John E. Flaherty 

Jonathan M.H. Short 

McCARTER & ENGLISH, LLP 

Four Gateway Center 

100 Mulberry Street 

Newark, New Jersey 07102 

(973) 622-4444 

Attorneys for Plaintiffs Counterclaim-Defendants 

AstraZeneca AB Aktiebologet Hӓssle, 

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

Of Counsel: 

Henry J. Renk 

Bruce C. Haas 

Joshua I. Rothman 

FITZPATRICK, CELLA, HARPER 

 & SCINTO 

1290 Avenue of the Americas 

New York, New York 10104-3800 

(212) 218-2100 

Einar Stole 

COVINGTON & BURLING LLP 

1201 Pennsylvania Avenue, NW 

Washington, DC 20004-2401 

(202) 662-6000 

UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF NEW JERSEY 

ASTRAZENECA AB, AKTIEBOLAGET 

HӒSSLE, ASTRAZENECA LP, KBI INC., 

and KBI-E INC., 

Plaintiffs and 

Counterclaim-Defendants, 

 

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

Hon. Joel A. Pisano, USDJ 

Hon. Tonianne J. Bongiovanni, USMJ 

v. Motion Date: January 22, 2013 

HANMI USA, INC., HANMI 

PHARMACEUTICAL CO., LTD., HANMI 

FINE CHEMICAL CO., LTD., and HANMI 

HOLDINGS CO., LTD. 

Defendants and 

Counterclaim-Plaintiffs. 

 

BRIEF IN SUPPORT OF ASTRAZENECA’S MOTION 

FOR RECONSIDERATION OF CLAIM CONSTRUCTION 

Case 3:11-cv-00760-JAP-TJB Document 260-1 Filed 12/21/12 Page 1 of 14 PageID: 9753
- i - 

TABLE OF CONTENTS 

TABLE OF AUTHORITIES .......................................................................................................... ii

INTRODUCTION ...........................................................................................................................1

LEGAL STANDARD ......................................................................................................................3

ARGUMENT ...................................................................................................................................3

I. The Court Appears Not to Have Applied the Federal Circuit’s Controlling 

Decision in Rambus in Construing “Alkaline Salt.” ............................................................3

II. The Court Appears to Have Placed Undue Reliance on the Language of 

the Specification and Relied Upon Inapposite Precedent in Addressing the 

Presumption of Claim Differentiation. ................................................................................7

CONCLUSION ................................................................................................................................9

Case 3:11-cv-00760-JAP-TJB Document 260-1 Filed 12/21/12 Page 2 of 14 PageID: 9754
- ii - 

TABLE OF AUTHORITIES 

Cases

Interdigital Communications v. ITC, 

690 F.3d 1318 (Fed. Cir. 2012)....................................................................................... 8, 9 

Laitram Corp. v. Rexnord, Inc., 

939 F.2d 1533 (Fed Cir. 2000).................................................................................... 2, 8, 9 

Liebel-Flarsheim Co. v. Medrad, Inc., 

358 F.3d 898 (Fed. Cir. 2000)......................................................................................... 2, 8 

Rambus Inc. v. Infineon Technologies, 

318 F.3d 1081 (Fed. Cir. 2003).................................................................................. passim

Seachange Int’l, Inc. v. C-COR, Inc., 

413 F.3d 1361 (Fed. Cir. 2005)....................................................................................... 2, 8 

Stolinski v. Pennypacker, 

Civ. No. 07-3174, 2009 WL 1651168, at *2 (D.N.J. June 11, 2009) ................................. 3 

U. S. v. Compaction Sys. Corp., 

88 F. Supp. 2d 339 (D.N.J. 1999) ....................................................................................... 3 

Statutes and Regulations

Local Rule 7.1(i) ......................................................................................................................... 1, 3 

Case 3:11-cv-00760-JAP-TJB Document 260-1 Filed 12/21/12 Page 3 of 14 PageID: 9755
- 1 - 

INTRODUCTION 

Pursuant to Local Rule 7.1(i), AstraZeneca moves for reconsideration 

of the Court’s construction of the term “alkaline salt” in the December 12, 2012 

opinion on claim construction. (D.I. 257) (“Opinion”). The Court construed the 

term “alkaline salt” in independent claim 1 of U.S. Patent No. 5,714,504 (“the ʼ504 

patent”) to be limited to the six specific salt species recited in dependent claim 3. 

Plaintiffs submit, with respect, that the Court overlooked or misapprehended the 

effect of the prosecution history on the construction of “alkaline salt.” 

