IN THE UNITED STATES DISTRICT COURT

WESTERN DISTRICT OF ARKANSAS

TEXARKANA DIVISION

ST. JUDE MEDICAL, INC. and

ST. JUDE MEDICAL PUERTO RICO LLC PLAINTIFFS

VS. CASE NO. 08-CV-4101

ACCESS CLOSURE, INC. DEFENDANT

ORDER

Before the Court is a Motion to Compel filed by Plaintiffs. (Doc. 53). In their motion,

Plaintiffs ask the Court to enter an order compelling Defendant to produce certain documents relating

to the evaluation or testing of Defendant’s products in development.1 Defendant has responded to

the motion. (Doc. 62). Plaintiffs have filed a reply. (Doc. 67). Defendant has filed a sur-reply.

(Doc. 70). The Court held a hearing on this motion on February 25, 2010. The Court finds this

matter ripe for consideration.

Plaintiffs argue that Defendant should be compelled to produce documents regarding its

vascular closure products in development.2 However, Defendant contends that Plaintiffs are not

entitled to discovery regarding Defendant’s products in development, because its activities regarding

any of its potential products is protected by the safe harbor provision of 35 U.S.C. § 271(e)(1). This

provision provides a safe harbor or exemption from patent infringement for anyone who makes, uses,

1
Plaintiffs have also asked the Court to compel Defendant to produce certain documents being
withheld by Defendants on the basis of form objections. However, the Court understands that this
issue is not yet ripe for a decision.
2
Plaintiffs have requested that Defendant produce “[a]ll documents that refer or relate to any
evaluation or testing of Defendant’s [p]roducts, including without limitation both technical and
marketing testing (e.g., customer and user perceptions of such products).
offers to sell, or sells within the United States a patented invention “solely for uses reasonably related

to the development and submission of information under a Federal law.” 35 U.S.C. § 271(e)(1).

The Court notes that § 271(e)(1) is directed to the development of information for submission to the

FDA. Amgen, Inc. v. Int’l Trade Comm’n, 565 F.3d 846, 852 (Fed. Cir. 2009). However, the §

271(e)(1) safe harbor provision does not apply to all pre-FDA approval activities, and each of the

accused activities must be evaluated separately to determine whether the exemption applies. Id. at

852. More specifically, “it is apparent that commercial and marketing studies are more clearly

subject to separate evaluation for application of the exemption.” Id.

Defendant maintains that all of its highly secretive documents regarding its products under

development relate to the development and submission of information necessary to receive FDA

approval for those products. More specifically, Defendant states that its activities regarding potential

products concern either pre-design research technologies or bench-top evaluations that may lead to

a regulatory submission to the FDA.

Upon consideration, the Court finds that Plaintiff’s Motion to Compel should be and hereby

is DENIED as it relates to “[a]ll documents that refer or relate to any evaluation or testing of

Defendant’s [p]roducts.” However, Defendant is ordered to produce to Plaintiffs any documents that

refer or relate to any evaluation or testing of Defendant’s products that do not solely relate to the

development and submission of information under a federal law, including but not limited to, any

commercial or marketing studies.

IT IS SO ORDERED, this 4th day of March, 2010.

/s/ Harry F. Barnes

Hon. Harry F. Barnes
United States District Judge