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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/CounterclaimDefendants AstraZeneca AB, 

 Aktiebolaget Hässle, AstraZeneca LP, 

 KBI Inc. and KBI-E Inc. 

Of Counsel: 

Errol B. Taylor 

Fredrick M. Zullow 

MILBANK, TWEED, HADLEY 

 & McCLOY LLP 

1 Chase Manhattan Plaza 

New York, New York 10005-1413 

(212) 530-5000 

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 

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. 

Oral Argument Requested

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

Judge Joel A. Pisano 

Magistrate Judge Tonianne J. Bongiovanni 

PLAINTIFFS’ RESPONSE IN OPPOSITION TO 

DEFENDANTS’ 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” 

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TABLE OF CONTENTS 

Page 

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

II. FACTUAL BACKGROUND ............................................................................................. 3

III. LEGAL STANDARDS ...................................................................................................... 5

A. Definiteness............................................................................................................. 5

B. Written Description ................................................................................................. 6

C. Enablement ............................................................................................................. 7

D. Summary Judgment ................................................................................................ 8

IV. HANMI’S MOTION 3 OF INVALIDITY SHOULD BE DENIED .................................. 9

A. The meaning of “solid state” would be clear to one skilled in the art .................... 9

B. “Solid state” means “solid material” to a person of skill in the art...................... 10

C. “Pure solid state alkaline salts” are described in the ’504 Patent ......................... 10

D. A person of ordinary skill in the art could make and use “pure solid state 

alkaline salts” ........................................................................................................ 13

1. The facts relevant to evaluation of the In re Wands factors are in 

dispute ....................................................................................................... 13

a. The breadth of the claims is in dispute ......................................... 13

b. The amount of direction and guidance is in dispute ..................... 14

c. The presence of working examples is in dispute .......................... 15

d. The quantity of experimentation is in dispute............................... 15

e. Professor Davies establishes that the Wands factors, when 

considered together, demonstrate at most routine 

experimentation would be required to make and use the 

claimed invention .......................................................................... 16

2. The Prosecution History of the ’504 Patent Further Shows That 

The Enablement Requirement Is Met ....................................................... 17

V. CONCLUSION ................................................................................................................. 17 

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TABLE OF AUTHORITIES 

Page(s) 

CASES

All Dental Prodx, LLC v. Advantage Dental Prods., Inc., 

309 F.3d 774 (Fed. Cir. 2002)..............................................................................................5, 11 

Amgen, Inc. v. Chugai Pharm. Co., 

927 F.2d 1200 (Fed. Cir. 1991)..................................................................................................7 

Amgen Inc. v. Hoechst Marion Roussel, Inc., 

314 F.3d 1313 (Fed. Cir. 2003)..................................................................................................7 

Anderson v. Liberty Lobby, Inc., 

477 U.S. 242 (1986) ...................................................................................................................8 

Ariad Pharm., Inc. v. Eli Lilly & Co., 

598 F.3d 1336 (Fed. Cir. 2010) (en banc)............................................................................6, 10 

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

Civ. A. No. 05-5553 (JAP), 2010 WL 1981790 (D.N.J. May 18, 2010) (Pisano, J.) ...... passim

Atlas Powder Co. v. E.I. Du Pont De Nemours & Co., 

750 F.2d 1569 (Fed. Cir. 1984)..................................................................................................7 

Automotive Technologies International, Inc. v. BMW of North America, Inc., 

501 F.3d 1274 (Fed. Cir. 2007)................................................................................................16 

Bancorp Servs., L.L.C. v. Hartford Life Ins. Co., 

359 F.3d 1367 (Fed. Cir. 2004)..................................................................................................5 

Energizer Holdings, Inc. v. Int’l Trade Comm’n, 

435 F.3d 1366 (Fed. Cir. 2006)..................................................................................................5 

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

149 F.3d 1309 (Fed. Cir. 1998)..................................................................................................8 

Hynix Semicond’r Inc. v. Rambus Inc.,

645 F.3d 1336 (Fed. Cir. 2011)............................................................................................5, 10 

ICU Med., Inc. v. Alaris Med. Sys., Inc., 

 558 F.3d 1368, 1376 (Fed. Cir. 2009) .................................................................................5, 10 

In re Gabapentin Patent Litig., 

395 F. Supp. 2d 175 (D.N.J. 2005) ........................................................................................6, 7 

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In re Gaubert, 

524 F.2d 1222 (CCPA 1975) .................................................................................................7, 8 

In re Wands, 

858 F.2d 731 (Fed. Cir. 1988)..............................................................................................7, 15 

In re Wright, 

866 F.2d 422 (Fed. Cir. 1989)..................................................................................................11 

Koito Mfg. Co. v. Turn-Key-Tech, LLC, 

381 F.3d 1142 (Fed. Cir. 2004)................................................................................................11 

Martek Biosci. Corp. v. Nutrinova, Inc., 

579 F.3d 1363 (Fed. Cir. 2009)..................................................................................................7 

Microsoft Corp. v. i4i Ltd., 

131 S. Ct. 2238 (2011) ...............................................................................................................8 

PPG Indus., Inc. v. Guardian Indus. Corp., 

75 F.3d 1558 (Fed. Cir. 1996)....................................................................................................7 

Spine Solutions, Inc. v. Medtronic Sofamor Danek USA, Inc. 