In arriving at its construction, the Court appears to have overlooked 

the Federal Circuit’s controlling decision in Rambus Inc. v. Infineon Technologies,

318 F.3d 1081, 1094-95 (Fed. Cir. 2003), which holds that a court should not 

construe a patent claim term more narrowly than its plain and ordinary meaning 

unless the intrinsic evidence as a whole, including the prosecution history, 

consistently and uniformly requires the narrower construction. In its analysis, the 

Court does not mention the ʼ504 patent prosecution history. Assessing such 

relevant intrinsic evidence is necessary to proper claim construction. 

Also, in arriving at its current construction, the Court rejected the 

presumption that underlies the principle of claim differentiation. The intrinsic 

evidence is not consistent with the Court’s rejection of the presumption. In finding 

an exception to the presumption of “claim differentiation,” the Court appears to 

Case 3:11-cv-00760-JAP-TJB Document 260-1 Filed 12/21/12 Page 4 of 14 PageID: 9756
- 2 - 

have relied exclusively on the patent specification without considering the patent 

prosecution history. The court reasoned that the patent specification defined 

“alkaline salt” to six specific salt species and was sufficient to overcome the 

presumption of claim differentiation, relying in part upon Seachange Int’l, Inc. v. 

C-COR, Inc., 413 F.3d 1361 (Fed. Cir. 2005), and Laitram Corp. v. Rexnord, Inc.,

939 F.2d 1533 (Fed Cir. 2000). (Opinion at 6-7). Yet, the prosecution history of 

the ’504 patent demonstrates that claims 1 and 3 differ in scope. 

Plaintiffs also respectfully submit that the Court may have 

misapprehended the applicability here of Seachange and Laitram. Seachange is 

inapplicable because it concerned the differentiation in scope between claims 

unrelated by dependency. Seachange does not concern facts, as here, where the 

differentiation in scope is between independent and dependent claims. When 

assessing independent and dependent claims, the presumption of different scope is 

at its strongest. See Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 905-6 

(Fed. Cir. 2000). And, in Laitram, the Federal Circuit was careful to explain that 

under its construction of the disputed claim language, the compared claims did not 

“have exactly the same scope and, thus, claim differentiation [wa]s maintained.” 

939 F.2d at 1538. 

Also, because the Court has construed the term “pharmaceutically 

acceptable salt” in U.S. Patent 5,877,192 (“the ’192 patent”) to have the same 

Case 3:11-cv-00760-JAP-TJB Document 260-1 Filed 12/21/12 Page 5 of 14 PageID: 9757
- 3 - 

meaning as “alkaline salt,” Plaintiffs also respectfully request the Court reconsider 

its construction of “alkaline salt” in the context of the ’192 patent. 

LEGAL STANDARD 

Local Rule 7.1(i) provides that a party moving for reconsideration 

must set forth “the matter or controlling decisions which the party believes” the 

Court overlooked in its prior decision. Local Rule 7.1(i). To prevail, the movant 

must show that “dispositive factual matters or controlling decisions of law were 

brought to the Court’s attention but not considered.”1 Stolinski v. Pennypacker, 

Civ. No. 07-3174, 2009 WL 1651168, at *2 (D.N.J. June 11, 2009) (citation 

omitted). The court will entertain a motion for reconsideration where the court has 

overlooked matters that, if considered, might reasonably have resulted in a 

different conclusion. U. S. v. Compaction Sys. Corp., 88 F. Supp. 2d 339, 345 

(D.N.J. 1999). That standard is met here. 

ARGUMENT 

I. The Court Appears Not to Have Applied the Federal Circuit’s 

Controlling Decision in Rambus in Construing “Alkaline Salt.” 

There is a “heavy presumption” that claim terms carry the plain and 

ordinary meaning. (D.I. 176 at 7). In construing “alkaline salt,” the Court 

concluded that language in the specification required a narrower definition of that 

 

1 The evidence cited in this paper was brought to the attention of the Court during 

the claim construction proceedings.

Case 3:11-cv-00760-JAP-TJB Document 260-1 Filed 12/21/12 Page 6 of 14 PageID: 9758
- 4 - 

term—one that included only six salts. (Opinion at 6). In doing so, however, the 

Court did not appear to apply the Federal Circuit’s controlling decision in Rambus. 

Rambus makes clear that, before limiting the full scope of the claim on the basis of 

statements in the specification, all intrinsic evidence, including the specification as 

a whole and the prosecution history, must uniformly support that limitation. See 

id. Although AstraZeneca cited Rambus in briefing and argued that it precluded 

limiting “alkaline salt” in the manner that Hanmi proposed, (D.I. 176 at 5), the 

Court did not cite Rambus or appear to follow that decision in construing the term 

in question. (See generally Opinion at 5-8). 

