ME1 12508463v.1

John E. Flaherty 

Jonathan M.H. Short 

McCARTER & ENGLISH, LLP 

Four Gateway Center 

100 Mulberry Street 

Newark, New Jersey 07102 

(973) 622-4444 

Attorneys for Plaintiffs/Counterclaim-Defendants 

AstraZeneca AB, Aktiebolaget Hässle, 

AstraZeneca LP, KBI Inc. and KBI-E Inc. 

Of Counsel: 

Henry J. Renk 

Bruce C. Haas 

Colleen Tracy 

Joshua I. Rothman 

FITZPATRICK, CELLA, HARPER 

 & SCINTO 

1290 Avenue of the Americas 

New York, New York 10104-3800 

(212) 218-2100 

Errol B. Taylor 

Fredrick M. Zullow 

MILBANK, TWEED, HADLEY 

 & McCLOY LLP 

1 Chase Manhattan Plaza 

New York, New York 10005-1413 

(212) 530-5000 

Einar Stole 

COVINGTON & BURLING LLP 

1201 Pennsylvania Avenue, NW 

Washington, DC 20004-2401 

(202) 662-6000 

UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF NEW JERSEY 

ASTRAZENECA AB; AKTIEBOLAGET 

HÄSSLE; ASTRAZENECA LP; KBI INC.; 

and KBI-E INC., 

Plaintiffs and 

Counterclaim-Defendants,

 v. 

HANMI USA, INC., HANMI 

PHARMACEUTICAL CO., LTD., HANMI 

FINE CHEMICAL CO., LTD, and HANMI 

HOLDINGS CO., LTD., 

 

Defendants and 

Counterclaim-Plaintiffs. 

Civil Action No. 3:11-CV-00760-JAP-TJB 

Judge Joel A. Pisano 

Magistrate Judge Tonianne J. Bongiovanni 

ASTRAZENECA’S OPENING MARKMAN BRIEF 

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TABLE OF CONTENTS 

Page 

I. Introduction ..........................................................................................................................1 

II. Background ..........................................................................................................................2 

III. Claim Construction Principles .............................................................................................3 

A. Ordinary Meaning in the Context of the Claims ......................................................3 

B. Intrinsic Evidence ....................................................................................................4 

C. Extrinsic Evidence ...................................................................................................5 

IV. Construction of the Disputed Claim Language ....................................................................6 

A. ’504 Patent Claim Language ....................................................................................7 

1. “Alkaline salt” (claims 1, 2, 4, 6 and 7) .......................................................7 

2. “(–)-Enantiomer of 5-methoxy-2[[(4-methoxy-3,5-

dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole” 

alone (claims 1, 3–7 and 10) and as modified by “optically 

pure” (claim 2) ...........................................................................................11 

3. “Administration of” (claim 6) and “administration to” 

(claim 7) .....................................................................................................12 

4. “A mammal including man in need of such treatment” 

(claim 7) .....................................................................................................15 

B. ’192 Patent Claim Language ..................................................................................16 

1. “Pharmaceutically acceptable salt” (claims 1–7, 10–19 and 

21–23) ........................................................................................................16 

2. “Consisting essentially of the (–)-enantiomer of 5-methoxy2[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-

1H-benzimidazole” (claims 1–7, 10–19, 21 and 22) .................................19 

3. “Administering to a mammal in need of treatment” (claims 

1–7, 10, 11 and 23) ....................................................................................20 

V. Claim Construction Issues Raised in Hanmi’s Summary Judgment 

Motions ..............................................................................................................................22 

VI. Conclusion .........................................................................................................................22 

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TABLE OF AUTHORITIES 

Cases

AstraZeneca AB v. Dr. Reddy’s Labs., Ltd., 

2010 WL 1981790 (D.N.J. May, 18, 2010) ............................................................... passim

Columbia Sportswear N. Am., Inc. v. Cerf Bros. Bag Co., 

2007 WL 1792304 (D. Or. 2007)...................................................................................6, 14 

Dayco Prods., Inc. v. Total Containment, Inc., 

258 F.3d 1317 (Fed. Cir. 2001)................................................................................6, 13, 16 

DSW, Inc. v. Shoe Pavilion, Inc., 

537 F.3d 1342 (Fed. Cir. 2008)............................................................................................5 

Emerson Elec. Co. v. Spartan Tool, LLC, 

223 F.Supp.2d 856 (N.D.Ohio 2002) ......................................................................6, 13, 16 

Harris Corp. v. IXYS Corp., 

114 F.3d 1149 (Fed. Cir. 1997)......................................................................................6, 14 

Interactive Gift Exp., Inc. v. Compuserve Inc., 

256 F.3d 1323 (Fed. Cir. 2001)............................................................................................3

Liquid Dynamics Corp. v. Vaughan Co., Inc., 

355 F.3d 1361 (Fed. Cir. 2004)............................................................................................3 

Markman v. Westview Instruments, Inc., 52 F.3d 967, 970–71, 980 

(Fed. Cir. 1995), aff’d 517 U.S. 370 (1996) ....................................................................3–5

Omega Eng’g, Inc. v. Raytek Corp., 

334 F.3d 1314, 1324 (Fed. Cir. 2003)..................................................................................5 

Phillips v. AWH Corp., 

415 F.3d 1303 (Fed. Cir. 2005)..............................................................................3–5, 9, 10

RF Delaware. v. Pac. Keystone Techs., 

326 F.3d 1255 (Fed. Cir. 2003)..................................................................................4, 9–10

Teleflex, Inc. v. Ficosa N. Am. Corp., 

299 F.3d 1313 (Fed. Cir. 2002)......................................................................................4, 10 

Vitronics Corp. v. Conceptronic, Inc., 

90 F.3d 1576 (Fed. Cir. 1996)..............................................................................................4

Wellman, Inc. v. Eastman Chem. Co., 

642 F.3d 1355 (Fed. Cir. 2011)............................................................................................6 

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Rules and Statutes

35 U.S.C. § 112 ............................................................................................................................3, 4 

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I. Introduction 

AstraZeneca1 submits this opening brief in support of its proposed constructions 

of disputed claim terms in AstraZeneca’s U.S. Patent Nos. 5,714,504 (“the ’504 patent”; Chen 

Exh. 1) and 5,877,192 (“the ’192 patent”; Chen Exh. 2).2 

This is a Hatch-Waxman patent infringement action. Hanmi3 submitted an 

application to the U.S. Food and Drug Administration (“FDA”) seeking approval to market a 

generic version of AstraZeneca’s Nexium® esomeprazole magnesium product prior to the 

expiration date of the ’504 and ’192 patents. See D.I. 1, 7. Hanmi’s proposed generic product, 

like Nexium®, is an alkaline salt of esomeprazole. Hanmi uses strontium in place of magnesium 

in its alkaline esomeprazole salt. D.I. 7, 90-2, 113. Nexium® is used, and, if approved, Hanmi’s 

proposed product will be used, to treat gastrointestinal disorders. 

