Opinion ID: 781500
Heading Depth: 3
Heading Rank: 2

Heading: Allergan's Action for Induced Infringement

Text: 39 The district court concluded that, in the case of a method of use patent, section 271(e)(2) only makes the filing of an ANDA an act of infringement when the patent at issue claims the use for which FDA approval is sought in the ANDA. Allergan, 200 F.Supp.2d at 1230, 63 USPQ2d at 1435. Allergan argues that the district court erred in its ruling. For their part, Alcon and B & L contend that the district court correctly held that only when the ANDA speaks to the use that is claimed in the patent at issue may the patent holder bring suit under section 271(e)(2). 40 This issue was decided in Warner-Lambert. Warner-Lambert held that, pursuant to section 271(e)(2), a method of use patent holder may not sue an ANDA applicant for induced infringement of its patent, if the ANDA applicant is not seeking FDA approval for the use claimed in the patent and if the use claimed in the patent is not FDA-approved. Warner-Lambert, 316 F.3d at 1354-55, 65 USPQ2d at 1484. Warner-Lambert reasoned that because an ANDA may not seek approval for an unapproved or off-label use of a drug under 21 U.S.C. § 355(j)(2)(A)(i), it necessarily follows that 35 U.S.C. 271(e)(2)(A) does not apply to a use patent claiming only such a use. Id. at 1356, 65 USPQ2d at 1485. 41 In the Warner-Lambert case, Warner-Lambert obtained FDA approval through a NDA to market 1-aminomethyl-1-cyclohexane acetic acid (gabapentin) for use in adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults with epilepsy. This method of use was claimed in United States Patent No. 4,087,544 (the epilepsy method patent). Warner-Lambert is also the assignee of a second method of use patent, United States Patent No. 5,084,479 (the neurodegenerative method patent), which covers the treatment of neurodegenerative diseases with gabapentin. 7 Warner-Lambert claimed gabapentin itself in United States Patent No. 4,024,175 (the product patent). 42 On April 17, 1998, Apotex filed an ANDA seeking approval to market a generic formulation of gabapentin upon the expiration of Warner-Lambert's epilepsy method patent on January 16, 2000. After Apotex notified Warner-Lambert that it had filed the ANDA and a Paragraph IV certification, Warner-Lambert instituted suit within 45 days in the United States District Court for the Northern District of Illinois. Warner-Lambert alleged that Apotex's submission of an ANDA for gabapentin was an act of infringement of its neurodegenerative method patent under 35 U.S.C. § 271(e)(2). 8 The district court held that Warner-Lambert was entitled to proceed on an induced infringement theory under 35 U.S.C. § 271(e)(2) and that it was irrelevant whether the asserted method of use patent claimed the use covered by Apotex's ANDA. The court concluded that [t]he proper inquiry for this Court on the present motion is whether there exists a genuine issue of any material fact as to whether Apotex's gabapentin product, if manufactured, used, or sold, would actively induce the infringement of the '479 patent. Warner-Lambert Co. v. Apotex Corp., 1999 WL 259946, at , 1999 U.S. Dist. LEXIS 6208,  (N.D.Ill. Apr. 8, 1999). After discovery, the district court entertained motions for summary judgment and concluded that there was no evidence that Apotex actively induced physicians to prescribe its product for neurodegenerative diseases or that Apotex knew its product would be prescribed for neurodegenerative diseases. Warner-Lambert Co. v. Apotex Corp., 2001 WL 1104618, at , 2001 U.S. Dist. LEXIS 14592,  (N.D.Ill. Sept. 14, 2001). The district court therefore granted Apotex's motion for summary judgment of non-infringement. Id. at , 2001 U.S. Dist. LEXIS 14592, at . Warner-Lambert's appeal to this court followed. 43 On appeal, the Warner-Lambert court expressed concern that permitting a cause of action under section 271(e)(2) for off-label method of use patents would confer substantial additional rights on pioneer drug patent owners that Congress quite clearly did not intend to confer. Warner-Lambert, 316 F.3d at 1359, 65 USPQ2d at 1487. The court also expressed concern about the threat of abuse by a patent holder attempting to extend its patent exclusion. Id. Accordingly, the court held that a method of use patent holder may not bring an action under section 271(e)(2) for infringement of a method of use patent that does not claim a FDA-approved use. 44 The court also determined that Warner-Lambert would have needed to demonstrate the existence of a genuine issue of material fact to support a traditional infringement claim, i.e., that Apotex induced or will induce infringement of the neurodegenerative method patent. Id. at 1356, 65 USPQ2d at 1485. Upon considering Warner-Lambert's cause of action under section 271(b), the court concluded that [i]n the absence of any evidence that Apotex has or will promote or encourage doctors to infringe the neurodegenerative method patent, there has been raised no genuine issue of material fact. Id. at 1364, 65 USPQ2d at 1491. The court, therefore, affirmed the district court's dismissal of Warner-Lambert's suit. 45 Under Warner-Lambert, Allergan is precluded from suing Alcon and B & L under section 271(e)(2) for inducing infringement of the '415 and '741 patents, because Alcon and B & L are not seeking FDA approval for the uses claimed in the patents and because the uses claimed in the patents are not FDA-approved. 9