In Rambus, the Federal Circuit explained that while a couple of 

statements in the specification “taken alone” may suggest some limitation of the 

term “bus,” “the remainder of the specification and prosecution history show[ed] 

that Rambus did not clearly disclaim or disavow such claim scope.” 318 F.3d at 

1094-95. The Federal Circuit observed that while statements about the “present 

invention” may sometimes limit the meaning of claim terms in patent cases, “such 

language must be read in context of the entire specification and the prosecution 

history.” Id. at 1094. And when one reviewed the entire specification and 

prosecution history in Rambus, it was clear that, notwithstanding a couple of 

potentially limiting statements in the specification, the inventors did not intend to 

limit the scope of “bus.” Id. at 1095. 

Case 3:11-cv-00760-JAP-TJB Document 260-1 Filed 12/21/12 Page 7 of 14 PageID: 9759
- 5 - 

This Court’s decision is inconsistent with Rambus’ in that the Court 

appears not to have considered (or given necessary weight to) the patent 

prosecution history. Rambus provides a clear directive that potentially limiting 

statements in the specification must be viewed in the context of the prosecution 

history as well. 318 F.3d at 1094. Here, the prosecution history supports the full 

claim scope of “alkaline salt.” (D.I. 176, at 7-8). 

When the application for the ’504 patent was filed, the broadest 

compound claim was limited to six species of salts:

1. An optically pure enantiomeric compound 

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

[(+)-omeprazole] or [(-)-omeprazole], wherein R is an 

alkyl with 1-4 carbon atoms. 

(Doc. 111.0 at 37, emphasis added; for convenience, copy attached as Exh. A; 

Exhibits referenced herein are attached to the accompanying declaration of Joshua 

I. Rothman). 

Following a January 1997 interview in which the Examiner noted that 

the scope of the claims “will depend on the data submitted,” (D.I. 111.0 at 76-77, 

Exh. B), AstraZeneca cancelled all of the original claims 1-34, and added new 

claims 35-44, which later issued as claims 1-10 of the ’504 patent. (D.I. 111.2 at 5, 

Exh. C). 

Claim 35 replaced cancelled original claim 1, and used the broader

term “alkaline salt,” thereby expanding coverage beyond the mere six salts that had 

Case 3:11-cv-00760-JAP-TJB Document 260-1 Filed 12/21/12 Page 8 of 14 PageID: 9760
- 6 - 

previously been listed in original claim 1. Applicants presented data 

demonstrating that esomeprazole in the form of both sodium (“Na+”) and 

magnesium (“Mg2+”) salts supported the patentability of the broadest claim. (D.I. 

111.2 at 20-34, Exh. D). Applicants also argued repeatedly that this data showed 

that any alkaline salt of esomeprazole provided surprising and unexpected results 

that support patentability. For example, applicants argued as follows: 

As shown in the Andersson Declaration the (-)-

omeprazole enantiomer, as administered in the form of its 

alkaline salts, unexpectedly exhibits a different and more 

advantageous pharmacokinetic profile than the racemic 

mixture or the (+)-enantiomer of omeprazole. 

(Id. at 8, emphasis added, highlighted in Exh. E); and:

As discussed at the interview, the pharmaceutical 

formulations for oral administration comprising pure 

solid state alkaline salts of the (-)-enantiomer of 

omeprazole to which the new claims are directed, are 

patentable over the prior art and the cited references. 

(Id. at 12, emphasis added, highlighted in Exh. E). See also eight other highlighted 

portions of Exh. E and two highlighted portions of Exh. D. 

The Examiner allowed both the new broad independent claim reciting 

“alkaline salt” and the new narrower dependent claim reciting the six salt species. 

Plainly, applicants and the Examiner both viewed these two claims as having 

different scope. If the Examiner had concluded that the specification defined 

Case 3:11-cv-00760-JAP-TJB Document 260-1 Filed 12/21/12 Page 9 of 14 PageID: 9761
- 7 - 

“alkaline salt” as being limited to just the six species, she never would have 

allowed both claim 1 and claim 3. 

The Court’s reliance on portions of the specification to find intent to 

limit “alkaline salt” in claim 1 to only the six species cannot be reconciled with the 

prosecution history. Under Rambus, such reconciliation is required. Here, as in 

Rambus, when isolated statements in the specification are viewed in the context of 

the prosecution history, support for the conclusion that applicants clearly intended 

to confer a narrow scope on the claims disappears. 

II. The Court Appears to Have Placed Undue Reliance on the 

Language of the Specification and Relied Upon Inapposite 

Precedent in Addressing the Presumption of Claim Differentiation. 

This Court’s construction of “alkaline salt” should be reconsidered 

because the present construction is contrary to the presumption of claim 

differentiation, and would thereby render claim 3 meaningless. Claim 3 is directed 

to the “pharmaceutical formulation according to claim 1,” with the added 

limitation that the “alkaline salt” is restricted to the salts Na+

, Mg2+, Li+, K+, Ca2+

or N+(R)4. (Opinion at 7). Under the Court’s construction, however, “alkaline 

salt” in claim 1 is already limited to these six particular salts, meaning that the 

added limitation in claim 3 would not differentiate that claim from claim 1, 

rendering claim 3 meaningless. 