The ’504 and ’192 patents cover pharmaceutical compositions containing alkaline 

salts of esomeprazole and methods of use thereof. Construction of certain terms in the claims of 

these patents, whose meaning is disputed, is necessary to resolution of infringement and validity 

issues in this case. 

This Court previously construed certain terms in the ’504 and ’192 patents. See 

AstraZeneca AB v. Dr. Reddy’s Labs., Ltd., 2010 WL 1981790 (D.N.J. May 18, 2010) (Pisano, 

J.). 

 

1

 “AstraZeneca” refers collectively to plaintiffs AstraZeneca AB, Aktiebolaget Hässle, 

AstraZeneca LP, KBI Inc. and KBI-E Inc. 

2

 Submitted herewith are the Declarations of Patrick L. Chen (“Chen”), Dr. Stephen G. 

Davies (“Davies”) and Dr. David Johnson (“Johnson”). 

3

 “Hanmi” refers collectively to defendants Hanmi, Inc., Hanmi Pharmaceutical Co., Ltd., 

Hanmi Fine Chemical Co., Ltd. and Hanmi Holdings Co., Ltd. 

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II. Background 

Omeprazole, discovered by AstraZeneca, is a drug known as a proton pump 

inhibitor (“PPI”). The proton pump is an enzyme, located in the parietal cells that line the 

stomach, that plays a role in gastric acid production. 

Omeprazole is a “racemic mixture” or “racemate,” which means that it consists of 

a 50:50 mixture of two compounds called “enantiomers.” Enantiomers are mirror images of 

each other, much like our hands are mirror images of each other. The two enantiomers—the 

“(–)” or “S” enantiomer and the “(+)” or “R” enantiomer—are shown below. The (–) or S 

enantiomer of omeprazole is known as “esomeprazole.” Davies ¶¶ 11, 21–24. 

N

N

H

S

O

N

O

O

(–) or (S) omeprazole

N

N

H

S

O

N

O

O

(+) or (R) omeprazole

mirror plane

Although successful in treating a number of gastric-acid-related diseases, 

omeprazole exhibited substantial interindividual variation in therapeutic efficacy. Scientists at 

AstraZeneca discovered that alkaline salts of esomeprazole provided improved efficacy and 

decreased interindividual variation; the esomeprazole magnesium in Nexium® is an alkaline salt 

of esomeprazole. The ’504 and ’192 patents protect these inventions. 

The asserted claims of the ’504 patent (claims 1–7 and 10) are directed to 

“pharmaceutical formulation[s]” containing an “alkaline salt” of esomeprazole and methods of 

use thereof for “inhibiting gastric acid secretion” and “treatment of gastrointestinal inflammatory 

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disease.” 4 The asserted claims of the ’192 patent (1–7, 10–19 and 21–23) are directed to 

methods for the “treatment of gastric acid related diseases” with esomeprazole “or a 

pharmaceutically acceptable salt thereof” and to methods for the “production of a medicament 

for treating gastric acid related diseases” containing the same. 

In February 2001, AstraZeneca obtained FDA approval to market Nexium® 

esomeprazole magnesium. Today, Nexium® is the gold standard in PPI therapy. 

III. Claim Construction Principles 

The claims of a patent define the scope of the invention and the patentee’s rights. 

Markman v. Westview Instruments, Inc., 52 F.3d 967, 970–71, 980 (Fed. Cir. 1995), aff’d 517 

U.S. 370, 373–74 (1996). Courts construe claims as “necessary to resolve disputes about claim 

terms and to assign a fixed, unambiguous, legally operative meaning to the claim.” Liquid 

Dynamics Corp. v. Vaughan Co., Inc., 355 F.3d 1361, 1367 (Fed. Cir. 2004). This determination 

is made from the perspective of the hypothetical person of ordinary skill in the art in question 

(“person of ordinary skill”) as of the effective filing date of the patent application, and is an issue 

of law for the court to decide. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) 

(en banc); Markman, 517 U.S. at 384, 390. 

A. Ordinary Meaning in the Context of the Claims 

When construing claims, the “analytical focus must begin and remain centered on 

the language of the claims themselves, for it is that language that the patentee chose to use to 

‘particularly point out and distinctly claim the subject matter which the patentee regards as his 

invention.’” Interactive Gift Exp., Inc. v. Compuserve Inc., 256 F.3d 1323, 1331 (Fed. Cir. 2001) 

(quoting 35 U.S.C. § 112, ¶ 2, textual modifications adopted); Phillips, 415 F.3d at 1312. Thus, 

claim construction begins with a determination of the “ordinary and customary meaning [a] term 

 

4

 Pending before the Court is AstraZeneca’s motion to amend its statement of asserted 

claims to include claims 3, 5 and 10. See D.I. 81, 82, 86, 90. For completeness, 

AstraZeneca will include these claims in the present claim construction briefing. 

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would have” to a person of ordinary skill, “in the context of the particular claim in which the 

disputed term appears.” Phillips, 415 F.3d at 1312–13 (citations omitted). Extrinsic evidence 

may be consulted to ascertain the ordinary meaning, id. at 1317–19 (see below), but when “the 

ordinary meaning of claim language as understood by a person of skill in the art [is] readily 

apparent even to lay judges,” claim construction “involves little more than the application of the 

widely accepted meaning of commonly understood words.” Id. at 1314. 

B. Intrinsic Evidence 

Claim terms must also be viewed in the context of the intrinsic evidence—

including other claims, the rest of the patent specification and the prosecution history (the back 

and forth communications between the patent applicant and the U.S. Patent and Trademark 

Office (“Patent Office”)). Id. at 1313; Markman, 52 F.3d at 980. 