620 F.3d 1305 (Fed. Cir. 2010)............................................................................................6, 10 

Trading Techs. Int’l, Inc. v. eSpeed, Inc., 

595 F.3d 1340, 1359 (Fed. Cir. 2010) .......................................................................................8 

TriMed, Inc. v. Stryker Corp., 

608 F.3d 1333 (Fed. Cir. 2010)..................................................................................................8 

Union Oil Co. Cal. v. Atl. Richfield Co., 

208 F.3d 989 (Fed. Cir. 2000)....................................................................................................6 

STATUTES

35 U.S.C. § 282 ................................................................................................................................8 

OTHER AUTHORITIES

Court’s Markman .............................................................................................................................9 

U.S. Patent No. 5,714,504...................................................................................................... passim

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I. INTRODUCTION 

AstraZeneca’s1

 U.S. Patent No. 5,714,504 in suit (the “’504 Patent”; Parezo Decl. 

Exh. B)2 describes and claims pharmaceutical formulations comprising the pure solid state 

alkaline salts of esomeprazole3 and methods for inhibiting gastric acid production and treating 

gastrointestinal inflammatory disease. The claimed inventions are based on the discovery that 

esomeprazole has certain improved properties, and provides certain biological benefits, as 

compared to omeprazole. For example, the inventors discovered that esomeprazole produces 

improved pharmacokinetic and metabolic properties, which will give an improved therapeutic 

profile, such as a lower degree of interindividual variation. (Parezo Decl. Exh. B, col.1 ll. 50–

53.) 

Hanmi4 has applied for permission from the U.S. Food and Drug Administration to sell a 

generic version of Nexium® that uses esomeprazole strontium, prior to the expiration of the ’504 

Patent. In its Motion 3, Hanmi contends that the ’504 Patent does not meet the written 

description, enablement, and definiteness requirements of Section 112 of the Patent Code. Each 

argument advanced by Hanmi is inconsistent with its expressed willingness to be bound by the 

Court’s prior ruling that “solid state” had a clear meaning to skilled artisans. 

In a May 18, 2010 opinion in another action involving the ’504 Patent, AstraZeneca AB v. 

Dr. Reddy’s Laboratories, Ltd., Civ. A. No. 05-5553 (JAP), 2010 WL 1981790 (D.N.J. May 18, 

 

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 Jessica L. Parezo (“Parezo Decl.”), Dr. 

Stephen G. Davies (“Davies Decl.”) and Hon. Lawrence J. Goffney, Jr. (“Goffney Decl.”). 

3

 Esomeprazole is also known as the (–)-enantiomer of omeprazole, (–)-omeprazole, (S)-

omeprazole, and the S-enantiomer of omeprazole. 

4

 “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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2010) (Pisano, J.) (henceforth “Dr. Reddy’s”), this Court held that the term “solid state” in the 

’504 Patent had a plain and clear meaning to persons of ordinary skill in the art. Id. at *9. 

Hanmi has agreed to be bound by this decision. In a letter to the Court, Hanmi states that the 

instant summary judgment motion “seeks a judgment of invalidity of the asserted claims of the 

’504 Patent based on their inclusion of the term ‘solid state,’ which was previously construed by 

the Court.” (Defs.’ Ltr. to Court of Oct. 19, 2011, n.1, D.I. 121.) Hanmi has confirmed its 

agreement to be bound by the Court’s decision by omitting “solid state” from the list of terms 

requiring construction in the claim construction proceedings of this case. (See Joint Claim 

Constr. & Preh’g Stmt. of Sept. 14, 2011, D.I. 92.)

Hanmi’s motion should be denied. Hanmi’s motion should be precluded by, at least, its 

agreement to be bound by this Court’s prior decision. Contrary to Hanmi’s argument, this Court 

did not find that the term “solid state” excludes material in a “solid form,” as Hanmi now says is 

required. This Court simply determined that for “solid state”: 1) its ordinary and customary 

meaning would be clear to one skilled in the art, and 2) the plain meaning of the term as 

understood by someone of ordinary skill shall apply. Not only is Hanmi’s position inconsistent 

with the Court’s prior Order, but Professor Stephen G. Davies, an expert in organic chemistry, 

confirms that a person of ordinary skill in the art would have understood “solid state” to mean 

solid material, whether crystalline or amorphous. (Davies Decl. ¶ 83). For all these reasons, 

Hanmi’s Motion 3 that alleges that claims 1, 2, 4, 6 and 7 of the ’504 Patent are indefinite must 

fail. Hanmi’s arguments for invalidity based on lack of written description and enablement also 

rely on its failed allegation of alleged indefiniteness of “solid state.” These arguments, too must 

fail, and summary judgment should be denied with prejudice. 

