UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF NEW JERSEY

____________________________________

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ASTRAZENECA AB, et al. :

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Plaintiffs, : Civil Action No. 11-760 (JAP)

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v. :

: OPINION

HANMI USA, INC., et al. :

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Defendants. :

____________________________________:

PISANO, District Judge.

In this Hatch-Waxman patent infringement action brought by Plaintiffs AstraZeneca 

AB, Aktiebolaget Hässle, AstraZeneca LP, KBI Inc. and KBI-E Inc. (collectively, 

“AstraZeneca” or “Plaintiffs”) against defendants Hanmi, Inc., Hanmi Pharmaceutical Co., 

Ltd., Hanmi Fine Chemical Co., Ltd. and Hanmi Holdings Co., Ltd. (collectively, “Hanmi” or 

“Defendants”), Hanmi originally filed five motions seeking summary judgment. Two of the 

motions, those designated by the parties as Motion No. 1 and Motion No. 5, were previously

decided by the Court. See Opinion and Order, D.I. 226, 227. This Opinion addresses the 

remaining three, specifically, those motions designated by the parties as Motion No. 2, Motion 

No. 3 and Motion No. 4. The Court heard oral argument on Motion Nos. 2 and 4, and it

decides the remaining motion without oral argument pursuant to Federal Rule of Civil 

Procedure 78. For the reasons below, the Court denies Hanmi’s motions.

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I. BACKGROUND

A background summary is set forth in the Court’s earlier Opinion and, therefore, need 

not be repeated here. See Opinion at D.I. 226. Facts relevant to each of the instant motions are 

set forth below.

II. SUMMARY JUDGMENT MOTIONS

A. Summary Judgment Standard

A court shall grant summary judgment under Rule 56 of the Federal Rules of Civil 

Procedure “if the movant shows that there is no genuine dispute as to any material fact and the 

movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). The substantive law 

identifies which facts are critical or “material.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 

248 (1986). A material fact raises a “genuine” issue “if the evidence is such that a reasonable 

jury could return a verdict” for the non-moving party. Healy v. N.Y. Life Ins. Co., 860 F.2d 

1209, 1219 n.3 (3d Cir. 1988). 

On a summary judgment motion, the moving party must show, first, that no genuine 

issue of material fact exists. Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). If the moving 

party makes this showing, the burden shifts to the non-moving party to present evidence that a 

genuine fact issue compels a trial. Id. at 324. The non-moving party must then offer 

admissible evidence that establishes a genuine issue of material fact, id., not just “some 

metaphysical doubt as to the material facts.” Matsushita Elec. Indus. Co. v. Zenith Radio 

Corp., 475 U.S. 574, 586 (1986). 

The Court must consider all facts and their logical inferences in the light most favorable 

to the non-moving party. Pollock v. American Tel. & Tel. Long Lines, 794 F.2d 860, 864 (3d 

Cir. 1986). The Court shall not “weigh the evidence and determine the truth of the matter,” but 

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need determine only whether a genuine issue necessitates a trial. Anderson, 477 U.S. at 249. If 

the non-moving party fails to demonstrate proof beyond a “mere scintilla” of evidence that a 

genuine issue of material fact exists, then the Court must grant summary judgment. Big Apple 

BMW v. BMW of North America, 974 F.2d 1358, 1363 (3d Cir. 1992).

B. Motion No. 2 – Invalidity Of U.S. Patent No. 5,877,192 – Claims 12, 19, 21, and 22

The ‘192 patent describes and claims a method for treating gastric acid related diseases 

with esomeprazole and a method for the production of an esomeprazole-containing medicament 

for treating gastric acid related diseases. The claimed inventions are based on the discovery 

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

compared to the prior art racematic compound omeprazole. The ‘192 patent states that it issued 

from an application that was a continuation-in-part of U.S. Patent Application No. 08/376,512 

filed January 23, 1995, later issuing as U.S. Patent No. 5,714, 504, which was a continuationin-part of U.S. Patent Application No. 08/256,174 filed June 28, 1994, later issuing as United 

States Patent No. 5,693,818. As alleged by AstraZeneca, the “family tree” of the ‘192 patent 

can be summarized as follows:

● Swedish Priority Application SE 9301830-7 (filed May 28, 1993) →

● Patent Cooperation Treaty application (“PCT application”) designated 

PCT/SE/00509, filed May 27, 1994 (“ ‘509 application”), which published as WO ‘988 on 

December 8, 1994 →

● United States Patent Application (a national stage application under 35 U.S.C. § 371)

No. 256,174 (the ‘174 application) filed June 28, 1994, later issuing as United States Patent No. 

