LITE DEPALMA GREENBERG, LLC 

Allyn Z. Lite 

Michael E. Patunas 

Mayra V. Tarantino 

Two Gateway Center, Suite 1201 

Newark, New Jersey 07102 

(973) 623-3000 

alite@litedepalma.com

mpatunas@litedepalma.com

mtarantino@litedepalma.com

Attorneys for Defendants Hanmi USA, Inc., 

Hanmi Pharmaceutical Co., Ltd., 

Hanmi Fine Chemical Co., Ltd., and 

 Hanmi Holdings Co., Ltd. 

IN THE UNITED STATES DISTRICT COURT 

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. 

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

Motion Day: November 19, 2012 

Oral Argument Requested 

MEMORANDUM IN SUPPORT OF HANMI’S MOTION 

TO AMEND ITS CONTENTIONS

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TABLE OF CONTENTS 

I. INTRODUCTION AND BRIEF SUMMARY ....................................................................1

II. HANMI HAS SHOWN GOOD CAUSE FOR PERMITTING THE PROPOSED 

AMENDMENT....................................................................................................................2

III. THE PROPOSED AMENDMENTS SHOULD BE PERMITTED ....................................4

A. Because AstraZeneca Cannot Assert A Claim Scope That Is Not Enabled Or 

Described, The Claims Of Both Patents-In-Suit Exclude Hydrates ........................4

1. The ‘504 Patent ............................................................................................4

2. The ‘192 Patent ..........................................................................................12

B. Hanmi’s Proposed Amendment Should At Least Be Permitted To The Extent It 

Addresses The Status Of “Hydrates” Defenses Raised In Motion No. 4 ..............13

IV. CONCLUSION ..................................................................................................................15

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TABLE OF AUTHORITIES 

Cases

AK Steel Corp. v. Sollac, 344 F.3d 1234 (Fed. Cir. 2003) ........................................................ 9, 11 

Alt v. Medtronic, Inc., 2006 U.S. Dist. LEXIS 4435 (E.D. Tex. Feb. 1, 2006) .............................. 2 

ALZA Corp. v. Andrx Pharmaceuticals LLC, 603 F.3d 935 (Fed. Cir. 2010) ........................ 10, 12 

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

501 F.3d 1274 (Fed. Cir. 2007) ......................................................................................... 10, 11, 12 

Chiron Corp. v. Genentech Inc., 363 F.3d 1247 (Fed. Cir. 2004) ................................................ 14 

Connectel, LLC v. Cisco Sys., Inc., 391 F. Supp. 2d 526, 528 (E.D.Tex. 2005) ............................ 3 

Liebel-Flarsheim v. Medrad, 481 F.3d 1371 (Fed. Cir. 2007) ........................................ 8, 9, 10, 11 

Mediostream, Inc. v. Microsoft Corp., Civil Action No. 2:08-cv-369-CE, 

201 WL 4118589 at *1 (E.D. Tex. Oct. 18, 2010). ........................................................................ 2 

Plant Genetic Systems v. DeKalb Genetics Corp., 315 F.3d 1335 (Fed. Cir. 2003) ........ 7, 8, 11, 14 

TFH Pubs., Inc., v. Doskocil Mfg. Co., Inc., 705 F. Supp. 2d 361, 366 (D.N.J. 2010) .................. 2 

Rules 

Local Patent Rule 3.6 ...................................................................................................................... 1 

Local Patent Rule 3.7 .................................................................................................................. 1, 2 

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Pursuant to Local Patent Rules 3.6 and 3.7, Defendants Hamni USA, Inc., Hanmi 

Pharmaceutical Co., Ltd., Hanmi Fine Chemical Co., Ltd. (collectively “Hanmi”), respectfully 

submit this Memorandum in Support of Hanmi’s Motion to Amend Its Contentions. Hanmi’s 

second amended contentions are attached as Exhibit A to the Declaration of Mayra V. Tarantino 

(“Tarantino Dec.”) in redline form based on Hanmi’s last-served contentions dated December 9, 

2011. By email on October 11, 2012, Hanmi provided Plaintiffs AstraZeneca AB, Aktiebolaget 

Hässle, AstraZeneca LP, KBI Inc. and KBI-E Inc. (collectively “AstraZeneca”) with Hanmi’s 

draft of the proposed amendment and inquired whether AstraZeneca would consent to this 

motion. On October 15, 2012, AstraZenceca responded that it opposes the amendment. 