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AstraZeneca respectfully requests that the Court confirm its ruling in Dr. Reddy’s that the 

ordinary and customary meaning of “solid state” would be clear to a skilled person, and rule, 

now, that the plain meaning of “solid state” is “solid material in any form.” Because resolution 

of Motion 3 depends on these claim construction issues, AstraZeneca proposes that the Court 

schedule resolution of Motion 3 as part of the ongoing Markman proceedings. 

Finally, disputed issues of material fact also preclude summary judgment. Hanmi is not 

only moving for summary judgment on an inherently factual issue, but is doing so before any 

discovery—fact or expert—has taken place. Hanmi relies heavily on the declaration of an expert 

whom Plaintiffs have had no opportunity to depose. Plaintiffs expect that a deposition would 

reveal further disputed issues of material fact. Plaintiffs have provided a declaration from 

Professor Davies that confirms what the Court already knows: that the meaning of “sold state” is 

plain and clear to persons of skill in the art. 

II. FACTUAL BACKGROUND 

Omeprazole is a racemic mixture of its two single enantiomers, the (+)-enantiomer and 

the (–)-enantiomer. The (–)-enantiomer of omeprazole is also known as “esomeprazole.” The 

inhibition of gastric acid secretion is desirable in the treatment of gastric acid-related diseases 

and gastrointestinal inflammatory diseases in mammals and man, such as gastric ulcer, duodenal 

ulcer, reflux esophagitis and gastritis. (Parezo Decl. Exh. B, col.2 ll.17–23.) 

The ’504 patent5

 relates to pure alkaline salts of (–)-omeprazole (Parezo Decl. Exh. B, 

col.2 l.42– col.3 l.35; col.5 ll.12–20) and pharmaceutical formulations and methods for treating 

gastric acid-related conditions. The inventors found that the newly discovered alkaline salts of 

 

5

 All discussion herein of the ’504 Patent disclosure applies equally to the disclosure of the 

original patent application from which the ’504 Patent directly issued. 

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(–)-omeprazole provided advantages of purity and stability, which result in improved 

pharmacokinetic properties. (Id. col.13 ll.31–48.) The ’504 Patent further relates to the 

inhibition of gastric acid secretion and treatment of gastric acid-related conditions and 

gastrointestinal diseases. (Id. col.2 ll.16–30.) 

This Court previously has held, in an order that Hanmi agreed to be bound by, that the 

ordinary and customary meaning of “solid state” is clear and, therefore, that its plain meaning 

applies in the claims of the ’504 Patent. Dr. Reddy’s, at *9. In Dr. Reddy’s, AstraZeneca had 

proposed that “solid state” should be construed as “a solid form rather than liquid, such as, a 

syrup or oil.” Id. The defendant, Dr. Reddy’s Laboratories, had proposed that no construction of 

“solid state” was necessary or, in the alternative, that it should be construed as “solid form.” Id. 

The Court stated: 

With respect to its proposed construction, Astra provides no 

justification for the language that distinguishes a “solid form” from 

a “liquid, such as, a syrup or oil.” Moreover, the Court agrees with 

DRL that no construction of this term is necessary finds that its 

ordinary and customary meaning would be clear to one skilled in 

the art. Therefore, the plain meaning of the term as understood by 

someone of ordinary skill shall apply. 

Id. (emphases added). 

 “Solid state” does, in fact, have a plain and ordinary meaning to a person of ordinary 

skill in the art. (AZ SOF ¶¶ 106; 129.) Professor Davies, an expert in organic chemistry, 

confirms that one of ordinary skill in the art would have understood “solid state” to mean solid 

material in any form. (Davies Decl. ¶ 83; AZ SOF ¶ 109.) Such solid material would have 

included crystalline solids and amorphous solids. (Davies Decl. ¶ 83; AZ SOF ¶ 109.) A person 

of ordinary skill in the art would also have understood that crystalline solids and amorphous 

solids could be used to form solid pharmaceutical formulations, including powder and tablets. 

(Davies Decl. ¶ 83; AZ SOF ¶ 110.) 

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A person of ordinary skill in the art in 1993 would have understood, based on the ’504 

Patent specification, that the clamed solid state salts were described in the specification and that 

the inventors had possession of the claimed solid state salts. (Davies Decl. ¶ 95; AZ SOF ¶¶ 

130–132.) In addition, a person of ordinary skill in the art would have understood how to make 

and use the claimed solid state salts, based on the ’504 Patent specification. (Davies Decl. ¶ 135; 

AZ SOF ¶¶ 133–152.) Moreover, and consistent with this Court’s determination in Dr. Reddy’s, 

a person of ordinary skill in the art would have found the claimed solid state salts to have a plain 

and ordinary meaning in the art and clear scope. (Davies Decl. ¶ 93; AZ SOF ¶¶ 106; 108–110; 

129.) 

