Sean R. Kelly (srk@saiber.com) 

Katherine A. Escanlar (kescanlar@saiber.com) 

SAIBER LLC

18 Columbia Turnpike

Suite 200 

Florham Park, NJ 07932

(973) 645-4801 

Counsel for Defendant and Counterplaintiff 

Anchen Pharmaceuticals, Inc. 

Anthony W. Shaw (shaw.anthony@arentfox.com) 

Richard J. Berman (berman.richard@arentfox.com) 

Aziz Burgy (burgy.aziz@arentfox.com) 

Bradford C. Frese (frese.bradford@arentfox.com) 

Crystal R. Canterbury (canterbury.crystal@arentfox.com) 

(Vimovo@arentfox.com) 

ARENT FOX LLP

1050 Connecticut Avenue, NW

Washington, DC 20036-5339

(202) 857-6000

Counsel to Defendant and Counterplaintiff 

Anchen Pharmaceuticals, Inc. 

UNITED STATES DISTRICT COURT

DISTRICT OF NEW JERSEY

ASTRAZENECA AB, ASTRAZENECA LP, 

KBI-E INC., and POZEN INC.,

Plaintiffs,

v.

ANCHEN PHARMACEUTICALS, INC.

Defendant.

Civ. No. 11-cv-06348-JAP-(DEA)

(Consolidated for discovery purposes 

with Civ. No. 11-cv-02317-JAP-DEA

and Civ. No. 11-cv-04275-JAP-DEA) 

ANCHEN’S RESPONSIVE CLAIM CONSTRUCTION BRIEF

Case 3:11-cv-02317-JAP-DEA Document 105 Filed 09/27/12 Page 1 of 21 PageID: 3343
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TABLE OF CONTENTS

Page

TABLE OF AUTHORITIES.......................................................................................................... ii

I. INTRODUCTION .............................................................................................................1

II. SUMMARY OF ANCHEN’S RESPONSE.....................................................................2

III. U.S. Patent No. 6,926,907 .................................................................................................4

A. “wherein said unit dosage form provides for coordinated release” ........................4

B. “an acid inhibitor present in an amount effective to raise the gastric pH 

of said patient to at least 3.5 upon administration of one or more of 

said unit dosage forms” .........................................................................................7

C. “a coating that, upon ingestion of said unit dosage form by said patient, 

prevents the release of essentially any NSAID from said dosage form 

unless the pH of the surrounding medium is 3.5 or higher” .............................11

D. “at least a portion of said acid inhibitor is not surrounded by an enteric 

coating and, upon ingestion of said unit dosage form by said patient, is 

released regardless of whether the pH of the surrounding medium is 

below 3.5 or above 3.5” and “enteric coating” ..................................................11

IV. U.S. Patent Nos. 6,369,085, 7,411,070, and 7,745,466 ..............................................122

A. “magnesium salt of S-omeprazole trihydrate”...................................................12

B. “highly crystalline form”.....................................................................................12

C. “characterized by the following major peaks in its X-ray 

diffractogram” ......................................................................................................13

D. “represented by FIG. 1”.......................................................................................16

V. CONCLUSION................................................................................................................18

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TABLE OF AUTHORITIES

Page(s)

CASES

Digital Biometrics, Inc. v. Identix, Inc.,

149 F.3d 1335 (Fed. Cir. 1998)........................................................................................... 5

Ethicon Endo-Surgery, Inc. v. U.S. Surgical Corp.,

93 F.3d 1572 (Fed. Cir. 1996) ..........................................................................................................14

Gentry Gallery, Inc. v. Berkline Corp.,

134 F.3d 1473 (Fed. Cir. 1998).................................................................................................2

Sinorgchem Co. v. Int'l Trade Comm'n,

511 F.3d 1132 (Fed. Cir. 2007)...............................................................................................10

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I. INTRODUCTION

Defendant Anchen Pharmaceuticals, Inc. (“Anchen”) submits this response to the 

Opening Markman Submission of Plaintiffs AstraZeneca AB, AstraZeneca LP, KBI-E Inc., 

and Pozen Inc. (collectively, “Plaintiffs”) for the disputed claim terms of U.S. Patent No. 

6,926,907 (“the ’907 patent”), U.S. Patent No. 6,369,085 (“the ’085 patent”), U.S. Patent 

No. 7,411,070 (“the ’070 patent”), and U.S. Patent No. 7,745,466 (“the ’466 patent”) 

(collectively, “the Patents-in-Suit.”). Each of Plaintiffs’ proposed constructions is 

inconsistent with the meaning of the claim terms in light of its specification and prosecution 

history, and cannot be reconciled with the relevant extrinsic evidence regarding the use of 

those terms in the art. In addition, Plaintiffs’ constructions impermissibly add vagueness to 

the claims. In contrast, Anchen’s constructions provide clear and definite meaning to the 

claim terms at issue, while also being true to both the intrinsic and extrinsic evidence. 