5,693,818 (the “‘818 patent”) →

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● United States Patent Application No. 376,512 (the “’512 application”) filed January 

23, 1995, later issuing as the (the “‘504 patent”) →

● United States Patent Application No. 833,962 (the “’962 application”) filed April 11, 

1997, later issuing as the ‘192 patent. 

Thus, according to AstraZeneca, the ‘192 patent claims priority to the applications 

leading to the ‘504 patent and the ‘818 patent. 

Hanmi seeks summary judgment that claims 12, 19 and 21-22 (to the extent dependent 

on claims 12 and 19) of the ‘192 patent are anticipated and therefore invalid. Specifically, 

Hanmi alleges that claims 12, 19 and 21-22 are anticipated and invalid under 35 U.S.C. § 

102(b) because each limitation of those claims is allegedly found in WO 94/27988, published 

December 8, 1994 (“WO ‘988”). Hanmi contends that the ‘192 patent is not entitled to claim 

the benefit of a filing date earlier than its April 1997 filing date, and, therefore, the WO ‘988 

reference is a prior art reference that anticipates the disputed claims. AstraZeneca disputes that 

the WO ‘988 is a prior art reference.

1. Legal Standards

a. Anticipation

A patent is invalid if “the invention was patented or described in a printed publication in 

this or a foreign country ... more than one year prior to the date of the application for patent in 

the United States.” 35 U.S.C. § 102(b). If “each and every limitation is found either expressly 

or inherently in a single prior art reference,” then a claim is invalid under § 102 for 

anticipation. Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1375 (Fed. Cir. 2006) (quoting 

Celeritas Techs. Ltd. v. Rockwell Int'l Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998)). 

Anticipation is a question of fact that must be established by clear and convincing evidence. 

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Sanofi–Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082 (Fed. Cir. 2008). Although a fact 

question, summary judgment of anticipation may be appropriate if there is no genuine dispute 

of any material fact. Encyclopaedia Britannica, Inc. v. Alpine Elecs. of Am., Inc., 609 F.3d 

1345, 1349 (Fed. Cir. 2010). 

b. Priority

Section 120 of Title 39 of the United States Code governs entitlement of a patent 

application to an earlier filing date and provides that an application for a patent may “have the 

same effect, as to such invention, as though filed on the date of the prior application” if certain 

requirements are met.

1

 The Federal Circuit has summarized these requirements as follows:

A patent is entitled to the priority date of an earlier filed application if (1) the 

written description of the earlier filed application discloses the invention 

claimed in the later filed application sufficient to satisfy the requirements of § 

112; (2) the applications have at least one common inventor; (3) the later 

application is filed before the issuance or abandonment of the earlier filed 

application; and (4) the later application contains a reference to the earlier filed 

application. 

In re NTP, Inc., 654 F.3d 1268, 1277 (Fed. Cir. 2011). Further, “if the later filed application 

claims priority through the heredity of a chain of applications, each application in the chain 

must satisfy § 112.” Id. “[I]f any application in the priority chain fails to make the requisite 

disclosure of subject matter, the later-filed application is not entitled to the benefit of the filing 

date of applications preceding the break in the priority chain.” Hollmer v. Harari, 681 F.3d 

1351, 1355 (Fed. Cir. 2012)

 1

This section reads in the relevant part as follows:

[a]n application for patent for an invention disclosed in the manner provided by section 112(a) 

(other than the requirement to disclose the best mode) in an application previously filed in the 

United States, or as provided by section 363 of this title, which is filed by an inventor or 

inventors named in the previously filed application shall have the same effect, as to such 

invention, as though filed on the date of the prior application[.]

35 U.S.C. § 120.

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2. Analysis

As noted earlier, Hanmi contends that claims 12, 19, 21 and 22 of the ‘192 patent are 

anticipated by WO ‘988 because the WO ‘988 reference is prior art against the ‘192 patent 

claims and each and every limitation in these claims is allegedly disclosed in WO ‘988. 

Hanmi’s position that the WO ‘988 reference is a prior art reference is based upon two 

independent grounds. First, Hanmi alleges that the WO ‘988 reference is admitted in the ‘192 

patent to be a prior art reference. Second, Hanmi argues that the ‘192 patent is not entitled to 

priority to any earlier application and, therefore, the WO ‘988 reference is a statutory prior art 

reference under § 102(b) because it was published more than one year before the effective 

filing dates of the claims at issue.

