John E. Flaherty 

Jonathan M. H. Short 

MCCARTER & ENGLISH, LLP

Four Gateway Center 

100 Mulberry Street 

Newark, New Jersey 07102 

T (973) 622-4444 

F (973) 624-7070 

Attorneys for all Plaintiffs 

 

Of Counsel: 

Eric J. Lobenfeld 

Arlene L. Chow 

HOGAN LOVELLS US LLP 

875 Third Avenue 

New York, New York 10022 

(212) 918-3000 

Attorneys for all Plaintiffs 

Philippe Y. Riesen 

HOGAN LOVELLS HORITSU 

JIMUSHO

Gaikokuho Kyodo Jigyo 

15th Floor Daido Seimei 

Kasumigaseki Building 

1-4-2 Kasumigaseki 

Chiyoda-ku, Tokyo 100-0013 

Japan 

(81) 3-5157-8200 

Attorneys for all Plaintiffs

Paul A. Ragusa 

Lisa Kole 

BAKER BOTTS LLP 

30 Rockefeller Plaza 

New York, NY 10112 

(212) 408-2588 

Attorneys for Plaintiff 

Ethypharm, S.A.

IN THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF NEW JERSEY 

TAKEDA PHARMACEUTICAL COMPANY 

LIMITED, TAKEDA PHARMACEUTICALS 

NORTH AMERICA, INC., TAKEDA 

PHARMACEUTICALS LLC, TAKEDA 

PHARMACEUTICALS AMERICA, INC., and 

ETHYPHARM, S.A., 

 Plaintiffs and Counterclaim-Defendants, 

 v. 

MYLAN PHARMACEUTICALS INC., 

 Defendant and Counterclaim-Plaintiff. 

:

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Civil Action No. 3:11-CV-02506-JAP-TJB 

REVISED JOINT CLAIM CONSTRUCTION 

AND PREHEARING STATEMENT 

Case 3:11-cv-02506-JAP-TJB Document 91 Filed 08/21/12 Page 1 of 23 PageID: 1848
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INTRODUCTION 

 Pursuant to L. Pat. R. 4.3, Plaintiffs Takeda Pharmaceutical Company Limited, Takeda 

Pharmaceuticals North America, Inc., Takeda Pharmaceuticals LLC, and Takeda 

Pharmaceuticals America, Inc. (collectively, "Takeda") and Ethypharm, S.A. ("Ethypharm") 

(Takeda and Ethypharm together "Plaintiffs") and Defendant Mylan Pharmaceuticals Inc. 

("Mylan") provided their Joint Claim Construction And Prehearing Statement on February 9, 

2012 (D.I. 59). The parties have since agreed to the construction of the following claim terms: 

(1) "fine granules" (U.S. Patent No. 6,328,994); (2) "a composition" (U.S. Patent No. 6,328,994); 

and (3) "A rapidly disintegratable tablet for oral administration and disintegration in the buccal 

cavity without the use of water" (U.S. Patent No. 5,464,632). To reflect the parties' agreement as 

to those terms, the parties hereby provide their Revised Joint Claim Construction And Prehearing 

Statement in advance of the hearing scheduled for August 23, 2012 at 9:30 AM. 

I. Construction Of Terms On Which The Parties Agree

1. U.S. Patent No. 6,328,994 ("the '994 patent") 

CLAIM TERM AGREED CONSTRUCTION 

Claim 1 

fine granules fine granules up to and including the enteric 

coating layer 

a composition composition up to but not including the enteric 

coating layer 

said composition having 10 weight % or more of an 

acid-labile physiologically active substance that is 

lansoprazole 

said composition up to but not including the enteric 

coating layer having 10 weight % or more of an 

acid-labile physiologically active substance that is 

lansoprazole 

and (ii) an additive Plain and ordinary meaning; no construction 

needed. 

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CLAIM TERM AGREED CONSTRUCTION 

having a hardness strength of about 1 to about 20 

kg 

Plain and ordinary meaning; no construction 

needed. 

Claim 3 

wherein the fine granules further comprise a basic 

inorganic salt. 

Plain and ordinary meaning; no construction 

needed. 

Claim 4

wherein the additive comprises a water-soluble 

sugar alcohol. 

Plain and ordinary meaning; no construction 

needed. 