III. LEGAL STANDARDS 

A. Definiteness 

A claim can be found indefinite only if the challenger proves that it is “insolubly 

ambiguous.” Bancorp Servs., L.L.C. v. Hartford Life Ins. Co., 359 F.3d 1367, 1346 (Fed. Cir. 

2004). Before a claim can be found to be indefinite, an effort must be made to construe it. See, 

e.g., Energizer Holdings, Inc. v. Int’l Trade Comm’n, 435 F.3d 1366, 1368 (Fed. Cir. 2006) (“An 

analysis of claim indefiniteness under § 112 ¶ 2 is inextricably intertwined with claim 

construction.”) (internal quotation marks omitted); All Dental Prodx, LLC v. Advantage Dental 

Prods., Inc., 309 F.3d 774, 780 (Fed. Cir. 2002) (“[Determining indefiniteness] requires a 

construction of the claims according to the familiar canons of claim construction. Only after a 

thorough attempt to understand the meaning of a claim has failed to resolve material ambiguities 

can one conclude that the claim is invalid for indefiniteness.”). 

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B. Written Description 

Lack of an adequate written description must be established by the challenger by clear 

and convincing evidence. Hynix Semicond’r Inc. v. Rambus Inc., 645 F.3d 1336, 1351 (Fed. Cir. 

2011) (citing ICU Med., Inc. v. Alaris Med. Sys., Inc., 558 F.3d 1368, 1376 (Fed. Cir. 2009)). 

The written description requirement is satisfied if “the disclosure of the application relied 

upon reasonably conveys to those skilled in the art that the inventor had possession of the 

claimed subject matter as of the filing date.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 

1336, 1351 (Fed. Cir. 2010) (en banc). The written description requirement “does not demand 

any particular form of disclosure,” and it is well established that the specification need not 

“recite the claimed invention in haec verba.” Id. at 1352. Inherent disclosure is sufficient to 

provide written description support for the claimed invention. Spine Solutions, Inc. v. Medtronic 

Sofamor Danek USA, Inc., 620 F.3d 1305, 1313–14 (Fed. Cir. 2010). 

“The test [for written description] requires an objective inquiry into the four corners of 

the specification from the perspective of a person of ordinary skill in the art. . . . This inquiry, as 

we have long held, is a question of fact.” Ariad, 598 F.3d at 1351; see, e.g., Union Oil Co. Cal. 

v. Atl. Richfield Co., 208 F.3d 989, 996 (Fed. Cir. 2000) (“In written description cases, the 

primary consideration is factual and depends on the nature of the invention and the amount of 

knowledge imparted to those skilled in the art by the disclosure.”) (internal quotation marks 

omitted). 

Because written description is a question of fact, courts have recognized that it typically 

cannot be resolved on summary judgment. See, e.g., In re Gabapentin Patent Litig., 395 F. 

Supp. 2d 175, 180 (D.N.J. 2005) (denying summary judgment of invalidity based on written 

description and noting that “[t]he relevant inquiry is factual and focuses on whether one skilled 

in the art would understand the supporting language in the specification to describe the same 

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inventive concept found in the claims.”). The District Court of New Jersey has recognized that 

conflicting expert affidavits in particular are sufficient basis for denying summary judgment on 

written description: “That expert affidavits conflict concerning the written description 

requirement has been held sufficient to preclude summary judgment.” Id. (emphasis added). 

C. Enablement 

A claim is enabled if the patent specification “teach[es] those skilled in the art how to 

make and use the full scope of the claimed invention without undue experimentation.” Martek 

Biosci. Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1378 (Fed. Cir. 2009) (internal quotation marks 

omitted). “Whether undue experimentation is needed is not a single, simple factual 

determination, but rather is a conclusion reached by weighing many factual considerations.” In 

re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988) (emphasis added). In other words, “[t]hat some 

experimentation is necessary does not preclude enablement.” Atlas Powder Co. v. E.I. Du Pont 

De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984). Rather, a “considerable amount of 

experimentation is permissible, if it is merely routine.” PPG Indus., Inc. v. Guardian Indus. 

Corp., 75 F.3d 1558, 1564 (Fed. Cir. 1996). 

In Wands, 858 F.2d at 737, the Federal Circuit identified the eight distinct factual issues 

that may be pertinent to whether the enablement requirement is satisfied. However, “it is not 

necessary that a court review all the Wands factors to find a disclosure enabling. They are 

illustrative, not mandatory. What is relevant depends on the facts.” Amgen, Inc. v. Chugai 

Pharm. Co., 927 F.2d 1200, 1213 (Fed. Cir. 1991). 

In addition, it is well established that to satisfy the enablement requirement, “[t]he 

specification need not explicitly teach those in the art to make and use the invention; the 

requirement is satisfied if, given what they already know, the specification teaches those in the 

art enough that they can make and use the invention without ‘undue experimentation.’” Amgen 

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Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1334 (Fed. Cir. 2003); see, e.g., In re 

Gaubert, 524 F.2d 1222, 1226 (CCPA 1975) (“Enablement is the criterion, and every detail need 

not be set forth in the written specification if the skill in the art is such that the disclosure enables 

one to make the invention.”) (internal quotation marks omitted). 