I. INTRODUCTION AND BRIEF SUMMARY 

 Hanmi seeks leave to amend to assert non-infringement of the asserted claims of the ‘504 

and ‘192 patents-in-suit, based on AstraZeneca’s position in opposition to Hanmi’s Motion for 

Summary Judgment No. 4 (relating to invalidity due to hydrate scope), and the Court’s August 

30, 2012 Opinion (D.I. 233). Hanmi should be permitted to show that its proposed tetrahydrate 

product does not infringe the claims literally or under the doctrine of equivalents. 

 In the alternative, if the Court denies the amendment asserting the grounds of noninfringement proposed, Hanmi respectfully asks that its proposed amendment be permitted to the 

extent it addresses the “hydrates” invalidity defenses raised in Motion No. 4, in light of 

AstraZeneca’s position and the Court’s ruling. In particular, Hanmi’s amendment should be 

permitted to bar AstraZeneca from asserting that Hanmi’s defenses raised in Motion No. 4 are 

foreclosed by the Court’s ruling in D.I. 233, and Hanmi identifies issues reserved for trial that 

were raised by the summary judgment record. 

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II. HANMI HAS SHOWN GOOD CAUSE FOR PERMITTING THE PROPOSED 

AMENDMENT 

 

Section 3.7 of the Local Civil Rules, among the exemplary instances that call for the 

issuance of Court order to amend, provides: 

(a) a claim construction by the Court different from that proposed by the party 

 seeking amendment ... 

(d) disclosure of an infringement contention by a Hatch-Waxman Act party asserting 

infringement ... that requires response by the adverse party because it was not 

previously or reasonably anticipated. 

The Court has recognized that “Rule 3.7 is not a straightjacket into which litigants are locked 

from the moment their contentions are served” and that “while the Local Patent Rules strive to 

have a party establish its contentions early on, it is important to recognize that preliminary 

infringement contentions are still preliminary.” See TFH Pubs., Inc., v. Doskocil Mfg. Co., Inc., 

705 F. Supp. 2d 361, 366 (D.N.J. 2010) (quotation marks, citations, and brackets omitted). 

 Courts having implemented patent rules expressly recognize that such frameworks 

contemplate amendment of contentions. Mediostream, Inc. v. Microsoft Corp., Civil Action No. 

2:08-cv-369-CE, 201 WL 4118589 at *1 (E.D. Tex. Oct. 18, 2010); Alt v. Medtronic, Inc., 2006

U.S. Dist. LEXIS 4435 at *1 (E.D. Tex. Feb. 1, 2006) (granting motion to amend invalidity 

contentions in light of plaintiff's shifting case theories).1 Courts have broad discretion to allow 

amendment of contentions. Local Patent Rule 3.7 provides non-exhaustive examples of grounds 

for good cause, absent undue prejudice to the adverse party. As noted above, these include an 

 

1

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

Rules of the Northern District of California, the Court may look to cases from those districts for 

guidance. TFH Pubs., Inc., 705 F. Supp. 2d at 365 n.3. 

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adverse claim construction or disclosure of a contention by a Hatch-Waxman party asserting 

infringement under L. Pat. R. 3.6(g) that requires a response by the adverse party because it was 

not previously presented or reasonably anticipated. 

 In the current situation, AstraZeneca having brought suit and provided infringement 

contentions, Hanmi reasonably believed that AstraZeneca was asserting the ‘504 and ‘192 

patents to encompass Hanmi’s tetrahydrate form of esomeprazole strontium salt. However, this 

reasonable premise has turned out to be incorrect, based on the Court’s ruling denying Summary 

Judgment Motion No. 4 and AstraZeneca’s assertions in its opposition brief. As discussed 

below, this fundamental shift in the underlying premises of this litigation in light of the Court’s 

decision and AstraZeneca’s position – i.e., “hydrates” are not set forth in, and are not material to 

the claims, and therefore do not have to be described or enabled – results in hydrates being 

excluded from the scope of the asserted ‘504 and ‘192 patent claims. Courts have recognized 

that, where a party effectively changes preliminary infringement contentions, a defendant is 

unable to crystallize its non-infringement and invalidity theories. Connectel, LLC v. Cisco Sys., 

