LITE DEPALMA GREEBERG, LLC

Allyn Z. Lite 

Michael E. Patunas 

Mayra V. Tarantino 

Two Gateway Center, 12th Floor 

Newark, New Jersey 07102 

Telephone: (973) 623-3000 

Facsimile: (973) 877-3872 

alite@litedepalma.com 

mpatunas@litedepalma.com 

mtaratino@litedepalma.com 

Attorneys for Defendants Hanmi USA, Inc., 

Hanmi Pharmaceutical Co., Ltd., 

Hanmi Fine Chemical Co., Ltd., and Hanmi 

Holdings Co., Ltd. 

I THE UITED STATES DISTRICT COURT 

THE DISTRICT OF EW 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. 

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

DEFEDATS’ BRIEF I OPPOSITIO TO PLAITIFFS’ MOTIO 

TO AMED THEIR DISCLOSURE OF ASSERTED CLAIMS OF 

 U.S. PATET O. 5,714,504 

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ii 

TABLE OF COTETS 

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

II. STATEMENT OF FACTS .............................................................................................- 4 - 

III. ARGUMENT..................................................................................................................- 8 - 

A. Legal Standard ....................................................................................................- 8 - 

B. AstraZeneca Does Not Have Good Cause To Add To Its Disclosure Of Asserted 

Claims .................................................................................................................- 9 - 

C. Hanmi Would Be Unfairly Prejudiced By AstraZeneca’s Proposed Addition of 

Asserted Claims ................................................................................................- 14 - 

D. AstraZeneca’s Proposed Amendment is Futile.................................................- 17 - 

IV. CONCLUSION.............................................................................................................- 18 -

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iii 

TABLE OF AUTHORITIES 

Cases 

Atmel Corp. v. Info. Storage Devices, Inc., 1998 U.S. Dist. LEXIS 17564 

(N.D. Cal. Nov. 5, 1998).......................................................................................-9- 

Berger v. Rossignol Ski Co., Inc., 2006 U.S. Dist. LEXIS 23085 

(N.D. Cal. April 25, 2006) ........................................................................... -9-, -15- 

JSR Corp. v. Tokyo Ohka Kogyo Co., 2001 U.S. Dist. LEXIS 24959 

(N.D. Cal. Sep. 13, 2001)............................................................................. -9-, -15- 

O2 Micro Int’l Ltd. v. Monolithic Power Systems, Inc., 467 F.3d 1355 

(Fed. Cir. 2006).....................................................................................................-9- 

Softvault Sys., Inc v. Microsoft Corp., 2007 U.S. Dist. LEXIS 33060 

(E.D. Tex. 2007) ........................................................................................ -10-, -18- 

THF Publications, Inc. v. Doskocil Mfg. Co., Inc., 705 F. Supp. 2d 361 

(D.N.J. 2010)............................................................................................................9 

Statutes 

35 U.S.C. § 112................................................................................................-5-, -12-, -13- 

 Rules

21 C.F.R. § 314.52......................................................................................................................- 4 - 

Local Patent Rule 3.7....................................................................................................... - 9 -, - 11 - 

Other Authorities

Report of the District of New Jersey Local Rules Committee, Explanatory 

Notes for 2011 Amendments. ...........................................................................................-9- 

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TABLE OF EXHIBITS 

Exhibit 1 U.S. Patent No. 5,714,504 (HAN0038817-HAN0038825) 

Exhibit 2 December 29, 2010 Notice of Paragraph IV Certification (HAN0026234-

HAN0026278) (filed under seal) 

Exhibit 3 Defendant’s April 1, 2011 Letter Producing NDA 202342 (HAN0000001-

HAN0022677) 

Exhibit 4 Hanmi’s May 25, 2011 Non-Infringement and Invalidity Contentions 

(filed under seal) 

Exhibit 5 Email chain re AstraZeneca’s request to add claims 3, 5, and 10 

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Defendants Hanmi USA, Inc., Hanmi Pharmaceutical Co., Ltd., Hanmi Fine Chemical 

Co., Ltd. and Hanmi Holdings Co., Ltd. (collectively “Hanmi”) respectfully submit this brief in 

opposition to the motion of Plaintiffs AstraZeneca AB, Aktiebolaget Hässle, AstraZeneca LP, 

KBI Inc. and KBI-E Inc. (collectively “AstraZeneca”) to add newly asserted claims of U.S. 

Patent 5,714,504 (“the ’504 patent”) (Ex. 1). 1

I. ITRODUCTIO 

This is a Hatch-Waxman patent infringement case. The Local Patent Rules of this 

District use a carefully crafted framework in such cases, according to which the patent holder 

first makes a Disclosure of Asserted Claims that lists each claim of each patent that is allegedly 

infringed, followed by an accused party’s disclosure of contentions in opposition to the patent 

holder’s assertions of infringement. This approach not only is logical from a legal standpoint, 

but fair from a case management standpoint. The patentee’s asserted claims control the scope 

of the infringement case, and the accused infringer’s non-infringement and invalidity 

contentions necessarily are responsive to the asserted claims, not vice versa. 

Moreover, which of its claims are allegedly infringed is controlled by the patent 

holder’s assessments of its own patents and the accused products, nothing else. Contrary to 

AstraZeneca’s suggestion, the Local Patent Rules do not call for a disclosure of claims selected 

by patentee to initially test out for survival of an accused party’s legal theories and contentions, 

and indeed there is no provision permitting select disclosure and secret reservation of assertable 

claims to assert in the event selected claims do not survive. Such piecemeal prosecution of a 

case is fundamentally at odds with the letter and intent of the Rules. AstraZeneca first had a 

 

1 All exhibits referenced herein are attached to the Declaration of Renita S. Rathinam 

submitted herewith. 

