F.3d at 1315 (noting that claims “are part of ‘a fully

integrated written instrument,’ and ‘must be read in view of the specification, of which they are a

part’”’) (citing Markman vy. Westview Instruments, Inc., 52 F.3d 967, 978 (Fed. Cir. 1995), aff'd,

517 U.S. 376 (1996)). As the Federal Circuit put it, “[c]laims define and circumscribe, the written

description discloses and teaches.” Ariad Pharms., Inc. v. Elf Lilly & Co., 598 F.3d 1336, 1347

(Fed. Cir. 2010). “Although words in a claim are generally given their ordinary and customary

meaning, a patentee may choose to be his own lexicographer and use terms in a manner other than

their ordinary meaning, as long as the special definition of the term is clearly stated in the patent

specification or file history.” Vitronics Corp., 90 F.3d at 1582. However, while “[t}he written

description and other parts of the specification [] may shed contextual light on the plain and

ordinary meaning [], they cannot be used to narrow a claim term to deviate from the plain and

ordinary meaning unless the inventor acted as his own lexicographer or intentionally disclaimed

or disavowed claim scope.” Aventis Pharms, Inc. vy. Amino Chemicals Ltd., 715 F.3d 1363, 1373

(Fed. Cir. 2013).

Third, a court “should also consider the patent’s prosecution history, if it is in evidence.”

Markman, 52 F.3d at 980. “This history contains the complete record of all the proceedings before

the [Patent and Trademark Office (“PTO”)|, including any express representations made by the

applicant regarding the scope of the claim.” Vitronics Corp., 90 F.3d at 1582. “A patent’s

prosecution history, though less useful for claim construction purposes than the claim language

and written description, plays various roles in resolving uncertainties about claim scope.” Mass,

Inst. of Tech. v. Shire Pharms., Inc., 839 F.3d 1111, 1118 (Fed. Cir. 2016) (internal quotation

marks and citations omitted). The prosecution history can often inform the meaning of the claim

language by demonstrating how the inventor understood the invention. Phillips, 415 F.3d at 1317.

For example, the prosecution history may “limit[] the interpretation of claim terms so as to exclude

any interpretation that was disclaimed during prosecution.” Southwall Techs., Inc. v. Cardinal IG

Co., 54 F.3d 1570, 1576 (Fed. Cir. 1995) (citation omitted). To limit the scope of a claim based

on prosecution statement, the patentee must have made “clear and unmistakable prosecution

arguments limiting the meaning of a claim term in order to overcome a rejection.” SanDisk Corp.

v. Memorex Prod, Inc., 415 F.3d 1278, 1286 (Fed. Cir, 2005) (citing Omega Eng’sg, Inc, v. Raytek

Corp., 334 F.3d 1314, 1324 (Fed. Cir. 2003)). However, “because the prosecution history

represents an ongoing negotiation between the PTO and the applicant, rather than the final product

of that negotiation, it often lacks the clarity of the specification and thus is less useful for claim

construction purposes,” Phillips, 415 F.3d at 1317.

Finally, in some cases, the “district court will need to look beyond the patent’s intrinsic

evidence and to consult extrinsic evidence in order to understand, for example, the background

science or the meaning ofa term in the relevant art during the relevant time period.” Teva Pharms.

USA, Ine, vy. Sandoz, Inc., 574 U.S. 318, 331 (2015). “Extrinsic evidence consists of all evidence

external to the patent and prosecution history, including expert and inventor testimony,

dictionaries, and learned treatises.” Marlonan, 52 F.3d at 980. However, “[i]n those cases where

the public record unambiguously describes the scope of the patented invention, reliance on any

extrinsic evidence is improper.” Vitronics Corp., 90 F.3d at 1583. “When an analysis of intrinsic

evidence resolves any ambiguity in a disputed claim term, it is improper to rely on extrinsic

evidence to contradict the meaning so ascertained.” Jniel Cerp. v. VIA Techs., Inc., 319 F.3d 1357,

1367 (Fed. Cir. 2003) (emphasis in original), “Extrinsic evidence [] cannot be used to alter a claim

construction dictated by a proper analysis of the intrinsic evidence.” On-Line Tech. v.

Bodenseewerk Perkin-Elier, 383 F.3d 1133, 1139 (Fed. Cir. 2004) (citations omitted),

Ill. CLAIM CONSTRUCTION

A. Preliminary Matters

The parties agree that the patents in suit share the same specification, (Tr. 15:25—-16:3,

60:1-60:5), and “originate from the same parent application,” (id. at 60:13; see also id. at 16:4—

10). The patents in suit also share the same inventors. (See ’580 Patent, at [75]; °683 Patent, at

[75]; °248 Patent, at [72]; °989 Patent, at [72]; 940 Patent, at [72]; Patent, at [72], *790 Patent,

at [72]). The parties also agree that, because the patents in suit are part of the same patent “family,”

the “prosecution history of related patents is relevant to all patents in that family.” (/d. at 16:46;

17:1-13; 59:25—60:11); see also Gemalto S.A. v. HTC Corp., 754 F.3d 1364, 1371 (Fed. Cir. 2014)

(“When multiple patents derive from the same initial application, the prosecution history regarding

acclaim limitation in any patent that has issued applies with equal force to subsequently issued

patents that contain the same claim limitation”) (quoting Elkay Mfg. Co. v. Ebco Mfg. Co., 192

F.3d 973, 980 (Fed. Cir. 1999)) (alteration removed). Accordingly, the Court uses prosecution

histories of other Trokendi patents, the °191 and ’576 Patents, in this claim construction.

The parties also agree that, while the disputed claim terms appear in multiple patent claims

within the patents in suit, their constructions should be uniform. (Tr. 17:14-22; 60:1-5.) Thus,

unless noted otherwise, the Court’s constructions of the disputed claim terms apply across the

patents in suit. See Omega Eng’g, Inc., 334 F.3d at 1334 (“[W]e presume, unless otherwise

compelled, that the same claim term in the same patent or related patents carries the same construed

meaning.”).

B. Person of Ordinary Skill in the Art

Claims are construed from the vantage point of a person of ordinary skill in the art

(“POSA”) at the time of the invention, Phillips, 415 F.3d at 1313. Before the Court construes the

claims in light of the specification, it must establish the level of skill that a POSA possessed at the

time of the invention. Supernus Pharms., Inc. v. Actavis Inc.,2016 WL 901837, at *2 (D.N.J. Mar.

9, 2016) (citing Voice Computing PLC y. Nuance Comme’ns, Inc., 504 F.3d 1236, 1240 (Fed.