Inc., 391 F. Supp. 2d 526, 528 (E.D.Tex. 2005). AstraZeneca cannot proceed to trial on a claim 

scope that is not enabled or described, and Hanmi therefore should be permitted to assert that its 

tetrahydrate product cannot infringe because claim scope has been limited by AstraZeneca’s 

litigation position and the Court’s decision. Accordingly, the proposed amendment will not 

impact the case schedule or the scope of discovery, or prejudice AstraZeneca; rather, Hanmi is 

merely conforming its present contentions (sent in draft to AstraZeneca on October 11, 2012) to 

the existing summary judgment record. Under these circumstances, Hanmi’s request to amend 

its contentions is fully justified, and should be granted. 

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III. THE PROPOSED AMENDMENTS SHOULD BE PERMITTED 

A. Because AstraZeneca Cannot Assert A Claim Scope That Is Not Enabled Or 

Described, The Claims Of Both Patents-In-Suit Exclude Hydrates 

1. The ‘504 Patent 

Based on the positions advanced by AstraZeneca in opposition to Hanmi’s Motion for 

Summary Judgment No. 4 and the Court’s decision relating to hydrate scope, Hanmi should be 

permitted to assert that its proposed product does not infringe any asserted claim of the ‘504 

patent, because the claims do not and cannot encompass hydrated forms of the claimed salts of 

the (-)-enantiomer of omeprazole. See Tarantino Dec., Exhibit A at pp. 3, 15-26 and 36. 

In its Opposition, AstraZeneca urged that: 

The ‘504 Patent provides written description support for the claimed pure 

solid state alkaline salts of esomeprazole as of the filing date. “Hydrates” is term 

that is simply not recited in any of the claims in this case. By imposing a written 

description requirement for hydrates, Hanmi contradicts fundamental patent law 

principles. The ‘504 patent also enables one of ordinary skill in the art to make 

and use the claimed pure solid state alkaline salts of esomeprazole as of the filing 

date, without undue experimentation. Hanmi’s attempt to focus the enablement 

inquiry on “hydrates” is in violation of the prohibition on importing limitations 

into the claims—the claims in the ’504 Patent are not limited to “hydrates.” 

D.I. 153, page 2. 

 AstraZeneca further urged that: 

First, Hanmi is improperly importing a “hydrates” limitation into the claim 

language which case law prohibits. It is established law that limitations cannot be 

imported into claimed subject matter. 

D.I. 153, page 4. AstraZeneca went on to argue: 

Hanmi’s premise that there is a “hydrates issue” is not relevant to an 

enablement inquiry, because the scope of the ’504 Patent claims is not limited to 

hydrates and the so-called “hydrates issue” is based on technology not in 

existence as of the filing date of the ’504 Patent claims. 

D.I. 153, pages 12-13. In arguing against Hanmi’s non-enablement position, AstraZeneca told 

the Court regarding Wands factors that: 

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The predictability or unpredictability of which hydrate may or may not 

form is not relevant to this analysis. 

D.I. 153, page 14. AstraZeneca stated that: 

Hanmi argues that “there is no disclosure in the’504 Patent specification 

that describes any hydrate form of a esomeprazole salt, the production of hydrated 

salt forms, or the manner and process of making a hydrated form of the claimed 

alkaline salts of esomeprazole.” (Defs.’ Br. Summ. J. 2.) This premise, however, 

is entirely incorrect, as a matter of law, and thus, has no relevance to the 

enablement inquiry. 

The ’504 Patent enables one of ordinary skill in the art to make and use 

the claimed pure solid state alkaline salts of esomeprazole as of the filing date, 

without undue experimentation. Hanmi’s attempt to focus the enablement inquiry 

on “hydrates” is in violation of the prohibition on importing limitations into the 

claims—the claims in the ’504 Patent are not limited to “hydrates.” 