D. Summary Judgment 

Summary judgment may not be granted unless the moving party demonstrates that there 

is no genuine dispute of material fact and that the undisputed facts establish the movant’s 

entitlement to judgment as a matter of law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247–

48 (1986). Courts may grant summary judgment only “when no reasonable jury could return a 

verdict for the nonmoving party.” Ethicon Endo-Surgery, Inc. v. U.S. Surgical Corp., 149 F.3d 

1309, 1315 (Fed. Cir. 1998) (internal quotation marks omitted). 

In considering a motion for summary judgment, the Court must “view the evidence in a 

light most favorable to the party opposing the motion with doubts resolved in favor of the 

opponent.” Ethicon, 149 F.3d at 1315. Evidence in support of summary judgment “is viewed 

through the prism of the evidentiary standard of proof that would pertain at a trial on the merits.” 

TriMed, Inc. v. Stryker Corp., 608 F.3d 1333, 1339–40 (Fed. Cir. 2010). Because patents carry a 

strong presumption of validity, see 35 U.S.C. § 282, Hanmi must prove the disputed facts 

underlying an invalidity contention by clear and convincing evidence, a burden which is 

“constant and never changes.” Microsoft Corp. v. i4i Ltd., 131 S. Ct. 2238, 2243 (2011) (internal 

quotation marks omitted). 

Summary judgment should be denied when a dispute of material fact exists between the 

parties regarding the adequacy of the disclosure in a patent application to which a later-filed 

application claims priority. See Trading Techs. Int’l, Inc. v. eSpeed, Inc., 595 F.3d 1340, 1359 

(Fed. Cir. 2010) (affirming the District Court’s denial of summary judgment because 

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irreconcilable testimony regarding the adequacy of the disclosure in a provisional patent 

application created a dispute of material fact). 

IV. HANMI’S MOTION 3 OF INVALIDITY SHOULD BE DENIED 

Hanmi’s Motion 3 should be denied for several reasons. First, Motion 3 for a summary 

judgment of indefiniteness is foreclosed by its agreement to be bound by the Court’s prior ruling 

that the term “solid state” has a plain and ordinary meaning that is clear to persons of ordinary 

skill in the art. Plainly, a claim term whose meaning is “clear” cannot render a claim indefinite. 

Hanmi represented to the Court that it is not challenging the Court’s prior construction of 

the term “solid state.” (Defs.’ Ltr. to Court of Oct. 19, 2011, n.1, D.I. 121; Joint Claim Constr. & 

Preh’g Stmt. of Sept. 14, 2011, D.I. 92.) If Hanmi disagreed with the Court’s decision that the 

term would be clear to a person of ordinary skill in the art, Hanmi should have raised the issue 

during the Markman proceedings in this case. It did not do so. Hanmi should not be allowed to 

circumvent the Court’s Markman proceedings through summary judgment. Accordingly, 

Hanmi’s motion for a summary judgment of indefiniteness should be denied. 

A. The meaning of “solid state” would be clear to one skilled in the art 

The Court has already determined and Hanmi has already agreed that the meaning of 

“solid state” would be clear to one of ordinary skill in the art. Dr. Reddy’s, at *9. Yet Hanmi 

now asserts that a that the Court held to have a plain and ordinary meaning and is clear to 

persons of ordinary skill in the art somehow has “fatal ambiguity” that renders it indefinite 

(Defs.’ Br. Summ. J. 23.) Hanmi should be bound by its representations in this case. Hanmi’s 

assertion cannot be squared with this Court’s conclusion. 

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B. “Solid state” means “solid material” to a person of skill in the art 

The term “solid state” had a clear meaning to persons of ordinary skill in the art. 

Professor Davies explains that a one of ordinary skill in the art would have understood, based on 

the ’504 Patent disclosure, that the meaning of “solid state” was plain and clear. (Davies Decl. 

¶¶ 78–93; AZ SOF ¶ 106.) The plain meaning of “solid state” is solid material in any form. 

(Davies Decl. ¶ 83; AZ SOF ¶ 109.) Solid material would have included at least crystalline 

solids and amorphous solids, as well as solid pharmaceutical formations such as powders and 

tablets. (Davies Decl. ¶ 83; AZ SOF ¶¶ 109–110. ) This understanding of the scope of the term 

“solid state alkaline salts of (–)-omeprazole” by one of ordinary skill establishes that the ’504 

Patent satisfies the definiteness requirement of Section 112. 

AstraZeneca respectfully requests that the Court adopt “solid material” as the meaning of 

“solid state,” an issue of claim construction, as part of the ongoing Markman proceedings. 

C. “Pure solid state alkaline salts” are described in the ’504 Patent 

Hanmi falls far short of carrying its burden of establishing, based on undisputed facts, 

that claims 1, 2, 4, 6 and 7 of the ’504 Patent fail to satisfy the written description requirement of

Section 112. The claims of the ’504 Patent are presumed to be supported by an adequate written 

description. Hanmi has failed to establish by clear and convincing evidence that the patent does 

not meet this requirement. Hynix, 645 F.3d at 1351 (citing ICU Med., 558 F.3d at 1376). 