Other claims of the patent in question, both asserted and unasserted, can be 

“valuable sources of enlightenment.” Phillips, 415 F.3d at 1314. Because claim terms are 

“normally used consistently throughout the patent, the usage of a term in one claim can often 

illuminate the meaning of the same term in other claims.” Id. Moreover, “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.” Id. at 1314–15; RF Delaware. v. Pac. 

Keystone Techs., 326 F.3d 1255, 1263 (Fed. Cir. 2003). 

The rest of the patent specification should also be considered; it can be “the single 

best guide to the meaning of a disputed claim term,” due to its statutory role to “describe the 

claimed invention in ‘full, clear, concise, and exact terms.’” Phillips, 415 F.3d at 1315, 1316 

(quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) and 35 

U.S.C. § 112 ¶ 1). However, absent “words or expressions of manifest exclusion or restriction,” 

claims should not be restricted to embodiments disclosed in the specification. Teleflex, Inc. v. 

Ficosa N. Am. Corp., 299 F.3d 1313, 1327, 1328 (Fed. Cir. 2002); Phillips, 415 F.3d at 1323 

(“Although the specification often describes very specific embodiments of the invention, [the 

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Federal Circuit has] repeatedly warned against confining the claims to those embodiments.”) 

(citations omitted). 

The prosecution history can also be useful in determining the meaning of a claim 

term, as it provides evidence of “how the [Patent Office] and the inventor understood the patent,” 

and whether a term was “limited” or “explained” during prosecution. Phillips, 415 F.3d at 1317; 

Markman, 52 F.3d at 980. However, claims are not limited by the prosecution history unless 

there is a clear and unambiguous disclaimer of subject matter. Omega Eng’g, Inc. v. Raytek 

Corp., 334 F.3d 1314, 1324 (Fed. Cir. 2003); Markman, 52 F.3d at 980. 

In the absence of contravening intrinsic evidence, the ordinary and customary 

meaning of a claim term controls. DSW, Inc. v. Shoe Pavilion, Inc., 537 F.3d 1342, 1347 (Fed. 

Cir. 2008). 

C. Extrinsic Evidence 

A court also may consider extrinsic evidence, which is “all evidence external to 

the patent and prosecution history.” Markman, 52 F.3d at 980. Common forms of extrinsic 

evidence include expert testimony, technical articles and treatises, and dictionaries. Phillips, 415 

F.3d at 1317–19. These may be helpful to “establish that a particular term in the patent . . . has a 

particular meaning in the pertinent field,” to “explain how an invention works” or to “provide 

background on the technology at issue.” Id.; Markman, 52 F.3d at 980. Extrinsic evidence, 

however, is generally “less reliable than the patent and its prosecution history in determining 

how to read claim terms,” and thus may not be “used to contradict claim meaning that is 

unambiguous in light of the intrinsic evidence.” Phillips, 415 F.3d at 1319, 1324; Markman, 52 

F.3d at 980. 

* * * 

During claim construction, “[t]he sequence of steps used by the judge in 

consulting various sources is not important; what matters is for the court to attach the appropriate 

weight to be assigned to those sources.” Phillips, 415 F.3d at 1324. Importantly, in this process, 

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claim terms need be construed “only to the extent necessary to resolve the controversy.” 

Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). Thus, if the 

ordinary meaning of a term is “readily apparent,” the Court may simply rule that the term should 

carry its ordinary and customary meaning and not be limited in a particular manner proposed by 

a party. See, e.g., Columbia Sportswear N. Am., Inc. v. Cerf Bros. Bag Co., 2007 WL 1792304, 

*7, 9–11 (D. Or. 2007) (declining to adopt accused infringer’s proposed constructions, stating: 

“this court will not issue an advisory opinion by undertaking to construe the claim terms with 

greater specificity than necessary to resolve the instant dispute”); Harris Corp. v. IXYS Corp., 

114 F.3d 1149, 1152 (Fed. Cir. 1997) (Where a proposed construction would “contribute nothing 

but meaningless verbiage to the definition of the claimed invention,” the term need not be 

construed.). Relatedly, a Court may decline to entertain a proposed construction that is “so 

convoluted and artificial” that it “is simply unhelpful” to the claim construction process, Dayco 

Prods., Inc. v. Total Containment, Inc., 258 F.3d 1317, 1324 (Fed. Cir. 2001), because 

construction must be “firmly anchored in reality.” Emerson Elec. Co. v. Spartan Tool, LLC, 223 

F.Supp.2d 856, 870–71 (N.D.Ohio 2002) (“claim construction is not philosophy; we need not 

wring our hands when considering the implications of a metaphysical analysis of claim terms. 

Instead, we need only recognize that claim construction is firmly anchored in reality[.]”) (citation 

omitted). 

IV. Construction of the Disputed Claim Language 

Each disputed claim term is addressed in turn below. AstraZeneca’s proposed 

constructions are consistent with the ordinary meaning of the claim language and the intrinsic 

evidence. Hanmi’s proposed constructions are not. 

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A. ’504 Patent Claim Language 

1. “Alkaline salt” (claims 1, 2, 4, 6 and 7) 

AstraZeneca’s Proposed Construction Hanmi’s Proposed Construction 

a basic salt (here, a salt in which (–)-

omeprazole is negatively charged) that is 

suitable for use in a pharmaceutical 

formulation 

Na+, Mg2+, Li+, K+, Ca2+ or N+(R)4 salt 

The term “alkaline salt” appears expressly in ’504 patent independent claims 1, 6 

and 7 as part of the phrase “alkaline salt of [esomeprazole],” and, by dependence, in dependent 

claims 2 and 4. The Court did not construe “alkaline salt” in Dr. Reddy’s. 

AstraZeneca submits that “alkaline salt” should be given its customary and 

ordinary meaning. Hanmi asserts, incorrectly, that “alkaline salt” should be limited to the few 

salts identified in the specification of the ’504 patent as examples of “alkaline” salts. 

a. Ordinary Meaning in the Context of the Claims 

The words “salt” and “alkaline salt” have ordinary meanings that are well 

understood by a person of ordinary skill in the art. In particular, a “salt” is a chemical compound 

made up of two kinds of “ions”—positively-charged “cations” and negatively-charged “anions.” 

