Opinion ID: 781500
Heading Depth: 3
Heading Rank: 1

Heading: Claims of Induced Infringement Under Section 271(e)(2) Generally

Text: 32 Preliminarily, we must determine whether, as a general matter, section 271(e)(2) may serve as an umbrella for a claim of induced infringement for a method of use patent. As noted above, the district court concluded that it could not. The district court reasoned that the type of claims that accrue upon the filing of an ANDA are limited to those claims that a patent holder could have brought in the absence of section 271(e)(1), such as an infringement claim against a generic drug manufacturer for using the patent in the development of a generic drug. The district court determined that a claim of induced infringement, based upon conduct of a third party that would occur upon approval of an ANDA, was not a claim that a patent holder could have brought before the enactment of section 271(e)(1). Allergan, 200 F.Supp.2d at 1231, 63 USPQ2d at 1436. The district court concluded that [s]ection 271(e)(2) ... does not provide a predicate for Allergan to sue for inducing infringement. Id. at 1230, 63 USPQ2d at 1435. 33 We do not share the district court's view of 35 U.S.C. § 271(e)(2). To begin with, the language of section 271(e)(2) does not limit the reach of the statute to direct infringement actions to the exclusion of actions for induced infringement. Additionally, in Glaxo, we did not limit the scope of section 271(e)(2) to direct infringement actions. Instead, we stated that a court must employ a traditional infringement analysis, focusing on all of the elements of infringement. Glaxo, 110 F.3d at 1567, 42 USPQ2d at 1262 (The plain language of the statute does not alter a patentee's burden of proving infringement....). The only difference in the analysis of a traditional infringement claim and a claim of infringement under section 271(e)(2) is the timeframe under which the elements of infringement are considered. Id. at 1569, 42 USPQ2d at 1263 ([T]he question of infringement must focus on what the ANDA applicant will likely market if its application is approved....). Glaxo does not preclude patentees from asserting claims for induced infringement under 35 U.S.C. § 271(e)(2). In fact, a patent holder asserting infringement of a patent that claims a FDA-approved method of use for which an ANDA seeks approval will, in many instances, have to prove induced infringement. Therefore, section 271(e)(2) may support an action for induced infringement. 34 Finally, we do not agree with the district court that the case or controversy requirement of Article III of the Constitution precludes a patentee from bringing a claim of induced infringement under section 271(e)(2). The district court was of the view that, in the case of a claim of induced infringement predicated on direct infringement by third party physicians, there is not a sufficiently immediate threat that there will be a violation of the patent laws so as to warrant judicial determination. Allergan, 200 F.Supp.2d at 1232, 63 USPQ2d at 1437. 35 The case or controversy clause in Article III of the Constitution requires injury in fact, connection between the challenged conduct and the injury, and redressability of the injury by the requested remedy. Steel Co. v. Citizens for a Better Env't, 523 U.S. 83, 103-04, 118 S.Ct. 1003, 140 L.Ed.2d 210 (1998) (This triad of injury in fact, causation, and redressability comprises the core of Article III's case-or-controversy requirement....). A claim under 35 U.S.C. § 271(e)(2) is, by its very nature, speculative to a certain degree, as acknowledged in Glaxo. See Glaxo, 110 F.3d at 1569, 42 USPQ2d at 1263 (The only difference in actions brought under § 271(e)(2) [from actions brought under section 271(a)] is that the allegedly infringing drug has not yet been marketed and therefore the question of infringement must focus on what the ANDA applicant will likely market if its application is approved, an act that has not yet occurred.). While a section 271(e)(2) induced infringement claim may be speculative, it is not sufficiently so to contravene the case or controversy requirement. In Glaxo, we stated that section 271(e)(2) provided patentees with a defined act of infringement sufficient to create case or controversy jurisdiction to enable a court to promptly resolve any dispute concerning infringement and validity. Glaxo, 110 F.3d at 1569, 42 USPQ2d at 1263. Additionally, in the setting of a declaratory judgment action, we have held that Article III does not preclude an action by a potential defendant for a determination that its conduct does not induce infringement, prior to any acts of infringement having taken place. See Fina Research, S.A. v. Baroid Ltd., 141 F.3d 1479, 1485, 46 USPQ2d 1461, 1467 (Fed.Cir.1998) ([W]e decline ... to create a per se rule that an actual controversy predicated only on induced infringement may exist only if direct infringement has already occurred.). Thus, under Fina, a method of use patent holder could potentially bring an action against a generic drug manufacturer for induced infringement under 35 U.S.C. § 271(b) on the day the ANDA was approved before a single prescription of the generic drug was written by third party physicians. Id. A claim of induced infringement under section 271(e)(2), filed prior to the occurrence of direct infringement, does not violate the case or controversy requirement of Article III. 36 Summary judgment of non-infringement under section 271(e)(2), therefore, is inappropriate where the plaintiff can demonstrate the existence of a genuine issue of material fact with respect to the claim that the ANDA filer will induce infringement of its patent upon approval of the ANDA. Warner-Lambert, 316 F.3d at 1356, 65 USPQ2d at 1485. The district court found that Allergan presented a triable issue of fact with respect to induced infringement by Alcon sufficient to allow the parties to proceed to discovery. See supra note 5; Allergan, 200 F.Supp.2d at 1225, 63 USPQ2d at 1431. Allergan presented evidence that third-party doctors and patients will likely infringe its two method of use patents and that Alcon and B & L may knowingly induce this infringement through their actions. See Manville Sales Corp. v. Paramount Sys., Inc., 917 F.2d 544, 553, 16 USPQ2d 1587, 1594 (Fed. Cir.1990) (The plaintiff has the burden of showing that the alleged infringer's actions induced infringing acts and that he knew or should have known his actions would induce actual infringements.) (emphasis in original). 37 We must now determine whether Congress has prohibited the particular action for induced infringement brought by Allergan. 38