Hanmi’s written description argument rests on two fundamental errors. First, Hanmi 

mistakenly asserts that a person of skill in the art would have found the term “solid state” 

unclear. (Defs.’ Br. Summ. J. 10.) Second, Hanmi’s argument disregards that the written 

description requirement “does not demand any particular form of disclosure, or that the 

specification recite the claimed invention in haec verba.” Ariad, 598 F.3d at 1352 (internal 

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citation omitted). Although Hanmi makes much of the absence of the phrase “solid state” in the 

specification, it is well established that the specification does not need to use the exact same 

terms as used in the claims to satisfy the written description requirement. See Spine Solutions, 

620 F.3d at 1313–14 (granting summary judgment of adequate written description upon 

determining that “[t]he fact that the specification never mentions the word . . . is not sufficient to

create a genuine dispute of material fact”); see also Koito Mfg. Co. v. Turn-Key-Tech, LLC, 381 

F.3d 1142, 1154 (Fed. Cir. 2004) (holding that terms need not be used in haec verba). On the 

contrary, “[t]he fact . . . that the exact words . . . in question . . . are not in the specification is not 

important” to the written description inquiry. In re Wright, 866 F.2d 422, 425 (Fed. Cir. 1989). 

Indeed, with respect to newly-added claim language involving forms of material, the 

Federal Circuit has confirmed that the patent application need not expressly include details on 

such forms of material. In All Dental Prodx, 309 F.3d at 779, the Federal Circuit considered the

written description support for the claimed phrase “original unidentified mass” of material for 

making dental impressions. The application as originally filed did not contain this phrase, nor 

did it mention the shape or form of the mass anywhere in the patent specification. Id. However, 

the Federal Circuit held that the claimed phrase satisfied the written description requirement 

because “the failure of the specification to specifically mention a limitation that later appears in 

the claims is not a fatal one when one skilled in the art would recognize upon reading the 

specification that the new language reflects what the specification shows has been invented.” Id. 

The Federal Circuit reversed the District Court’s grant of summary judgment of invalidity. Id. 

The holding of All Dental Prodx is squarely applicable here. The ’504 Patent discloses 

and teaches how to make alkaline salts of (–)-omeprazole that are in crystalline form, amorphous 

form, powders or tablets—all forms that a person of ordinary skill would recognize as solid state. 

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Professor Davies explains that a person of ordinary skill would understand from the’504 

Patent that the inventors were in possession of the claimed formulation comprising, among other 

features, pure solid state alkaline salts of (–)-omeprazole. (Davis Decl. ¶ 95; AZ SOF ¶¶ 130–

132.) The ’504 Patent describes throughout its specification that the alkaline salts products of 

(–)-omeprazole are “crystalline.” (See, e.g., Parezo Decl. Exh. B, col.1 ll.56–58; col.3 ll.35–37, 

40–41.) Multiple examples set forth in the ’504 Patent—Examples 2, 5 and 6—detail the 

preparation of alkaline salts of (–)-omeprazole in crystalline form and as powder. For example, 

Example 6 states that “[t]he product was crystalline as shown by powder X-ray diffraction . . . .” 

(Id. col.8 ll.49–50.) The plain meaning of “solid state” includes solid material such as the 

crystals and powder expressly described in the ’504 Patent specification. (Davies Decl. ¶¶ 83; 

95; 120–22; AZ SOF ¶¶ 117–129.) 

Finally, the phrase “solid state” was endorsed by the Examiner in the Interview 

Summary. (Goffney Decl. ¶ 38; see Defs.’ Rathinam Decl. Exh. 3, HAN0039582; AZ SOF ¶

98.) The Examiner is required to address a claim term by using their “plain meaning,” which is 

the meaning given to the term by those of ordinary skill in the art. (Goffney Decl. ¶ 37 (citing 

MPEP § 2111.01, 2100-44 to -45 (6th ed. rev. 2, July 1996)); AZ SOF ¶ 100.) Also, the USPTO 

directs examiners to consider all Section 112 issues, including written description, during 

examination. (Goffney Decl. ¶ 39; AZ SOF ¶ 101.) Accordingly, the Examiner considered 

whether the agreed-upon claim term “solid state” was in compliance with the written description 

requirement. (Goffney Decl. ¶ 40; AZ SOF ¶ 104.) Further, the Examiner is charged with 

ensuring that claim language has sufficient written description, again by applying the 

understanding of those of ordinary skill in the art. MPEP at § 2163.04, 2100-131 to -132. In 

particular, the Examiner is charged with analyzing new claim language to ensure that no new 

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matter is presented in claim amendments. See id. at §§ 2163.05, 2163.06, 2100-132 to -134. 