Common table salt (sodium chloride) is an example of a salt, made up of positively-charged 

sodium cations and negatively charged chloride anions. Davies ¶ 35. 

An “acidic” salt is one that is generated under acidic conditions or that generates 

an acidic solution when put into water. A “basic” salt (also called an “alkaline” salt) is one that 

is generated under basic or alkaline conditions or that generates a basic or alkaline solution when 

put into water.5

 Davies ¶ 36. 

 

5

 In chemistry, the degree of acidity or alkalinity of a solution is reflected by a numerical 

“pH’ scale. A pH of 7.0 is neutral. Solutions with a pH below 7.0 are acidic, and 

solutions with a pH above 7.0 are basic (or alkaline). Davies ¶ 36 fn. 1. 

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In chemistry, the word “alkaline” derives from two different groups of metals that 

react with water to form basic solutions—the “alkali” metals (which include lithium, sodium, 

potassium, rubidium, and cesium) and the “alkaline earth” metals (which include beryllium, 

magnesium, calcium, strontium, barium, and radium). Davies ¶ 36. 

Thus, in the context of the ’504 patent claims, the ordinary meaning of “alkaline 

salt” of esomeprazole is a basic salt of esomeprazole; that is, a salt of esomeprazole that is 

generated under basic or alkaline conditions, or one that generates a basic or alkaline solution 

when put into water. One of ordinary skill in the art would understand that suitable cations for 

forming an “alkaline salt” of esomeprazole would include, at least, the alkaline metals and 

alkaline earth metals. One skilled in the art also would understand that such suitable cations also 

would include an ammonium group,6

 which is an honorary alkaline salt, since ammonia, when 

dissolved in water, forms a basic or alkaline solution. Davies ¶¶ 36, 37. 

For a salt of esomeprazole to be basic, esomeprazole must be anionic (negatively 

charged) in the salt, and not cationic (in which esomeprazole would be positively charged and 

acidic), which excludes acid addition salts. Davies ¶¶ 37–40. 

In addition, the claims are drawn to a “pharmaceutical formulation” comprising 

an “alkaline salt” of esomeprazole or methods of use thereof. Thus, the term “pharmaceutical 

formulation” would be understood to limit “alkaline salts” to those salts suitable for use in 

pharmaceutical formulations. Davies ¶ 41. 

b. Intrinsic Evidence 

The specification and prosecution history of the ’504 patent both support 

AstraZeneca’s proposed construction of “alkaline salt.” 

 

6

 The chemical group designated “N+(R)4” in the ’504 patent is an ammonium group. 

Davies ¶ 41 fn. 2. 

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For example, in the ’504 patent specification, (i) the “most preferred” salts 

depicted in structures I and II in column 3 are individual enantiomers of omeprazole with a 

negative charge; (ii) the general description of the salt formation specifies that esomeprazole is 

treated “with a base,” rendering it negatively charged, col. 4, ll. 51–61; (iii) Examples 1–3, 6 and 

7, in which salts of esomeprazole are initially formed, involve deprotonation of neutral 

esomeprazole with a base affording it a negative charge; (iv) all exemplary counterions 

mentioned throughout the specification are positively charged, meaning esomeprazole must bear 

a negative charge in salts with such counterions; and (v) the specification emphasizes “the 

surprising high stability in alkaline conditions for the compounds of the invention,” as contrasted 

to the “acidic conditions” employed in unsuccessful prior efforts to prepare “optically pure 

[individual enantiomers of] omeprazole,” compare col. 13, l. 31 – col. 14, l. 4 (discussing the 

stability under alkaline conditions), to col. 1, ll. 27–42 (noting that acidic conditions “would be 

devastating” for the individual enantiomers of the invention). In addition, the specification 

discusses the pharmaceutical uses for the invention throughout, supporting the understanding that 

the claimed “alkaline salts” of esomeprazole are suitable for use in a pharmaceutical formulation. 

Davies ¶¶ 44–51. 

Hanmi’s proposal to limit the scope of “alkaline salt” to those specific salts 

exemplified in the specification (“Na+

, Mg2+, Li+, K+, Ca2+ or N+(R)4”), is inconsistent with the 

claims and specification of the ’504 patent. In fact, dependent claims 3 and 10 are limited to the 

specific “alkaline salts” that Hanmi would have independent claims 1, 6 and 7 limited to. 

Therefore, under the doctrine of claim differentiation, these independent claims presumptively 

should not be limited as Hanmi proposes. Phillips, 415 F.3d at 1314–15; RF Delaware., 326 

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F.3d at 1263. The specification also confirms that the salt forms in claims 3 and 10 are merely 

examples: 

Alkaline salts of the single enantiomers of the invention are, as mentioned above, 

beside the sodium salts (compounds Ia and Ib) and the magnesium salts 

(compounds IIa and IIb), exemplified by their salts with Li+, K+, Ca2+ and 

N

+

(R)4[.] 

Col. 5, ll. 7–11 (emphasis added); Davies ¶¶ 53–54. There are no words or expressions of 

manifest exclusion or restriction to justify Hanmi’s effort to import limitations from the 

specification into the claims. Teleflex, 299 F.3d at 1327, 1328; Phillips, 415 F.3d at 1323 

Hanmi has cited to various events during the prosecution of the ’504 patent in an 

effort to support its improperly narrow proposed construction. For example, Hanmi cites to a 

January 21, 1997 Examiner Interview Summary addressing the patentability of claims, in which 

the Examiner stated: 

A pharmaceutical formulation for oral administration of pure solid state (–) 

enantiomer of omeprazole Na-salt may be allowable after reviewing the data in 

affidavit form. . . . The scope of the claim will depend on the data submitted. 

Chen Exh. 3. Subsequent events during prosecution, however, demonstrate that Hanmi’s 

proposed construction is not suggested by the prosecution history. In a February 18, 1997 

response and amendment, the Applicants discussed and submitted a declaration disclosing: 

clinical studies which involved both the monovalent sodium salt and the divalent 

magnesium salt of the (–)-enantiomer of omeprazole, thus supporting the full 

scope of the genus of alkaline salts disclosed in the application and as claimed 

herein, as suggested by the Examiner at the interview. 