Claim 9 

wherein the basic inorganic salt is a salt of 

magnesium and/or a salt of calcium. 

Plain and ordinary meaning; no construction 

needed. 

Claim 15 

wherein the fine granules are produced by 

fluidized-bed granulation method. 

Plain and ordinary meaning; no construction 

needed. 

Claim 16 

wherein the enteric coating layer comprises an 

aqueous enteric polymer agent. 

Plain and ordinary meaning; no construction 

needed. 

Claim 17 

wherein the aqueous enteric polymer agent is a 

methacrylate copolymer. 

Plain and ordinary meaning; no construction 

needed. 

Claim 18 

wherein the sustained-release agent is a 

methacrylate copolymer. 

Plain and ordinary meaning; no construction 

needed. 

Claim 19 

wherein the sustained-release agent is in an amount

of 5-15 weight % relative to 100 weight % of the 

aqueous enteric polymer agent. 

Plain and ordinary meaning; no construction 

needed. 

Claim 21 

wherein the water-soluble sugar alcohol is 

mannitol. 

Plain and ordinary meaning; no construction 

needed. 

Claim 22 

wherein the water-soluble sugar alcohol is in an 

amount of 5 to 97 weight % relative to 100 weight 

% of the orally disintegrable tablet apart from the

fine granules. 

Plain and ordinary meaning; no construction 

needed. 

Claim 23 

wherein the crystalline cellulose is in an amount of 

3 to 50 weight % relative to 100 weight % of the 

tablet apart from the fine granule. 

Plain and ordinary meaning; no construction 

needed. 

Claim 26 

which further comprises crospovidone. Plain and ordinary meaning; no construction 

needed. 

Claim 27 

wherein the oral disintegration time is one minute 

or less. 

Plain and ordinary meaning; no construction 

needed. 

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CLAIM TERM AGREED CONSTRUCTION 

Claim 44 

wherein the sustained-release agent is in an amount

of 5 to 30 weight % relative to 100 weight % of the

aqueous enteric polymer agent. 

Plain and ordinary meaning; no construction 

needed. 

2. U.S. Patent No. 5,464,632 ("the '632 patent")

CLAIM TERM, PHRASE, OR CLAUSE AGREED CONSTRUCTION 

Claim 1 

A rapidly disintegratable tablet for oral 

administration and disintegration in the buccal 

cavity without the use of water 

A tablet that disintegrates rapidly in the mouth 

without the use of water 

wherein said tablet comprises an active substance 

and 

Plain and ordinary meaning; no construction 

needed. 

said active substance being multiparticulate and in

the form of coated microcrystals, or coated 

microgranules 

Plain and ordinary meaning; no construction 

needed. 

and wherein said mixture of excipients comprises Plain and ordinary meaning; no construction 

needed. 

a disintegrating agent a substance, or mixture of substances, added to a 

tablet that is a causal agent in its breakup or 

disintegration after administration 

and swelling agent a substance, or mixture of substances, which, when 

contacted with liquid, absorbs the liquid and 

expands in volume 

which are responsible for the disintegration of the

tablet with the saliva present in the mouth 

Plain and ordinary meaning; no construction 

needed. 

to achieve in less than 60 seconds a suspension 

easy to swallow 

Plain and ordinary meaning; no construction 

needed. 

Claim 4 

The tablet of claim 1, wherein the mixture of 

excipients comprises at least one disintegrating 

agent selected from the group consisting of 

carboxymethylcellulose, insoluble reticulated PVP 

and at least one swelling agent selected from the 

group consisting of starch, modified starch, and 

microcrystalline cellulose. 

Plain and ordinary meaning; no construction 

needed. 

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II. Proposed Constructions Of Disputed Terms 

 Exhibit A includes (1) each party's proposed construction of each disputed term; (2) an 

identification of all references from the intrinsic evidence that support that construction, and (3) 

an identification of any extrinsic evidence known to the party on which it intends to rely either to 

support its proposed construction or to oppose any other party's proposed construction, including, 

but not limited to, as permitted by law, dictionary definitions, citations to learned treatises and 

prior art, and testimony of all witnesses including experts. 

