Appendix 20

• Author: Kenneth Dorsney
• Pages: 639-660

639

JOI NT CLA IM CON ST RU CT IO N AND PR EH EA RI NG STA TE ME NT

IN THE UNITED STATES DISTRICT COURT

[Name of District]

—

[DISTRICT COURT CAPTION]

JOINT CLAIM CONSTRUCTION AND PREHEARING STATEMENT

[Insert Table of Contents]

INTRODUCTION

Pursuant to Paragraph 6 of the most recent scheduling order entered in the

above-captioned coordinated cases, Plaintiffs [Name of Plaintiffs] (collectively,

“Plaintiff”) and Defendants [Name of Defendant 3] (collectively, “Defendant 3”); [Name

of Defendant] and [Name of Defendant 4] (collectively, “Defendant”); and [Name of

Defendant 4], [Name of Defendant 5], [Name of Defendant 6] (collectively,

“Defendant 2”) hereby provide their Joint Claim Construction And Prehearing

Statement.

The Court has stayed claim construction concerning U.S. Patent No. 1

(“‘001 patent”) pending issuance of the Federal Circuit’s mandate in Appeals Nos.

_____ and _____. Therefore, this document only addresses the construction of the

claims of U.S. Patent No. 2 (“‘002 patent”). To the extent permitted, the parties

reserve their rights to amend or supplement the constructions and intrinsic and

extrinsic evidence set forth herein.

I. Construction Of Terms On Which The Parties Agree

The parties agree on the construction of the following ‘002 patent claim

terms:

a. “sustained release” (all claims)

release of active pharmaceutical ingredient over an extended

period of time

b. “excipient” (all claims)

any substance other than an active pharmaceutical ingredient

c. methoxy content (claim 3–9, 13)

amount of methoxyl substituents in hydroxypropyl

methylcellulose

d. hydroxypropoxy content (claim 3–9, 13)

amount of hydroxypropoxyl substituents in hydroxypropyl

methylcellulose

A–20

APPENDIX

640

“greater than 25.8% by weight” (claim 3–9, 13)

more than 25.8% by weight

e. “hemifumarate salt” (claim 10, 13)

plain and ordinary meaning; no construction needed

f. “treating” (claim 13)

plain and ordinary meaning; no construction needed

g. “an effective amount” (claim 13)

plain and ordinary meaning; no construction needed

II. Proposed Constructions Of Disputed Terms

The parties disagree on the construction of the following ‘002 patent claim

terms. Exhibit A attached summarizes the parties’ proposed constructions of these

disputed terms.

a. whether “sustained release” is a limitation of the claims (all

claims)

1. Plaintiff’s position

Plaintiff contends that the term “sustained release”

is a limitation for each claim of the ‘002 patent.

2. Defendants’ position

The parties do not dispute the construction of the term

“sustained release.” Whether the term “sustained release”

is a limitation of the claims of the ‘002 patent is not an

issue required to be addressed in this Joint Statement and

is more appropriately addressed at a later stage of this

case.

b. “a gelling agent” (all claims):

1. Plaintiff’s proposed construction of “a

gelling agent”

one or more substances capable of forming a gel

A. Intrinsic Evidence

‘002 patent and prosecution history, e.g., col. 2, ll.

43–52

B. Extrinsic Evidence

The American Heritage Dictionary of the English

Language, 4th ed. (2000) definition of “agent”