Before Archer, Circuit Judge, Cowen, Senior Circuit Judge, and Clevenger, Circuit Judge.
CLEVENGER, Circuit Judge.
Intermedics, Inc. appeals from the September 13, 1991 judgment of the United States District Court for the Northern District of California granting summary judgment to Ventritex Co., Michael Sweeney and Benjamin Pless. Intermedics, Inc. v. Ventritex, Inc., 775 F. Supp. 1269, 20 USPQ2d 1422 (N.D. Cal. 1991). The district court held that Ventritex's allegedly infringing uses of its accused implantable defibrillator fell within the patent infringement clinical trial exemption of 35 U.S.C. § 271(e)(1) (1988) and that the application of this exemption precluded granting declaratory relief to Intermedics. We affirm.
Ventritex developed an implantable defibrillator, which it named "Cadence." In order to obtain approval for commercial sales from the Food and Drug Administration (FDA), Ventritex began clinical trials of the Cadence in 1989, believing that it was immune from claims of infringement because of the FDA clinical testing exemption provided in 35 U.S.C. § 271(e)(1). Intermedics filed suit against Ventritex. In its complaint, Intermedics alleged, inter alia, that the Cadence infringed seven of its patents relating to implantable defibrillators.*fn* Intermedics also requested declaratory relief to determine whether Ventritex's activities threatened its patents with immediate infringement. Intermedics subsequently filed a motion for summary judgment challenging Ventritex's right to assert a section 271(e)(1) defense due to Ventritex's intent to commercialize its product before the expiration of Intermedics' patents. Ventritex responded with a motion to dismiss, which the district court converted into a motion for summary judgment. That motion asserted that Intermedics' infringement claims were precluded by Ventritex's section 271(e)(1) defense. Intermedics responded to that motion by filing, inter alia, a cross-motion for summary judgment asserting that Ventritex's activities were not solely for uses reasonably related to submitting data to the FDA.
The district court denied Intermedics' motion for summary judgment, rejecting Intermedics' argument that Ventritex could not claim a section 271(e)(1) exemption because it intended to commercialize its implantable defibrillator before the expiration of Intermedics' allegedly infringed patents. Intermedics, 775 F. Supp. at 1275, 20 USPQ2d at 1426.
The district court granted Ventritex summary judgment, finding that Ventritex's allegedly infringing acts of manufacture, use and sale of the patented invention were exempted by section 271(e)(1) because these acts were solely for uses reasonably related to generating data to submit to the FDA. The district court first distinguished noninfringing acts from infringing acts, noting that engaging in noninfringing acts that fall outside the uses permitted by section 271(e)(1) do not affect the exemption. Id. at 1278, 20 USPQ2d at 1428. Then the district court addressed each allegedly infringing activity. The district court found that every Cadence sold in the United States was used in a clinical trial and that Ventritex's decision to continue clinical trials after submitting its initial application to the FDA was reasonably related to obtaining FDA approval because a prudent applicant cannot know whether the FDA will require more data before the application is granted. Id. at 1282, 20 USPQ2d at 1431. The district also found that Ventritex's sales to foreign distributors were reasonably related to developing information to be submitted to the FDA because all Cadences sold to such distributors were ultimately resold to FDA-approved clinical investigators. Id. at 1283, 20 USPQ2d at 1432. The district court further found that Ventritex's testing activities in Germany were reasonably related to generating data for submission to the FDA because the data generated were only used in submissions to the FDA. There was no evidence that the German data were submitted to any German authorities for any purpose. Id. at 1284, 20 USPQ2d at 1432-33. The district court also found that a safety inspection of Cadence's programmer by German authorities before its use in German clinical trials was reasonably related to generating data for submission to the FDA because the tested programmer is not a part of the Cadence defibrillator and because the safety inspection was a necessary prerequisite to German import approval to conduct the FDA trials in Germany. Id. at 1285, 20 USPQ2d at 1433. The district court also found that Ventritex's demonstrations of the Cadence at scientific trade shows did not create a viable infringement claim. Id. at 1288-89, 20 USPQ2d at 1436-37. Finally, the district court granted Ventritex's motion to dismiss Intermedics' declaratory judgment claims because there was no current case or controversy arising under federal patent law. Ventritex's current infringing activities were exempt from suit under section 271(e)(1) and it was impossible to determine when FDA would grant approval to Ventritex's product thereby ending the exemption. Id. at 1289-90, 20 USPQ2d at 1437-38.
Intermedics makes three distinct arguments on appeal. First, Intermedics contends that genuine issues of material fact preclude granting summary judgment on two issues: whether Ventritex's German activities are covered by the exemption and whether Ventritex's activities at medical trade shows are covered by the exemption.
Second, Intermedics argues that the district court erred in refusing to exercise its declaratory relief jurisdiction. A sufficient case or controversy exists because the existence of Ventritex's Cadence and the possibility that it may be put to nonexempt uses creates a threat of infringement of Intermedics' patents.
Finally, Intermedics contends that the district court erred when it failed to rule as a matter of law that Ventritex is not entitled to assert a section 271(e)(1) exemption for any of its activities because Ventritex intends to commercialize its implantable defibrillator before Intermedics' patents have expired. According to Intermedics, the legislative history of section 271(e)(1), the feasibility of determining Ventritex's intent to commercialize, and the impact of the exception on the economic interests of patent holders all support a narrow application of section 271(e)(1).
Ventritex replies that no genuine factual issues exist which would bar summary judgment on the issue of whether the section 271(e)(1) exemption applies in this case. All of its activities providing clinical units of the Cadence to its researcher in Germany were solely reasonably related to generating data for FDA approval. Similarly, Ventritex's trade show practices were reasonably related to conducting clinical trials.
Ventritex also argues that until FDA approves the Cadence there is no justiciable controversy to sustain a declaratory judgment action.
Finally, Ventritex argues that application of section 271(e)(1) does not depend on the manufacturer's intent to commercialize its allegedly infringing product before the expiration of the accuser's patents because Congress did ...