Anchen’s constructions, therefore, should be adopted.

In cases Civ. No. 11-cv-02317-JAP-DEA and Civ. No. 11-cv-04275-JAP-DEA, now 

consolidated with the present case for discovery (the “Consolidated Cases”), Dr. Reddy’s 

Laboratories Inc. and Dr. Reddy’s Laboratories Ltd. (together “DRL”), and Lupin Ltd. and 

Lupin Pharmaceuticals Inc. (together “Lupin”) are jointly filing a brief titled “DRL and 

Lupin’s Responsive Claim Construction Brief” (the “DRL/Lupin Response”) concurrently 

with Anchen’s filing of this response. As specifically indicated infra, Anchen adopts stated 

portions of the DRL/Lupin Response addressing certain claim terms in the patents listed 

above.1 This response generally focuses on disputed claim terms not addressed in the 

DRL/Lupin Response. 

 

1

The DRL/Lupin Response has been designated as “Highly Confidential” under the Stipulated 

Discovery Protective Order (D.I. 42) in this matter and filed under seal. To the extent certain 

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II. SUMMARY OF ANCHEN’S RESPONSE

With regard to the ’907 patent, Plaintiffs’ constructions are in stark contrast with 

what the patentee consistently and unequivocally held out as being its invention. For 

instance, Plaintiffs acknowledge that, in the asserted invention of the ’907 patent, “[t]he 

delayed release coating would prevent release of the NSAID in the stomach until the amount 

of acid there had been reduced to safe levels....” Plaintiffs’ Opening Markman Submission 

(“Pl. Op. Br.”), D.I. 101, at 2 (emphasis added). This fundamental aspect of the asserted 

invention is captured in Anchen’s construction of the phrase “wherein said unit dosage form 

provides for coordinated release.” Anchen’s Opening Claim Construction Brief (“Anchen 

Op. Br.”), D.I. 100, at 4.2 Yet Plaintiffs attempt to distance themselves from the patentee’s 

purported invention. Specifically, Plaintiffs ignore that the claims require the gastric pH to 

rise to above 3.5 “upon administration... of one or more” tablets including an acid inhibitor, 

and that this rise in gastric pH results in “coordinated release” of the NSAID. Because 

Anchen’s construction preserves an essential aspect of the alleged invention, it should be 

adopted.3

 

sections of the DRL/Lupin Response are incorporated into this document, Anchen designates 

those incorporated sections (and those sections only) as Highly Confidential, and their 

incorporation in this document shall not serve to circumvent any order to seal any portion of the 

DRL/Lupin Response.

2 Anchen construes this phrase to mean “release of the NSAID in the unit dosage form is 

prevented until the acid inhibitor in the unit dosage form increases gastric pH [to at least 3.5].”

3

Plaintiffs’ construction, in essence, is significantly broader than the invention disclosed in the 

’907 patent, which requires the acid inhibitor to raise the pH of the stomach as a precondition to 

release of the NSAID in the stomach. Because Plaintiffs’ construction omits an element the 

patentees deemed essential to their invention, it is improper. See Gentry Gallery, Inc. v. Berkline 

Corp., 134 F.3d 1473, 1479 (Fed. Cir. 1998) (“[I]t is clear that [the inventor] considered the 

location of the recliner controls on the console to be an essential element of his invention. 

Accordingly, his original disclosure serves to limit the permissible breadth of his later-drafted 

claims.”). For the same reason, Plaintiffs’ construction would render the claims invalid. Anchen 

intends to amend its invalidity contentions accordingly if Plaintiffs’ construction is adopted.

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Plaintiffs’ construction of the term “an acid inhibitor present in an amount effective to 

raise the gastric pH of said patient to at least 3.5 upon administration of one or more of said 

unit dosage forms” is similarly irreconcilable with fundamental aspects of the alleged invention 

as described by the patentee. The ’907 specification clearly shows the invention involved the 

use of acid inhibitors present in an amount effective to raise gastric pH to at least 3.5 “upon 

administration of one or more of said unit dosage forms,” and that the “one or more of said unit 

dosage forms” is meant to cover the situation in which a patient takes more than one tablet or 

capsule at once. Plaintiffs’ construction should therefore be rejected. Anchen’s construction, 

however, preserves this meaning—the “acid inhibitor is present in the unit dosage form in an 

amount effective to raise gastric pH to at least 3.5 at the time the unit dosage form is 

administered”—and should therefore be adopted.