Cir, 2007)), Here, Plaintiff provided the following definition for a POSA:

person of ordinary skill in the art here is someone in the 2006

time frame with at least a Bachelor of Science degree in

Pharmaceutical Sciences or a related field, approximately three to

five years of experience in drug delivery technology or a related

field, and working knowledge regarding pharmacokinetics (or a

person of commensurate education and experience).

(P1.’s Opening Br. 6, ECF No. 68.) At the Markman hearing, Defendants agreed to this definition.

(Tr. 6:22-7:3.) Accordingly, the Court defines a POSA according to the un-objected to definition

provided by Plaintiff, see Al/Voice Computing PLC, 504 F, 3d at 1240 (adopting one party’s POSA

definition where the other party “did not pose a different definition nor dispute the above

definition”), and construes the claims from the vantage point of this POSA.

C. Claim Construction

The parties dispute the construction of five “term groups.” (Defs.’ Opening Br. 11-28,

ECF No. 67; Pl.’s Opening Br. 6-15.) The Court examines each term group below,

1, Term Group No. 1: “Release(d}(s} Topiramate in a Continuous Manner” or

“Released... Continuously”

Claim Term | “Release topiramate in a continuous manner”

“Releases topiramate in a continuous manner”

“Released topiramate in a continuous manner”

“Released ... continuously”

Plaintiff's Requires no construction — plain and ordinary meaning

Proposed

Construction | “Release topiramate in a manner without interruption”

“Releases topiramate in a manner without interruption”

“Released topiramate in a manner without interruption”

“Released... without interruption”

9

Defendants’ | “Release topiramate without interruption, though the rate of release may be

Proposed variable”

Construction | “Releases topiramate without interruption, though the rate of release may be

variable”

“Released topiramate without interruption, though the rate of release may be

variable”

“Released topiramate without interruption, though the rate of release may be

variable”

Court's Requires no construction — plain and ordinary meaning

Construction

“Release topiramate in a manner without interruption”

“Releases topiramate in a manner without interruption”

“Released topiramate in a manner without interruption”

“Released .. . without interruption”

The above terms appear in the ’580 Patent, claims 1, 3-11, 13-17, 19-26, 28-30; the °248

Patent, claims 1-12, 14-20; the ’683 Patent, claims 1, 2, 4-15, 17-20, 23, 24; the °989 Patent,

claims 14, 18~-20; the Patent, claims 14, 18-20; and the Patent, claims 13, 17-29, (Joint

Prehr’g Stmt. Ex, A.) At the Markman hearing, Defendants agreed to “adopt [P]laintiff’s

construction for this; with the proviso that [Defendants] are not... waiving [their] argument that

the rate of release could be variable.” (Tr. 69:12-19.) Thus, the Court adopts Plaintiffs

construction and acknowledges that Defendants have not waived this argument. (Ud. at 70:5—8.)

2. Term Group No. 2: “Immediately and Continuously”

“Immediately and continuously”

Plaintiff's Requires no construction — plain and ordinary meaning

Proposed

Construction | “Without delay and without interruption”

Defendants’ | “Without delay and without interruption, though the rate of release may be

Proposed variable”

Construction

Court’s Requires no construction — plain and ordinary meaning

Construction

“Without delay and without interruption”

10

a. Parties’ Arguments

The parties agree that “immediately” means “without delay,” but dispute whether the

construction of “continuously” also requires the phrase, “though the release rate may be variable.”

Responsive Br, 10, ECF No. 77; Defs.’ Responsive Br. 9, ECF No. 76.) Plaintiff argues that

“continuous” means “without interruption” with no additional language because, during

prosecution of the ’191 Patent, the applicants stated that “continuous” means “simply ‘without

interruption.’” (P1.’s Opening Br. 8—9 (citing ’191 Patent, U.S. Appl. No. 12/926,936 (hereinafter,

‘°191 Patent Prosecution History”), Amendment and Reply under 37 C.F.R. § 1.116, Remarks 10

(Apr. 2, 2013)), Decl. of Richard F. Kurz in Support of PL.’s Opening Br. (“Kurz Deci.”) Ex. 2,

ECF No. 68-1.) The applicant also stated, “[t]he term ‘continuous’ does not define the amount of

drug release, only the manner in which it is released (7.e., “continuously”).” Ud. (citing 7191 Patent

Prosecution History, Remarks 10) (emphasis in original).) Thus, Plaintiff argues that “Defendants

cannot reasonably rely on these statements to add extraneous ‘variability’ concepts to the definition

of ‘continuous’ release.” (Id. at 9.)4

Defendants assert that the patentee’s “agreement” to the patent examiner’s statement,

term ‘continuous manner’ does not require the amount be release at any particular level;

only that there be some release,” (191 Patent Prosecution History, Remarks 10), acknowledged

that the rate of release may be variable, (see Defs.’ Opening Br. 12). Defendants further contend

‘ Plaintiff also points to extrinsic evidence, including dictionary definitions and the expert report

of Mansoor A. Khan, R.Ph., Ph.D., to support its proposed construction. (Ud at 7-8; see also

MERRIAM- WEBSTER’S COLLEGIATE DICTIONARY 270 (11th ed, 2004), Kurz Decl, Ex, 3, ECF No.

68-1; Opening Khan Decl.) At the Markman hearing, Plaintiff noted that the Court does not need

to rely on the extrinsic evidence to construe these terms. (Tr. at 11:20-25.) Thus, for this term

and the remaining terms, the Court dees not rely on extrinsic evidence because it finds the terms

clear based on intrinsic evidence alone. See Intel Corp., 319 F.3d at 1367.

11

that “[a] skilled artisan would be aware of at least the problems with achieving a zero-order release

rate (i.e., wherein the rate is not variable),” and “[p]rior art had disclosed the problem with

achieving a zero-order (non-variable) release rate.” (/d.; Defs.’ Responsive Br. 3-4.) Thus,

Defendants argue, “absent a clear claim element indicating that the claimed formulation has a

constant rate of release, the claims should be construed to account for and permit the variability

that was known in the prior art.” (Defs.’ Opening Br, 12 (citing Nat’? Oifwell Varco, LP. v. Auto-

Dril, Inc., Civ. No. 09-85, 2011 WL 3648532, at *17 (E.D. Tex. Aug. 16, 2011).)

b. Court’s Construction

The Court begins with the claim language. See Vitronics Corp., 90 F.3d at 1582. The term

“immediately and continuously” appears in the ’989 Patent, claims 14, 18-20; the °940 Patent,

claims 14, 18-20; and the °983 Patent, claims 13, 17-29, (Joint Prehr’g Stmt, Ex. A.) These

claims cover “sustained release formulation[s} of topiramate,” where the topiramate “is released

immediately and continuously ... ,” as well as methods to administer these formulations, (989

Patent col, 21 1, 1-35, col, 22 1. 22-col. 23 |, 7; °940 Patent col. 21 |. 59-col. 22 1. 27, col. 23 1.