* * * 

Accordingly, the entire premise of Hanmi’s arguments concerning the 

“‘hydrates’ issue” is completely incorrect as a matter of law because this issue is 

inapposite to an enablement inquiry relating to claimed subject matter of the ’504 

Patent as of the filing date. 

D.I. 153, pages 15-16. 

 AstraZeneca’s opposition tried to straddle the fence by asserting on the one hand that 

Hanmi was “importing a hydrates limitation into the claims,” while on the other hand appearing 

to argue that the claims were generic to hydrates and other species (see D.I. 153, page 4: “None 

of the claims in the ’504 Patent is limited to “hydrates,” and thus Hanmi’s inquiry focused only 

on this subset is improper.”). Yet, AstraZeneca appeared to persuade the Court that hydrates are 

outside the scope of the asserted claims, based on the Court’s ruling on Motion No. 4. In 

particular, the Court's August 30, 2012 Opinion sided with AstraZeneca’s various positions 

referenced above, in concluding that “Hanmi has not convinced the Court that ‘hydrates’ are 

material to the written description or enablement inquiry, as such inquiries relate only to those 

matters set forth in the claims.” D.I. 233, page 19 (emphasis added). 

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 The Court’s decision and AstraZeneca’s position that “hydrates” are not set forth in the 

claims, and therefore do not have to be described or enabled, results in hydrates being excluded 

from the scope of the asserted ‘504 patent claims, and not generically encompassed by them. 

Thus, Hanmi should be permitted to assert that its tetrahydrate product cannot infringe, because 

claim scope has been limited by AstraZeneca’s litigation position, and the Court’s ruling. 

 AstraZeneca cannot proceed to trial on a claim scope which is not enabled or described. 

In Hanmi’s summary judgment reply brief, Hanmi urged in response to AstraZeneca’s abovereferenced positions that AstraZeneca cannot have it both ways – that since the claims were 

asserted by AstraZeneca to encompass hydrates, hydrated forms must be enabled as of the filing 

date under well-settled Federal Circuit precedent demanding full scope enablement. D.I. 168, 

pages 9-11 (citing AK Steel, Plant Genetic and Liebel-Flarsheim, each discussed below). Since 

the Court did not mention or distinguish Hanmi’s full scope enablement precedent, and viewed 

hydrates as not “material” to enablement and written description, and not “set forth in the 

claims,” the result on the present record is that the scope of each asserted claim of the ‘504 

patent excludes hydrates. 

 To be clear, any interpretation of the Court’s ruling on Motion No. 4 which results in the 

claims-in-suit not having to be enabled because they do not expressly recite an element (such as 

hydrates) even though asserted to be generically encompassed – which is apparently the result 

AstraZeneca seeks – would be fundamentally contrary to Federal Circuit precedent. Clear 

Federal Circuit authority holds that a patent claim must be enabled over the full scope asserted 

against an accused infringer -- regardless of whether specific features of the accused product 

are recited in the claim. 

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For the Court’s convenience, Hanmi respectfully provides below a summary of five 

Federal Circuit cases that are particularly relevant to this issue of claim scope, written description, 

and enablement. A chart comparing the facts of each case is also provided to more clearly show 

the parallels in the facts of these cases to the case at bar. 

In Plant Genetic Systems v. DeKalb Genetics Corp., 315 F.3d 1335 (Fed. Cir. 2003), 

claims to a transformed “plant cell” were found to be invalid for lack of enablement. Plant cells 

could be categorized as either “monocots” or “dicots.” Neither type of plant was recited in the 

claims, but the claims were asserted to generically encompass both forms. All the examples in 

the patent were dicots (tomatoes, potatoes, etc.), but Dekalb's accused products were monocots 

(corn). The specification was found enabling for dicots but not for monocots – a later developed 

embodiment with respect to the genetic transformation at issue. The Court distinguished In re 

Hogan, 559. F.2d 595 (CCPA 1977),2 on a variety of grounds. First, the Plant Genetics court 

stated, “We do not read Hogan as allowing an inventor to claim what was specifically desired but 

difficult to obtain at the time the application was filed, unless the patent discloses how to make 

and use it.” 315 F.3d at 1340. 

