Appendix 21

• Author: Kenneth Dorsney
• Pages: 661-675

661

DEF EN DA NT ’S CLA IM CON ST RU CT IO N BR IE F

IN THE UNITED STATES DISTRICT COURT

[Name of District]

[DISTRICT COURT CAPTION]

OPENING MARKMAN BRIEF OF DEFENDANTS

[Insert Table of Contents for Brief]

[Insert Table of Authorities for Brief]

)6 ),1/-$2#1)-,

Plaintiff's patent-in-suit, U.S. Patent No. 1 (the "'001 patent"), is the subject of

this Markman proceeding. As this Court correctly indicated during the parties' status

conference of [Date], this is not the most complicated Markman dispute. Claim 1

illustrates this point. The patentee simply claimed a sustained-release formulation of

GenX that includes nothing more than a gelling agent and other excipients.

This Court is familiar with sustained-release formulation technology from prior

lawsuits. [Cite]. This Court also is familiar with GenX from prior litigation involving this

drug. There is no dispute that GenX is prior art to its related '001 formulation patent.

Here too, the excipients disclosed in the '001 patent used to achieve sustained release of

GenX are all admitted prior art.

From Defendant's perspective, the only new matter in this lawsuit involves the

particular types of excipients used by the patentee to achieve a sustained release

formulation for GenX. To that end, Defendant submits that the claims and the

specification are all that this Court needs to resolve any dispute regarding claim

construction. As shown below, the intrinsic evidence provides (i) explicit definitional

language and/or (ii) significant guidance as to what the proper constructions for the

disputed terms should be. Although the prosecution histories for both the 001 patent and

its earlier-filed provisional application are limited, to the extent they provide guidance,

they too confirm the meanings provided by the patentee in the written description.

While unnecessary in view of the intrinsic evidence, Defendant also has

summarized the extrinsic evidence, including inventor testimony, the inventors'

documents used during development of the invention, and expert testimony as to what a

person of ordinary skill in the art would understand these disputed terms to mean.

Defendant relies on this extrinsic evidence only to corroborate the meanings of the claim

terms as defined by the intrinsic evidence.

For example, at the forefront of the dispute between the parties is the meaning of

the term "a gelling agent." As Defendant highlights, and the Court correctly noted during

the [Date] status conference, the patentee could not have been more clear: an unequivocal

definition is provided in column 2, lines 43–53 on the very first page of the written

description of the '001 patent:

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