With regard to the ’085, ’070 and ’466 patents (the “trihydrate patents”), Plaintiffs’ 

construction of the term “characterized by the following major peaks in its X-ray

diffractogram” increases the ambiguity of the claim language, rather than reducing it, and 

outright ignores certain limitations of the claims. Further, Plaintiffs’ construction of this 

term lacks any basis in the intrinsic or extrinsic record. Anchen’s construction, however, 

provides meaning for the claim term and simplifies any determinations with regard to 

noninfringement and invalidity. Likewise, Plaintiffs’ construction of the term “represented 

by FIG. 1,” while facially based in the claim language, provides no further guidance as to 

the scope of the claim or how to determine noninfringement or invalidity of the claim. 

Because Anchen’s proposed constructions are better grounded in the language of the claim, 

while also providing a basis on which to assess invalidity and noninfringement, the Court 

should adopt Anchen’s constructions.

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III. U.S. PATENT NO. 6,926,907

Anchen adopts the section of the DRL/Lupin Response addressing the ’907 patent 

with the following additional claim terms and arguments.

A. “wherein said unit dosage form provides for coordinated release”

Claim(s) Plaintiffs’ Construction Anchen’s Construction

5, 15, 52-54 wherein the single entity for drug 

administration provides for the 

sequential release of acid 

inhibitor followed by NSAID

release of the NSAID in the unit dosage 

form is prevented until the acid 

inhibitor in the unit dosage form 

increases gastric pH [to at least 3.5]4

Anchen’s construction of this phrase requires that the release of the NSAID in the unit 

dosage form is prevented until the acid inhibitor in that same unit dosage form has raised gastric 

pH (i.e., the amount of acid in the stomach has been reduced to safe levels). Plaintiffs 

acknowledge the importance of this concept to the asserted invention of the ’907 patent. Pl. Op. 

Br. at 2. Yet their proposed construction ignores it.

Plaintiffs seek to close debate on the meaning of “coordinated release” by citing a 

single passage from the ’907 patent that allegedly equates “coordinated release” with 

“sequential release,” and arguing that “[t]he use of ‘i.e.’ in this passage indicates the 

patentee’s intent to define ‘coordinated release’ to mean ‘the sequential release of acid 

inhibitor followed by [NSAID].’” Pl. Op. Br. at 9 (citing Edwards Lifesciences LLC v. 

Cook Inc., 582 F.3d 1322, 1334 (Fed. Cir. 2009)). But Plaintiffs fail to mention that the 

’907 patent also uses “i.e.” in another passage describing “coordinated release,” namely:

A unit dosage form of the present invention preferably provides for 

coordinated drug release, in a way that elevates gastric pH and reduces 

the deleterious effects of the NSAID on the gastroduodenal mucosa, 

 

4

The “to at least 3.5” language in Anchen’s construction is included simply to provide context 

for the language found earlier in the claim, i.e. “an acid inhibitor present in an amount effective 

to raise the gastric pH of said patient to at least 3.5” (emphasis added). The “to at least 3.5” 

language is not itself in dispute and does not itself form a part of Anchen’s proposed construction 

for the phrase “wherein said unit dosage form provides for coordinated release.”

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i.e., the acid inhibitor is released first and the release of NSAID is 

delayed until after the pH in the GI tract has risen. 

’907 patent at 3:62–4:2 (emphasis added). This passage requires coordinated release “in a 

way that elevates gastric pH” by releasing the acid inhibitor first and delaying release of the 

NSAID until after the pH has risen. See also Response dated July 22, 2004 at 3 (“the 

dosage form deliver[s] these drugs in a coordinated fashion such that the acid inhibitor is 

released first and the NSAID is not released until after the gastric pH of the patient is 3.5 or 

higher” (emphasis added)).5 

Plaintiffs’ construction thus takes a single passage in the specification and uses it to 

define the invention, rather than construing the claims in light of the entirety of the intrinsic 

evidence. This renders Plaintiffs’ construction improper. See Digital Biometrics, Inc. v. 

Identix, Inc., 149 F.3d 1335, 1345 (Fed. Cir. 1998) (“[Plaintiff] points to one isolated 

passage in the written description to support its claim construction ... This isolated passage 

therefore does not alter our construction, which is based on the entire written description.”). 

Anchen’s construction, in contrast, captures the mechanism by which the disclosed dosage 

form achieves “coordinated release” because it states that “release of the NSAID in the unit 

dosage form is prevented until the acid inhibitor in the unit dosage form increases the gastric 

 

5

 Indeed, Plaintiffs’ own expert, Dr. Robert Williams admits that it is necessary to delay the 

release of the NSAID until after the pH has risen.

Q. In the context of the ’907 patent, do you believe it’s necessary for the NSAID to 

be delayed until after the pH in the GI tract has risen?