The court went on to distinguish Hogan as a patentability decision, which didn’t involve 

the same infringement-validity interplay of a court case: 

Moreover, Hogan cannot be read to assist “improper enforcement against 

later developers.” Id. at 607. Hogan simply held that one could not use a laterexisting state of the art to invalidate a patent that was enabled for what it claimed 

at the time of filing. In addressing the issue of whether a claim may be of sufficient 

breadth to cover the later state of the art, Hogan stated: 

The business of the PTO is patentability, not infringement. Like 

the judicially-developed doctrine of equivalents, designed to 

 

2 Hogan was the case propounded by AstraZeneca and referenced by the Court in D.I. 233, at pp. 

17-19. 

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protect the patentee with respect to later-developed variations of 

the claimed invention, the judicially-developed “reverse doctrine 

of equivalents,” requiring interpretation of claims in light of the 

specification, may be safely relied upon to preclude improper 

enforcement against later developers. 

Id. If the present case were comparable to Hogan, PGS could avoid 

invalidation of the cell claims by at least asserting that these claims were not 

understood by those skilled in the art as encompassing monocots when the ‘236 

patent was filed. However, PGS concedes that the cell claims cover monocot 

cells. Only by doing so can PGS sue DeKalb, which makes monocotproducts, 

for infringement. Having agreed that the cell claims encompass monocot cells, 

a later development, PGS’ reliance on Hogan ignores the validity-infringement 

differentiation Hogan made. 

*** 

We conclude that the law does not support PGS’ assertion that the ‘236 patent 

is entitled to both a broad scope of coverage and a lower standard of 

enablement. 

315 F.3d at 1341 (emphasis added). The court plainly held that if the claim generically covered 

transformed monocot cells, the specification had to enable that subject matter as of the filing date. 

The Plant Genetic case expressly recognized that the patentee’s option to preserve validity was 

to have not asserted a monocot scope in the litigation, and that the Hogan case, being a Patent 

Office decision, simply didn't involve the interplay between infringement and validity, as occurs 

in infringement litigation. 

In Liebel-Flarsheim v. Medrad, 481 F.3d 1371 (Fed. Cir. 2007), the claims related to a 

computer-controlled injector. The details are not relevant, except to note the claims did not 

expressly call for a pressure jacket (unlike the original claims as filed), but were generic to both 

jacketless and jacket embodiments. The specification disclosed only the jacket embodiment, yet 

the patent was asserted against Medrad’s jacketless embodiment. The claims were found invalid 

for lack of enablement and written description, because the full scope of the claims as including 

the jacketless embodiment was not described or enabled. 481 F.3d at 1374-75. 

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The Federal Circuit affirmed the judgment of nonenablement, finding that full scope 

enablement includes the enablement of features not recited in the claims, but encompassed by the 

claims: 

We agree with Medrad that the district court correctly determined that the 

asserted claims of the front-loading patents are invalid for lack of enablement. 

The enablement requirement is set forth in 35 U.S.C. §112, ¶ 1 and provides in 

pertinent part that the specification shall describe “the manner and process of 

making and using [the invention], in such full, clear, concise, and exact terms as 

to enable any person skilled in the art to which it pertains, or with which it is most 

nearly connected, to make and use the [invention].” We have stated that the 

“enablement requirement is satisfied when one skilled in the art, after reading the 

specification, could practice the claimed invention without undue 

experimentation.” AK Steel, 344 F.3d at 1244; see also Wands, 858 F.2d at 736-

37. 

We have previously construed the claims of the front-loading patents 

such that they are not limited to an injector with a pressure jacket, and therefore 

the full scope of the claimed inventions includes injectors with and without a 

pressure jacket. That full scope must be enabled, and the district court was 

correct that it was not enabled. 

481 F.3d at 1378-79 (emphasis added). Any assertion by AstraZeneca that “hydrates” do not 

have to be enabled, because they are not expressly recited in the asserted claims, would be clearly 

at odds with this binding precedent, discussed in Hanmi’s prior briefing, as noted above. 

The Liebel-Flarsheim court relied on AK Steel Corp. v. Sollac, 344 F.3d 1234 (Fed. Cir. 