Chen Exh. 4 at 5 (emphasis added). The claims subsequently allowed are the same claims that 

ultimately issued. Thus, contrary to Hanmi’s argument, the Examiner concluded that the data 

submitted by the Applicants was sufficient to support the full scope of claims to “alkaline salts.” 

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* * * 

The intrinsic evidence reinforces the ordinary and customary meaning of “alkaline 

salt,” and thus no additional extrinsic evidence need be consulted. Properly construed, the claim 

language “alkaline salt” means a basic salt (here, a salt in which (–)-omeprazole is negatively 

charged), which covers salts suitable for use in a pharmaceutical formulation and is not limited 

to the exemplary salt forms in the specification. 

2. “(–)-Enantiomer of 5-methoxy-2[[(4-methoxy-3,5-dimethyl-2-

pyridinyl)methyl]sulfinyl]-1H-benzimidazole” alone (claims 1, 3–7 

and 10) and as modified by “optically pure” (claim 2) 

AstraZeneca’s Proposed Construction Hanmi’s Proposed Construction 

(–)-omeprazole in at least 94% enantiomeric 

excess 

– and when modified by “optically pure” – 

in at least 98% enantiomeric excess 

(–)-omeprazole or (–)-enantiomer of 

omeprazole 

– and when modified by “optically pure” – 

essentially free of (+)-omeprazole alkaline 

salt, i.e., the single enantiomer

The term “(–)-enantiomer of 5-methoxy-2[[(4-methoxy-3,5-dimethyl-2-

pyridinyl)methyl]sulfinyl]-1H-benzimidazole” appears in ’504 patent independent claims 1, 6 

and 7, and, by dependence, in the remaining asserted claims. In claim 2, this term is modified by 

“optically pure.” The Court previously construed these terms in Dr. Reddy’s, 2010 WL 

1981790, at *6–8, to mean (–)-omeprazole in at least 94% enantiomeric excess7 and, when 

modified by “optically pure,” in at least 98% enantiomeric excess. In doing so, the Court 

rejected arguments now advanced by Hanmi here. Id. The Court’s previous constructions were 

 

7

 The ratio of enantiomers in a mixture is sometimes generally referred to as its “optical 

purity.” “Enantiomeric excess” (e.e.), is one way to quantify optical purity, and reflects 

the difference between the percentages of the major and minor enantiomers in a mixture. 

For example, 94% enantiomeric excess (–)-omeprazole means that the ratio of major to 

minor enantiomers in the mixture is 97:3 (an excess of 94% of (–) relative to (+)). Davies 

¶ 30. 

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correct. AstraZeneca respectfully requests that the Court adopt those constructions here, for the 

reasons set forth in Dr. Reddy’s. 

3. “Administration of” (claim 6) and “administration to” (claim 7) 

AstraZeneca’s Proposed Construction Hanmi’s Proposed Construction 

No construction is necessary for these terms; 

their ordinary and customary meaning would 

be clear to one skilled in the art. Should 

construction be undertaken, these terms 

should be construed to mean: 

delivery by any suitable means, including but 

not limited to ingestion, which may include 

the prescription by a physician or other 

licensed healthcare professional, dispensing 

and ingestion 

the prescription by a physician or other 

licensed healthcare professional, dispensing 

and ingestion 

The term “administration of” appears in asserted claim 6 of the ’504 patent and 

“administration to” appears in asserted claim 7. The Court did not construe these terms in Dr. 

Reddy’s. 

The dispute over “administration [of/to]” concerns whether its meaning should be 

limited in the manner proposed by Hanmi: “prescription by a physician or other licensed 

healthcare professional, dispensing and ingestion;” or should be given its ordinary and customary 

meaning as proposed by AstraZeneca. 

a. Ordinary Meaning in the Context of the Claims 

The Court need not consult a dictionary or an expert in order to determine that 

“administration,” e.g., of a medicine, does not require “prescription by a physician or other 

licensed healthcare professional, dispensing and ingestion.” While it is true that drugs are often 

prescribed by a physician and dispensed by a pharmacist, many drugs may be obtained over-thecounter and administered without a prescription or involvement of any “licensed healthcare 

professional.” Omeprazole magnesium (in Prilosec® OTC) is one such example. Johnson ¶¶ 

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24, 26. Hanmi’s proposed construction is not found anywhere in the intrinsic evidence and it is 

“convoluted and artificial” and not “firmly anchored in reality,” and therefore should be 

dismissed. Dayco Prods., 258 F.3d at 1324; Emerson Elec., 223 F.Supp.2d at 870–71. 

Moreover, in the claims, these terms are always modified by “oral,” from which a 

person of ordinary skill would understand that “administration” refers to the means of delivery of 

the medicine (i.e., by mouth), rather than to “the prescription by a physician or other licensed 

healthcare professional, dispensing and ingestion,” modification of which by “oral” would be 

nonsensical. Johnson ¶¶ 29, 32. 

Thus, based just on the ordinary meaning of these terms as used in the claims in 

which they appear, the Court should decline to adopt Hanmi’s proposed construction. 

b. Intrinsic Evidence 

Hanmi’s proposed construction is also inconsistent with the intrinsic evidence. 

The specification explains that the compounds of the invention are “formulated into 

pharmaceutical formulations for oral, rectal, parenteral or other modes of administrations.” Col. 

5, ll. 12–15. From this context, and the subsequent elaboration of exemplary formulations for 

“oral administration,” “rectal administration” and “parenteral administration”, and the reference 

to the “route of administration” in the context of discussing dosage, it is evident that 

“administration” in the ’504 patent is often used to convey the means by which the compositions 

of the invention may be delivered. Col. 5, l. 25 – col. 6, l. 24; col. 12, ll. 43–54. Nowhere is the

specification limited to an “administration” requiring a prescription or the involvement of any 

“licensed healthcare professional.” Although a licensed healthcare professional or physician is 

required to diagnose and prescribe a prescription medicine, the specification is not so limited 

and, as discussed above, such a limitation would be inconsistent with the term’s usage in 

reference to the means of delivery. Johnson ¶¶ 28, 30–32. 