A. Well, I mean, the claim term that I construed is the NSAID is – basically, the 

release of the NSAID is prevented unless the pH of the surrounding medium is 3.5 or 

higher. So that’s what the claim term says.

Deposition of Dr. Robert O. Williams, III (“Williams Dep.”), Ex. 1 to Declaration of Crystal R. 

Canterbury (“Canterbury Decl.”) in support of Anchen’s Responsive Claim Construction Brief, 

111:15-21, Sept. 19, 2012. All Exhibits are attached to the Canterbury Declaration 

accompanying this brief.

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pH [to at least 3.5].” Because Anchen’s construction is supported by the totality of the 

intrinsic evidence considered together, and not merely by a single isolated passage devoid of 

context, it should be adopted.

Further, the Examples in the ’907 patent refute, rather than reinforce, Plaintiffs’ 

construction. While Plaintiffs point to the Examples in the ’907 patent as supporting their 

proposed construction, Pl. Op. Br. at 10 (citing ’907 patent at 8:35-49; 9:50-62), these 

Examples are each directed to tablets containing famotidine as the acid inhibitor and 

methacrylic acid copolymers as the delayed release coating. See ’907 patent at 8:14-15, 40-

41; 9:39-40, 52-56. Famotidine is a fast-acting acid inhibitor that raises gastric pH within 40 

minutes after administration. See D. Decktor et al., “The Action of 10 mg Famotidine 

Versus 200 mg Cimetidine: Onset and Magnitude of Antisecretory Action Within the First 2 

Hours After Administration,” AM. J. OF THERAPEUTICS 5, 97–100 (1998), Ex. 2 to Canterbury 

Decl., at 100. And Plaintiffs admit that “[t]he function of methacrylic acid copolymers is to 

prevent the release of naproxen until the pH of the stomach rises.” ’907 patent at 10:60-62. 

This exemplary dosage form would work exactly as the patentee contemplated: release of the 

NSAID (naproxen) does not occur until the acid inhibitor (famotidine) raises gastric pH. 

Thus, the Examples cited by Plaintiff support Anchen’s construction of “wherein said unit 

dosage form provides for coordinated release” to mean “release of the NSAID in the unit 

dosage form is prevented until the acid inhibitor in the unit dosage form increases gastric 

pH.”6

 

6

Plaintiffs erroneously allege that “Anchen seeks to limit the release of the NSAID to only one 

part of the GI tract – the stomach....” Pl. Op. Br. at 10. Consistent with Anchen’s construction 

of claim term 3, however, release of the NSAID may depend on time or pH, and the location of 

NSAID release in the GI tract has no bearing on Anchen’s construction of the “coordinated 

release” term.

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Plaintiffs bow to reality when they admit, as they must, that their proposed 

construction of the “coordinated release” term would result in the ’907 patent covering “a 

dosage form that passes through an ‘unprotected stomach,’” i.e., where the acid inhibitor in 

the dosage form has not had any effect on gastric pH, and releases the NSAID in the small 

intestine. Pl. Op. Br. at 11. This example shows how Plaintiffs’ overly broad construction 

cannot be correct. Since the acid inhibitor in this example has not had any effect on gastric 

pH, the dosage form would operate no differently than an enteric coated NSAID, which the 

patentee criticizes. See ’907 patent at 1:57-63. Because Plaintiffs’ proposed construction 

ignores the patentee’s statements on scope of coverage, it should be rejected. Anchen’s 

construction is consistent with the patentee’s statements and so should be adopted.

B. “an acid inhibitor present in an amount effective to raise the gastric pH 

of said patient to at least 3.5 upon administration of one or more of said 

unit dosage forms”

Claim(s) Plaintiffs’ Construction Anchen’s Construction

5, 15, 52-54 an acid inhibitor present in an 

amount capable of raising the 

gastric pH of said patient to at 

least 3.5 upon the administration 

of one or more single entities for 

drug administration over a period 

of time.

an acid inhibitor is present in the unit 

dosage form in an amount effective to 

raise gastric pH to at least 3.5 at the 

time the unit dosage form is 

administered

Anchen’s construction of this term should be adopted because it imparts greater clarity to 

the claim. Plaintiffs’ construction not only ignores the words “upon administration” but also 

allows for the self-contradictory administration of “one... single entity... over time.” Anchen’s 

construction, in contrast, requires that the acid inhibitor in the unit dosage form be present in an 

amount effective to raise gastric pH to at least 3.5 at the time the unit dosage form is 

administered. 