2003), another highly pertinent case on full scope enablement, summing it up aptly as follows: 

The facts of this case are, in fact, more analogous to AK Steel than to 

Spectra Physics. In AK Steel, the patentee argued, as it does here, that the patent 

disclosed several embodiments within the properly construed claim, and that the 

specification need not teach the full claimed scope in order for the claims to be 

enabled. 344 F.3d at 1243. The claims in AK Steel read on steel strips containing 

either a Type 1 or a Type 2 aluminum coating [the claims at issue only recited an 

aluminum coating, not specifying the form of aluminum]. The specification 

clearly described only Type 2 aluminum coating. We stated, however, that “as part 

of the quid pro quo of the patent bargain, the applicant’s specification must enable 

one of ordinary skill in the art to practice the full scope of the claimed invention.”

Id. at 1244 (latter emphasis added). 

We explained that the specification need not necessarily describe how to 

make and use every embodiment of the invention “because the artisan's 

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knowledge of the prior art and routine experimentation can often fill in the gaps.” 

Id. However, because the full scope of the claims included both Type 1 and Type 

2 aluminum coating, the relevant inquiry became whether one skilled in the art 

would have been able to make and use a steel strip containing a Type 1 aluminum 

coating at the time of the patent's effective filing date. Id. We held that the 

specification taught against using a Type 1 aluminum coating, and therefore that 

the claims were invalid for lack of enablement. 

Similarly, in this case, the asserted claims read on, and the full scope of the 

claimed invention includes, an injector system with and without a pressure jacket. 

There must be “reasonable enablement of the scope of the range” which, in this 

case, includes both injector systems with and without a pressure jacket. 

481 F.3d at 1380 (matter in brackets added). AstraZeneca here is similarly situated to patentee 

Liebel: 

The irony of this situation is that Liebel successfully pressed to have its 

claims include a jacketless system, but, having won that battle, it then had to show 

that such a claim was fully enabled, a challenge it could not meet. The motto, 

“beware of what one asks for,” might be applicable here. 

481 F.3d at 1380. 

In ALZA Corp. v. Andrx Pharms LLC, 603 F.3d 935 (Fed. Cir. 2010), the claims at issue 

encompassed both osmotic and non-osmotic dosage forms, even though neither type was 

expressly recited; the claim simply said “dosage form.” Even non-osmotic encompassed both 

oral and non-oral dosage forms. Non-osmotic, non-oral dosage forms were included in the full 

scope of the claimed invention, were found to be not enabled by the specification, and the claims 

were held invalid. See 603 F.3d at 943 (“In this case, ALZA successfully argued to the district 

court that the claims encompassed both osmotic and non-osmotic dosage forms. However, 

ALZA’s patent specification does not enable the full scope of the claims, namely non-osmotic 

oral dosage forms with ascending release rates.”). 

In Automotive Techs. Int’l Inc. v. BMW of North America Inc., 501 F.3d 1274 (Fed. Cir. 

2007), the claims were directed to a velocity sensor and generically covered both mechanical and 

electrical side impact sensors. Electrical types – even though not expressly claimed but only 

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generically covered – were found not enabled by the disclosure, and the claims were held invalid 

on summary judgment, which was affirmed on appeal. See 501 F.3d at 1282 (“[W]e conclude 

that all asserted claims 1-44 are invalid for lack of enablement because they all recite a sensor, 

and the full scope of the claims includes mechanical and electronic sensors, the latter of which has 

not been enabled.”). The Court clearly viewed the full scope enablement requirement as 

extending to unrecited embodiments only generically covered by the claims: 

Similarly, in this case, the claim construction of the relevant claim 

limitation resulted in the scope of the claims including both mechanical and 

electronic side impact sensors. Disclosure of only mechanical side impact sensors 

does not permit one skilled in the art to make and use the invention as broadly as it 

was claimed, which includes electronic side impact sensors. Electronic side 

impact sensors are not just another known species of a genus consisting of sensors, 

but are a distinctly different sensor compared with the well-enabled mechanical 

side impact sensor that is fully discussed in the specification. Thus, in order to 

fulfill the enablement requirement, the specification must enable the full scope of 

the claims that includes both electronic and mechanical side impact sensors, which 

the specification fails to do. 

We stated in Liebel: “The irony of this situation is that Liebel successfully pressed 

to have its claims include a jacketless system, but, having won that battle, it then 

had to show that such a claim was fully enabled, a challenge it could not meet.” 