In response, AstraZeneca does not contest the substantive basis of Hanmi’s anticipation 

argument, but instead challenges the availability of the WO ‘988 reference as prior art. 

AstraZeneca first contends, contrary to Hanmi’s assertions, that the WO ‘988 reference is not 

“admitted” prior art. AstraZeneca further argues that the ‘192 patent is entitled to priority to at 

least the ‘174 application, which pre-dates the WO ‘988 reference. The Court addresses each 

argument in turn below. 

As relevant to Hanmi’s first argument, the “Background of the Invention” section of the 

‘192 patent acknowledges that the “[d]ifferent salts of the single enantiomers of omeprazole” 

were described in the WO ‘988 reference. ‘192 patent, col. 1, lines 63-64. Hanmi contends

that this statement “set the stage” for the invention described in the following sections and that, 

when read in context, the ‘192 patent characterizes the WO ‘988 reference as prior art. Hanmi 

argues that such statements are binding upon AstraZeneca for the purposes of whether the WO 

‘988 reference is prior art against the ‘192 claims. Additionally, Hanmi notes that the applicant 

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submitted the WO ‘988 reference as part of an Information Disclosure Statement (“IDS”) with 

the Patent Office during prosecution of the ‘192 patent in which the applicant described WO 

‘988 as a reference. According to Hanmi this is a confirmation by AstraZeneca of the prior art 

status of WO ‘988 (although Hanmi is clear that it is not arguing that the filing of the 

document in the IDS constituted an admission that it is prior art).

AstraZeneca responds to Hanmi’s assertions by pointing out that “[o]ne’s own work 

may not be considered prior art in the absence of a statutory basis.” Riverwood Int’l Corp. v. 

R.A. Jones & Co., 324 F.3d 1346, 1355 (Fed. Cir. 2003) (“[A] patentee should not be 

‘punished’ for being as inclusive as possible and referencing his own work in an [Information 

Disclosure Statement].”); Reading & Bates Construction Co. v. Baker Energy Resources Corp., 

748 F.2d 645, 650 (Fed. Cir. 1984) ([T]here is an important distinction between the situation 

where the inventor improves upon his own invention and the situation where he improves upon 

the invention of another. In the former situation, where the inventor continues to improve upon 

his own work product, his foundational work product should not, without a statutory basis, be 

treated as prior art solely because he admits knowledge of his own work.”). As these cases 

make clear, patents issued to the same inventive entity are not prior art by admission. 

Riverwood, 324 F.3d at 1355. One of the two inventors listed in the ‘192 patent is Per 

Lindberg. One of the two Inventor/Applicants listed in the WO ‘988 reference is Per Lindberg. 

As such, and in light of the early stage of the case and the limited record before it on the 

question, the Court finds that Hanmi has not shown that entry of summary judgment in its favor 

based on the issue of “admitted” prior art is appropriate.

Turning to Hanmi’s second argument, the Court finds that issues of material fact exist 

that preclude summary judgment. Hanmi argues that the WO ‘988 reference is a statutory prior 

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art reference under § 102(b) because the ‘192 patent is not entitled to the benefit of the filing 

dates of the earlier applications. As relevant to the instant motion, the ‘192 patent claims 

priority back to the mid-1994 filing date of the ‘174 application, prior to the December 1994 

publication of WO ‘988. As noted earlier, under 35 U.S.C. § 120, the ‘192 patent is entitled to 

the benefit of the filing date of an earlier application if four basic requirement are met. 

First, the invention described in the new application must be disclosed [in the 

manner provided by 35 U.S.C. § 112] in an application previously filed in the 

United States. Second, the application must be filed by an inventor or inventors 

named in the previously filed application. Third, the application must be copending with the earlier application, or filed before the patenting or 

abandonment of or termination of proceedings on the first application. Fourth, 

the application must contain or be amended to contain a specific reference to the 

earlier filed application.

Encyclopaedia Britannica, Inc. v. Alpine Electronics of America, Inc., 609 F.3d 1345, 1350 

(Fed. Cir. 2010) (internal citations, quotations omitted). “The plain and unambiguous meaning 

of [§ ] 120 is that any application fulfilling the requirements therein shall have the same effect 

as if filed on the date of the application upon which it claims priority.” Transco Prods., Inc. v. 

Performance Contracting, Inc., 38 F.3d 551, 556 (Fed. Cir. 1994) (internal quotation omitted). 