III. Identification Of Most Significant Terms For Construction 

1. The '994 patent claim terms, the construction of which will be most significant, include: 

 a. "An orally disintegrable tablet" (Claim 1) 

b. "fine granules having an average particle diameter of 400 μm or less" (Claim 1) 

c. "an enteric coating layer comprising a first component which is an enteric coating 

agent and a second component which is a sustained-release agent" (Claim 1) 

d. "wherein said tablet . . . is orally disintegrable" (Claim 1) 

 e. "wherein the average particle diameter of the fine granule is 300 to 400 μm" 

 (Claim 2) 

2. The '632 patent claim terms, the construction of which will be most significant, include: 

 a. "a mixture of non-effervescent excipients" (Claim 1) 

 b. "permits to obtain reduced ph influence in the digestive tract" (Claim 1) 

 c. "permits to obtain . . . reduced influence of viscosity" (Claim 1) 

IV. Identification of Terms Whose Construction Will Be Case Dispositive or 

Substantially Conducive to Promoting Settlement 

1. The '994 patent claim terms, the construction of which may be dispositive of this action 

or substantially conducive to promoting settlement, are: 

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a. "fine granules having an average particle diameter of 400 μm or less" (Claim 1) 

b. "an enteric coating layer comprising a first component which is an enteric coating 

agent and a second component which is a sustained-release agent" (Claim 1) 

c. "wherein the average particle diameter of the fine granule is 300 to 400 μm" 

 (Claim 2) 

2. The '632 patent claim terms, the construction of which may be dispositive of this action 

or substantially conducive to promoting settlement, are: 

a. "a mixture of non-effervescent excipients" (Claim 1) 

 b. "permits to obtain reduced ph influence in the digestive tract" (Claim 1) 

 c. "permits to obtain . . . reduced influence of viscosity" (Claim 1) 

V. Anticipated Length Of Claim Construction Hearing

 The parties anticipate that the claim construction hearing will require one day. 

VI. Identification Of Claim Construction Witnesses And Testimony

The parties have agreed not to call any witnesses (factual or expert) to offer testimony at 

the hearing. However, the parties will rely on the declarations and deposition testimony 

(together with accompanying exhibits) of expert witnesses Dr. Stephen Byrn and Dr. Russell 

Mumper. 

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 Respectfully submitted, 

Dated: August 21, 2012 

By: s/John E. Flaherty 

John E. Flaherty 

Jonathan M.H. Short 

MCCARTER & ENGLISH, LLP 

Four Gateway Center 

100 Mulberry Street 

Newark, New Jersey 07102 

(973) 622-4444 

Eric J. Lobenfeld 

Arlene L. Chow 

 

HOGAN LOVELLS US LLP 

875 Third Avenue 

New York, New York 10022 

(212) 918-3000 

 

Philippe Y. Riesen 

HOGAN LOVELLS HORITSU JIMUSHO

Gaikokuho Kyodo Jigyo 

15th Floor Daido Seimei 

Kasumigaseki Building 

1-4-2 Kasumigaseki 

Chiyoda-ku, Tokyo 100-0013 Japan 

(81) 3-5157-8200 

Attorneys for all Plaintiffs 

Paul A. Ragusa 

Lisa Kole 

BAKER BOTTS LLP

30 Rockefeller Plaza

New York, NY 10112 

(212) 408-2588 

Attorneys for Plaintiff Ethypharm, S.A

By: s/Arnold B. Calmann 

Arnold B. Calmann 

Geri L. Albin 

Saiber LLC 

One Gateway Center 

10th Floor 

Newark, New Jersey 07102-5311 

(973) 622-3333 (phone) 

(973) 622-3349 (facsimile) 

abc@saiber.com 

galbin@saiber.com 

Thomas J. Parker 

Deepro R. Mukerjee 

Alston & Bird LLP 

90 Park Avenue 

New York, NY 10016-1387 

(212) 210-9400 (phone) 

(212) 210-9444 (facsimile) 

thomas.parker@alston.com 

Attorneys for Defendant 

Mylan Pharmaceuticals Inc. 