Id. at 1380. ATI sought to have the scope of the claims of the ‘253 patent include 

both mechanical and electronic side impact sensors. It succeeded, but then was 

unable to demonstrate that the claim was fully enabled. Claims must be enabled to 

correspond to their scope. 

501 F.3d at 1285. 

The following table summarizes key points from the above cases, compared against the 

present case: 

Case Claim Language 

Embodiments 

Covered But Not 

Recited 

Result 

Plant Genetic plant cell monocots and dicots 

dicots enabled, 

monocots not enabled – 

invalid 

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Liebel-Flarsheim injector with pressure jacket, 

and jacketless 

Pressure jacket 

enabled; jacketless 

type was not enabled – 

invalid 

AK Steel aluminum coating Type 1 Al and Type 2 

Al 

Type 2 enabled, Type 

1 not enabled – invalid 

ALZA v. Andrx dosage form 

osmotic and nonosmotic, oral and nonoral 

osmotic dosage forms 

enabled, non-osmotic 

oral forms were not – 

invalid 

Auto. Tech. velocity sensor mechanical and 

electrical sensors 

mechanical sensors 

enabled, electrical 

were not – invalid

AZ v. Hanmi salts of 

esomeprazole anhydrous and 

hydrated forms 

hydrates not recited in 

claims, and a scope 

including hydrates 

does not have to be 

enabled 

Thus, under the above controlling precedent, AstraZeneca should not be permitted to 

proceed to trial, asserting its claims against hydrated forms of the compounds, without being 

required to enable or describe those forms. Nonetheless, its position that enablement is not 

required because hydrates are not recited in the claims, and the Court’s decision confirms that 

hydrates must be excluded from the ‘504 patent’s scope. Consequently, Hanmi should be entitled 

to assert that its proposed tetrahydrate product would not infringe the asserted claims of the ‘504 

patent. 

2. The ‘192 Patent 

 For the same reasons set forth in connection with the ‘504 patent above, the asserted ‘192 

patent claims exclude hydrated forms of esomeprazole salts from their scope, because the only 

description of salt forms in the ‘192 patent is subject matter incorporated by reference from the 

parent ‘504 patent (assuming incorporation is proper in whole or in part). Thus, the ‘192 claims 

can have no broader scope than ‘504 with respect to hydrates. Thus, Hanmi should be permitted 

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13 

to contend that none of the asserted claims of the ‘192 patent would be infringed by Hanmi’s 

proposed tetrahydrate product. See Tarantino Dec., Exhibit A at pp. 59-60. 

B. Hanmi’s Proposed Amendment Should At Least Be Permitted To The Extent It 

 Addresses The Status Of “Hydrates” Defenses Raised In Motion No. 4 

In any case, should Hanmi not be permitted to amend to assert non-infringement on the 

above basis, the Court should allow Hanmi to amend its contentions to bar AstraZeneca from 

asserting that Hanmi’s invalidity defenses raised in Motion No. 4 are foreclosed by the Court’s 

ruling in D.I. 233 denying the motion. See Tarantino Dec., Ex. A at pages 23-26, 84, 91 and 141. 

The Court found that: “Moreover, given the dueling expert reports submitted and the fact that 

the Court must draw all reasonable inferences in light of the non-moving party, the Court finds 

that there exist factual issues that would preclude summary judgment in any event.” D.I. 233, 

pages 19-20. The competing positions of the parties’ experts set forth on the summary judgment 

record, and the parties’ dispute over whether hydrates are exempted from the written description 

and/or enablement requirement as “later-developed technology” – an issue raised for the first 

time in AstraZeneca’s opposition (D.I. 153) – would be issues reserved for trial. Whether 

hydrates can be shown to be “later-developed technology” is an entirely different issue than 

avoiding section 112 requirements merely because “hydrates” is not explicitly recited in the 

asserted claims. In this regard, AstraZeneca asserted that it was not required to enable 

technology that was not in existence as of the filing date. D.I. 153, pages 15-16. AstraZeneca 

relied primarily on the Phillips and Hogan cases, discussed at pages 17-19 of the Court’s opinion 

(D.I. 233). The Court did not expressly exempt “hydrates” from section 112 requirements on 

the grounds of “later-developed technology.” 