14-col, 24 1, 33; °983 Patent col. 21 1. 32-67, col. 22 |. 55—col. 24 1, 44) (disputed term bolded).)

The parties’ agreed upon construction of “immediately” as “without delay” is consistent

with the plain language of the claims and the prosecution history of the °576 Patent. In the

prosecution history, the applicants distinguished their invention from the prior art by stating that

claim invention, by contrast, does not delay release of topiramate, but rather extends the

duration of its release. In other words, according to the present invention, the release of topiramate

starts immediately upon administration...” (576 Patent, U.S. Appl. No. 11/941,475 (hereinafter,

Patent Prosecution History”), Amendment and Reply under 37 C.F.R. § 1.111, Applicant

Remarks 28 (July 27, 2010), Decl. of Joseph H. Kim in Support of Defs.’? Opening Br. (“Kim

12 .

Decl.”) Ex. 2, ECF No. 67-3 (emphasis in original),) Accordingly, the Court agrees with the parties

that “immediately” means “without delay.”

Turning to “continuously,” the Court agrees with Plaintiff that “continuously” means

“without interruption.” The claims themselves do not indicate that “continuously” should include

the phrase “though the rate of release may be variable;” they state only that the “topiramate” is

released “immediately and continuously.” (Z.g., °989 Patent col. 21 1. 1-35.)

Next, Defendants argue that the specification demonstrates that the rate of release can be

variable. (Defs.’? Responsive Br. 4-5.) They point to an embodiment where there is an

“instantaneous” dissolution of topiramate from the outside coating of a capsule, followed by a

“sustained release” of the rest of the topiramate from the inside coating of the capsule. (See 7580

Patent col. 11 L 8-12.) However, while this embodiment teaches a particular embodiment of the

overall invention, it does not further explain or define the meaning of the word “continuously.”

(See col. 10 1. 65—col. 11 1. 13.) The “Definitions” section does not include the term “continuous”

or “continuously,” (see id. col. 3 1, 30-col. 4 1. 43), and the specification does not otherwise define

this term, (see generally id). Thus, nothing in the specification “intentionally disclaim[s] or

disavow[s] claim scope,” as is required for the Court to adopt a construction outside of the plain

and ordinary meaning of a term. See Aventis Pharms. Inc., 715 F.3d at 1373; see also Texas

lastruments Inc. y. U.S. Int’l Trade Comm’n, 988 F.2d 1165, 1171 (Fed. Cir, 1993) (“Courts can

neither broaden nor narrow claims to give the patentee something different than what he has set

forth.”) (quoting Autogiro Co. of Am. v. United States, 384 F.2d 391, 396 (Ct. Cl. 1967)) (alteration

omitted).

Further, the prosecution history supports Plaintiff's construction, In the prosecution of the

°191 Patent, the patentee noted that “continuous” meant “simply” “without interruption.” (191

13

Patent Prosecution History, Remarks 10 (emphasis added).) Defendants’ argument about the

prosecution history, that the patentee’s agreement to the statement, “[t]he term ‘continuous

manner’ does not require the amount be released at any particular level; only that there be some

release,” means that “continuous” includes the “variable rate of release” language, is unpersuasive.

(See Defs.” Opening Br. 12.) When read in context, the patentee further stated that “[t]he term

‘continuous’ does not define the amount of drug release, only the manner in which it is released

“continuously”). (191 Patent Prosecution History, Remarks 10 (emphasis in original).) The

latter statement supports Plaintiff's construction — specifically that the “amount of drug release”

is a function of the “rate of release,’ and it does not refer to the manner in which it is released,

. which is “continuous,”

Thus, the construction of “continuously” as “without interruption” needs no further

construction because its plain and ordinary meaning is clear, and nothing “clearly stated in the

patent specification or file history” demonstrates that the patentee intended to “use [this term] in a

manner other than fits] ordinary meaning.” See Vitronics Corp., 90 F.3d at 1582.

Finally, the Court notes that, like the parties’ resolution with “release topiramate in a

continuous manner,” Defendants have not waived their argument that the release rate may be

variable, see supra III.C.1, as this may be relevant in determining infringement, see Lazare Kaplan

Int'l, Inc. v. Photoscribe Techs., Inc., 628 F.3d 1359, 1376 (Fed. Cir. 2010); Biotec Biclogische

Naturverpackungen GmbH & Co. KG v. Biocorp, Inc., 249 F.3d 1341, 1349 (Fed. Cir. 2001). The

Court does not decide this at the claim construction stage, however, where the Court “should not

The shared specification of the patents in suit defines “rate of release” or “release rate” as a

function of “the quantity of drug released from a dosage form per unit time, e.g., milligrams of

drug released per hour (mg/hr) or a percentage of a total drug dose released per hour.” (580 Patent

col. 3 1. 53-57.)

14

resolve questions that do not go to claim scope, but instead go to infringement.” Kon Corp, IP

Holdings LLC y. Silver Spring Networks, Inc., 815 F.3d 1314, 1319 (Fed. Cir. 2016). Thus, any

disputes regarding whether certain processes (e.g., those with or without variable rates of releases)

are “continuous” are appropriately submitted to the finder of fact at the infringement stage. See

Biotech, 249 F.3d at 1349 (rejecting the argument that “the district court ‘failed to discharge its

duty under Markman’ when the court declined to construe ‘melting’” because the “issue in dispute

was the application of the melting step in the accused process, a factual question of infringement”);

Lazare, 628 F.3d at 1375-76 (rejecting the argument that the district court failed to construe the

scope of the term “positional accuracy of placement” because “the parties did not dispute the

construction of the claim but rather the proper test to determine infringement, which is a factual

question appropriate for the jury”).

3, Term Group No. 3: “Immediate Release”

“Immediate release”

Plaintiff's Requires no construction — plain and ordinary meaning

Proposed

Construction | “Releases greater than or equal to about 80% of the pharmaceutical agent in less

than or equal to about | hour”

Defendants’ | “Characterized by measured reiease of topiramate without delay and release of

Proposed 80% or more of the topiramate contained in the immediate release component

Construction | within 1 hour”

Court’s “Releases greater than or equal to about 80% of the pharmaceutical agent in less

Construction | than or equal to about 1 hour”

a. Parties’ Arguments

Plaintiff asserts that “[t]he specification expressly defines ‘immediate release

formulation’” and “[t]his explicit definition controls.” (PI.’s Opening Br. 9-10 (citing Martek

6 In their original submissions, Defendants’ proposed construction also included “after

administration of the dosage form” after “within 1 hour.” (See Joint Prehr’g Stmt. Ex. A.) At the

Markman hearing, the parties agreed that Defendants would remove this phrase from their

proposed construction, (Tr. 70:22—72;10,)

15

Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1381 (Fed. Cir. 2009)).) According to

Plaintiff, “for Defendants to so drastically narrow the scope of ‘immediate release’—an

unambiguous term explicitly defined in the specification—they would have to identify

‘disavowing actions or statements made during prosecution [that are] both clear and

unmistakable,” (Pl.’s Responsive Br. 6 (quoting Omega Eng’g, Inc., 334 F.3d at 1325-26)

(alteration in original).)