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description of Hanmi’s accused esomeprazole strontium product in December, 2010 upon 

receipt of the Paragraph IV Notice Letter, and then received a copy of Hanmi’s full NDA 

describing the product in detail in early April, 2011, as part of Hanmi’s early disclosures. No 

new facts about Hanmi’s product came to light prior to AstraZeneca’s decision to assert claims 

1, 2, 4 and 6-7 of the ’504 patent on May 11, 2011.

The Local Patent Rules properly mandate that leave to amend contentions requires the 

moving party to demonstrate that, proceeding diligently, it could not reasonably have made the 

additional disclosure by the established deadline. 

Here, no new underlying operative facts have arisen with respect to infringement by the 

accused Hanmi products since well before this case was filed. On the contrary, AstraZeneca’s 

extensive legal team of outside and in-house counsel have been litigating the Nexium® patent 

portfolio for six years and have known the active ingredient in the accused Hanmi products to 

be esomeprazole strontium since the receipt of Hanmi’s Notice of Paragraph IV Certification 

(the “Notice Letter”) (Ex. 2) in December of 2010. Of the eleven Orange Book listed patents 

that were the subject of Hanmi’s Paragraph IV notification letter of December 29, 2010, 

AstraZeneca’s team made a calculated decision to sue only on the ’504 and ’192 patents. 

Given the clear requirements of the Rules, claims 1, 2, 4 and 6-7 are the only claims of the ’504 

patent that AstraZeneca’s vast legal team concluded would be infringed by Hanmi’s accused 

products, if approved by the FDA. This is not a case of new facts coming to light. Because 

AstraZeneca initially determined that claims 3, 5 and 10 of the ’504 patent would not be 

infringed by Hanmi’s proposed esomeprazole strontium salt with respect to the newly proposed 

claims covering different salts, it simply cannot meet its burden of showing the diligence 

required for leave to expand its assertions at this stage of the litigation. 

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If AstraZeneca were permitted to back off from its initial conclusion that claims 3, 5 

and 10 were not infringed by Hanmi’s proposed product, and add new infringement claims in 

the present circumstances, every patentee could do it in every case, end-running the very 

purpose of the Local Patent Rules and essentially eviscerating them. A patentee then could 

dribble out new patents or claims one or two at a time, and seek to delay each case indefinitely. 

Such a circumstance not only would flout the beneficial framework of the Local Patent Rules, 

but would prejudice the rights of drug manufacturers seeking to provide their medicines to the 

public as provided by the terms of the Hatch-Waxman Act. 

Moreover AstraZeneca’s assertion that Hanmi’s May 25, 2011 “expanded array of 

defenses” somehow necessitated its belated attempt to add claims to the case is disingenuous. 

AstraZeneca boldly misrepresents that Hanmi advised of the invalidity of claims 1, 2, 4 and 6-7 

of the ’504 patent for the first time in its May 25, 2011 non-infringement and invalidity 

contentions. To the contrary, as shown below, AstraZeneca has been aware of Hanmi’s 

position that the asserted claims of ’504 are invalid if construed to encompass any salt other 

than Na+

, Mg2+, Li+, Ca2+, K+ or N+(R)4 salts of esomeprazole (viz., strontium salt product) 

since Hanmi’s Notice Letter of December 29, 2010, let alone since the Answer and 

Counterclaims (ECF No. 7) filed in this case which challenged the validity of each and every 

claim of the ’504 patent. 

AstraZeneca’s motion is baseless and improper and should be denied. AstraZeneca’s 

initial determination that claims 3, 5 and 10 were not infringed – with full knowledge of 

Hanmi’s proposed product – stands as a stark admission of non-infringement of those claims. 

A party’s change of substantive positions, especially when not well-grounded in fact, as here, 

does not meet the good cause or diligence standards of the Local Patent Rules. 

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II. STATEMET OF FACTS 

 Hanmi is the holder of New Drug Application (“NDA”) No. 2023422

 seeking approval 

to market esomeprazole strontium capsules in the United States. AstraZeneca’s approved 

product is Nexium®, which contains esomeprazole magnesium. Therefore, because the 

products contain different salt forms, Hanmi was required to submit a Section 505(b)(2) (21 

U.S.C. § 355(b)(2)) application to the FDA, meaning that although Hanmi’s submission relies 

on safety and efficacy information from the reference listed drug, Hanmi’s product is not 

identical to AstraZeneca’s product. As part of its NDA, Hanmi submitted a Paragraph IV 

certification against each of AstraZeneca’s eleven listed Orange Book patents for Nexium®, 

including U.S. Patent No. 5,714,504 (“the ’504 patent”) and U.S. Patent No. 5,877,192 

(“the ’192 patent”) (collectively “the patents-in-suit”) that AstraZeneca now asserts against 

Hanmi. 

 On December 29, 2010, as required by 21 U.S.C. § 355(b)(3)(D)(ii) and 21 C.F.R. 