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EXHIBIT A – Parties' Proposed Constructions and Evidentiary Support for Disputed Claim Terms of 

6,328,994 and 5,464,632 

Parties' Proposed Constructions and Evidentiary Support for USP 6,328,994 

CLAIM TERM PLAINTIFFS' PROPOSED CONSTRUCTION 

AND EVIDENTIARY SUPPORT 

DEFENDANT'S P

CONSTRUCTION AND 

SUPPOR

Claim 1 An orally disintegrable tablet Proposed Construction: 

Plain and ordinary meaning. Evidentiary Support: 1) Specification: Col. 1, ll. 9-11 Col. 13, ll. 9-15 Col. 17, ll. 57-67 Col. 18, ll. 1-6 

Proposed Construction: 

"A tablet that is capable of dthe mouth with saliva or swallowed" Evidentiary Support: 1) Specification: Col. 1, ll. 9-11 Col. 13, ll. 9-15 Col. 17, ll. 57-67 Col. 18, ll. 1-6 

fine granules having an average particle diameter of 400 μm or less 

Proposed Construction: fine granules up to and including the enteric coating layer having an average particle diameter of 400 μm 

(± 10%) or less 

Proposed Construction: 

"fine granules having an aveof 400 μm or less, with diameter of 425 μm or less" 

Case 3:11-cv-02506-JAP-TJB Document 91 Filed 08/21/12 Page 8 of 23 PageID: 1
2 

CLAIM TERM PLAINTIFFS' PROPOSED CONSTRUCTION 

AND EVIDENTIARY SUPPORT 

DEFENDANT'S P

CONSTRUCTION AND 

SUPPOR

Evidentiary Support: Construction taken from Takeda Pharm. Co. Ltd. et al. v. Zydus Pharms. USA Inc., et al., Civil Action No. 10-1723 (D.N.J.) (JAP) (Dkt. 113), dated Oct. 5, 2011 at p. 7.1) Specification: Claim 1 Abstract Col. 2, ll. 18-21 Col. 5, ll. 43-50, 57-63 Col. 12, ll. 58-59 Col. 19, ll. 32-37 2) Extrinsic Evidence: US Pharmacopeia 429 Snorek, J. of Pharm. Sci., 96:1451-1467 (2007)

Evidentiary Support: 

1) Specification: Abstract Col. 1, l. 30-39 Col. 1, ll. 44-52 Col. 2, ll. 12-22 Col. 2, ll. 41-49 Col. 3, ll. 14-22 Col. 3, ll. 36-41 Col. 4, ll. 49-62 Col. 5, ll. 43-56 Col. 5, l. 57 – Col. 6, l. 9 Col. 12, ll. 56-65 Col. 13, ll. 52-53 Col. 14, ll. 30-39 Col. 14, ll. 59-60 

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3 

CLAIM TERM PLAINTIFFS' PROPOSED CONSTRUCTION 

AND EVIDENTIARY SUPPORT 

DEFENDANT'S P

CONSTRUCTION AND 

SUPPOR

Col. 16, ll. 11-17 Col. 19, ll. 32-37 Col. 20, ll. 25-30 Col. 22, ll. 16-25, 48-50 Col. 24, ll. 11-17 Col. 26, ll. 4-9 Col. 28, ll. 26-31 Col. 30, ll. 38-43 Col. 32, ll. 52-57 Col. 35, ll. 8-14 Col. 36, ll. 34-39 Examples 1-9 2) Prosecution History: Shimizu Declaration dated Se4-7 EP Patent No. 761,212 (ShimU.S. Patent No. 5,501,861 (M

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CLAIM TERM PLAINTIFFS' PROPOSED CONSTRUCTION 

AND EVIDENTIARY SUPPORT 

DEFENDANT'S P

CONSTRUCTION AND 

SUPPOR

an enteric coating layer comprising a first component which is an enteric coating agent and a second component which is a sustained-release agent

Proposed Construction: The "enteric coating layer" includes a first component that is an "enteric coating agent" which can be a methacrylate copolymer and a second component that is a "sustained-release agent" whichcan be a methacrylate copolymer. Evidentiary Support: 1) Specification: Col 4, ll. 4-16 Col. 5, ll.16-26 Col. 9, ll. 9-35 '994 Patent, claims 17 and 18 '994 Patent, claims 39 and 40 2) Prosecution History: Office Action, dated August 21, 2000 Amendment, dated December 8, 2000 Declaration of Shimizu, dated September 21, 2000 Amendment, dated May 9, 2001 

Proposed Construction:

"an enteric coating layer comphysically separate componcomponent which is an entersecond component which iagent, wherein the enteric coalocation in the digestive sysingredient is released and agent releases the activpredetermined rate in order tor prolonged drug concentperiod of time" Evidentiary Support: 1) Specification: Col. 9, ll. 9-35 Col. 20, ll. 30-40 Col. 22, ll. 28-35 Col. 24, ll. 20-28 Col. 25, ll. 50-58 Col. 27, ll. 40-50 Col. 27, ll. 60-68 

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CLAIM TERM PLAINTIFFS' PROPOSED CONSTRUCTION 

AND EVIDENTIARY SUPPORT 

DEFENDANT'S P

CONSTRUCTION AND 

SUPPOR

3) Extrinsic Evidence:WO 2006/011159 US 2008/0113030 US 2009/0304789 Vasilevska, K. et al. "Effect of mixtures of soluble Eudragits on release rate of diltiazem hydrochloride from pellets." Pharmazie 46 (Jan. 1991), p. 54. Obeidat, W. et al. "Sustained Release Tablets Containing Soluble Polymethacrylates: Comparison with Tableted Polymethacrylate IPEC Polymers." AAPS PharmSciTech, Vol. 11, No. 1, pp. 54-63, March 2010. Obeidat, W. et al. "Novel Combination of Anionic and Cationic Polymethacrylate Polymers for Sustained Release Tablet Preparation." Drug Dev. and Indus. Pharm., 34:650-660 (2008). Alvarez, D. et al. "Drug-Release Mechanisms. Comparison of Eudragit FS 30D & Eudragit L30 D55 as Matrix Formers in Sustained-Release Tablets."www.drugdeliverytechonline.com/drugdelivery/200707 (printed 1/9/2012) Holgado, M. et al. "Physical characterization of carteolol: Eudragit L binding interaction." Int'l J. of Pharm. 114 (1995) 13-21. 

Col. 29, ll. 60-68 Col. 30, ll. 17-25 Col. 32, ll. 9-16 Col. 32, ll. 30-40 Col. 34, ll. 27-35 Col. 34, ll. 46-55 Col. 36, ll. 42-50 Examples 1-9 2) Prosecution History: 

Office Action dated August 2Claim Amendment dated De1-3, 6 Office Action dated March 13Claim Amendment dated May Notice of Allowability dated JEP Patent No. 761,212 (Shim

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AND EVIDENTIARY SUPPORT 

DEFENDANT'S P

CONSTRUCTION AND 

SUPPOR

U.S. Patent No. 5,501,861 (M3) Extrinsic Evidence: 

Remington's Pharmaceutical 1670; 1676-1677 (18th ed. 199

Herbert A. Lieberman et al., PDosage Forms, Tablets, Vol. 120 (2nd ed. 1990) 

enteric coating layer Proposed Construction: 

The "enteric coating layer" may be constructed by plural (e.g., 2 or 3) layers. Evidentiary Support: 1) Specification: Col. 16, ll. 37-38. 

Proposed Construction: 

This claim limitation should its plain and ordinary meanin

an enteric coating agent and sEvidentiary Support: 

See Mylan’s Responsive Cla(D.E. 81) at 14-20; SupplemeRussell J. Mumper (D.E. 8exhibits cited therein. 

wherein said tablet . . . is orally disintegrable 

Proposed Construction: Plain and ordinary meaning Evidentiary Support: 1) Specification: 

Proposed Construction: "wherein said tablet is capeither in the mouth with salivswallowed" Evidentiary Support: 

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CLAIM TERM PLAINTIFFS' PROPOSED CONSTRUCTION 

AND EVIDENTIARY SUPPORT 

DEFENDANT'S P

CONSTRUCTION AND 

SUPPOR

Col. 1, ll. 9-11 Col. 13, ll. 9-15 Col. 17, ll. 57-67 Col. 18, ll. 1-6 

1) Specification: 

Col. 1, ll. 9-11 Col. 13, ll. 9-15 Col. 17, ll. 57-67 Col. 18, ll. 1-6 

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CLAIM TERM PLAINTIFFS' PROPOSED CONSTRUCTION 

AND EVIDENTIARY SUPPORT 

DEFENDANT'S P

CONSTRUCTION AND 

SUPPOR

Claim 2wherein the average particle diameter of the fine granule is 300 to 400 μm 

Proposed Construction: wherein the average particle diameter of the fine granule is 300 to 400 μm (± 10%) 

Evidentiary Support: 