Defendants assert that Plaintiffs construction “can inform, but it’s not a verbatim

construction or definition,” (Tr, 73:16-18; see also Defs.’ Responsive Br. 6), because it relies on

the definition for “immediate release formulation,” but here, the term refers to “immediate release

component(s).” (Defs.’ Opening Br. 13-14 (emphases added).) Defendants propose the following

modifications to Plaintiff's proposed construction:

First, Defendants argue that including “without delay” will clarify when the “immediate

release component [is] being administered,” (See Tr. 72:17-20; Defs.’ Opening Br. 14 (citing □□□□

Patent Prosecution History, Applicant Remarks 28 and °580 Patent col. 11 1, 4-12), and make the

construction of “immediate” in “immediate release” consistent with “immediately” in

“immediately and continuously,” (see supra I1.C.2; Tr. 77:11—78:4.)

Second, Defendants assert that the construction of “immediate release” should specify that

the “pharmaceutical agent” is “topiramate contained in the immediate release component.” (Dets.’

Opening Br, 15-18.) Defendants argue that the intrinsic evidence shows that “immediate release”

refers to the “immediate release of a topiramate-containing component.” (See Defs,’ Opening Br.

17-18.) Defendants cite the claims themselves (id at 16-17), which refer to the “immediate

release” component as “topiramate-containing,” (°580 Patent col. 20 1, 26-27; °248 Patent col. 20

1. 23-24; °989 Patent col. 21 1. 9-10; °940 Patent col. 22 1.12; ’983 Patent col. 21 1. 41-42; °790

16

Patent col 20 |. 44~45), or as having “topiramate contained therein,” (683 Patent col. 20 1. 30—

32). Defendants also cite the specification and prosecution history, which refer to “immediate

release topiramate-containing component[s].” (Defs.’ Opening Br. 17-18 (citing °580 Patent col.

1 1. 15-46 and °576 Patent Prosecution History, Amendment and Reply under 37 C.F.R. § L114,

Applicant Remarks 22-23 (Mar. 28, 2011), Kim Decl. Ex. 3, ECF No. 67-4 and ’191 Patent

Prosecution History, As-Filed Specification { [0021] (Dec, 17, 2010), Kim Decl. Ex. 14, ECF No.

67-15).)

Third, Defendants argue that the term “immediate release” requires the topiramate to be

released “within one hour,” not “less than or equal to about one hour.” (Ud. at 18.) Defendants

argue that, because the patentee “chose not to include ‘about’ as a qualifier to the descriptions of

the IR component release profiles while including it as a qualifier to the descriptions of the XR

component release profiles,” the patentee did not want “about” to modify the immediate release

component release profiles. (/d. at 19.)’

b. Court’s Construction

This term appears in the patents in suit as an “immediate release” component in a

“sustained release formulation.” The term appears in the ’580 Patent, claims 1, 3-11, 13-17, 19-

26, 28-30; the °683 Patent, claims 1-2, 4-15, 17-20, 23-24; the ’248 Patent, claims 1-12, 14-20;

the °989 Patent, claims 14, 18—20; the °940 Patent, claims 14, 18-20; the Patent, claims 13,

17-29; and the ’790 Patent, claims 1-10, 12-24. (Joint Prehr’g Stmt. Ex. A.) Specifically, the

term appears in claims covering sustained release formulations comprising an extended release

? Defendants also include in their proposed claim construction that “immediate release” is

“characterized by measured release of topiramate ....” (See Joint Prehr’g Stmt. Ex. A.) However,

their briefs do not explain what they mean by “measured release” and how this language is

necessary in the construction of “immediate release.” (See generally Defs.” Opening Br.; Defs.’

Responsive Br.) Thus, the Court does not consider this in Defendants’ proposed construction.

17

topiramate-containing component or components and optionally, “an immediate release (IR)

topiramate containing component,” (see ’580 Patent col. 20 1, 25-27; ’248 Patent col. 20 |. 22-24;

°989 Patent col, 21 1, 810; °946 Patent col, 21 167-col. 22 1, 2; °983 Patent col. 21 1. 40-42; °790

Patent col 20 1, 43-45) (disputed term bolded), or non-optionaily, “an immediate release (IR)

component, wherein 80% of the topiramate contained therein is released in vitro in not more than

| hour,” (see 7683 Patent col. 20 1. 30-32 (disputed term bolded).)

The specification defines “immediate release formulation” as “a formulation that releases

greater than or equal to about 80% of the pharmaceutical agent in less than or equal to about 1

hour.” (580 Patent col. 3 1. 33-35.)

The Court adopts Plaintiff's construction and finds the specification’s definition of

“immediate release formulation” instructive to construe “iminediate release.” First, there is a

presumption “that the same phrase in different claims of the same patent should have the same

meaning... , overcome only if ‘it is clear’ that the same phrase has different meanings in different

claims.” Jn re Varma, 816 F.3d 1352, 1363 (Fed. Cir, 2016) (quoting Fin Control Sytems Pty, Ltd.

OAM, Inc., 265 F.3d 1311, 1318 (Fed. Cir. 2001). Here, Defendants have not pointed to a

reason why “immediate release” should have different meanings for “immediate release

formulation” and “immediate release components.” See id, at 1363-64. Rather, at the Markman

hearing, Defendants agreed that “immediate release” is its own term of art in the industry and agree

that it “requires a release profile where at least 80% is released within one hour,” (See Tr. 38:4—

14, 76:18-77:3; Defs.’ Opening Br. 14.)

Second, the definition of “sustained release” is helpful in construing “immediate release.”

The specification defines “sustained release” as “release of a pharmaceutical agent in a continuous

manner over a prolonged period of time.” (580 Patent col, 3 1. 44-46.) By comparison, it defines

18

“immediate release formulation” as “a formulation that releases greater than or equal to about 80%

of the pharmaceutical agent in less than or equal to one hour,” (id, col. 3 1. 33-35). Comparing

these definitions shows that the specification describes the type of release (“immediate” or

“sustained”) in the same terms: by how the “pharmaceutical agent” is released over a specified

period of time. (See id. col. 3 1. 33-35, 44-46.)