§ 314.52, Hanmi sent AstraZeneca a Notice of Paragraph IV Certification (the “Notice Letter”) 

(Ex. 2). The Notice Letter included a 38 page (single spaced) detailed statement of the legal 

and factual bases, including issues concerning non-infringement and invalidity, for Hanmi’s 

Paragraph IV certifications. The Notice Letter further “reserve[d] the right to assert other noninfringement, invalidity, and/or unenforceability positions at a later time, and to alter the 

positions stated herein based on information that is presently unknown to Hamni.” Id. at 

Exhibit A, page 2 (HAN0026235). Of course, in any Hatch-Waxman case, the defendants’ 

 

2 AstraZeneca incorrectly characterizes Hanmi’s NDA 202343 as an ANDA seeking to 

market a generic version of Nexium® (magnesium esomeprazole). (See Plaintiffs’ 

Memorandum in Support of Their Motion to Amend Their Disclosure of Asserted Claims 

(“Plaintiffs’ Mem.”) ECF No. 82 at 1). Hanmi’s NDA is directed to an original strontium 

salt formulation of esomeprazole, for which Hanmi has been issued its own patent. 

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ultimate contentions evolve over the litigation from the initial Paragraph IV positions, as 

discovery into the asserted claims progresses. 

With respect to the ’504 patent, Hanmi asserted that none of claims 1-7 and 10 was 

infringed because, inter alia, due to claim construction or the literal language of those claims, 

none of them covered an esomeprazole strontium product, either literally or under the doctrine 

of equivalents.3 Id. at pages 27-31 (HAN0026263- 6267). 

Claims 3, 5 and 10 recited specific salt forms of esomeprazole other than strontium (Ex. 

1), and were initially determined by AstraZeneca not to be infringed (ECF No. 60) based on the 

Notice Letter and Hanmi’s production of its NDA in early April, 2011. (Ex. 3, Defendant’s 

April 1, 2011 Letter Producing NDA 202342 (HAN0000001-HAN0022677); see also Ex. 4, 

Hanmi’s Initial Non-infringement and Invalidity Contentions Pursuant to L. Pat. R. 3.6 at page 

1 ( again specifying that HAN0000001 - HAN0022677 corresponds to NDA 202342 )). 

AstraZeneca’s present motion is based wholly on the allegation that it had no prior 

knowledge that Hanmi ever previously advised AstraZeneca specifically of its position that 

claims 1, 2, 4 and 6-7, directed to an “alkaline salt” of esomeprazole, if construed to encompass 

any salt other than Na+, Mg2+, Li+, Ca2+, K+ or N+(R)4 salts of esomeprazole, would be invalid 

under 35 U.S.C. § 112, first paragraph. But AstraZeneca is wrong. Indeed, Hanmi’s Notice 

Letter made clear that: 

Furthermore, if the claim term "pure solid state alkaline salt of the (-)-

enantiomer of [omeprazole]" were not limited to the six specific salts disclosed 

in the '504 patent, the patent would be invalid for lack of enablement. See 

Generation II Orthotics, Inc. v. Med. Tech., Inc.,

 

3

 Claims 8 and 9 of the ’504 patent do not purport to claim salt forms of esomeprazole, and 

are not relevant to this case. 

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263 F.3d 1356, 1365 (Fed. Cir. 2001)... As explained above above, claims 1-7 

and 10 of the '504 patent require "a pure solid state alkaline salt of the (-)-

enantiomer of [omeprazole]." However, salt selection is inherently

unpredictable. See Sanofi-Synthelabo v. Apotex, Inc., 492 F. Supp. 2d 353, 374 

(S.D.N.Y. 2007)... Accordingly, if the Court were to construe the claim term 

"pure solid state alkaline salt of the (-)-enantiomer of [omeprazole]" as being 

broader than the teachings of the '504 patent, the patent would be rendered 

invalid as failing to enable the full scope of claimed subject matter. And, it is 

well-settled that "claims are generally construed so as to sustain their validity, if 

possible." Whittaker Corp. v. U1R Indus., Inc., 911 F.2d 709, 712 (Fed. Cir. 

1990). 

 (Ex. 2, Notice Letter, Exhibit A at pages 28-29). Additionally, with its Notice Letter, Hanmi 

offered AstraZeneca confidential access to its NDA and DMF (Ex. 2 at Exhibit B), and 

produced its NDA and DMF to AstraZeneca’s counsel in the course of this litigation on April 1, 

2011 (Ex. 3) – long before AstraZeneca advised that claims 1, 2, 4 and 6-7 were allegedly 

infringed on May 18, 2011. 

 Over the last six years, AstraZeneca has filed at least seven separate complaints to block 

the introduction of other manufacturers’ introductions of generic esomeprazole products 

relating to the patents-in-suit in this District alone. Continuing in its efforts to enforce its 

esomeprazole patents, AstraZeneca commenced this action against Hanmi on February 9, 2011 

(ECF No. 1) seeking to block the introduction of Hanmi’s esomeprazole strontium capsules in 

the United States before the expiration of the patents-in-suit. 

Hanmi answered the complaint and asserted counterclaims on March 1, 2011 (ECF No. 

7). Hanmi asserted that each claim of the ’504 patent was not infringed and was invalid. 

On April 1, 2011, Hanmi served its complete NDA, which fully described the products 

at issue (Ex. 3). 

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On May 11, 2011, the Court issued a Letter Order setting the schedule for the case (ECF 

No. 56). AstraZeneca was given even more time than the default times set under the Local 

patent Rules to serve its Disclosure of Asserted Claims. 