In the instant case, the first factor -- continuity of disclosure -- is the only factor disputed, and, 

therefore, the sole issue for resolution of Hanmi’s motion is whether this requirement has been 

met. See Def. Brf. at 10.

“In order to gain the benefit of the filing date of an earlier application under 35 U.S.C. § 

120, each application in the chain leading back to the earlier application must comply with the 

written description requirement of 35 U.S.C. § 112.” Lockwood v. Am. Airlines, Inc., 107 F.3d 

1565, 1571 (Fed. Cir. 1997). Hanmi’s argument regarding the alleged lack of continuity 

centers on its contention that the ‘512 application does not disclose the subject matter of the 

claims at issue as required by § 112. Specifically, Hanmi claims that this immediate parent 

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application does not disclose the neutral or free base form of esomeprozole in a medicament for 

the treatment of gastric acid related diseases, which is an element in each of the claims at issue 

on this motion. Thus, according to Hanmi, the alleged break in the priority chain negates 

entitlement to any earlier filing date. 

In response to Hanmi’s motion, AstraZeneca has submitted the declaration of Dr. 

Davies who concludes that the compounds described in the ‘504 patent “quite clearly include at 

least the optically pure (-)-enantiomer of omeprazole in both neutral and salt forms.” Davies 

Decl. ¶ 60; see also ¶¶ 59-62. Dr. Davies opines that to a person of ordinary skill in the art, the 

neutral form of esomeprazole and its use as a medicament for the treatment of gastric acid 

related diseases is described in the ‘504 patent. Id. ¶ 63. He reaches a similar conclusion 

regarding the ‘818 patent. Id. ¶ 68. As such, the Court finds that AstraZeneca has shown there 

are disputed issues of material fact that include whether using the neutral form of esomeprazole 

in a medicament for the treatment of gastric acid related diseases is disclosed in the earlier 

applications as required by § 120. Consequently, such disputed issues of material fact preclude 

the summary judgment that Hanmi seeks by way of this motion. The Court denies Hanmi’s 

motion No. 2. 

C. Motion No. 3 - Invalidity Of U.S. Patent No. 5,714,504 – Claims 1, 2, 4, 6, and 7

Hanmi moves for summary judgment of invalidity of the ‘504 patent, claims 1, 2, 4, 6, 

and 7. Hanmi’s motion centers on its contention that the claim term “solid state” is indefinite, 

and, therefore, the asserted claims fail. Hanmi also argues that the patent is invalid because the 

“solid state” salts of the asserted claims are neither adequately described or enabled.

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1. Legal Standards

a. Indefiniteness

To be sufficiently definite, a patent specification must “conclude with one or more 

claims particularly pointing out and distinctly claiming the subject matter which the applicant 

regards as his invention.” 35 U.S.C. § 112, ¶ 2. The boundaries of the claim must be 

discernible to one skilled in the art based on the language of the claim, the specification, and 

the prosecution history, as well as that person’s knowledge of the relevant field of art. See 

Halliburton Energy Servs., Inc. v. M–ILLC, 514 F.3d 1244, 1249–51 (Fed. Cir.2 008). Claims 

that are “not amenable to construction” or “insolubly ambiguous” are indefinite. Datamize 

LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1347 (Fed. Cir. 2005). The Federal Circuit has 

noted that “because claim construction frequently poses difficult questions over which 

reasonable minds may disagree, proof of indefiniteness must meet an exacting standard.” 

Haemonetics Corp. v. Baxter Healthcare Corp., 607 F.3d 776, 783 (Fed. Cir. 2010) (quotations 

omitted). “[A] claim is indefinite only if the ‘claim is insolubly ambiguous, and no narrowing 

construction can properly be adopted.’ ” Honeywell Int'l, Inc. v. Int’l Trade Comm'n, 341 F.3d 

1332, 1338–39 (Fed. Cir. 2003) (quoting Exxon Research & Eng’g Co. v. United States, 265 

F.3d 1371, 1375 (Fed. Cir. 2001).). However, “[i]f the meaning of the claim is discernible, 

even though the task may be formidable and the conclusion may be one over which reasonable 

persons will disagree, we have held the claim sufficiently clear to avoid invalidity on 

indefiniteness grounds.” Exxon, 265 F.3d at 1375.

b. Written Description and Enablement

One of the statutory conditions for patentability under the Patent Act is adequate 

disclosure of the invention. As set forth in Section 112 of Title 35,

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[t]he specification shall contain a written description of the invention, and of the 

manner and process of making and using it, 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 same, and shall set forth 

the best mode contemplated by the inventor of carrying out his invention.