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Contrary to Plaintiffs’ allegation, Anchen’s construction does not limit the claims by

reading out the “or more” language. See Pl. Op. Br. at 6. Simply put, it is irrelevant to the 

construction whether one or more unit dosage form is administered because it is necessary for 

the acid inhibitor present in any single unit dosage form to be present in an amount effective to 

raise gastric pH to at least 3.5 at the time the unit dosage form is administered. Anchen’s 

construction embraces both the “one” and the “or more” possibilities. Plaintiffs’ assertion to the 

contrary is incorrect.

In contrast to Anchen’s construction, which contemplates administration of one or more 

unit dosage forms to raise gastric pH to at least 3.5, Plaintiffs’ construction effectively eliminates 

the possibility of one single unit dosage form working to raise gastric pH to at least 3.5. Indeed, 

the Plaintiffs’ construction embraces the possibility that the “acid inhibitor is present in an 

amount capable of raising the gastric pH of said patient to at least 3.5 upon the administration of 

one ... single [entity] for drug administration over time,” without stating how it is possible to 

administer one single entity for drug administration “over a period of time.” 

Further, Plaintiffs’ expert, Dr. David Johnson, testified that administration of a single unit 

dosage form would not work despite the clear language of claim 1 requiring “an acid inhibitor 

present in an amount effective to raise gastric pH of said patient to at least 3.5 upon the 

administration of one ... of said unit dosage forms.” 

Q. That's not my question. I’m asking, can you give an expert opinion as to whether 

the administration of one single unit dosage form can raise the gastric pH of a patient to 

3.5 or higher?

A. Again, it would not be predictable, and it would not be standard, and it would not 

be mechanistically how these drugs would work.

Deposition of Dr. David A. Johnson, M.D. (“Johnson Dep.”), Ex. 3 to Canterbury Declaration, 

122:16-22, Sept. 11, 2012. 

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Dr. Johnson’s conclusion that one single unit dosage form would not work is based on the 

flawed premise that “at least 3.5” requires a steady-state pH that is reached after several days, 

weeks, months, or years of administration. Johnson Dep., Ex. 3 to Canterbury Declaration 

106:10 – 107:13. Dr. Johnson’s opinions, however, do not comport with what the applicant 

claimed as its invention, which is merely reaching a gastric pH of at least 3.5.

Plaintiffs’ construction improperly requires repeated administration of the single unit 

dosage form over a period of time. As support, Plaintiffs rely on the declaration of their expert, 

Dr. Johnson, who contends that a person of ordinary skill in the art “would understand ‘an 

amount effective’ in the claim language at issue to include amounts of PPIs that are effective 

upon administration one or more times over a period of time.” Declaration of Dr. David A. 

Johnson, M.D. (“Johnson Decl.”), Ex. 4 to Canterbury Declaration, at ¶ 37. 

Dr. Johnson’s contention suffers from several infirmities. First, it disregards the ’907 

patent’s express claim language, which a person of ordinary skill in the art would understand to 

require “an acid inhibitor present in an amount effective to raise the gastric pH of said patient to 

at least 3.5 upon the administration of one or more of said unit dosage forms.” Rebuttal 

Declaration of Dr. Roy Orlando, M.D. (“Orlando Rebuttal Decl.”), Ex. 5 to Canterbury 

Declaration, at ¶ 4 (emphasis added); ’907 patent, claim 1 (emphasis added). In other words, the 

claim requires that the acid inhibitor raise gastric pH at the time the unit dosage form is 

administered. Id. Thus, the fact that this may be difficult or even impossible is simply

irrelevant.

Second, Dr. Johnson’s opinion also fails because it is factually incorrect. For example, it 

is inconsistent with the ’907 patent’s own specification. Specifically, the ’907 patent 

contemplates dosages of PPIs in the range of 5 mg to 600 mg per unit dose and, as such, 

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describes a dose range that would enable even a single dose of PPI to raise gastric pH to 3.5 or 

above. Orlando Rebuttal Decl., Ex. 5 to Canterbury Declaration, at ¶ 5. Therefore, Plaintiffs’ 

construction that “an ‘amount effective’ would include amounts of acid inhibitors that are 

effective upon administration of one or more times over a period of time” is belied by the 

intrinsic evidence.

Plaintiffs also allege that Anchen’s construction excludes the preferred embodiment from 

the claims. This is incorrect. The ’907 patent does not list proton pump inhibitors such as 

esomeprazole as preferred embodiments; instead, the specification lists the preferred acid 

inhibitors as H2 receptor antagonists generally and famotidine specifically. ’907 patent at 3:28-

36. These acid inhibitors, as well as other acid inhibitors present in an amount effective to raise 

gastric pH to at least 3.5 at the time the unit dosage form is administered, are within Anchen’s 

construction. 