Pursuant to the Letter Order, on May 18, 2011, AstraZeneca served its Disclosure of 

Asserted Claims pursuant to Local Patent Rule 3.1. With respect to the ’504 patent, 

AstraZeneca asserted infringement of claims 1, 2, 4 and 6-7, all reciting a “pure solid state 

alkaline salt” of esomeprazole. Claims 3 and 10 that AstraZeneca now seeks to add recite six 

specific species of alkaline salts -- Na+, Mg2+, Li+, Ca2+, K+ or N+(R)4 -- of esomeprazole, while 

claim 5 is limited to the Mg2+, salt (Ex. 1). 

Since being sued on the ’504 and ’192 patents in February, Hanmi has invested 

significant resources and time evaluating them, preparing for discovery, claim construction, and 

developing its defenses and counterclaims. AstraZenenca’s May 18, 2011 determination that 

only the “alkaline salt” claims of the ’504 patent would allegedly be infringed by Hanmi’s 

esomeprazole strontium product focused the analysis leading to Hanmi’s detailed preliminary 

contentions served May 25, 2011 (Ex. 4, Initial Non-infringement and Invalidity Contentions 

Pursuant to Local Patent Rule 3.6(c)), as well as its First Request for Production of Documents 

and Things on July 20, 2011. 

Relying on AstraZeneca’s determination that claims 3, 5 and 10 were not infringed, 

Hanmi has invested significant resources and time in strategically selecting terms for 

construction, invested significant resources and time in proposing claim constructions, and 

determining relevant supporting intrinsic and extrinsic as to asserted claims 1, 2, 4 and 6-7. 

The parties have now already exchanged terms for construction on August 1, 2011 and 

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preliminary constructions and supporting evidence pursuant to Local Patent Rule 4.2 on August 

15, 2011. 

Notably, AstraZeneca first raised the issue of asserting new claims on July 1, 2011 (Ex. 

5, Email chain re AstraZeneca’s request to add claims 3, 5, and 10 at July 1, 2011 - Tracy to 

Rathinam)), and Hanmi advised that it would oppose on July 5th, following the holiday 

weekend (Id. at July 5, 2011 Rathinam to Tracy). Over a month later and after Hanmi’s 

continued substantial investments in developing its case based on assertion of alkaline salt 

claims, through the instant motion AstraZeneca belatedly seeks to amend its May 18, 2011 

infringement contentions to add new claims of the ’504 patent. 

III. ARGUMET 

A. Legal Standard 

 Local Patent Rule 3.6(b) provides that the party asserting patent infringement shall 

serve a “Disclosure of Asserted Claims” listing each claim of each patent allegedly infringed by 

the defendant. In Hatch-Waxman actions, this early disclosure of each patent and claim 

allegedly infringed is particularly important to “help narrow the focus of a generic’s invalidity 

contentions” and “eliminates speculation and added work by the generics in formulating their 

non-infringement and invalidity contentions.” Report of the District of New Jersey Local Rules 

Committee, Explanatory Notes for 2011 Amendments. Thus, “[t]he rules are designed to 

require parties to crystallize their theories of the case early in the litigation and to adhere to 

those theories once they have been disclosed.” THF Publications, Inc. v. Doskocil Mfg. Co., 

Inc., 705 F. Supp. 2d 361, 365-66 (D.N.J. 2010) (quoting Atmel Corp. v. Info. Storage Devices, 

Inc., 1998 U.S. Dist. LEXIS 17564 (N.D. Cal. Nov. 5, 1998)); see also Berger v. Rossignol Ski 

Co., Inc., 2006 U.S. Dist. LEXIS 23085, *7 (N.D. Cal. April 25, 2006) (“The patent rules are 

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designed to avoid “vexatious shuffling of positions” that could occur if the parties are permitted 

to freely modify their infringement contentions at any point in the action.”) (quoting JSR Corp. 

v. Tokyo Ohka Kogyo Co., 2001 U.S. Dist. LEXIS 24959, *18 (N.D. Cal. Sep. 13, 2001)).4 

 In contrast to the liberal standards for amending pleadings, Local Patent Rule 3.7 

permits amendment of disclosures “only by order of the Court upon a timely application and 

showing of good cause.” Local Patent Rule 3.7; THF Publications, 705 F. Supp. 2d 361, 365-

66. “Good cause” requires that the party seeking to amend its contentions show diligence. O2 

Micro Int’l Ltd. v. Monolithic Power Systems, Inc., 467 F.3d 1355, 1366 (Fed. Cir. 2006) 

(addressing N.D. Cal. Local Patent Rule 3-7). The burden is on the party seeking leave to 

amend to demonstrate diligence, not on the opposing party to demonstrate a lack of diligence. 

Id. And that burden requires that the movant show that it could not reasonably have made the 

additional disclosure by the established deadline. Softvault Sys., Inc v. Microsoft Corp., 2007 

U.S. Dist. LEXIS 33060, *3 (E.D. Tex. 2007). 

B. AstraZeneca Does ot Have Good Cause To Add To Its Disclosure Of 

Asserted Claims 

 AstraZeneca attempts to manufacture “new” information in this case based on Hanmi’s 

May 25, 2011 invalidity contentions. However, Hanmi’s legal theories of invalidity of claims 1, 

2, 4 and 6-7 have nothing to do with AstraZeneca’s determination of which its claims are 

allegedly infringed. A patent holder’s decision to assert claims is controlled by its assessment 

of an accused product and its own patents, not by opposing counsel’s work product. Per the 

 

4

 Because this district and the Eastern District of Texas adopted verbatim the Local Patent 

Rules of the Northern District of California, the Court may look to those cases for guidance. 