Thus, the fact that the Examiner endorsed the term “solid state” evidences that the term has a 

plain meaning to persons of ordinary skill in the art and demonstrates that the USPTO 

specifically considered whether there was adequate written description for the term, and 

concluded that there was. 

D. A person of ordinary skill in the art could make and use “pure solid 

state alkaline salts” 

Enablement is generally a fact-dependent inquiry, and in this case there are numerous 

material facts in dispute. The specification of the ’504 Patent properly and adequately enables a 

person of ordinary skill in the art to make and use the pharmaceutical formulations and methods 

of claims 1, 2, 4, 6 and 7 through working examples, and the amount of direction and guidance it 

provides. The facts that led to allowance of claims 1, 2, 4, 6 and 7 also support a conclusion that 

the USPTO considered and determined that pure “solid state” alkaline salts were enabled by the 

‘504 patent. 

1. The facts relevant to evaluation of the In re Wands factors are in 

dispute 

a. The breadth of the claims is in dispute 

The scope of claims 1, 2, 4, 6 and 7 is disputed. Hanmi’s Dr. Genck concludes that the 

claim scope is allegedly undefined, because the term “solid state” is allegedly undefined. (Genck 

Decl.6

 ¶ 62; Defs.’ Br. Summ. J. 19.) Dr. Genck’s opinion and conclusion is based on an 

instruction, presumably from Hanmi’s counsel, to exclude “solid forms” from the plain and 

 

6

 References to “Genck Decl.” herein refer to “Declaration of Wayne J. Genck, Ph.D.” 

filed by Hanmi as D.I. 108 with Motion 3. 

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ordinary meaning of the claim phrase “solid state.”7

 (Id.) Professor Davies disagrees and 

explains that one of ordinary skill in the art would have understood the plain and ordinary 

meaning of “solid state” to be solid material in any form. (Davies Decl. ¶¶ 83; 136; AZ SOF 

¶¶ 109–134.) Solid material would have included at least crystalline solids, amorphous solids 

and powders, which are disclosed in at least the Examples of the ’504 Patent. (Davies Decl. ¶¶ 

83; 136; AZ SOF ¶¶ 117–119; 134.) 

Because all justifiable inferences are to be drawn in favor of the non-moving party, the 

Court must assume that the facts and views presented by Professor Davies are correct, and that 

the term “solid state” is clear and well-defined to a person of ordinary skill. 

b. The amount of direction and guidance is in dispute 

Hanmi argues that “solid state” is not disclosed and that the specification provides no 

direction or guidance for making a “solid state” salt. (Defs.’ Br. Summ. J. 20 (citing internal 

Section [II]-B-1 on written description).) Professor Davies, however, explains that the ’504 

Patent provides full direction and guidance on how to prepare and identify alkaline salts of 

esomeprazole in the solid state. (Davies Decl. ¶¶ 137–38; AZ SOF ¶ 135.) The ’504 Patent 

describes crystalline alkaline salts of esomeprazole that are obtained using the methods of 

preparation disclosed in the specification. (See, e.g., Parezo Decl. Exh. B, col.3 ll.40–41; col.4 

ll.58–61; AZ SOF ¶ 136.) Professor Davies also explains that it would have been clear to a 

 

7

 “I am informed that the Court considered the meaning of the term ‘solid state’ in prior 

litigation involving the ’504 patent. Based on that record, I have been asked to assume that the 

term ‘solid state’ in the ’504 patent is to be ascribed its plain and ordinary meaning to one of 

ordinary skill in the art at in 1993-1995, but I am informed that the term does not mean a ‘solid 

form’ or ‘a solid form rather than a liquid, such as, a syrup or oil.’” (Genck Declaration ¶ 35 

(emphasis added).) 

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person of ordinary skill in the art that the crystalline alkaline salts of esomeprazole are in a “solid 

state” because crystalline material is solid material. (Davies Decl. ¶ 137; AZ SOF ¶ 137.) 

c. The presence of working examples is in dispute 

Hanmi takes the bizarre position that the examples of the ’504 Patent do not describe how 

to make and use a “solid state” alkaline salt of (–)-omeprazole. (Defs.’ Br. Summ. J. 20 (citing 

internal Section [II]-B-1 on written description).) Professor Davies disagrees and explains that 

the examples in the ’504 Patent provide detailed procedures for preparing alkaline salts of 

(–)-omeprazole in the solid state. (AZ SOF ¶ 130.) For example, Examples 2, 5 and 6 detail 

procedures that prepare salts of (–)-omeprazole as powders and crystalline forms. Both forms 

are solid materials and are thus “solid state”. (Davies Decl. ¶¶ 139–47; AZ SOF ¶¶ 141–144.) 

Example 6, in particular, describes how to prepare a magnesium salt of (–)-omeprazole and states 

that “[t]he product was crystalline as shown by powder X-ray diffraction . . . .” (Davies Decl. 

¶ 139 (citing Parezo Decl. Exh. B, col.8 ll.49–50); AZ SOF ¶ 143.) Thus, the procedures 

detailed in at least Examples 2, 5 and 6 of the ’504 Patent specification teach a person of 

ordinary skill to how to make and use solid state alkaline salts of (–)-omeprazole. (Davies Decl. 

