Free Claim Construction Chart - District Court of Delaware - Delaware

Case 1:06-cv-00033-SLR

Document 145

Filed 10/08/2007

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE TAKEDA PHARMACEUTICAL COMPANY, LTD., and TAP PHARMACEUTICAL PRODUCTS INC., Plaintiffs and Counterclaim-Defendants, v. TEVA PHARMACEUTICALS USA, INC., and TEVA PHARMACEUTICAL INDUSTRIES LTD., Defendants and Counterclaim-Plaintiffs. ) ) ) ) ) ) ) ) ) ) ) )

C.A. No. 06-033 (SLR)

JOINT CLAIM CONSTRUCTION CHART FOR THE DISPUTED CLAIM TERMS OF U.S. PATENTS NO. 5,045,321 AND 4,628,098 Pursuant to the Court's March 21, 2006 Scheduling Order and D. Del. LR 16.3, Plaintiffs and Counterclaim-Defendants Takeda Pharmaceutical Company, Ltd. and TAP Pharmaceutical Products, Inc. and Defendants and Counterclaim-Plaintiffs Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. submit this joint claim construction chart setting forth the parties' respective proposed constructions for disputed claim terms in U.S. Patents No. 5,045,321 and 4,628,098. I. U.S. Patent No. 5,045,321 Claim Language 1. A pharmaceutical composition, Plaintiffs' Proposed Construction a medicinal drug product in a state suitable for administration to a patient Defendants' Proposed Construction the mixture of lansoprazole with a basic inorganic salt of magnesium and/or calcium, which may contain any necessary additives that are used to make the tablet or granules but does not include any excipients used for coating the pharmaceutical composition

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Claim Language wherein the composition is made up into tablets or granules

Plaintiffs' Proposed Construction term "granule" refers to small pellets that are typically combined with other granules into a tablet or capsule

Defendants' Proposed Construction term "granule" means either an irregularly shaped or a spheroid shaped mass of particles made up of a pharmaceutical composition, which also may contain additives "coated by a coating agent" means the tablets or granules containing the pharmaceutical composition are coated with a material that masks the taste or provides enteric or sustained release properties Ordinary meaning

and then coated by a coating agent,

"coated by a coating agent" refers to covering a tablet or granule with a pharmaceutically acceptable coating

which comprises an effective amount of the anti-ulcer compound 2-[[3-methyl-4(2,2,2-trifluoroethoxy-2pyridyl]methylsulfinyl] benzimidazole, and at least one of the basic inorganic salts of magnesium and calcium selected from heavy magnesium carbonate, magnesium carbonate, magnesium oxide, magnesium hydroxide, magnesium metasilicate aluminate, magnesium silicate aluminate, magnesium silicate, magnesium aluminate, synthetic hydrotalcite, aluminum magnesium hydroxide, precipitated calcium carbonate and calcium hydroxide; the amount of the basic inorganic salt relative to parts by weight of the benzimidazole compound

Ordinary meaning

Ordinary meaning

Ordinary meaning

phrase "the amount of the basic inorganic salt relative to parts by weight of the benzimidazole compound

phrase "the amount of the basic inorganic salt relative to parts by weight of the benzimidazole compound

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Claim Language being about 0.3-20 parts by weight;

Plaintiffs' Proposed Construction being about 0.3-20 parts by weight" means that the ratio of magnesium carbonate to lansoprazole by weight in the pharmaceutical composition is between 0.3 and 20 "the benzimidazole compound being in contact with the basic inorganic salt evenly" means a mixture of the benzimidazole compound in contact with the basic (i.e., alkaline) inorganic salt in a uniformly basic environment Ordinary meaning

Defendants' Proposed Construction being about 0.3-20 parts by weight" means the weight of the basic inorganic salt that is in even contact with the benzimidazole falls between about 0.3 to 20 parts by weight "the benzimidazole compound being in contact with the basic inorganic salt evenly" means the benzimidazole compound and the inorganic salt are mixed homogenously together

the benzimidazole compound being in contact with the basic inorganic salt evenly.

2. A pharmaceutical composition as claimed in claim 1, wherein the basic inorganic salt of magnesium is magnesium carbonate. II.

Ordinary meaning

U.S. Patent No. 4,628,098 Claim Language Plaintiffs' Defendants' Proposed Proposed Construction Construction Ordinary meaning Ordinary meaning

1. A compound of the formula

wherein R1 is hydrogen, methoxy or trifluoromethyl, R2 and R3 are independently hydrogen or methyl, R4 is a C2-5 fluorinated

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Claim Language

Plaintiffs' Defendants' Proposed Proposed Construction Construction

alkyl and n denotes 0 or 1, and a pharmacologically acceptable salt thereof. 10. A compound according to claim 1, wherein the compound is 2-[3-methyl-4-(2,2,2-trifluoroethoxy)-pyrid2yl]methylsulfinylbenzimidazole. Ordinary meaning Ordinary meaning

MORRIS, NICHOLS, ARSHT & TUNNELL LLP

YOUNG CONAWAY STARGATT & TAYLOR LLP

/s/ James W. Parrett, Jr. (#4292)
__________________________________ Jack B. Blumenfeld (#1014) Mary B. Graham (#2256) Rodger D. Smith II (#3778) James W. Parrett, Jr. (#4292) 1201 N. Market Street P.O. Box 1347 Wilmington, DE 19801 (302) 658-9200 Attorneys for Plaintiffs OF COUNSEL: Eric J. Lobenfeld Tedd W. Van Buskirk Arlene L. Chow Dillon Kim HOGAN & HARTSON LLP 875 Third Avenue New York, NY 10022 (212) 918-3000 Philippe Y. Riesen HOGAN & HARTSON LLP Shinjuku Center Building, 46th Floor 25-1 Nishi-Shinjuku 1-chome Shinjuku, Tokyo 163-0646 Japan (81) 3-5908-4070

/s/ Karen L. Pascale (#2903)
Josy W. Ingersoll (#1088) Karen L. Pascale (#2903) Karen E. Keller (#4489) The Brandywine Building 1000 West St., 17th Floor P.O. Box 391 Wilmington, DE 19899-0391 (302) 571-6600 Attorneys for Defendants OF COUNSEL: John L. North Jeffrey J. Toney Jeffrey D. Blake SUTHERLAND, ASBILL & BRENNAN LLP 999 Peachtree Street Atlanta, GA 30309-3996 (404) 853-8000 Attorneys for Defendants, Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd.

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Richard de Bodo HOGAN & HARTSON LLP 1999 Avenue of the Stars, Suite 1400 Los Angeles, CA 90067 (310) 785-4600 Attorneys for Plaintiff Takeda Pharmaceutical Company Limited

William F. Cavanaugh Stuart E. Pollack Chad J. Peterman PATTERSON BELKNAP WEBB & TYLER LLP 1133 Avenue of the Americas New York, NY 10036 (212) 336-2000 Attorneys for Plaintiff TAP Pharmaceutical Products Inc. Dated: October 8, 2007
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