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Hanmi points to sections in the ’504 patent specification containing the term 

“patient,” presumably to bolster its argument that “administration” requires the involvement of a 

physician. Col. 2, ll. 12–37 and col. 6, ll. 21–25. However, “patient” as used in the ’504 patent, 

describes nothing more than a person with a condition that may benefit from treatment; it does 

not always or necessarily require the participation of a physician. For example, the term 

“patients” is used in conjunction with “NSAID therapy.” Col. 2, ll. 25–26. NSAIDs (nonsteroidal anti-inflammatory drugs) include common over-the-counter medications like aspirin, 

ibuprofen and naproxen, and thus “patients,” as used in that portion of the ’504 patent, does not 

require the participation of a physician. Johnson ¶¶ 33–35. 

* * * 

Because the meaning of this term is readily apparent and the specification does 

not introduce any ambiguity or support Hanmi’s narrow construction, no additional extrinsic 

evidence need be consulted. “Administration [of/to]” should be given its ordinary and customary 

meaning and not be limited in the manner that Hanmi has proposed. Columbia Sportswear, 2007 

WL 1792304, at *7, 9–11; Harris, 114 F.3d at 1152. Should the Court wish to provide a 

construction that reflects the ordinary meaning, AstraZeneca has proposed a construction that is 

consistent with the intrinsic evidence and that (in an effort to compromise) incorporates Hanmi’s 

proposed language: delivery by any suitable means, including but not limited to ingestion, which 

may include the prescription by a physician or other licensed healthcare professional, 

dispensing and ingestion. 

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4. “A mammal including man in need of such treatment” (claim 7) 

AstraZeneca’s Proposed Construction Hanmi’s Proposed Construction 

No construction is necessary for this term; its 

ordinary and customary meaning would be 

clear to one skilled in the art. Should 

construction be undertaken, this term should 

be construed to mean: 

a mammal including man who may obtain a 

benefit 

a mammal including man in whom the need 

for treatment of gastrointestinal inflammatory 

disease is recognized and/or appreciated by 

the physician or other licensed healthcare 

professional 

The term “a mammal including man in need of such treatment” appears in 

asserted claim 7 of the ’504 patent. The Court did not construe this term in Dr. Reddy’s. 

The dispute here concerns whether this language should be limited to the narrow 

meaning proposed by Hanmi: “a mammal including man in whom the need for treatment of 

gastrointestinal inflammatory disease is recognized and/or appreciated by the physician or other 

licensed healthcare professional,” or should be given its ordinary and customary meaning as 

AstraZeneca proposes. 

a. Ordinary Meaning in the Context of the Claims 

The Court need not consult a dictionary or an expert in order to determine that “a 

mammal including man in need of such treatment” does not require “the need for treatment of 

gastrointestinal inflammatory disease [to be] recognized and/or appreciated by the physician or 

other licensed healthcare professional.” Generally speaking, while the “need” for a medical 

treatment may be assessed by a physician, as noted above many drugs may be obtained over-thecounter and administered without a prescription or involvement of any “licensed healthcare 

professional.” Here, a person of ordinary skill in the art would understand the term “man in need 

of such treatment” to mean a person with a condition, i.e., a class of patient (e.g., persons with a 

gastrointestinal inflammatory disease); the term does not require recognition or appreciation by 

anyone, let alone a physician. Johnson ¶¶ 39–41. Hanmi’s position is nowhere set forth in the 

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intrinsic evidence and is yet another “convoluted and artificial” construction not “firmly 

anchored in reality” that should be dismissed. Dayco Prods., 258 F.3d at 1324; Emerson Elec., 

223 F.Supp.2d at 870–71. 

b. Intrinsic Evidence 

Nowhere does the specification limit claim 7 to require recognition or 

appreciation by a physician or anyone else. Johnson ¶¶ 42, 43. 

* * * 

Because the meaning of this term is readily apparent and the specification does 

not introduce any ambiguity or support Hanmi’s narrow construction, no additional extrinsic 

evidence need be consulted. The term “a mammal including man in need of such treatment” 

should be given its ordinary and customary meaning and not be limited in the manner that Hanmi 

has proposed. Should the Court wish to provide a construction that reflects the ordinary 

meaning, a reasonable construction would be a mammal including man who may obtain a 

benefit. 

B. ’192 Patent Claim Language 

1. “Pharmaceutically acceptable salt” (claims 1–7, 10–19 and 21–23) 

AstraZeneca’s Proposed Construction Hanmi’s Proposed Construction 

a basic salt (here, a salt in which (–)-

omeprazole is negatively charged) that is 

suitable for pharmaceutical administration 

Na+, Mg2+, Li+, K+, Ca2+ or N+(R)4 salt 

– or – 

an acid or alkaline pharmaceutically 

acceptable nontoxic salt 

The term “pharmaceutically acceptable salt” appears expressly or by dependence 

in all of the asserted claims of the ’192 patent. The Court declined to construe this term in Dr. 

Reddy’s, ruling that the ordinary meaning would be understood by a person of ordinary skill. Dr. 

Reddy’s, *21. In Dr. Reddy’s, however, there was no controversy necessitating the construction 

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of this term with any further specificity. Here, Hanmi’s contentions raise issues that were not 

present in Dr. Reddy’s, warranting construction of this term. 

As with the term “alkaline salt,” the parties dispute whether “pharmaceutically 

acceptable salt” in the ’192 patent claims should be limited to the exemplary salts in the 

specification of the ’504 patent, as Hanmi proposes, or should carry the ordinary meaning of 

“alkaline salt” discussed above, as AstraZeneca proposes. Hanmi has also proposed an 

alternative construction that would allow the “pharmaceutically acceptable salts” of the invention 

to cover acid addition salts; a construction with which AstraZeneca disagrees. 

a. Ordinary Meaning in the Context of the Claims 

A “pharmaceutically acceptable salt” is one suitable for pharmaceutical 

administration. This ordinary understanding is supported by the fact that these claims are 

directed to the administration of the claimed salts in pharmaceutical methods of treatment. In the 

claims of the ’192 patent, “pharmaceutically acceptable salt” always modifies the chemical name 

for esomeprazole. Thus, the claimed salt is a salt of esomeprazole suitable for pharmaceutical 

administration. Davies ¶¶ 60–62. 

b. Intrinsic Evidence 

The intrinsic evidence reveals that the meaning of “pharmaceutically acceptable 

salt” in the ’192 patent claims is the same as that for “alkaline salt” in the ’504 patent claims. 

