Brief in Support of Motion in Limine?Exclude Expert Testimony

• Author: Kenneth L. Dorsney
• Pages: 901-909

IV. CONCLUSION

Brief in Support of Motion in Limine—Exclude Expert

Testimony

IN THE UNITED STATES DISTRICT COURT

[Name of District]

[DISTRICT COURT CAPTION]

BRIEF IN SUPPORT OF DEFENDANT’S MOTION IN LIMINE

[ ]

[]

Defendants in this lawsuit move to preclude Plaintiff [Name of Plaintiff]’s

retained expert, [Name], from providing testimony at trial as to issues of invalidity under

35 U.S.C. § 103.

I.

There can be no dispute that the focus of the claims of the only patent in this

lawsuit U.S. Patent No. 1 (“the ’001 Patent”) is sustained-release solid oral dosage

formulations of [ ]. It is therefore essential that a person having ordinary

skill in the art (“PHOSITA”) who opines on the claims of the ’001 patent be educated and

professionally trained in, inter alia, the types of experiments used to prepare solid oral

dosage forms, the considerations routinely assessed during their design and development,

and the techniques used to physically prepare the dosages. This understanding is

corroborated by at least the background of the three named inventors, [Name], [Name]

and [Name], who are all drug formulators with years of “hands on” formulation

experience. This is further confirmed by the parties’ selection of nearly 10 other expert

witnesses in this lawsuit who, individually, each have decades of actual experience and

education in preparing sustained-release drug formulations of solid oral dosages—

including Plaintiff’s own expert [Name].

[Name], on the other hand, is Plaintiff’s new expert who has been retained to

provide a rebuttal to Defendants’ invalidity challenge to the ’001 patent. Unlike

Defendants’ invalidity experts [Name] is a rheologist. Rheology is a field that emphasizes

the study of the flow of matter—not the mechanisms of solid oral dosage formulations

that release pharmaceutical drugs over an extended period.

Although [Name] insists that he is an expert in sustained-release formulations

generally, the record reflects otherwise. As set forth in detail infra, [Name] possesses

expertise in materials and components that were never actually used in sustained-release

formulations and admitted by him to be “irrelevant” to the claimed technology (e.g.,

nanoparticles, liposomes, multilamellar vesicles, polymersomes and cyclodextrins). If

901

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