Third, the phrases that Defendants propose to be inserted in the construction of “immediate

release” are not supported by the claims, specification, or prosecution history. The Court will not

construe “immediate release” to include the phrase “without delay” for the purpose of being

consistent with the construction of “immediately and continuously.” (See supra IILC.2.b.) While

“the same claim term in the same patent or related patents carries the same construed meaning,”

Omega Eng’g, Inc., 334 F.3d at 1334, here, “immediately” in the context of “immediately and

continuously” and “immediate release” is not the same claim term. As noted above, the parties

agree that “immediate release,” is a term of art in the industry, distinct from the term “immediately

and continuously.” (See Tr. 38:4~14, 76:18-77:3.) Further, the terms “immediate release” and

“immediately and continuously” are used in different contexts within the claims. “Immediately

and continuously” appears in the claim preamble to describe how the “sustained release

formulation” is released, (see, ¢.g., °989 Patent col. 19 1. 41), while “immediate release” describes

“topiramate-containing component(s)” contained in the sustained release formulation, (fd. col. 19

1, 47-48). Recognizing that, in construing a claim, a POSA is deemed to read the term in the

context of the claim it appears, see Bradium Techs. LLC v. lancu, 923 F.3d 1032, 1042-43 (Fed.

Cir, 2019) (citing Phillips, 415 F.3d at 1313), the different contexts of “immediate release” and

“immediately and continuously” further demonstrate that these are two distinct terms, see, □□□□□

Comaper Corp. v. Antec, Inc., 596 F.3d 1343, 1348-49 (Fed. Cir. 2010) (construing “drive bay”

19

and “drive bay slot” as two distinct terms, based on “the intrinsic evidence support[ing] . . . that

‘drive bay’ and ‘drive bay slot’ have different meanings”), Thus, despite including the term

“without delay” in the construction of “immediately and continuously,” the Court will not do so

here absent a clear intention that the patentee intended to include this limiting phrase to the term

“immediate release.” See Aventis Pharms. Inc., 715 F.3d at 1373.

Additionally, the Court rejects Defendants’ argument to remove the term “about” from the

definition, which would “narrow [the] claims to give the patentee something different than what

he has set forth.” See Texas Instruments Inc., 988 F.2d at 1171 (citation omitted). The

specification clearly states that the term “about” “account[s] for variations, which can arise from

inaccuracies in measurement inherent and understood by those of ordinary skill in the chemical

and pharmaceutical arts.” (°580 Patent, col. 61. 25-29.) Accordingly, where the patent states how

a POSA would understand the term “about,” no further construction of this term is needed. See

Merck & Co., Inc, v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1369-70 (Fed, Cir. 2005) (noting

that “about” should be given its plain meaning of “approximately” unless clearly defined otherwise

in the specification).

Further, the Court rejects Defendants’ argument that “pharmaceutical agent” should be

replaced with “the topiramate contained in the immediate release component.” (See Defs.’

Opening Br. 16-18.) The claims and the specification both state that the immediate release

components may include other agents in addition to topiramate. (#.g., °580 Patent col. 20 1, 25—

49 (describing claim 1, which states that the “immediate release (IR) topiramate containing

component compris[es] ...a complexing agent... and/or an enhancing agent... .”); °248 Patent

col. 20 1. 25-46 (stating the same); °580 Patent col. 8 1, 14-28 (in describing the “topiramate-

containing beads of the present invention,” noting, “[t]he beads may further comprise other

20

pharmaceutically active agents suitable for use in combination with topiramate for treatment or

prevention of a pathological condition”); id. col. 9 1. 46—51 (describing an embodiment where an

“FIR fenhanced immediate release] composition comprises a highly soluble complex of topiramate

with a complexing agent that is represented by, but not limited to, cyclodextrins . ..”); id. col. 17

1. 2-col. 18 1. 21 (describing examples 3 and 4, where topiramate enhanced immediate release

beads contain “non-complexing enhancers” and “micronized particles”), Thus, Defendants’

proposed construction would limit the scope of “immediate release” to specify that “topiramate”

is released, when the claims and specification indicate that other agents may also be released. The

Court will not construe this term so narrowly, See Aventis Pharms. Inc., 715 F.3d at 1373.

Finally, to specify “topiramate” instead of “pharmaceutical agent” would render the

remaining words in the claims redundant. The claims themselves already include a phrase to

clarify that the “release” refers to “the topiramate contained therein,” (e¢.g., °683 Patent col. 20 I.

30-32), or “an immediate release (IR) topiramate containing component... wherein all of the

components release topiramate in a continuous manner... ,” (¢.g., 580 Patent, col. 20 |. 26-27,

50-51). Thus, where the claims specifically refer to the “release” of the “topiramate containing

component,” or the “topiramate contained therein,” the Court does not need to construe the term

“immediate release” to also include that reference. See Merck, 395 F.3d at 1372 (noting that a

“claim construction that gives meaning to all terms of the claim is preferred over one that does not

do so”). Accordingly, the Court adopts Plaintiff's proposed construction of “immediate release.”

21

4, Term Group No, 4: “Extended Release (XR) Component(s)” and “Extended

Release Topiramate-Containing Component(s)”

Claim Terms | “Extended release (XR) component” or “extended release component”

“Extended release (XR) topiramate-containing component(s)” or “extended

release topiramate-containing component(s)”

Plaintiff's Requires no construction — plain and ordinary meaning

Proposed

Construction | “A component that releases pharmaceutical agent over a prolonged period of

time”

“A component or components that release topiramate over a prolonged period

of time”

Defendants’ ; “An extended release topiramate-containing component which is not an

Proposed immediate release component”

Construction

Court’s “A component that releases topiramate in a continuous manner and is adjusted

Construction | in such a way that 80% of the active ingredient is released in vitro in the

redetermined period of time”

a. Parties’ Arguments

Plaintiff argues that the prosecution history and specification support its construction that

“extended release component” means “a component that releases a pharmaceutical agent over a

prolonged period of time.” (P1.’s Opening Br. 12-14.) During prosecution, the applicants told the

Patent Offtce that “‘[e]xtended’ release formulations release drug in vivo over a prolonged period

of time (e.g., greater than 4, 12, 16, or even 24 hours) measured from administration,” (191 Patent

Prosecution History, Amendment and Reply under 37 C.F.R. § 1.116, Remarks 9 (Mar. 6, 2013),

Kurz Decl. Ex. 5), and that “‘extended release’ coatings comprise ‘extended release’ polymers,

which are designed to dissolve over an ‘extended’ period at a relatively constant rate,” (°576 Patent

Prosecution History, Amendment and Reply Under 37 C.F.R. § 1.111, Remarks 28 n.2 (July 27,

2010), Kurz Decl, Ex. 6). (See Pl.’s Opening Br. 12-13; Pl.’s Responsive Br. 12.) Plaintiff asserts

that these remarks “clearly convey to a POSA that ‘extended release’ means release over an

extended or prolonged period of time,” (Pl.’s Opening Br. 13.)