The ’192 patent states at the outset: “The description of salt forms of the single 

enantiomers of omeprazole and the process of making the same is herein incorporated by 

reference to copending Ser. No. 08/376,512.” Col. 1, ll. 10–13. U.S. Patent Application No. 

08/376,512 is the application that issued as the ’504 patent. Therefore, for all of the reasons 

stated above in the context of addressing the meaning of “alkaline salt” in the ’504 patent claims, 

the “salt” of the ’192 patent claims would be understood to be a basic salt, that is, one in which 

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esomeprazole is negatively charged, and not limited to the exemplified salts in the ’504 patent 

specification. Davies ¶ 64. In addition, the use of the salts in pharmaceutical compositions and 

methods of use in the ’504 patent, and in the methods of pharmaceutical administration of the 

’192 patent, confirm the ordinary understanding that the claimed salts are suitable for 

pharmaceutical administration. 

As for Hanmi’s alternative construction of this term—i.e., that it includes acid 

addition salts of esomeprazole—Hanmi cites to column 4, lines 14–16 of the ’192 patent, where 

it states that “the term ‘pharmaceutically acceptable salt’ refers to both acid and alkaline 

pharmaceutically acceptable non-toxic salts.” This statement, however, appears in a paragraph 

that is not limited to esomeprazole as the only active pharmaceutical ingredient, and in fact 

indicates that “other therapeutic ingredients are especially of interest.” Col. 4, ll. 9–19. In the 

overall content of the ’192 patent, a person of ordinary skill thus would not read this statement to 

say that the salts of esomeprazole could be acid addition salts. Because of its unambiguous 

reference to the “salt forms of the single enantiomers of omeprazole” as described in the ’504 

patent (see ’192 patent at col. 1, ll. 10–13), the ’192 patent plainly should be understood to be 

focused on alkaline salts of esomeprazole. Davies ¶¶ 65–66. 

Moreover, when addressing the term “alkaline salt,” the ’504 patent specification 

emphasizes “the surprising high stability in alkaline conditions for the compounds of the 

invention,” as contrasted to the “acidic conditions” employed in prior art in unsuccessful efforts 

to prepare “optically pure [individual enantiomers of] omeprazole.” Compare col. 13, l. 31 to 

col. 14, l. 4, to col. 1, ll. 27–42 (noting that acidic conditions “would be devastating” for the 

individual enantiomers of the invention). This text would confirm the understanding of a person 

of ordinary skill, that “pharmaceutically acceptable salts” of esomeprazole in the ’192 patent are 

“alkaline salts,” just as in the ’504 patent, and do not include acid addition salts. Davies ¶ 67. 

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* * * 

The intrinsic evidence thus provides an unambiguous meaning of 

“pharmaceutically acceptable salt”: a basic salt (here, a salt in which (–)-omeprazole is 

negatively charged), which is suitable for pharmaceutical administration, is not limited to the 

exemplary salt forms in the specification and does not include acid addition salts. No additional 

extrinsic evidence need be consulted. 

2. “Consisting essentially of the (–)-enantiomer of 5-methoxy-2[[(4-

methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1Hbenzimidazole” (claims 1–7, 10–19, 21 and 22) 

AstraZeneca’s Proposed Construction Hanmi’s Proposed Construction 

(–)-omeprazole in at least 98% enantiomeric 

excess 

[(–)-omeprazole or (–)-enantiomer of 

omeprazole] that may also contain substances 

that do not materially affect the claimed novel 

properties 

The term “consisting essentially of the (–)-enantiomer of 5-methoxy-2[[(4-

methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole” appears expressly or by 

dependence in asserted claims 1–7, 10–19, 21 and 22 of the ’192 patent. The Court previously 

construed this term in Dr. Reddy’s, at *9–10, to mean (–)-omeprazole in at least 98% 

enantiomeric excess. The Court’s previous construction was correct. AstraZeneca respectfully 

requests that the Court adopt that construction here, for the reasons set forth in Dr. Reddy’s. 

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3. “Administering to a mammal in need of treatment” (claims 1–7, 10, 11 

and 23) 

AstraZeneca’s Proposed Construction Hanmi’s Proposed Construction 

No construction is necessary for this term; its 

ordinary and customary meaning would be 

clear to one skilled in the art. Should 

construction be undertaken, this term should 

be construed to mean: 

delivery by any suitable means, including but 

not limited to ingestion, which may include 

the prescription by a physician or other 

licensed healthcare professional, dispensing 

and ingestion, to a mammal who may obtain a 

benefit 

the prescription by a physician or other 

licensed healthcare professional, dispensing 

and delivery by any suitable means 

The term “administering to a mammal in need of treatment” appears expressly or 

by dependence in asserted claims 1–7, 10, 11 and 23 of the ’192 patent. The Court did not 

construe this term in Dr. Reddy’s. 

As with the terms “administration [of/to]” and “a mammal including man in need 

of such treatment” in the ’504 patent claims, sections V.A.3. and 4. supra, the parties dispute 

whether this claim language should be limited to the narrow meaning proposed by Hanmi or 

should carry its ordinary and customary meaning, as AstraZeneca proposes. 

a. Ordinary Meaning in the Context of the Claims 

For the same reasons discussed above when addressing the terms “administration 

[of/to]” and “a mammal including man in need of such treatment” in the ’504 patent claims (at 

sections V.A.3. and 4. supra), the Court need not consult a dictionary or an expert in order to 

rule that Hanmi’s construction is unnecessarily narrow and not “firmly anchored in reality.” 

Johnson ¶¶ 46–49. 

b. Intrinsic Evidence 

Hanmi’s proposed construction is also inconsistent with the intrinsic evidence. 

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The specification reveals that “administering” in the ’192 patent, like 

“administration” in the ’504 patent, often refers to the means by which the compounds of the 

invention may be delivered. For example, claim 7, which depends from “claim 1 or 2” limits the 

methods to those in which the compounds are “administered orally.” Similarly, claim 19, which 

depends from claim 12, limits the method to those in which the “medicament” is produced for 

“oral administration.” Dependent claims 8, 9 and 20 similarly limit the methods to those in 

which the compound or “medicament” is “administered parenterally” or “administered by 

intravenous infusion.” The specification goes on to explain that the compounds of the invention 

are “suitable for oral, rectal or parenteral such as subcutaneous, intramuscular, and intravenous 

administration.” Col. 4, ll. 3–8, 19–21; Johnson ¶¶ 50, 51. 