¶¶ 139–47; AZ SOF ¶ 144.) 

d. The quantity of experimentation is in dispute 

Professor Genck contends that “the amount of experimentation needed to develop ‘solid 

state’ alkaline salts of (–)-omeprazole at the time of the effective filing date in 1995 would have 

been impossible to quantify.”8

 (Defs.’ Br. Summ. J. 20.) This conclusion, appears to be based 

 

8

 Hanmi states, without providing any evidence to satisfy its evidentiary burden for 

proving, that the effective filing date of the ’504 Patent was in 1995. Hanmi’s position on the 

effective filing date is incorrect. The effective filing date of the ’504 Patent is 1993, as all claims 

in the ’504 Patent are supported under ¶ 112 by the disclosure of SE 9301830, the foreign patent 

(continued...) 

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on his assumption that “solid state” cannot mean “solid form.” Professor Davies explains that a 

skilled person, at the priority date of the ’504 Patent, would have required at most a routine 

amount of experimentation, in light of the significant amount of direction and guidance provided 

by the ’504 Patent specification, for obtaining the claimed solid state alkaline salts of 

esomeprazole. (Davies Decl. ¶ 148; AZ SOF ¶ 152.) 

e. Professor Davies establishes that the Wands factors, when 

considered together, demonstrate at most routine 

experimentation would be required to make and use the 

claimed invention 

Professor Davies concludes, based on his consideration of factors bearing on whether the 

amount of experimentation is “undue,” that a person of ordinary skill in the art would have 

understood, based on the ’504 Patent specification, how to make and use solid state alkaline salts 

of (–)-omeprazole, as recited in claims 1, 2, 4, 6 and 7, without undue experimentation. (Davies 

Decl. ¶ 148; AZ SOF ¶ 152.) In light of his opinions, there is at least a dispute of material fact 

precluding summary judgment. 

Hanmi points to the decision in Automotive Technologies International, Inc. v. BMW of 

North America, Inc., 501 F.3d 1274 (Fed. Cir. 2007) as purportedly “squarely on point.” (Defs.’ 

Br. Summ. J. 15.) Hanmi states that “the patent specification in Automotive Technologies at least 

provided a general overview of the nonenabled embodiment. Here, in contrast, the ’504 Patent 

specification provides no disclosure of any kind . . . regarding how to make any ‘solid state’ 

alkaline salt of (–)-omeprazole.” (Defs.’ Br. Summ. J. 16.) Automotive Technologies is 

inapposite to the present case, because the ’504 Patent specification does in fact provide ample 

 

document to which the ’504 Patent claims priority. SE 9301830 was filed on May 28, 1993, and 

therefore the ’504 Patent is entitled to this 1993 date as its effective filing date. 

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disclosure, including detailed procedures for preparing the claimed alkaline salts of 

(–)-omeprazole in solid state. 

2. The Prosecution History of the ’504 Patent Further Shows That the 

Enablement Requirement Is Met 

The prosecution history of the ’504 Patent also demonstrates that the USPTO considered 

whether pure “solid state” alkaline salts were enabled and concluded that it was. As noted 

above, the phrase “solid state” was endorsed by the Examiner herself in the Interview Summary. 

(Goffney Decl. ¶ 38; see Defs.’ Rathinam Decl. Exh. 3, HAN0039582; AZ SOF ¶ 98.) The 

Examiner is charged with ensuring that claim language is enabled by the specification. (Goffney 

Decl. ¶ 39; AZ SOF ¶ 190.) Accordingly, the Examiner had considered whether the endorsed 

term “solid state” was in compliance with the enablement requirement. (Goffney Decl. ¶ 40.) 

The fact that the Examiner herself agreed to the term “solid state” shows that the USPTO has 

determined that one of skill in the art would understand how to make and use alkaline salts of 

(–)-omeprazole without undue experimentation based on the teachings of the ’504 Patent 

specification. Therefore, the endorsement of the term by the Examiner shows that the USPTO 

considered that “solid state” was enabled by the ’504 Patent specification. 

Hanmi’s enablement argument mischaracterizes the prosecution history of the ’504 

Patent. (See Defs.’ Br. Summ. J. 14.) Hanmi speculates that “solid state” was added to the 

claims to overcome a novelty rejection, based on the disclosure of an amorphous solid. The 

prosecution history shows only that the amorphous nature of the reference was not even at issue. 

(Davies Decl. ¶ 123–28.) 

V. CONCLUSION 

For the foregoing reasons, AstraZeneca respectfully requests that the Court deny Hanmi’s 

summary judgment Motion 3. 

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 Respectfully submitted, 

Dated: December 2, 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 

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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ME1 12633601v.1

CERTIFICATE OF SERVICE 

I hereby certify that on December 2, 2011, I caused a copy of the foregoing 

ASTRAZENECA’S BRIEF IN OPPOSITION TO HANMI’S 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” 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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