22

Defendants argue that their construction of “extended release component” is appropriate

because “immediate release components” and “extended release components” “are distinct from

one another.” (Defs.’ Opening Br. 21-24.) Defendants further assert that, under Plaintiffs

construction, “a single component could be both an XR component and an IR component as long

as the component releases topiramate over a span of time greater than an hour,” e.g., “a drug

product with a topiramate component that continuously releases 99% of the component within the

first fifteen minutes and the remaining 1% of the component over the next five hours would be

both an IR component and an XR component under Plaintiff's proposed construction.” (id. at 24.)

b. Court’s Construction

Beginning with the claim language, the terms “extended release” or “XR” components

appear in the seven of the patents in suit as “extended release” components that comprise “[a]

sustained release formulation of topiramate comprising topiramate as an active ingredient... .”

Patent col. 20 I. 15-25; °790 Patent col. 20 1. 36-40; ’248 Patent col. 201, 15-20; °989 Patent

col, 21 1. 1-6; 983 Patent col. 21 1. 32-38; see also °683 Patent col. 20 1. 20-29; *940 Patent col.

21 1. 59-65.) In the °580, °683, and °248 Patents, the “XR component [or components] releases

lor release] the topiramate contained therein such that greater than or equal to about 80% of the

topiramate is released in vitro in less than or equal to about 4 hours,” (580 Patent col, 20 1, 50—

54; see also °683 Patent col. 20 1. 26-29; °248 Patent col. 20 1, 47-50), or such that “greater than

or equal to about 80% of the topiramate is released in vitro in less than or equal to about 12 hours,”

Patent col. 22 1. 14-16). In the °989, °940, and ’983 Patents, the “XR component exhibits

vitro” rate of drug release is the typical way to measure drug release rates. (580 Patent col.

3 1. 58-59.) “In vitro” refers to “a quantity of drug release from the dosage form per unit time

measured under appropriate conditions and in a suitable fluid.” (/d. col, 3 1. 58-60.)

23

a maximum plasma concentration of topiramate in vivo at 16 or more hours after a single initial

dose.” (989 Patent col. 21 1. 33-35, col. 22 |. 67-col. 23 L. 3; °940 Patent col. 22 |. 25-27, col. 24

1, 25-28; °983 Patent col. 21 1, 65-67, col. 23 1. 32-35.) In the ’790 Patent, “the formulation

exhibits an in vivo steady state maximum plasma concentration of topiramate at 3 or more hours

after administration.” (°790 Patent col. 21 1. 1-3, col, 22 [. 20-23.)

The claim language alone does not provide a clear meaning of the term “extended release

component,” so the Court looks to the specification, See Phillips, 415 F.3d at 1315, The patent is

entitled “Sustained-Release Formulations of Topiramate,” and is characterized by the “sustained

release” of topiramate along a “pre-determined release profile.” (°580 Patent col. 2 1. 6-10.) The

“sustained release” distinguishes the Trokendi patents from Topamax, an “immediate release

formulation” where the “topiramate is rapidly absorbed with plasma drug concentrations peaking

in approximately 2 hours.” (See °380 Patent col, 1 1.31, col. 5 |. 2447.) The sustained release is

“achieved by incorporation into the formulation of an extended release component (XR) and an

optional immediate release component (IR).” (Id. col. 6 1. 9-17.) Extended release components

appear in all of the Trokendi patents, both asserted and not asserted, and, unlike immediate release

components, are not optional. (See generally °580 Patent; °683 Patent; °248 Patent; *989 Patent;

Patent; °983 Patent; °790 Patent; °004 Patent; ’°191 Patent; °576 Patent.) Thus, the extended

release components are key to achieving the “sustained release formulations of topiramate”

covered by the Trokendi patents.

The amount of cach component CXR and IR) is “determined according to the purpose of

administration and a pre-determined release profile.” (’580 Patent col. 6 |. 18-22.) The “pre-

? Unlike “in vitro,” which measures the quantity of drug release per unit of time in a controlled

setting, an “in vivo” measurement is based on quantity of topiramate in the human body, measured

by blood plasma concentration. (See °580 Patent col. 5 1. 19-47; see also Tr. 35:14-17.)

24

determined release profile” differs according to the purpose of the administration. (See id. col, 2

1. 46-58.) For example, “when a fast onset of action followed by sustained release is preferred,

as... in the cases of a breakthrough migraine episode,” a dosage form may include an immediate

release topiramate formulation “coating on the outside [of] a capsule that contains within it other

populations of topiramate such as extended release topiramate.” (/d. col. 11 1. 4-24.)

The specification provides a meaning for “XR component.” It states that “[t]he XR

component of the formulation of the present invention releases topiramate in a continuous manner

and is adjusted in such a way that 80% of the active ingredient is released in vitro in the —

predetermined period of time.” (/d. col. 6 L 30-33.)

The Court construes. “extended release component” to mean, as stated expressly in the

specification, a component that “releases topiramate in a continuous manner and is adjusted in

such a way that 80% of the active ingredient is released in vitro in the predetermined period of

time.” (Ud. col. 6 I. 30-33.) The “predetermined period of time” refers to the period of time

necessary to achieve the “predetermined release profile” for the particular “sustained release”

formulation, (See id. col. 2 |. 46-58, col. 11 1. 4-24.)

This construction is consistent with the sentence following the definition for “XR

component,” which states, “[b]y way of example, and by no means limiting the scope of the

invention, the period of time may be not more than 24 hours, not more than 16 hours, not more

than 12 hours, not more than 8 hours, or not more than 4 hours, depending on desired attributes of

the final product.” (Cd. col. 6 |, 34-38.) This construction also allows, as the specification and

claims contemplate, the “predetermined release profile” to differ based on the purpose of the

25

dosage administration. (See, ¢.g., 580 Patent col. 20 1. 50-54; ’248 Patent col, 22 1. 15-16; 580

Patent col. 11 1. 4-24,)!°

The Court does not adopt either Plaintiff's or Defendants’ constructions, both which

overlook the specification language describing “XR component,” Plaintiff’s construction

broadens the meaning of the term by removing language included in this description. (See □□□□

Patent col, 6 1, 30-33; Pl.’s Opening Br, 12-14); see also Nat’! Oilwell Varco, 2011 WL 3648532,

at *4 (rejecting construction that is an “improper attempt to broaden the claim”).

