Free Claim Construction Chart - District Court of Delaware - Delaware

Case 1:04-cv-00833-KAJ

Document 231

Filed 05/30/2006

Page 1 of 5

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE PHARMACIA & UPJOHN COMPANY, LLC, ) ) ) Plaintiff, ) ) v. ) ) SICOR INC. and SICOR ) PHARMACEUTICALS, INC., ) Defendants. )

C.A. No. 04-833-KAJ

JOINT CLAIM CONSTRUCTION CHART Pursuant to this Court's Amended Scheduling Order of December 6, 2005 and the Stipulated Order of May 22, 2006, Plaintiff Pharmacia & Upjohn Company, LLC ("Pharmacia") and Defendants Sicor, Inc. and SICOR Pharmaceuticals, Inc. (collectively, "Sicor") herein provide a Joint Claim Construction Chart listing the claim terms, as well as their proposed constructions, at issue in this case. For those terms that are contested, each Party's proposed construction is provided; for those terms that are not contested, a jointly proposed construction is provided. Claim 1 Claim Language A physiologically acceptable solution Pharmacia's Proposed Construction a solution that is stable, sterile, pyrogen-free, and otherwise suitable for administration to humans or animals of Sicor's Proposed Construction a solution that is suitable for administration to humans or animals including, but not limited to,

of

Case 1:04-cv-00833-KAJ

Document 231

Filed 05/30/2006

Page 2 of 5

Claim Language anthracycline glycoside

Pharmacia's Proposed Construction a class of chemical compounds having the following generic structure:
O OH R1 C CH 2R2 OH

Sicor's Proposed Construction a non-lyophilized preparate of the class of chemical compounds having the following generic structure:
O OH R1 C CH 2R2 OH

R5

O

OH R4

O O R5 O OH R4 O O

CH3 R3 NH2

CH3 R3 NH2

selected from the group either [element a], [element b], [element c] ... or [element x], but consisting of not combinations of the elements idarubicin hydrochloride a monohydrochloride salt form of an anthracycline glycoside compound having the following structure:
O OH O C OH CH 3

H

O

OH H O CH3 HO NH2

O HCl

doxorubicin hydrochloride

a monohydrochloride salt form of an anthracycline glycoside compound having the following structure:
O OH O C OH CH2OH

H3CO

O

OH H O CH3 HO NH2

O

HCl

2

Case 1:04-cv-00833-KAJ

Document 231

Filed 05/30/2006

Page 3 of 5

Claim Language epirubicin hydrochloride

Pharmacia's Proposed Sicor's Proposed Construction Construction a monohydrochloride salt form of an anthracycline glycoside compound having the following structure:
O OH O C OH CH2OH

H3CO

O

OH HO O CH3 H NH2

O HCl

dissolved in dissolved in a physiologically acceptable an aqueous solvent that is stable, an aqueous solvent that is aqueous solvent sterile, pyrogen-free, and suitable for administration to otherwise suitable for humans or animals administration to humans or animals having a pH adjusted to from obtaining a solution that has a pH within the specified range due 2.5 to 5.0 to the use of a pH adjusting agent with with a physiologically acceptable an acid that is stable, sterile, an acid that is suitable for acid pyrogen-free, and otherwise administration to humans or suitable for administration to animals humans or animals selected from the group either [element a], [element b], [element c] ... or [element x], but consisting of not combinations of the elements hydrochloric acid, sulfuric hydrochloric acid, sulfuric acid, phosphoric acid, methane acid, phosphoric acid, sulfonic acid, and tartaric acid methane sulfonic acid, and tartaric acid the concentration of said the concentration is between 0.1 and 100 mg/ml, inclusive anthracycline glycoside being from 0.1 to 100 mg/ml wherein said solution is wherein the solution is contained in contained in a sealed container a closed container which is a container that is closed in further secured against access, some fashion such that is does leakage and passage by a not allow the passage of the fastening, membrane, or coating solution that must be broken to be removed

3

Case 1:04-cv-00833-KAJ

Document 231

Filed 05/30/2006

Page 4 of 5

Claim 9 Claim Language The anthracycline glycoside solution of claim 1 wherein said solution exhibits storage stability Pharmacia's Proposed Sicor's Proposed Construction Construction an anthracycline glycoside solution meeting all of the limitations of claim 1 the solution exhibits a solution which retains physiological acceptability and at least 90% potency under suggested storage conditions for at least 18 months at least 90% of the original amount of anthracycline glycoside dissolved in solution remains in the solution when stored at a temperature of about 4°C or 8°C for a period of at least 180 days because the solution has a pH of within the specified range due to the use of hydrochloric acid, sulfuric acid, phosphoric acid, methane sulfonic acid, or tartaric acid Claim 11 Claim Language The solution of claim 1 wherein the concentration of anthracycline glycoside is about 1 mg/ml Pharmacia's Proposed Sicor's Proposed Construction Construction an anthracycline glycoside solution meeting all of the limitations of claim 1 the concentration of the anthracycline glycoside in solution is about 1 mg/ml

as a result of said pH being adjusted to said pH range using said acids

4

Case 1:04-cv-00833-KAJ

Document 231

Filed 05/30/2006

Page 5 of 5

Claim 12 Claim Language The solution of claim 11 wherein the physiologically acceptable acid is hydrochloric acid Pharmacia's Proposed Sicor's Proposed Construction Construction an anthracycline glycoside solution meeting all of the limitations of claims 1 and 11 the pH is adjusted to from 2.5 to 5.0 with hydrochloric acid

Claim 13 Claim Language The solution of claim 12 wherein the anthracycline glycoside is idarubicin hydrochloride Pharmacia's Proposed Sicor's Proposed Construction Construction an anthracycline glycoside solution meeting all of the limitations of claims 1, 11, and 12 the anthracycline glycoside in solution is idarubicin hydrochloride

MORRIS, NICHOLS, ARSHT & TUNNELL LLP ASHBY & GEDDES /s/ Maryellen Noreika Jack B. Blumenfeld (#1014) Maryellen Noreika (#3208) 1201 N. Market Street P.O. Box 1347 Wilmington, Delaware 19899-1347 (302) 658-9200 Attorneys for Plaintiff OF COUNSEL: Daniel A. Boehnen Joshua R. Rich McDONNELL BOEHNEN HULBERT & BERGHOFF LLP 300 S. Wacker Drive Chicago, Illinois 60606 (312) 913-0001 /s/ John G. Day Steven J. Balick (#2114) John G. Day (#2403) 222 Delaware Avenue, 17th Floor P.O. Box 1150 Wilmington, Delaware 19899 (302) 654-1888 Attorneys for Defendants OF COUNSEL: Reid L. Ashinoff David R. Baum SONNENSCHEIN NATH & ROSENTHAL LLP 1221 Avenue of the Americas New York, NY 10020 Jordan Sigale SONNENSCHEIN NATH & ROSENTHAL LLP 8000 Sears Tower Chicago, IL 60606 May 30, 2006

5