THF Publications, 705 F. Supp. 2d at 365 n.3. 

 

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definition of “Disclosure of Asserted Claims” and the Court’s Scheduling Order (ECF No. 56), 

it was incumbent upon AstraZeneca to disclose on May 18, 2011 each of the claims allegedly 

infringed by the accused products. AstraZeneca’s evaluations found that claims 3, 5 and 10 

were not infringed – obviously because Hanmi’s proposed product contained a different salt 

form than claimed. As a hedge against the possibility that an independent claim might be held 

invalid, every plaintiff has every incentive to assert every allegedly infringed dependent claim. 

The fact that AstraZenenca deliberately chose not to assert claims 3, 5 and 10 simply means it 

concluded that it could not, in good faith, pursue infringement of claims directed to wholly 

different compounds. 

AstraZeneca’s tactic appears designed to “pocket” certain claims, then “dole them out” 

piecemeal in contravention of the Rules. The motive appears to be simple delay, but the merits 

are futile. Such a scheme is wholly contrary to both the Local Patent Rules and long-standing 

fundamental rules of Federal Rules of Civil Procedure, such as Rules 16 and 11 which require 

diligence and a good faith basis for assertion. The fact that AstraZeneca’s several law firms 

and numerous in-house counsel initially concluded that claims 3, 5 and 10 of the ’504 patent 

were not infringed, completely undermines any current allegations of diligence in proposing the 

futile amendment. 

Except for AstraZeneca’s late realization that its originally asserted claims are not 

infringed and invalid, there is nothing new here. Since Hanmi’s December 29, 2010 Notice 

Letter and April production of its NDA, nothing has changed. The accused products have not 

changed and no new facts about them have been revealed in discovery. Hanmi has always 

taken the position that the claims of the asserted patents are not infringed, and are invalid if 

construed more broadly than the scope enabled by the teachings of the ’504 patent. (See Ex. 2, 

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Notice Letter, Exhibit A at 27-31; ECF No. 7). The fact that Hanmi further developed its 

contentions between the time of the Notice Letter and its preliminary contentions is of no 

moment. AstraZeneca cannot meet its required burden to show the necessary diligence 

required under the Local Patent Rules for amending its infringement contentions. 

 Local Patent Rule 3.7 identifies a number of “examples of circumstances that may, 

absent undue prejudice to the adverse party, support a finding of good cause” for amending 

contentions, including: (a) an unfavorable claim construction; (b) recent discovery of material 

prior art despite earlier diligence; (c) recent discovery of nonpublic information about the 

accused product not previously discovered despite diligent efforts; (d) disclosure of an 

infringement contention by a Hatch-Waxman Act party asserting infringement under L. Pat. 

R. 3.6(g) that requires response because it was not previously presented or reasonably 

anticipated; and (e) consent by the parties and a showing that the amendment will not delay the 

case. None of these situations apply here. 

 AstraZeneca does not and cannot urge any of the listed grounds, or anything akin to 

them, for belatedly asserting new claims.5

 Rather, all AstraZeneca can offer in support of the 

diligence required to meet its burden of showing good cause is that Hanmi’s May 25, 2011 

invalidity contentions contained expanded allegations and defenses – that AstraZeneca 

 

5

 AstraZeneca apparently attempts to equate its present situation with Local Patent Rule 3.7 

good cause example (d), “disclosure of an infringement contention by a Hatch-Waxman Act 

party asserting infringement under L. Pat. R. 3.6(g) that requires response by the adverse 

party because it was not previously presented or reasonably anticipated.” (See Plaintiffs’ 

Mem. at 2-3.) While the Local Patent Rule 3.7 examples are not exhaustive, the drafters 

easily could have included such an example based on invalidity contentions, but did not. 

That omission is entirely logical and proper because the scope of invalidity contentions 

properly is driven by the infringement contentions of the patent holder, not the other way 

around. In any case, AstraZeneca had clear notice of the bases of invalidity of the asserted 

claims, as pointed out above. 

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supposedly could not have foreseen – not disclosed in Hanmi’s December 29, 2010 Notice 

Letter or March 1, 2011 answer and counterclaims. (Plaintiffs’ Mem. at 1-2.) Thus, 

AstraZeneca argues that it could not identify all of the claims that it should assert because it did 

not know all of Hanmi’s grounds for invalidity of the patents-in-suit. (Plaintiffs’ Mem. at 3), 

and having now recognized that its asserted claims are not infringed and/or invalid, improperly 

seeks to add new claims. 

 Hanmi’s March 1, 2011 Answer and Counterclaims (ECF No. 7), however, includes the 

allegation that all claims of the ‘504 patent are invalid under 35 U.S.C. § 112 (ECF No. 7 

(Second Separate Defense; Second Count – Declaration of Invalidity of the ‘504 Patent)). As 

AstraZeneca of course well knows, 35 U.S.C. § 112 specifically includes indefiniteness and 

lack of written description as a grounds for invalidity. Thus, AstraZeneca was on notice for 

well over two months before disclosing its asserted claims that indefiniteness and lack of 

written description were in play as defenses to all claims of the ‘504 patent. And, as discussed 

above, nonenablement was specifically raised in the December, 2010 Notice Letter (Ex. 2, at 

Exhibit A, pages 28-29). Nevertheless, AstraZeneca evaluated infringement, and elected not to 

assert claims 3, 5 and 10. 