The Court also rejects Defendants’ proposed construction, which seeks to construe

“extended release component” as the inverse of “immediate release component.” A “negative

limitation” must be supported by the words of the claims, or “any express disclaimer or

independent lexicography in the written description that would justify adding that negative

limitation.” Omega Eng’g, Inc., 334 F.3d at 1323; see also Santarus, Inc. y. Par Pharm, Ine., 694

F.3d 1344, 1350-51 (Fed, Cir. 2012) (construing a claim to have a limitation that a particular

composition “contain[ed] no sucralfate,” where the claim language stated so and which was

supported by the specification “expressly list[ed] the disadvantages of using sucralfate”), Unlike

in Santarus, where the claim expressly included the negative limitation and the specification

repeatedly supported that limitation, 694 F.3d at 1350-51, here, the claim language and the

specification do not indicate that an “extended release component” should be defined as “not an

immediate release component,” as Defendants assert, (Defs.’ Opening Br. 20).

The Court does not reach the prosecution history for this term because the meaning of this term

is clear based on the claim language and specification. See Chiesi USA, Inc. y. Aurobindo Pharma

USA, Inc., Civ. No, 19-18756, 2021 WL 4860327, at *6 (D.N.J. Oct. 19, 2021) (declining to

consider the prosecution history, determining that “the statements made during prosecution do not

overcome the weight of the specification’s repeated descriptions of the invention . . .”).

26

The Court notes (and Plaintiff does not dispute) that the intrinsic evidence indicates that

“extended release” and “immediate release” components are different from each other. (See Tr.

45:17-21, 47:14.) These differences, however, do not justify importing a negative limitation into

the construction of “extended release component,” particularly where the intrinsic evidence

provides an affirmative description of this term. See Intel Corp. v. Qualconm Inc., 21 F.Ath 801,

812 (Fed. Cir. 2021) (noting that, before construing a claim with an “entirely [] negative”

construction, the Patent Trademark Appeals Board should conduct a “substance-focused analysis”

of the intrinsic evidence, “which seem[ed] likely to support an affirmative construction in place of

the Board’s purely negative one”). Thus, rather than define “extended release component” as the

inverse of “immediate release component,” the Court consttues “extended release component”

based on definition included in the written description.

5. Term Group No. 5: “A Coating Material Selected from the Group

Consisting of Cellulosic Polymers and Acrylic Polymers” and “Comprising

a Coating Material Selected _from the Group Consisting of Cellulosic

Polymers and Acrylic Polymers”

Claim Term | “A coating material selected from the group consisting of cellulosic polymers

and acrylic polymers”

“Comprising a coating material selected from the group consisting of cellulosic

polymers and acrylic polymers”

Plaintiff's Requires no construction — plain and ordinary meaning

Proposed

Construction | “A coating material selected from the group consisting of cellulosic polymers

and acrylic polymers”

“Comprising a coating material selected from the group consisting of

cellulosic polymers and acrylic polymers”

Defendants’ | “A coating material for each extended release component selected from the

Proposed group consisting of cellulosic polymers and acrylic polymers”

Construction

“Comprising a coating material for each extended release component selected

from the group consisting of cellulosic polymers and acrylic polymers”

Court’s "248, °989, *940, °983, and ’790 Patents: Requires no construction — plain and

Construction | ordinary meaning

27

and comprising a coating material selected from the group consisting of

cellulosic polymers and acrylic polymers” shall be construed as: “a release

controlling coating that is both specific for its component and also comprising a

coating material selected from the group consisting of cellulosic polymers and

acrylic polymers”

a. Parties’ Arguments

The principal disagreement is whether, in claims that have “at least two” extended release

components, eaci extended release component must have “a coating material selected from the

group consisting of cellulosic polymers and acrylic polymers.” (Pl.’s Opening Br. 15-16, Defs.’

Opening Br. 26-28.) Plaintiff argues that the plain language of the claims “does not specify or

require that ‘each component’ comprise the recited cellulosic and acrylic polymers,” and that, “[i]f -

the applicants wanted to include that requirement, they would have explicitly said so in the claim

itself” (P1.’s Opening Br. 16.) Plaintiff contends that the plain language of the claims “dictates

that the requirements for a release controlling coating and for the recited polymers are separate

requirements.” (dd)

Defendants argue that a “skilled artisan would understand the claims reciting two XR

components to describe two XR components that each have a coating material consisting of a

cellulosic polymer or an acrylic polymer.” (Defs.’ Opening Br. 27.) Defendants contend that

“[t]he independent claims reciting the disputed claim terms reference them in the context of an XR

component,” and thus, the “XR component(s) [] comprise the coating material consisting of

cellulosic polymers and acrylic polymers.” (/d. (citing *580 Patent, claim 1; °248 Patent, claim 1;

Patent, claim 14; °940 Patent, claim 14; °983 Patent, claim 13; and ’790 Patent, claim 1).)

Defendants further argue that the prosecution history, where applicants distinguished their patents

from the prior art based on the XR components being “coated with a release controlling coating

specific for its population,” further supports their construction. (Ud. at 27-28 (citing °576 Patent

28

Prosecution History, Amendment and Reply under 37 C.F.R. § 1.111, Applicant Remarks 27 (July

27, 2010) (emphasis in original).)

b, Court’s Construction

This term appears in several contexts in the asserted patents. The ’580 Patent claims “at

least two different extended release topiramate-containing components, wherein each component

comprises a release controlling coating specific for its component and comprising a coating

material selected from the group consisting of cellulosic polymers and acrylie polymers... .”

(580 Patent col. 20 1. 20-25 (disputed term bolded).)

The °248, °989, °940, and °983 Patents claim “an extended release (XR) topiramate-

containing component, comprising a coating material selected from the group consisting of

cellulosic polymers and acrylic polymers ....” (°248 Patent col. 20 L. 19-50; °989 Patent col,

21 1. 5-8, col. 22 1, 38-col 23 1. 3; °940 Patent col. 21 1. 64-67, col. 23 1. 31-34; ’983 Patent col.

21 1. 37-40 (disputed term bolded).)

The ’790 Patent claims “at least two extended release (XR) topiramate-containing

components, wherein each component comprises a coating material selected from the group

consisting of cellulosic polymers and acrylic polymers ....” (°790 Patent col, 20 1. 39-43

(disputed term bolded).)

The principal dispute is whether each extended release component in the asserted claims

must contain the specified coating. (Defs.’ Opening Br. 26-28; Pl.’s Opening Br. 15-16.) This

construction is necessary only for the ’580 Patent because the claim language in the other asserted

patents is clear that each extended release component must comprise the coating. The °248, °989,

"940, and *983 Patents claim only one extended release component, and thus, the phrase

“comprising a coating material selected from the group consisting of cellulosic polymers and

29

acrylic polymers” can only apply to that component. (E.g., 983 Patent col, 21 1. 37-40.) The

plain language of the Patent is also clear on this point, because it claims “at least two extended

release (XR) topiramate-containing components, wherein each component comprises a coating

material selected from the group consisting of cellulosic polymers and acrylic polymers.” (°790

Patent col, 20 1, 39-43 (emphasis added).) Thus, the plain language of the claims in the 248, *989,

°983, and °790 Patents is unambiguous that each of the extended release components claimed

contains the specified coating, In the context of these patents, no further construction is necessary,

and the plain meaning of this phrase governs the meaning of the disputed term.