AstraZeneca’s “later-developed technology” position is overbroad and incorrect. 

AstraZeneca confuses a “later-developed product” (Hanmi's esomeprazole strontium 

Case 3:11-cv-00760-JAP-TJB Document 238-1 Filed 10/15/12 Page 16 of 19 PageID: 8802
 

14 

tetrahydrate) with “later-developed technology.” Precedent makes clear that where the 

technology was generally known at the time of filing, such as transformed monocots in Plant 

Genetic, the narrow exception based on “later-developed technology” does not apply, and full 

scope enablement must be shown. Here, hydrates as polymorphic forms of pharmaceutical 

compounds were generally known as of the early to mid-1990s when AstraZeneca first filed for 

the patents-in-suit; such forms would have been desirable, and thus no exception to the full scope 

enablement rule exists here. Plant Genetic, 315 F.3d at 1340; Chiron Corp. v. Genentech Inc., 

363 F.3d 1247 (Fed. Cir. 2004). Hanmi’s Amended Contentions contain a number of literature 

cites, refuting AstraZeneca’s position that hydrates were “later-developed technology.” See 

Tarantino Dec., Exhibit A at pp. 24-25. Indeed, as shown therein, AstraZeneca had a number of 

its own patents in the relevant time frame which referenced various "hydrate" forms of 

pharmaceutical compounds, separate from salt forms. 

Even if hydrated forms of esomeprazole salts were found to be within the later-developed 

technology exception to the enablement requirement, that finding would have no bearing on the 

separate written description defense based on hydrates. In Chiron, a certain 1984 application 

was exempted from having to enable later-developed chimeric antibodies, which didn’t exist at 

the time. Nonetheless, the court affirmed invalidity for lack of written description, because the 

inventors could not have had possession of, and disclosed, the subject matter of chimeric 

antibodies that did not even exist at the time of filing. Chiron, 363 F.3d at 1253-55. 

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15 

IV. CONCLUSION 

 For the foregoing reasons, Hanmi respectfully requests that its motion be granted. A 

proposed Order is attached. 

Dated: October 15, 2012 Respectfully, 

 LITE DEPALMA GREENBERG, LLC 

 

 s/Mayra V. Tarantino 

Allyn Z. Lite 

Michael E. Patunas 

Mayra V. Tarantino 

Two Gateway Center, Suite 1201 

Newark, New Jersey 07102 

(973) 623-3000 

alite@litedepalma.com

mpatunas@litedepalma.com 

mtarantino@litedepalma.com

Mark Boland 

Michael R. Dzwonczyk 

Renita S. Rathinam 

SUGHRUE MION, PLLC 

2100 Pennsylvania Ave. NW 

Washington, DC 20037 

(202) 293-7060 

mboland@sughrue.com 

mdzwonczyk@sughrue.com 

rrathinam@sughrue.com

John B. Scherling 

SUGHRUE MION, PLLC 

 4250 Executive Square, Suite 900 

 La Jolla, California 92037 

 (858) 795.1180 

jscherling@sughrue.com

 Attorneys for Defendants Hanmi USA, Inc., 

 Hanmi Pharmaceutical Co., Ltd., 

 Hanmi Fine Chemical Co., Ltd., and 

 Hanmi Holdings Co., Ltd. 

Case 3:11-cv-00760-JAP-TJB Document 238-1 Filed 10/15/12 Page 18 of 19 PageID: 8804
CERTIFICATE OF SERVICE 

I, Mayra V. Tarantino, hereby certify that on October 15, 2012, I caused a copy of 

Hanmi’s (a) Notice of Motion to Amend Contentions, (b) Memorandum in Support of Hanmi’s 

Motion to Amend Its Contentions; (c) Declaration of Mayra V. Tarantino, (d) Form of Order, 

and (e) this Certificate of Service to be served on counsel for AstraZeneca through the Court’s 

ECF system and by email. 

 s/Mayra V. Tarantino 

 Mayra V. Tarantino 

Case 3:11-cv-00760-JAP-TJB Document 238-1 Filed 10/15/12 Page 19 of 19 PageID: 8805