 Moreover, AstraZeneca’s suggestion that the scope of the defenses dictates the scope of 

the claims asserted legally is inconceivable. Essentially, AstraZeneca argues that, because 

Hanmi challenged the validity of claim 1 in its invalidity contentions, AstraZeneca now is 

required to assert claims 3, 5 and 10 against Hanmi in case claim 1 ultimately is held invalid. 

That proposition, however, is true in every patent litigation, regardless of what invalidity 

defenses are raised in the contentions or how extensive they are. It is well-established that the 

validity of dependent claims survives any holding of invalidity of the claim on which they are 

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based, and any suggestion here that AstraZeneca’s decision to assert dependent claims 3, 5 and 

10 somehow depended on the scope of Hanmi’s challenges to claim 1 is contrary to law. 

 In short, Hanmi properly pled the invalidity of all claims of the '504 patent in its answer 

and counterclaims, including based on § 112 lack of written description. AstraZeneca made a 

calculated decision not to assert claims 3, 5 and 10 in its May 18, 2011 contentions, even 

though it had Hanmi's December 29, 2010 Notice Letter (invalidity based on § 112 lack of 

enablement), March 1, 2011 Answer and Counterclaims (invalidity of each claim) and full 

NDA describing the accused product in hand. See Softvault, 2007 U.S. Dist. LEXIS at *4-5 

(denying motion to amend infringement contentions when amendment not based on “new 

information” and patent holder – “either by choice or through lack of diligence” – did not assert 

earlier priority date). AstraZeneca has shown no diligence, either with respect to its initial 

contentions or its bringing of the instant motion two and a half months after Hanmi’s May 25, 

2011 non-infringement and invalidity contentions. See O2 Micro, 467 F.3d at 1367 (affirming 

denial of leave to amend infringement contentions when patent holder waited almost three 

months to move to amend from when it had reason to know of infringement theory).6

 

 On top of its lack of diligence, AstraZeneca’s attempt to interject new claims into the 

case at this juncture threatens to disrupt the carefully crafted framework the Local Patent Rules 

envision for Hatch-Waxman cases. In particular, the local rules plainly call for the patentee’s 

 

6

 The circumstances in the present case are in sharp contrast to the circumstances in the cases 

cited by AstraZeneca in which amendment was permitted. In THF Publications, for 

example, the Local Patent Rule disclosures were “in their infancy,” discovery demands had 

not yet been exchanged and the content of the parties’ future Markman briefing would not 

be altered. 705 F. Supp. 2d at 363-64, 366. In Mediostream, Inc. v. Microsoft Corp., 2010 

U.S. Dist. LEXIS 110420, *13 (E.D. Tex. October 18, 2010), the patent holder did not have 

the necessary information in time for its contentions due to delays of the defendant in 

providing discovery. 

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disclosure of asserted claims – not an accused party’s invalidity contentions – to set the stage 

for the parties’ legal positions. See Report of the District of New Jersey Local Rules 

Committee, Explanatory Notes for 2011 Amendments (the early disclosure of each patent and 

claim allegedly infringed is designed to “help narrow the focus of a generic’s invalidity 

contentions” and “eliminates speculation and added work by the generics in formulating their 

non-infringement and invalidity contentions”). Permitting AstraZeneca to amend its 

contentions now, with no showing of diligence, will contravene these proper principles of 

Hatch-Waxman case management embodied in the Local Patent Rules and result in the 

“vexatious shuffling of positions” that the Rules specifically were designed to avoid. See

Berger, 2006 U.S. Dist. LEXIS 23085 at *7 (quoting JSR Corp., 2001 U.S. Dist. LEXIS at *18). 

C. Hanmi Would Be Unfairly Prejudiced By AstraZeneca’s Proposed Addition 

of Asserted Claims 

 AstraZeneca argues that Hanmi will not be prejudiced by the addition of new claims in 

this case because “the claim construction process is just starting, and nothing beyond claim 

construction has yet been scheduled.” (Plaintiffs’ Mem. at 2; see Plaintiffs’ Mem. at 4.) 

Despite AstraZeneca’s arguments, however, permitting the amendment would result in real 

prejudice to Hanmi for a number of reasons. 

 Hamni would be prejudiced if the Court were to grant AstraZeneca’s motion for leave 

to amend because Hamni has relied on AstraZeneca’s infringement contentions for over three 

months and, based on those contentions, incurred substantial cost in assessing the issues 

concerning the claims asserted against it and developing its case strategy tailored to the specific 

claims asserted against it. See Berger, 2006 U.S. Dist. LEXIS 23085 at *12. Hanmi’s 

invalidity and non-infringement contentions are based on plaintiffs’ calculated determination 

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and disclosure of allegedly infringed claims. AstraZeneca has admitted that claims 3, 5 and 10 

of the ’504 patent would not be infringed by Hanmi’s proposed NDA products. 

 Should AstraZeneca’s motion be granted over this opposition, Hanmi agrees with 

AstraZeneca that existing case schedule need not be extended. Nonetheless, should 

AstraZeneca ever urge to the contrary, Hanmi will be prejudiced by any delay the case schedule 

would have on the timing of the ultimate resolution of this litigation. Unlike other previous 

Nexium® patent challengers who have either settled with AstraZeneca and have obtained an 

agreed market entry date7, or those who are not “first applicants” under 21 U.S.C. 