The Court turns to the’580 Patent, which claims “at least two extended release topiramate-

containing components, wherein each component comprises a release controlling coating specific

for its component and comprising a coating material selected from the group consisting of

cellulosic polymers and acrylic polymers,” (°580 Patent col. 20 1. 20-25.) For the following

reasons, the Court determines that the disputed phrase applies to each extended release component,

First, the most natural reading of the claim language is that the “release controlling coating”

is modified by both the phrase “specific for its component” and also the phrase “comprising a

coating material selected from the group consisting of cellulosic polymers and acrylic polymers.”

The “and” is a conjunctive article that links the phrases together as requirements for the “release

controlling coating.” See Medgraph, Inc. v. Medtronic, Inc., 843 F.3d 942, 949-50 (Fed. Cir.

2016) (noting that, unless the specification indicates otherwise, the use of the term “and” is

conjunctive).

Second, the Court rejects Plaintiff's proposed construction because it renders the disputed

phrase superfluous, See Wasica Finance GmbH v. Continental Automotive Systems, Inc., 853 F.3d

1272, 1288 n,10 (Fed. Cir. 2017) (“It is highly disfavored to construe terms in a way that renders

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them void, meaningless, or superfluous.”) Plaintiff argues that the claim does not specify that

““each component’ comprise the recited cellulosic and acrylic polymers,” and that, “Tif the

applicants wanted to include that requirement, they would have explicitly said so in the claim

itself.” (P1.’s Opening Br. 16.) Plaintiff does not explain why this phrase is in the claim if it is not

a “requirement” for each component. If the patentee wanted the coating to be “optional,” they

would have said so, as they did for other optional components. (E. g., °580 Patent col. 20 1. 25

(stating that the immediate release component was “optional”).) Similarly, if the patentee wanted

the coating to apply to only one of the extended release components, they would have said so, as

they did in other claims. (See, e.g., °580 Patent col. 20 1. 58-63 (in a claim dependent on claim 1,

stating that “at least one of the two XR components further comprises a binder ,. .”) Thus, looking

to both the independent and dependent claims, Plaintiffs proposed construction renders the

disputed phrase superfluous, Seé Jnnova/Pure Water, Inc. v. Safari Water Filtration Syps., dne., 381

F.3d 1111, 1119 (Ped. Cir. 2004) (noting that all terms in a claim should be given meaning).

Third, the specification supports the Court’s construction that the disputed term modifies

“release controlling coating.” The specification states that a “release controlling coating” is “a

coating that modifies and controls the release of topiramate from the beads,” (See ’580 Patent col.

6 I. 39-42), where the “beads” include “any structural units that may be incorporated into an oral

dosage form,” (id. col. 4 1, 40-43). The release controlling coating is “population-specific in the

sense that the rate of release of topiramate from every bead population is controlled by at least one

parameter of the release controlling coating.” (/d. col. 7 1. 13-17.) The specification also

contemplates the inclusion of cellulosic and acrylic polymers in the coating, stating, “[t]he coating

material is preferably selected from a group comprising cellulosic polymers, such as [lists

examples]; polyvinyl alcohol; acrylic polymers such as [lists examples], and other water-based or

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solvent-based coating materials.” (Jd. col. 7 1, 6-13.) Thus, reading the claims in light of the

specification, see Phillips, 415 F.3d at 1315, it makes sense to construe the “release controlling

coating” in the ’580 Patent as both (1) “specific for its component” (because the ’580 Patent

includes multiple extended release components, (see id, col. 20 1. 20-21, 50-54)); and also (2)

“comprising a coating material selected from the group consisting of cellulosic polymers and

acrylic polymers” (because the specification teaches that the release controlling coating may

include these polymers, (see id. col. 7 1, 6-13)).!! This construction also makes the 7580 Patent

consistent with the other patents in suit that require each XR component to comprise the specified

“release controlling coating.” (E.g.,°248 Patent col. 20 1. 19-22, col, 21 1. 37-40; °989 Patent col.

21 1. 5-8, col. 22 1. 38-41; °940 Patent col. 21 I. 64-67, col. 23 1, 31-34; °983 Patent col. 21 1. 37—

40, col, 23 1. 4-7; ’790 Patent col. 20 1. 39-43, col. 21 1, 57-61.)

Thus, the Court construes the “release controlling coating” in the ’580 Patent as both

specific for its component and comprising a coating material selected from the group of cellulosic

polymers and acrylic polymers. The Court confines this construction to the ’580 Patent. The

Court construes the disputed phrases in the °248, °989, 940, °983, and ’790 Patents as clear based

on their plain and ordinary meanings, and no further construction is necessary.

IV. CONCLUSION

For the foregoing reasons, the Court construes the disputed terms as follows. An

accompanying Order follows.

'' The Court does not reach the prosecution history because the meaning of the disputed claim

terms are clear from the claims and specification.

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“Release topiramate in a continuous manner” | Requires no construction — plain and ordinary

“Releases topiramate in a continuous manner” | meaning

“Released topiramate in a continuous manner”

“Released . .. continuously” “Release topiramate in a manner without

interruption”

“Releases topitamate in a manner without

interruption”

“Released topiramate in a manner without

interruption”

“Released , . . without interruption”

“Immediately and continuously” Requires no construction — plain and ordinary

meaning

“Without delay and without interruption”

“Immediate release” “Releases greater than or equal to about 80% of

the pharmaceutical agent in less than or equal

to about | hour”

“Extended release (XR) component” or | “A component that releases topiramate in a

“extended release component” continuous manner and is adjusted in such a

way that 80% of the active ingredient is

“Extended release (XR) topiramate-containing | released in vitro in the predetermined period of

component(s)” ‘or “extended release | time”

topiramate-containing components)”

“A coating material selected from the group | ’248, 989, °940, °983, and °790 Patents:

consisting of cellulosic polymers and acrylic | Requires no construction —~- plain and ordinary

polymers” meaning

“Comprising a coating material selected from | 580 Patent: the phrase, “a release controlling

the group consisting of cellulosic polymers and | coating specific for its component and

acrylic polymers” comprising a coating material selected from the

group consisting of cellulosic polymers and

acrylic polymers” shall be construed as: “a

release controlling coating that is both specific

for its component and also comprising a coating

material selected from the group consisting of

cellulosic polymers and acrylic polymers”

Chala

Date: December 1, 2022 MAKE Me nytt.

,GEORGEPTE CASTNER

( ited States District Judge

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