Plaintiffs argue that PPIs such as omeprazole, which require repeated administrations 

over several days to become effective, would be excluded from the claims under Anchen’s 

construction. See Pl. Op. Br. at 7-8. Such drugs are not the preferred embodiments however, but 

merely “[o]ther agents that may be effectively used.” ’907 patent at 3:36-38.7 Thus, the case 

law cited by Plaintiffs is inapposite. See Sinorgchem Co. v. Int'l Trade Comm'n, 511 F.3d 1132, 

1138 (Fed. Cir. 2007) (“Where, as here, multiple embodiments are disclosed, we have previously 

interpreted claims to exclude embodiments where those embodiments are inconsistent with 

unambiguous language in the patent's specification or prosecution history.”). It is clear from the 

 

7

Plaintiffs cite the ’907 patent at 7:9-11 as support for their assertion that PPIs such as 

omeprazole are preferred acid inhibitors. See Pl. Op. Br. at 8. This passage, however, merely

indicates that “[f]or example, the proton pump inhibitor omeprazole should be present in tablets 

or capsules in an amount from 5 to 50 mg, with about 20 mg per unit dosage form being 

preferred” (’907 patent at 7:9-11), and does not indicate any preference for PPIs generally or 

omeprazole specifically as the acid inhibitor.

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’907 specification that the applicant made a conscious and deliberate decision to direct its claims 

to acid inhibitors present in an amount effective to raise gastric pH to at least 3.5 at the time the 

unit dosage form is administered. Plaintiffs’ effort to retroactively annul this decision should be 

rejected.

C. “a coating that, upon ingestion of said unit dosage form by said patient, 

prevents the release of essentially any NSAID from said dosage form 

unless the pH of the surrounding medium is 3.5 or higher”

Claim(s) Plaintiffs’ Construction Defendants’ Construction

5, 15, 52-54 No construction is needed. This 

phrase should be given its plain 

and ordinary meaning.

a coating that, upon ingestion of said 

unit dosage form by said patient, 

controls the release of NSAID by time 

or pH and thereby prevents the release 

of essentially any NSAID from said 

dosage form unless the pH of the 

surrounding medium is 3.5 or higher

Anchen adopts the section of the DRL/Lupin Response addressing the construction 

of this claim term.

D. “at least a portion of said acid inhibitor is not surrounded by an enteric 

coating and, upon ingestion of said unit dosage form by said patient, is 

released regardless of whether the pH of the surrounding medium is 

below 3.5 or above 3.5” and “enteric coating”

Claim(s) Plaintiffs’ Construction Defendants’ Construction

5, 15, 52-54 at least a portion of said 

proton pump inhibitor is 

immediately released

at least some amount of acid inhibitor 

is not surrounded by an enteric coating 

and, upon ingestion of said unit dosage 

form by said patient, is released 

regardless of whether the pH of the 

surrounding medium is below 3.5 or 

above 3.5

5, 15, 52-54 “enteric coating” means a 

delayed release coating

“enteric coating” means a coating 

that controls the release of an active 

agent from a unit dosage form by 

pH

Anchen adopts the section of the DRL/Lupin Response addressing the construction 

of these claim terms.

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IV. U.S. PATENT NOS. 6,369,085, 7,411,070, AND 7,745,466

A. “magnesium salt of S-omeprazole trihydrate”

Claim(s) Plaintiffs’ Construction Defendants’ Construction

‘466 patent;

claims 1-5, 

7-14, and 16.

‘070 patent; 

claims 1-4.

‘085 patent; 

claims 1-4 

and 12.

“magnesium salt of” means a compound 

formed between positively-charged 

Magnesium (Mg) cations and negativelycharged S-omeprazole anions. “Someprazole trihydrate” means (S)-

omeprazole having a structure that has a 

theoretical ratio of three molecules of bound 

water per molecule of ((S)-omeprazole)2 

magnesium, but which does not necessarily 

contain exactly three molecules of water, 

whose structure may be determined by 

analytical methods identified in the patent 

and known to those of ordinary skill. In the 

‘085 patent the structure is determined by 

examining XRD.

a trihydrate of a magnesium salt

of S-omeprazole containing 

three molecules of water per 

molecule of magnesium salt of 

S-omeprazole in a unit cell of 

the crystal lattice that is 

substantially free from 

magnesium salts of 

R-omeprazole and other prior art

forms of magnesium salts of 

S-omeprazole including Someprazole dihydrate and 

amorphous forms

Anchen adopts the section of the DRL/Lupin Response addressing the construction 

of this claim term.