35 U.S.C. § 112. The Federal Circuit has interpreted § 112 as imposing a number of separate 

disclosure requirements, two of which are relevant here. The first is known as the written 

description requirement, found in the first sentence of Section 112, which requires that the 

specification contain an adequate “written description of the invention.” 35 U.S.C. § 112; see 

also Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) 

(“[A] separate requirement to describe one’s invention is basic to patent law. Every patent 

must describe an invention. It is part of the quid pro quo of a patent; one describes an 

invention, and, if the law’s other requirements are met, one obtains a patent. The specification 

must then, of course, describe how to make and use the invention (i.e., enable it), but that is a 

different task.”). 

“[T]he purpose of the written description requirement is to ‘ensure that the scope of the 

right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s 

contribution to the field of art as described in the patent specification.’” Ariad Pharms., Inc. v. 

Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed.Cir.2010) (en banc). It “serves both to satisfy the 

inventor’s obligation to disclose the technologic knowledge upon which the patent is based and 

to demonstrate that the patentee was in possession of the invention that is claimed.” Capon v. 

Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). 

As stated by the Federal Circuit, “[t]he test for sufficiency of a written description is 

whether the disclosure clearly allow[s] persons of ordinary skill in the art to recognize that [the 

inventor] invented what is claimed.” Crown Packaging Technology, Inc. v. Ball Metal 

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Beverage Container Corp., 635 F.3d 1373, 1380 (Fed. Cir. 2011) (internal quotations omitted, 

alterations in original). The “hallmark of written description is disclosure,” and a court 

examining the sufficiency of a written description must make “an objective inquiry into the 

four corners of the specification from the perspective of a person of ordinary skill in the art.” 

Ariad, 598 F.3d at 1351. To pass muster under that inquiry, “[t]he disclosure must reasonably 

convey[ ] to those skilled in the art that the inventor had possession of the claimed subject 

matter as of the filing date.” Crown, 635 F.3d at 1380 (internal quotations omitted, alteration in 

original). Said another way, “the specification must describe an invention understandable to 

that skilled artisan and show that the inventor actually invented the invention claimed.” Ariad, 

598 F.3d at 1351. 

“[D]etermining whether a patent complies with the written description requirement will 

necessarily vary depending on the context.” Id. The requirement “must be applied in the 

context of the particular invention and the state of the knowledge.” Capon v. Eshhar, 418 F.3d 

1349, 1358 (Fed. Cir. 2005). The inquiry into the written description requirement is a question 

of fact, however, it is “amenable to summary judgment in cases where no reasonable fact finder 

could return a verdict for the non-moving party.” Boston Scientific Corp. v. Johnson & 

Johnson, 647 F.3d 1353, 1361 (Fed. Cir. 2011) (quoting PowerOasis, Inc. v. T–Mobile USA, 

Inc., 522 F.3d 1299, 1307 (Fed. Cir. 2008)). A party challenging a patent based upon the 

written description requirement must provide clear and convincing evidence that persons 

skilled in the art would not recognize in the disclosure a description of the claimed invention. 

Centocor Ortho Biotech, Inc. v. Abbott Laboratories, 636 F.3d 1341, 1347 (Fed. Cir. 2011) 

(presumption of validity overcome only by clear and convincing evidence).

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Separate from the written description requirement is the “enablement” requirement 

codified in § 112. “To be enabling, the specification of a patent must teach those skilled in the 

art how to make and use the full scope of the claimed invention without ‘undue 

experimentation.’” ALZA Corp. v. Andrx Pharmaceuticals, LLC, 603 F.3d 935, 940 (Fed. Cir. 

2010) (quoting Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997). 

“Enablement is not precluded where a ‘reasonable’ amount of routine experimentation is 

required to practice a claimed invention, however, such experimentation must not be ‘undue.’” 

Id. In In re Wands, 858 F.2d 731, 735 (Fed. Cir. 1988), the Federal Circuit set forth the 

following factors that a court may consider when determining if a disclosure requires undue 

experimentation:

(1) the quantity of experimentation necessary, (2) the amount of direction or 

guidance presented, (3) the presence or absence of working examples, (4) the 

nature of the invention, (5) the state of the prior art, (6) the relative skill of those 

in the art, (7) the predictability or unpredictability of the art, and (8) the breadth 

of the claims.

858 F.2d at 737. A court need not consider all of the Wands factors in its analysis, but rather, a 

court is only required to consider those factors relevant to the facts of the case. See Amgen, 

Inc. v. Chugai Pharm. Co., Ltd., 927 F.2d 1200, 1213 (Fed. Cir. 1991).