§355(j)(5)(B)(iv)(II)(bb)8, the 30-month stay of Hanmi’s 505(b)(2) application expires in mid2013 and FDA is free to finally approve Hanmi’s application at that time. Any delays in the 

present case schedule would unfairly postpone the finality of the Court’s decision on the merits 

of Hanmi’s challenges, and unfairly increase the legal uncertainty and thus the risk of any 

prospective product launch after FDA approval. 

Although this is a relatively new case, AstraZeneca’s present motion is yet another in a 

line of tactics to delay the orderly progression of this matter, to Hanmi’s prejudice. Notably, 

after Hanmi filed its Answer and Counterclaims (ECF No. 7, March 1, 2011), AstraZeneca 

filed a frivolous Motion to Strike certain of Hanmi’s Defenses and Counterclaims as, e.g.,

improperly plead, and as not providing “fair notice” to AstraZeneca as to its claims and 

 

7

 See e.g., Ranbaxy Pharmceuticals (Astrazeneca AB et al v. Ranbaxy Pharmaceuticals, 

Inc. et al, 3:05-cv-05553-JAP -TJB (D.N.J.)); Teva and Ivax (Astrazeneca AB et al v. Ivax 

Corporation et al, 3:06-cv-01057-JAP-TJB (D.N.J.)); Dr. Reddy’s (Astrazeneca AB el al v. Dr. 

Reddy’s Laboratories, Ltd. et al, 3:08-cv-00328-JAP-TJB (D.N.J.)). 

8

 Hanmi believes that, e.g. Sun Pharmaceuticals (Astrazeneca AB et al v. Sun Pharma Global 

FZE et al, 3:10-cv-1017-JAP-TJB (D.N.J.)) may not be such a “first applicant” under the 

statute. 

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defenses.9 (ECF No. 16, March 24, 2011). When Hanmi later proposed a schedule to the Court 

that would align the present Markman Schedule with the schedule in other pending cases (ECF 

No. 51, 5/3/2011; ECF No. 52, 5/3/2011), AstraZeneca opposed that request, stating that its 

Motion to Strike was “dispositive”, because: 

The Court’s ruling on this motion will impact the scope of submissions 

required by the Local Patent Rules. As one example, under the Local 

Patent Rules, AstraZeneca would be required to disclose its asserted 

claims this Thursday (May 12); however, AstraZeneca should not be 

required to make such decisions until it knows the scope of the claims, 

defenses, and counterclaims properly raised by Hanmi, which depends 

on how the Court rules on AstraZeneca’s motion. 

(ECF No. 55, 5/10/11) (emphasis added). After adding new counsel to the case, AstraZeneca 

voluntarily withdrew its motion to strike in exchange for Hanmi’s agreement to a modest 

extension of three dates (ECF No. 74, 7/19/11) that would not otherwise impact the Courtordered schedule in this case. Without a doubt, AstraZeneca’s present motion seeks the very 

same relief as its withdrawn motion to strike -- the ability to “disclose its asserted claims” only 

after it “knows the scope of the claims, defenses, and counterclaims properly raised by Hanmi.” 

Having withdrawn its motion seeking that relief, representing to the Court its reasons for so 

doing (ECF No. 55, 5/10/11), AztraZeneca should not now be permitted to avoid its previous 

representations to the court and seek to delay the schedule further. 

 

9

 AstraZeneca’s motion was frivolous because it raised the identical arguments on at least three 

prior occasions, and lost all three times. See, e.g., Astra Aktiebolag v. Andrx Pharm., Inc., No. 

98-6521, 1998 U.S. Dist. LEXIS 22787, at *5 (S.D. Fla. Nov. 2, 1998) (“Defendant has met the 

liberal pleading requirements of the Federal Rules of Civil Procedure”); Astra Aktiebolag v. 

Cheminor Drugs, Ltd., No. 99-8927, 2000 U.S. Dist. LEXIS 2540, at *5 (S.D.N.Y. Mar. 8, 

2000) (“Astra is not prejudiced by the inclusion of additional defenses and counterclaims”); 

Astra Aktiebolag v. Kremers Urban Develop., No. 99-8928, 2000 U.S. Dist. LEXIS 2511 

(S.D.N.Y. Mar. 8, 2000) (same). In each of those earlier cases, AstraZeneca moved to strike 

certain defenses and dismiss invalidity counterclaims, arguing that it had been denied “fair 

notice” by the defendant’s insufficient pleadings. See e.g., D.I. 27, p. 1. 

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Hanmi will also be forced to incur significant additional expense associated with 

AstraZeneca’s re-do of its asserted claims. Hanmi has not undertaken the same analyses it 

would have otherwise undertaken had claims 3, 5 and 10, directed to six specific species of 

alkaline salts (Na+

, Mg2+, Li+, Ca2+, K+, N+(R)4 ) of esomeprazole, been previously asserted. 

Various analyses were not crafted with an eye toward the interplay of genus/species claims and 

scope analysis in view of the multiple patents procured by AstraZeneca year after year on one 

or more of these very same species. Hanmi would essentially be required to re-tailor its 

defenses and counterclaims as developed to date, amend its preliminary contentions, and go 

through rounds of additional contentions by both parties for these new claims while it should be 

focusing on the core issues presented to date. See Softvault, 2007 U.S. Dist. LEXIS 33060 at 

*5-6. 