Case 3:11-cv-00760-JAP-TJB Document 260-1 Filed 12/21/12 Page 10 of 14 PageID: 9762
- 8 - 

In its opinion, this Court reasoned that the claim differentiation 

doctrine was “not a hard and fast rule,” and that the “relevant intrinsic evidence” 

required the Court’s interpretation. (Opinion at 7). However, Federal Circuit 

precedent emphasizes that the presumption of claim differentiation is “especially 

strong” when, as here, “the limitation in dispute is the only meaningful difference 

between an independent and dependent claim.” Liebel-Flarsheim, 358 F.3d at 910. 

Under these circumstances, the presumption can only be overcome by “strong 

contrary evidence.” Interdigital Communications v. ITC, 690 F.3d 1318, 1324 

(Fed. Cir. 2012). It is respectfully submitted that the cases relied upon by the 

Court are inapposite to the matter at hand. In addition, as noted above, in 

discussing the relevant intrinsic evidence the Court did not address the patent 

prosecution history. 

First, in concluding that the presumption of claim differentiation had 

been overcome, this Court cited Seachange and Laitram. (Opinion at 7). But 

Seachange is inapplicable here; it concerned the differentiation in scope between 

separate claims not related by dependency. Seachange did not concern the 

situation where, as here, the differentiation in scope is between independent and 

dependent claims. It is just this situation where the presumption of different scope 

is at its strongest. Liebel-Flarsheim, 358 F.3d at 905-06. This Court also relied 

upon Laitram. There, however, the Federal Circuit was careful to explain that 

Case 3:11-cv-00760-JAP-TJB Document 260-1 Filed 12/21/12 Page 11 of 14 PageID: 9763
- 9 - 

under its construction of the disputed claim language, the compared claims did not 

“have exactly the same scope and, thus, claim differentiation [wa]s maintained.” 

Id. at 1538. 

Second, while this Court reasoned that the presumption of claim 

differentiation had been overcome by intrinsic evidence, the intrinsic evidence as a 

whole did not support this view. The Court relied only on language in the 

specification and does not appear to consider all intrinsic evidence (e.g., the 

prosecution history). The prosecution history makes clear that both the applicants 

and the Examiner understood “alkaline salt” to be broader than simply the six salts 

to which the Court has limited that term. If the applicants had intended to limit 

“alkaline salt” in claim 1 to the six salts listed in claim 3, why not explicitly recite 

six species in claim 1 and omit claim 3 altogether? And, if the Examiner had 

believed that the specification defined “alkaline salt” as being limited to just the six 

species, she never would have allowed both claim 1 and claim 3. In this case, the 

evidence is insufficient to overcome the strong presumption of claim 

differentiation, let alone the necessary “strong contrary evidence.” Interdigital, 

690 F.3d at 1324. 

CONCLUSION 

For the foregoing reasons, AstraZeneca respectfully requests that the 

Court reconsider its December 12, 2012 order on claim construction, and construe 

Case 3:11-cv-00760-JAP-TJB Document 260-1 Filed 12/21/12 Page 12 of 14 PageID: 9764
- 10 - 

the ʼ504 patent claim term “alkaline salt” consistent with its plain and ordinary 

meaning, as AstraZeneca proposed in its claim construction submissions. Because 

the Court has ruled that the claim term “pharmaceutically acceptable salt” in the 

’192 Patent carries the same meaning as “alkaline salt,” the Court should likewise 

reconsider that construction, as proposed in AstraZeneca’s claim construction 

submissions. 

Respectfully submitted, 

Dated: December 21, 2012 s/John E. Flaherty 

John E. Flaherty 

McCARTER & ENGLISH, LLP 

Four Gateway Center 

100 Mulberry Street 

Newark, New Jersey 07102 

(973) 622-4444 

Attorneys for Plaintiffs Counterclaim- 

 Defendants 

 AstraZeneca AB Aktiebologet Hӓssle, 

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

Of Counsel: 

Henry J. Renk 

Bruce C. Haas 

Joshua I. Rothman 

FITZPATRICK, CELLA, HARPER 

 & SCINTO 

1290 Avenue of the Americas 

New York, New York 10104-3800 

(212) 218-2100 

Case 3:11-cv-00760-JAP-TJB Document 260-1 Filed 12/21/12 Page 13 of 14 PageID: 9765
- 11 - 

Einar Stole 

COVINGTON & BURLING LLP 

1201 Pennsylvania Avenue, NW 

Washington, DC 20004-2401 

(202) 662-6000 

Case 3:11-cv-00760-JAP-TJB Document 260-1 Filed 12/21/12 Page 14 of 14 PageID: 9766