Importantly, to fulfill the enablement requirement, the full scope of each claim must be 

enabled. Sitrick v. Dreamworks, LLC, 516 F.3d 993, 999 (Fed. Cir. 2008). 

Enabling the full scope of each claim is part of the quid pro quo of the patent 

bargain. A patentee who chooses broad claim language must make sure the 

broad claims are fully enabled. The scope of the claims must be less than or 

equal to the scope of the enablement to ensure that the public knowledge is 

enriched by the patent specification to a degree at least commensurate with the 

scope of the claims.

Id. It is not sufficient for the specification to provide merely “a starting point, a direction for 

further research”; it must provide “reasonable detail” sufficient to enable a person of ordinary 

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skill in the art to make or use the invention. Automotive Technologies Intern., Inc. v. BMW of 

North America, Inc., 501 F.3d 1274, 1284 (Fed. Cir. 2007). Whether the enablement 

requirement has been satisfied is a question of law based upon underlying facts, and is 

determined as of the patent’s effective filing date. Sitrick, 516 F.3d at 999. 

2. Analysis 

AstraZeneca argues that Hanmi’s motion should be denied for a number of reasons. In 

particular, it points to this Court’s earlier ruling in a related case that the term “solid state” as 

used in the claims of the ‘504 patent has a plain and ordinary meaning to one that is skilled in 

the art. See AztraZeneca AB v. Dr. Reddy’s Laboratories, Ltd., 2010 WL 1981790, *9 (D.N.J. 

2010). This Court in Dr. Reddy’s held with regard to the term “solid state” that “no 

construction of this term is necessary [and] that its ordinary and customary meaning would be 

clear to one skilled in the art.” Id. However, Hanmi’s motion relies largely on its contentions 

that the term has no recognized meaning in describing pharmaceutical substances, and it argues 

that the term is not defined or described in the relevant patent application. 

According to AstraZeneca’s expert Professor Davies, whose declaration was submitted 

in response to this motion, one of ordinary skill in the art would have at the relevant time 

understood the term “solid state” to have an art-accepted meaning. Specifically, Dr. Davies 

states that the plain meaning of “solid state” is solid material in any form. Davies Decl. ¶ 80, 

83. Hanmi contends that this Court rejected such a construction in its Dr. Reddy’s decision, 

and Hanmi relies a great deal on this assumption. See Reply at 7 (“In reliance on the Court’s 

prior rejection of solid state as meaning ‘solid form rather than liquid, such as syrup or oil” ... 

Hanmi asserted [the instant defenses].”). However, a careful reading of the Court’s decision 

shows that, in fact, the Court did not determine (as Hanmi asserts) that “solid form” cannot 

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mean, for example, “solid material.” Rather, the Court simply found it unnecessary in Dr. 

Reddy’s to adopt either parties’ proposed construction.2

 While Hanmi makes much of the 

Court’s earlier purported “rejection,” Hanmi misinterprets it. Given the Dr. Reddy’s parties’ 

arguments, their similar proposed constructions, and the nature of the claim term, the issue 

before the Court in Dr. Reddy’s with respect to the term “solid state” was more about the extent 

to which claim construction was necessary than which (if either) of the parties’ proposed 

constructions should be adopted. See National Oilwell Varco, L.P. v. Auto–Dril, Inc., No. 09-

85, 2011 WL 3648532, at *6 (E.D. Tex. Aug.16, 2011) (noting that “[w]hile it is a district 

court’s duty is to construe the claims, part of this duty is to determine the extent [to which]

construction is even necessary.). The Court ultimately determined in Dr. Reddy’s that that no 

construction was necessary and the plain meaning should control in that case. Id. Contrary to 

Hanmi’s assertions, such a finding does not necessarily constitute a “rejection” of any 

particular construction, nor does it foreclose the possibility that the Court may need to adopt an 

express construction of the term in this case.

In light of the arguments raised in Hanmi’s motion and the parties’ disagreement over 

whether the claim term “solid state” has an ordinary and customary meaning, it has become 

apparent that adoption of a construction for “solid state” is necessary in this case. “When the 

parties raise an actual dispute regarding the proper scope of these claims, the court, not the jury, 

must resolve that dispute.” O2 Micro International Ltd. v. Beyond Innovation Technology Co., 

 2 Indeed, Hanmi itself notes that the parties in Dr. Reddy’s “proposed essentially the same construction.” Reply at 

7. A court is not required to construe a claim term when there is not a genuine dispute as to its meaning. See O2 

Micro Intern. Ltd. v. Beyond Innovation Tech. Co., Ltd.. 521 F.3d 1351, 1362 (Fed. Cir. 2008) (“[D]istrict courts 

are not (and should not be) required to construe every limitation present in a patent's asserted claims”); U.S. 

Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997) (“Claim construction is a matter of 

resolution of disputed meanings and technical scope, to clarify and when necessary to explain what the patentee 

covered by the claims, for use in the determination of infringement. It is not an obligatory exercise in 

redundancy.”).

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521 F.3d 1351, 1360 (Fed. Cir. 2008). The Court finds that AstraZeneca’s proposed 

construction, i.e., that “solid state” means “solid material,” is most consistent with the plain and 

ordinary meaning of the term, as well as with the Court’s earlier conclusion that the meaning of 

the term is clear to one skilled in the art. The Court also credits the opinion of Dr. Davies, who 

opined that “a person having ordinary skill in the art would have found the “solid state” 

alkaline salts to be understandable with a clear and ordinary meaning of solid material.” 

Davies Decl. ¶ 93. Consequently, the Court shall construe “solid state” consistent with 

AstraZeneca’s proposed construction to mean “solid material.” The Court rejects Hanmi’s 

contention that the term “solid state” is indefinite. 

 Having rejected Hanmi’s argument that a person of skill in the art would have found 

the term “solid state” to be unclear, the Court further finds that Hanmi has also failed to 

establish by clear and convincing evidence that claims 1, 2, 4, 6 and 7 of the ‘504 patent do not

satisfy the written description requirement of Section 112. The ‘504 patent discloses how to 

make alkaline salts of (-)-omeprazole that in forms that a person of ordinary skill would 

recognize as solid state -- crystalline form, amorphous form, powders, tablets. See Davies 

Decl. ¶ 83. The specification of the ‘504 patent describes the alkaline salt products of (-)-

omeprazole as “crystalline”). ‘504 patent, col. 1, lines 56-58; col. 3, lines 35-37, 40-41. 

Multiple examples detail the preparation of alkaline salts of (-)-omeprazole in crystalline form 

and as powder. In order to satisfy the written description requirement, the disclosure as 

originally filed does not have to provide in haec verba support for the claimed subject matter at 

issue.” Yingbin–Nature (Guangdong) Wood Industry Co., Ltd. v. International Trade Com'n, 

535 F.3d 1322, 1334 (Fed. Cir. 2008) (quoting Purdue Pharma L.P.v. Faulding Inc., 230 F.3d 

1320, 1323 (Fed. Cir. 2000)). 

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Finally, the Court agrees with AstraZeneca that, with respect to enablement, issues of 

material fact preclude summary judgment. Hanmi’s motion with respect to enablement

depends largely upon its assertion that “solid state” is not capable of being defined, a 

proposition that the Court has rejected. Having examined the relevant Wands factors in light of 

the claim construction set forth above, the Court finds that fact issues preclude summary 

judgment and denies Hanmi’s motion. 

D. Motion No. 4 – Invalidity Of U.S. Patent No. 5,714,504 – Claims 1, 2, 4, 6 and 7 

Claims 1, 2, 4, 6 and 7 are directed to “pharmaceutical formulation[s]” comprising “a 

pure solid state alkaline salt” of esomeprazole and methods of use thereof for “inhibiting gastric 

acid secretion” and treatment of gastrointestinal inflammatory disease.” ‘504 patent. Hanmi 

challenges the validity of the ‘504 patent claims on written description and enablement 

grounds. Specifically, Hanmi alleges that the patent contains no written description showing 

that AstraZeneca was in possession of any hydrated form of esomeprazole salt, and, further, 

that there is no disclosure of how to make any such hydrated form. According to Hanmi, 

because AstraZeneca construes the asserted ‘504 patent claims to encompass Hanmi’s proposed 

product, which contains esomeprazole strontium tetrahydrate as the active ingredient, the 

patent must meet the written description and enablement requirements of § 112 with respect 

hydrated forms of the alkaline salts of esomeprazole. 

AstraZeneca argues in response to Hamni’s motion that the ‘504 patent claims do not 

recite the term “hydrates” and, as such, the patent is not required to describe or enable such a 

form. First, AstraZeneca argues that Hamni is improperly importing a limitation into the 

patent’s claim for the written description inquiry. Second, AstraZeneca contends that Hanmi’s 

motion is improperly based upon a later-existing technology involving Hanmi’s tetrahydrate 

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form. AstraZeneca’s arguments rely primarily upon two cases: Phillips Petroleum Co. v. U.S. 