Nowhere do the claims or the specification indicate that a “licensed healthcare 

professional” must always be involved either for assessing “need” of a patient or for 

“administration,” and limiting the claim language in the manner proposed by Hanmi would be 

inconsistent with the term’s usage in reference to the means of delivery. Johnson ¶ 52. 

* * * 

Because the meaning of this term is readily apparent and the specification does 

not introduce any ambiguity or support Hanmi’s narrow construction, no additional extrinsic 

evidence need be consulted. The term “administering to a mammal in need of treatment” should 

be given its ordinary and customary meaning and not be limited in the manner that Hanmi has 

proposed. 

Should the Court wish to provide an alternative reflection of the ordinary 

meaning, AstraZeneca has proposed a construction that is consistent with the ordinary meaning 

and intrinsic evidence and that (in an effort to compromise) incorporates Hanmi’s proposed 

language: delivery by any suitable means, including but not limited to ingestion, which may 

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include the prescription by a physician or other licensed healthcare professional, dispensing and 

ingestion, to a mammal who may obtain a benefit. 

V. Claim Construction Issues Raised in Hanmi’s Summary Judgment Motions 

Hanmi has filed five summary judgment motions. D.I. 97–117. 

In its “Motion for Summary Judgment No. 3: Invalidity of U.S. Patent No. 

5,714,504 – Claims 1-2, 4, 6 and 7 Based on ‘Solid State’” (“Motion 3”), Hanmi asserts that the 

’504 patent claim term “solid state” has no art-recognized meaning. D.I. 101-2 at 8. But, this 

Court, in Dr. Reddy’s, determined that “solid state” should be given its customary and ordinary 

meaning which “would be clear to one skilled in the art.” Dr. Reddy’s, at *9. At a minimum, to 

the extent Hanmi is now contesting the Court’s prior claim construction determination, its 

Motion 3 will require the parties and the Court to address this as part of claim construction. 

In its “Motion for Summary Judgment No. 1: Non-Infringement of U.S. Patent 

No. 5,877,192 – Claims 1-11, 13-18 and 20-23” (“Motion 1”), Hanmi alleges that infringement 

of claims 1–13, 23–18 and 20–23 of the ’192 patent requires “clinical evaluation” of a particular 

benefit esomeprazole exhibits as compared to omeprazole. D.I. 98 at 3–4. For this theory, 

Hanmi relies on language in these claims that the Court previously construed, Dr. Reddy’s, at 

*10–19, and which construction the parties here agreed to adopt. D.I. 92. AstraZeneca submits 

that the Court’s previous construction does not require any “clinical evaluation,” and thus, at a 

minimum, some clarification of the Court’s previous claim construction is necessary to resolve 

Motion 1. 

AstraZeneca will respond to Hanmi’s summary judgment motions in due course. 

But, with respect to Hanmi’s Motions 1 and 3, AstraZeneca submits that any claim construction 

issues presented by those motions logically should be considered at the same time as the other 

claim construction issues described in this brief. Accordingly, AstraZeneca submits that the 

schedule of the present Markman proceedings be coordinated with any schedule for resolution of 

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Motions 1 and 3. It makes no sense for the Court to address different claim construction issues 

on different tracks. What makes sense is to conflate these different schedules into a single 

schedule. 

VI. Conclusion

For the foregoing reasons, AstraZeneca respectfully requests that the Court adopt 

AstraZeneca’s proposed constructions of the claim terms in dispute. 

 Respectfully submitted, 

Dated: November 7, 2011 By: s/ John E. Flaherty 

John E. Flaherty 

Jonathan M.H. Short 

McCARTER & ENGLISH, LLP 

Four Gateway Center 

100 Mulberry Street 

Newark, New Jersey 07102 

(973) 622-4444 

Attorneys for Plaintiffs 

ASTRAZENECA AB, 

AKTIEBOLAGET HÄSSLE, 

ASTRAZENECA LP, KBI INC. 

and KBI-E INC. 

Of Counsel: 

Henry J. Renk 

Bruce C. Haas 

Colleen Tracy 

Joshua I. Rothman 

FITZPATRICK, CELLA, HARPER 

& SCINTO 

1290 Avenue of the Americas 

New York, New York 10104-3800 

(212) 218-2100 

Errol B. Taylor 

Fredrick M. Zullow 

MILBANK, TWEED, HADLEY 

 & McCLOY LLP 

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1 Chase Manhattan Plaza 

New York, New York 10005-1413 

(212) 530-5000 

Einar Stole 

COVINGTON & BURLING LLP 

1201 Pennsylvania Avenue, NW 

Washington, DC 20004-2401 

(202) 662-6000 

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CERTIFICATE OF SERVICE 

I hereby certify that on November 7, 2011, I caused a copy of the foregoing 

ASTRAZENECA’S OPENING MARKMAN BRIEF and supporting documents to be served 

upon the following counsel by operation of the Court’s electronic filing system and/or electronic 

mail: 

Allyn Z. Lite (alite@litedepalma.com) 

Michael E. Patunas (mpatunas@litedepalma.com) 

Mayra V. Tarantino (mtarantino@litedepalma.com) 

LITE DEPALMA GREENBERG 

Two Gateway Center, 12th Floor 

Newark, New Jersey 07102 

T: (973) 623-3000 

Mark Boland (mboland@sughrue.com) 

Michael R. Dzwonczyk (mdzwonczyk@sughrue.com) 

Renita Rathinam (rrathinam@sughrue.com) 

SUGHRUE MION, PLLC 

2100 Pennsylvania Avenue, NW Suite 800 

Washington, D.C. 20037-3213 

T: (202) 293-7060 

John B. Scherling (jscherling@sughrue.com) 

SUGHRUE MION, PLLC 

4250 Executive Square, Suite 900 

La Jolla, California 92037 

T: (858) 795-1180 

 By: s/ John E. Flaherty 

 John E. Flaherty 

 

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