B. “highly crystalline form”

Claim(s) Plaintiffs’ Construction Defendants’ Construction

‘466 patent;

claims 4, 12

‘085 

patent; 

claims 2-4, 

and 12.

a form having a repeating pattern of 

atoms or molecules in an order that can 

be detected by techniques known in the 

art, that is more ordered than previously 

known and disclosed forms.

having a crystallinity higher 

than any other form of 

magnesium salt of Someprazole disclosed in the 

prior art

Anchen adopts the section of the DRL/Lupin Response addressing the construction 

of this claim term.

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C. “characterized by the following major peaks in its X-ray diffractogram”

Claim(s) Plaintiffs’ Construction Anchen’s Construction

’085 patent; 

1–4, 12

’466 patent; 

claims 3, 11

identifiable by reference to an X-ray 

diffractogram that includes the major 

peaks below

having all of the referenced 

major peaks in its X-ray 

diffractogram

Anchen’s construction requires that the X-ray diffractogram of a compound according to 

claim 1 of the ’085 patent and claims 3 and 11 of the ’466 patent have all of the referenced 

major peaks recited in Table 1. This construction imparts needed clarity to claim 1 of the ’085 

patent and claims 3 and 11 of the ’466 patent. In particular, Anchen’s construction clarifies that 

any compound with an X-ray diffractogram lacking any recited peaks is not an infringing 

compound. This is consistent with the language of the claim, which states that S-omeprazole 

magnesium trihydrate is “characterized by the following major peaks,” and then recites a table 

including the location and relative intensity of each peak in the diffractogram.

Plaintiffs’ construction, in contrast, ignores the claim language. Plaintiffs contend their 

construction means that “while the S-omeprazole trihydrate at issue should be ‘identifiable by 

reference’ to a diffractogram including the listed peaks, it does not necessarily have to exhibit all 

the listed peaks.” Pl. Op. Br. at 28. Plaintiffs’ construction would thus read explicit limitations

out of the claim. This fact alone renders Plaintiffs’ construction incorrect. See Ethicon EndoSurgery, Inc. v. U.S. Surgical Corp., 93 F.3d 1572, 1583 (Fed. Cir. 1996) (finding that the 

patentee need not have included a particular limitation in its claim, but that “having done so, it 

must live with the language it chose.”). 

Further, Plaintiffs’ construction introduces greater ambiguity into the claim language. It 

would make it unclear whether a sample of S-omeprazole trihydrate having a diffractogram that 

contains some, but not all, of the peaks listed in the table would infringe claim 1 of the ’085 

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patent. Plaintiffs’ construction, as such, ignores that the patentee drafted these claims to recite that 

the compound is “characterized by the following major peaks in its diffractogram,” rather than 

“characterized by at leastsome of the following major peaks in its diffractogram.” If the 

diffractogram contains some of the peaks, but at very different intensities from those recited in the 

table, does that compound infringe? If the diffractogram contains only the peaks listed as having 

“very strong” (vs) and “strong” (s) intensities, does the compound infringe? Plaintiffs’ 

construction raises rather than resolves such questions.

Plaintiffs also misconstrue the intrinsic evidence in support of their construction. For 

example, Plaintiffs state that “the intensities provided in Table 1 and the claims at issue are ‘less 

reliable’ than other characterization metrics” and cite to column 5, lines 25-30 of the ’085 patent 

in support of this assertion. However, that portion of the specification states that the “relative 

intensities” extracted from FIG. 1 “are less reliable, and instead of numerical values the following 

definitions are used,” followed by definitions of how the percent relative intensity corresponds to 

vs (very strong), s (strong), m (medium), w (weak) and vw (very weak). See the ’085 patent, 

5:25-42. In essence, the patentee defined certain relative measures for peak intensity, and required 

the peaks in the diffractogram to match those relative measures rather than the absolute 

quantitative measure of peak intensity. The ’085/’466 patent specification thus does not state 

anything about the reliability of “other characterization metrics” relative to XRPD. 

Likewise, while the specification does indicate, in the cited section, that certain “very 

weak peaks have been omitted” from Table 1, the specification provides no guidance as to why 

such peaks were eliminated, nor that the peaks included in Table 1 may be ignored when 

characterizing a compound. That certain peaks were “very weak” and were not included in the list 

of peaks recited in the specification and claims does not serve to diminish the importance of the 

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other peaks that were included, nor does it indicate that certain peaks may be read out of the 

claims. Further, the claim language identifies the peaks in Table 1 as “major peaks,” presumably 

in distinction from other “minor peaks,” which would include the “very weak” peaks that were not 

included in Table 1. As such, the patentee defined each peak in Table 1 as a “major peaks,” 

excluded those peaks that were not “major peaks,” and thus defined the invention as including 

compounds with an X-ray diffractogram containing each major peak listed in Table 1. As such, 

Plaintiffs’ proposed construction of this term lacks support in the intrinsic evidence.