Steel Corp., 673 F. Supp. 1278, 1290-91 (D. Del. 1987), aff’d 865 F.2d 1247, 1290 (Fed. Cir. 

1989) and In re Hogan, 559 F.2d 595, 605-07 (CCPA 1977).

In Phillips, the defendants argued that there was no written description support for the 

high molecular weight polypropylene used in its products. The claim at issue in that case read 

“Normally solid polypropylene, consisting essentially of recurring propylene units, having a 

substantial crystalline polypropylene content.” 673 F. Supp. at 1286. The defendants 

specifically argued that the intrinsic viscosity for polypropylene disclosed in the application 

was less than the intrinsic viscosity of its own product. However, the Court rejected 

defendants’ argument, noting that the claim at issue did not contain limitations regarding 

intrinsic viscosity or molecular weight: 

Defendants have misconstrued the inquiry under section 112. The focus of that 

inquiry is whether the claimed subject matter is adequately described. If the 

’851 claim contained a limitation regarding intrinsic viscosity or molecular 

weight, Defendants’ arguments would have merit. Yet, the ’851 claim contains 

no such limitation. The fact that the 1953 application specified a range of 

intrinsic iscosities of only 0.2 to 1.0 is, therefore, immaterial to the present 

inquiry.

Id. at 1291 (citations omitted). The Phillips court applied its analysis to both written

description and enablement: 

Thus, with respect to both the written description and enablement requirements, 

Defendants have misconstrued the inquiry under section 112. They have sought 

to read into the ’851 claim a molecular weight/intrinsic viscosity limitation 

which simply is not there. . . . A patent applicant is not required, however, to 

predict every possible variation, improvement or commercial embodiment of his 

invention. In seeking to impose such a requirement on Phillips, Defendants 

have wholly failed to carry their burden in establishing the insufficiency of 

Phillips’ 1953 application under section 112. 

Id at 1292 (citations omitted). 

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In Hogan, the patent application, filed in 1953, claimed a solid polymer, and the claims 

encompassed both crystalline and amorphous forms, even though the amorphous polymers did 

not exist until 1962. 559 F.2d at 605– 06. The specification disclosed methods for making the 

crystalline form, but not the amorphous polymers that it later became possible to produce. Id.

The court stated that the patent application was not required to disclose the later-existing 

amorphous polymers:

A later state of the art is that state coming into existence after the filing date of 

an application. This court has approved use of later publications as evidence of 

the state of art existing on the filing date of an application. That approval does 

not extend, however, to the use of a later . . . publication disclosing a later

(1962) existing state of the art in testing an earlier (1953) application for 

compliance with s 112, first paragraph. 

. . . 

Appellants disclosed, as the only then existing way to make such a polymer, a 

method of making the crystalline form. To now say that appellants should have 

disclosed in 1953 the amorphous form which on this record did not exist until 

1962, would be to impose an impossible burden on inventors and thus on the 

patent system. There cannot, in an effective patent system, be such a burden 

placed on the right to broad claims. To restrict appellants to the crystalline form 

disclosed, under such circumstances, would be a poor way to stimulate 

invention, and particularly to encourage its early disclosure. To demand such 

restriction is merely to state a policy against broad protection for pioneer 

inventions, a policy both shortsighted and unsound from the standpoint of 

promoting progress in the useful arts, the constitutional purpose of the patent 

laws. 

Id. at 605–06 (citations omitted).

The Court finds that Hanmi has not established that it is entitled to summary judgment

here. In light of Phillips and Hogan, 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. 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 

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Court finds that there exist factual issues that would preclude summary judgment in any event. 

As such, the Court denies Hanmi’s motion. 

III. CONCLUSION

For the reasons above, Hamni’s Motion No. 2 (Invalidity Of U.S. Patent No. 5,877,192 

– Claims 12, 19, 21, and 22), Motion No. 3 (Invalidity Of U.S. Patent No. 5,714,504 – Claims 

1, 2, 4, 6, and 7), and Motion No. 4 (Invalidity Of U.S. Patent No. 5,714,504 – Claims 1, 2, 4, 6 

and 7) are denied. An appropriate Order accompanies this Opinion. 

/s/ Joel A. Pisano

JOEL A. PISANO, U.S.D.J.

Dated: August 30, 2012

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