Construction taken from Takeda Pharm. Co. Ltd. et al. v. Zydus Pharms. USA Inc., et al., Civil Action No. 10-1723 (D.N.J.) (JAP) (Dkt. 113), dated Oct. 5, 2011 at p. 9. 1) Specification: Claims 1 and 2 Abstract Col. 2, ll. 18-21 Col. 5, ll. 43-50, 57-63 Col. 12, ll. 58-59 Col. 19, ll. 32-37 2) Extrinsic Evidence: US Pharmacopeia 429 Snorek, J. of Pharm. Sci., 96:1451-1467 (2007) 

Proposed Construction: 

"wherein the average particle granules is 300 to 400 μm or particle diameter of 425 μm oEvidentiary Support: 1) Specification: Abstract Col. 1, l. 30-39 Col. 1, ll. 44-52 Col. 2, ll. 12-22 Col. 2, ll. 41-49 Col. 3, ll. 14-22 Col. 3, ll. 36-41 Col. 4, ll. 49-62 Col. 5, ll. 43-56 Col. 5, l. 57 – Col. 6, l. 9 Col. 12, ll. 56-65 

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AND EVIDENTIARY SUPPORT 

DEFENDANT'S P

CONSTRUCTION AND 

SUPPOR

Col. 13, ll. 52-53 Col. 14, ll. 30-39 Col. 14, ll. 59-60 Col. 16, ll. 11-17 Col. 19, ll. 32-37 Col. 20, ll. 25-30 Col. 22, ll. 16-25, 48-50 Col. 24, ll. 11-17 Col. 26, ll. 4-9 Col. 28, ll. 26-31 Col. 30, ll. 38-43 Col. 32, ll. 52-57 Col. 35, ll. 8-14 Col. 36, ll. 34-39 Examples 1-9 2) Prosecution History: 

Shimizu Declaration dated Se

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CLAIM TERM PLAINTIFFS' PROPOSED CONSTRUCTION 

AND EVIDENTIARY SUPPORT 

DEFENDANT'S P

CONSTRUCTION AND 

SUPPOR

2-3, 5-7 EP Patent No. 761,212 (ShimU.S. Patent No. 5,501,861 (M

Parties' Proposed Constructions and Evidentiary Support for USP 5,464,632 

CLAIM TERM PLAINTIFFS' PROPOSED CONSTRUCTION 

AND EVIDENTIARY SUPPORT 

DEFENDANT'S P

CONSTRUCTION AND 

SUPPOR

Claim 1 a mixture of non-effervescent excipients 

Proposed Construction: mixture of excipients in which effervescent excipients, if any, are less than 5% by weight of the final composition Evidentiary Support: 1) Specification: Col. 2, ll. 40-49 Col. 3, ll. 15-28 2) Prosecution History: Request for Reexamination, dated December 31, 1998 

Proposed Construction: 

The absence of effervescen

mixture of excipients incapabin an aqueous environment" Evidentiary Support: 

1) Specification: Col. 2, ll. 44-49 Col. 3, ll. 15-28 Examples 1-5 2) Prosecution History: 

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AND EVIDENTIARY SUPPORT 

DEFENDANT'S P

CONSTRUCTION AND 

SUPPOR

USP 3,882,228 USP 4,687,662 WO 91/04757 EP 0 313 328 3) Extrinsic Evidence: Mohrle, R. "Effervescent Tablets." Pharm. Dosage Forms, pp. 285-328, 2nd Ed. 1989 

Anderson, N. et al. "Quantitative Evaluation of Pharmaceutical Effervescent Systems I: Design of Testing Apparatus." J. Pharm. Sci., Vol 71, No. 1 (Jan. 1982). Anderson, N. et al. "Quantitative Evaluation of Pharmaceutical Effervescent Systems II: Stability Monitoring by Reactivity and Porosity Measurements." J. Pharm. Sci., Vol. 71, No. 1 (Jan. 1982). Herbert A. Lieberman et al., Pharmaceutical Dosage Forms: Tablets, Vol. 1, Chapter 6, pp. 285, 287-288, 290-291 (2nd ed. 1989) 