As a final note, none of the extrinsic evidence cited by Plaintiffs specifically supports their 

construction over Anchen’s construction. Plaintiffs argue that “characterize” means “a 

distinguishing feature or quality” and that Patent and Trademark Office practice regards such a 

term as inclusive or open-ended and not excluding additional, unrecited elements. Anchen’s 

construction, however, is in line with these definitions as well, and in fact is more consistent with 

these definitions than Plaintiffs’ construction. For instance, a peak cannot be considered a 

“distinguishing feature or quality” of esomeprazole magnesium trihydrate if its presence or 

absence in an X-ray diffractogram could equally indicate the presence of esomeprazole 

magnesium trihydrate or any other form of esomeprazole magnesium.

Clearly, the claim language requires that the X-ray diffractogram of the claimed 

product must include all of the peaks listed. Plaintiffs’ proposed construction fails to 

capture this essential concept, and so must be rejected. Anchen’s construction, in contrast, 

clarifies that only a compound “having all of the referenced major peaks in its X-ray 

diffractogram” is covered by the claim. As such, Anchen’s construction should be adopted.

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D. “represented by FIG. 1”

Claim(s) Plaintiffs’ Construction Anchen’s Construction

’070 patent; 

claims 2, 4

’466 patent; 

claims 2, 10 

represented by Figure 1 of the ’070 

patent (or ’466 patent)

having an X-ray powder 

diffractogram the same as FIG. 

1

Claim 2 of the ’070 patent and claims 2 and 10 of the ’466 patent recite that the claimed 

magnesium salt of S-omeprazole trihydrate “is represented by FIG. 1.” Anchen’s 

construction imparts meaning to this claim term that is consistent with its usage. In particular, 

Anchen’s construction highlights that, for these claims to read on a compound, the compound 

must have an X-ray diffractogram identical to that in FIG. 1. Anchen’s construction thus 

meaningfully incorporates FIG. 1 into the limitations of the claim.

Plaintiffs allege that this claim language should be given its plain meaning. Allegedly to 

elucidate that meaning, however, they argue that the specification “makes it clear that ‘represented 

by’ does not have to mean ‘the same as.’” Pl. Op. Br. at 29. Plaintiffs’ construction thus 

introduces greater uncertainty into the meaning of the claim term. Indeed, Plaintiffs fail to 

identify what, if any, differences could be present in an X-ray diffractogram such that it would be 

“represented by FIG. 1” but not the same as FIG. 1. Would a compound having a diffractogram 

with additional peaks infringe this claim? Would a compound having a diffractogram missing 

certain peaks infringe this claim? Would a compound having a diffractogram with different peak

intensities infringe this claim? Plaintiffs’ construction has no power to resolve these issues, while 

Anchen’s construction provides a conclusive basis for answering such questions.

Further, while the Plaintiffs say their interpretation of the term “represented by” is 

supported by the intrinsic evidence, they merely point to a statement that a compound’s X-ray 

diffractogram “complies” with that in FIG. 1. Id. (citing the ’070 patent, 9:49-50). The fact that 

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the diffractogram of that compound “complies” (whatever that may mean) with FIG. 1 does not 

evince whether that diffractogram was the same as, or differed from, the one depicted in FIG. 1. 

Nor does that statement suggest which differences, exactly, may exist between a diffractogram of 

a compound according to claim 2 of the ’070 patent (or claims 2 and 10 of the ’466 patent) and 

that depicted in FIG. 1.

Anchen’s construction, therefore, provides needed specificity to the claim, while 

Plaintiffs’ construction vitiates it. In the context of the ’070 and ’466 patents, “represented by” 

must mean that the claimed product has an X-ray diffractogram that is the same as the X-ray 

diffractogram of Figure 1—neither reference to any portion of the specification or file history 

permits a different conclusion. Anchen’s construction must therefore be adopted. 

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V. CONCLUSION

For the foregoing reasons, Anchen respectfully requests that this Court adopt the 

constructions of the disputed terms that have been proposed by Anchen.

DATED: September 27, 2012

Respectfully submitted,

/s/ Sean R. Kelly

Sean R. Kelly

Katherine A. Escanlar

SAIBER LLC

One Gateway Center, 10th Floor

Newark, New Jersey 07102-5311

Telephone: (973) 622-3333

Facsimile: (973) 286-2465

Counsel for Defendant and Counterplaintiff 

Anchen Pharmaceuticals, Inc.

Richard J. Berman

Anthony W. Shaw

Aziz Burgy

Bradford C. Frese

Crystal R. Canterbury

ARENT FOX LLP

1050 Connecticut Avenue, NW

Washington, DC 20036-5339

(202) 857-6000

Counsel to Defendant and Counterplaintiff 

Anchen Pharmaceuticals, Inc.

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