Hanmi has played by the rules and no new facts have come to light. Simple fairness 

requires that AstraZeneca also play by the rules and abide by its disclosures in accord with the 

Court’s protocol for disclosure of contentions. 

D. AstraZeneca’s Proposed Amendment is Futile 

 AstraZeneca argues that it would be “substantially prejudiced” if the instant motion is 

denied and it is not permitted to add the new claims to this case in the event that the asserted 

claims are held invalid. (Plaintiffs’ Mem. at 2, 3-4.) Putting aside of the lack of diligence in 

timely selecting the claims to assert, AstraZeneca is not prejudiced because adding the 

proposed additional claims to this case would be futile. 

 An assertion of these claims is indeed frivolous, as AstraZeneca initially determined by 

choosing not to assert them with full knowledge of every detail of Hanmi’s product. As 

discussed above, claims 3, 5 and 10 that AstraZeneca now seeks to add are directed to one of 

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six specific alkaline salts -- Na+, Mg2+, Li+, Ca2+, K+ and N+(R)4 -- of esomeprazole. The 

specific salts covered by these claims simply do not include a strontium (Sr) salt, and therefore 

cannot be literally infringed. AstraZeneca properly understood these claims not to cover the 

accused Hanmi’s strontium salt product under the doctrine of equivalents.10 Claims 3, 5 and 10 

simply cannot be expanded under the doctrine of equivalents to include a strontium 

formulation, resulting in entire vitiation of the species recitations of the these claims. See 

Planet Bingo LLC v. GameTech Int'l, Inc., 472 F.3d 1338, 1344 (Fed. Cir. 2006); Sage 

Products, Inc. v. Devon Ind., Inc., 126 F.3d 1420, 1429 (Fed. Cir. 1997) (the doctrine of 

equivalents may not be used to erase meaningful structural and functional limitations of a 

claim). 

IV. COCLUSIO 

 For the reasons stated above, Hanmi respectfully request that the Court deny Plaintiffs’ 

Motion to Amend Their Disclosure of Asserted Claims. 

 

Dated: August 22, 2011 LITE DEPALMA GREEBERG, LLC

/s/ Mayra V. Tarantino 

Allyn Z. Lite 

Michael E. Patunas 

Mayra V. Tarantino 

Two Gateway Center, 12th Floor 

Newark, New Jersey 07102 

 

10 If the Court is inclined to grant AstraZeneca’s motion, Hanmi respectfully notes its intent to 

seek discovery as to why these claims were not previously asserted and whether or not there is 

any reasonable basis to assert these claims, including discovery of any allegedly privileged 

materials that would appear to contradict the present AstraZeneca position. It is believed that 

AstraZeneca would possess various documents and opinions concluding no infringement, 

which should become discoverable in the context of an about-face, belated assertion of 

infringement. Hanmi also reserves the right to seek its fees in connection having to defend 

against belated and frivolously asserted claims. 

Case 3:11-cv-00760-JAP-TJB Document 86 Filed 08/22/11 Page 22 of 24 PageID: 468
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Telephone: (973) 623-3000 

Facsimile: (973) 877-3872 

alite@litedepalma.com 

mpatunas@litedepalma.com 

mtarantino@litedepalma.com 

SUGHRUE MIO, PLLC 

Mark Boland 

Michael R. Dzwonczyk 

Renita S. Rathinam 

2100 Pennsylvania Ave., NW 

Washington, DC 20037-3213 

Telephone: (202) 293-7060 

Facsimile: (202) 293-7860 

mboland@sughrue.com 

mdzwoncyzk@sughrue.com 

rrathinam@sughrue.com 

SUGHRUE MIO, PLLC 

John B. Scherling 

4250 Executive Square 

Suite 900 

La Jolla, CA 92037 

Telephone: (858) 795-1180 

Facsimile: (858) 795-1199 

jscherling@sughrue.com 

Attorneys for Defendants and CounterclaimPlaintiffs, Hanmi USA, Inc., Hanmi 

Pharmaceutical Co., Ltd., Hanmi Fine Chemical 

Co., Ltd., and Hanmi Holdings Co., Ltd. 

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CERTIFICATE OF SERVICE

I hereby certify that on August 22, 2011, I caused a copy of the foregoing 

DEFEDATS’ OPPOSITIO TO PLAITIFFS’ MOTIO TO AMED THEIR 

DISCLOSURE OF ASSERTED CLAIMS, EXHIBITS 1- 5 and DECLARATIO OF 

REITA S. RATHIAM to be served upon the following counsel through the Court’s ECF 

system and via email.

John E. Flaherty, Esq. 

McCARTER & ENGLISH 

Four Gateway Center 

100 Mulberry Street 

Newark, New Jersey 07102 

(973) 622-4444 

jflaherty@mccarter.com 

Henry J. Renk, Esq. 

FITZPATRICK, CELLA, HARPER & SCINTO 

1290 Avenue of the Americas 

New York, NY 10104-3800 

(212) 218-2250 

HRenk@fchs.com 

Errol B. Taylor, Esq. 

Fredrick M. Zullow 

MILBANK, TWEED, HADLEY & McCLOY LLP 

1 Chase Manhattan Plaza 

New York, New York 10005-1413 

(212) 530-5000 

ETaylor@milbank.com 

FZullow@milbank.com 

 

 By: /s/ Mayra V. Tarantino 

 

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