Request for Re-Examination 1998 Claim Amendment Dated DecClaim Amendment Dated July U.S. Patent No. 2,887,437 U.S. Patent No. 3,882,228 U.S. Patent No. 4,016,254 U.S. Patent No. 4,017,598 U.S. Patent No. 4,547,359 U.S. Patent No. 4,666,703 U.S. Patent No. 4,687,662 U.S. Patent No. 4,710,384 U.S. Patent No. 4,867,987 U.S. Patent No. 4,874,614 U.S. Patent No. 4,881,178 U.S. Patent No. 4,886,669 U.S. Patent No. 4,904,477 

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AND EVIDENTIARY SUPPORT 

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CONSTRUCTION AND 

SUPPOR

U.S. Patent No. 4,950,484 U.S. Patent No. 5,047,247 U.S. Patent No. 5,069,910 U.S. Patent No. 5,178,878 U.S. Patent No. 5,198,228 U.S. Patent No. 5,409,711 U.S. Patent No. 5,629,016 WO 91/04757 WO 91/16043 EP 003,589 EP 207,041 EP 255,002 EP 273,005 EP 281,200 EP 313,328 EP 347,767 

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AND EVIDENTIARY SUPPORT 

DEFENDANT'S P

CONSTRUCTION AND 

SUPPOR

EP 408,273 GB 2,067,900 GB 2,086,725 3) Extrinsic Evidence: Herbert A. Lieberman et Dosage Forms: Tablets, Vo285, 287-288, 290-291 (2nd ed

Remington's Pharmaceutical 1634 (18th ed. 1990) 

A study of powder adhesioduring compression of effervetablets. Sendall F.E. et al., J

1986 Jul; 38(7):489-93. A new multiple-unit oral floaPreparation and in vitro evalusustained-release characteristal., J. Pharm. Sci. 1991 Nov; Herbert A. Lieberman et 

Dosage Forms: Tablets, Vo285, 287-289, 290-291 (2nd ed

Yamaguchi M. et al., A DiVaginal Tablets ComparisoPharmacol. 1990, 42(11). 

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AND EVIDENTIARY SUPPORT 

DEFENDANT'S P

CONSTRUCTION AND 

SUPPOR

Anderson M.P. et al., LacBetween Disulfiram Formulaa Tablet/Effervescent Tablet SScand. Suppl. 1992, 369:31-3Ash M. and Ash I., ed., HandbPharmaceutical Additives, Gr1995, pp. 47-50, 770. The Merck Index 12th ed. 199

1472. FDA database on Dosage Foravailable at http://www.fda.gov/drugs/dev

approvalprocess/formssubmisrequirements/electronicsubmimanualmonographs/mcm0716"granule, effervescent" and "t

permits to obtain reduced ph influence in the digestive tract 

Proposed Construction: the active ingredient in the tablet is less influenced by stomach pH (i.e., the drug is coated) 

Evidentiary Support: 

1) Specification: Reexamined Patent Claim 1 

Proposed Construction: 

This claim limitation is indefiEvidentiary Support: 1) Specification: Col. 3, ll. 41-51 

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CONSTRUCTION AND 

SUPPOR

Abstract Col. 1, ll. 6-16 Col. 1, ll. 26-37 Col. 3, ll. 41-51 Col. 7, ll. 9-14 2) Prosecution History: Amendment, dated January 5, 2000 

permits to obtain . . . reduced influence of viscosity 

Proposed Construction: the formulation influences viscosity less than the prior art formulations of record that have excipients increasing viscosity Evidentiary Support: Construction taken from Takeda Pharm. Co. Ltd. et al. v. Zydus Pharms. USA Inc., et al., Civil Action No. 10-1723 (D.N.J.) (JAP) (Dkt. 113), dated Oct. 5, 2011 at p. 13. 1) Specification: Reexamined Patent Claim 1 

Proposed Construction: 

This claim limitation is indefiEvidentiary Support: 1) Specification: Col. 3, ll. 41-51 

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16 

CLAIM TERM PLAINTIFFS' PROPOSED CONSTRUCTION 

AND EVIDENTIARY SUPPORT 

DEFENDANT'S P

CONSTRUCTION AND 

SUPPOR

Abstract Col. 3, ll. 41-51 2) Prosecution History Amendment, dated January 5, 2000 Request for Reexamination, dated December 31, 1998 U.S. Patent 4,886,669 

* * * 

To the extent permitted, the parties reserve their rights to amend or supplement the constructions and intrinsic an

set forth herein. 

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