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

Heading: Alcon's and B & L's ANDAs and Allergan's Lawsuit

Text: 19 In October of 2001, Alcon filed an ANDA for brimonidine, and in November of 2001, B & L filed one as well. In their ANDAs, Alcon and B & L stated that they were seeking approval from the FDA to produce and sell a generic version of brimonidine for use in lowering IOP in patients with open-angle glaucoma or ocular hypertension. Neither Alcon nor B & L sought FDA approval for the methods of using brimonidine claimed in the '415 and '741 patents. As part of their respective ANDAs, Alcon and B & L filed Paragraph IV certifications, based on Allergan's Orange Book listings, indicating that Allergan's '415 and '741 patents were not infringed and that, to the extent Allergan asserted that the patents covered IOP lowering, they were invalid. After Alcon and B & L gave Allergan notice of the filing of their ANDAs for brimonidine, Allergan instituted suit against both companies in the United States District Court for the Central District of California within the 45 day time period set forth in 21 U.S.C. § 355(j)(5)(B)(iii). Allergan brought its suit under 35 U.S.C. § 271(e)(2), alleging that if the FDA approved Alcon's and B & L's ANDAs, Alcon and B & L would induce doctors to infringe the '415 and '741 patents by prescribing brimonidine for neuroprotection and would induce patients to infringe by using brimonidine for neuroprotection. Allergan also alleged that, through the submission of their ANDAs, Alcon and B & L were liable for infringement because they violated 35 U.S.C. § 271(e)(2) directly. 20 As noted above, Alcon and B & L moved for summary judgment of non-infringement, arguing that a claim of induced infringement is not cognizable under section 271(e)(2) where, as here, the ANDA is for a use of the drug that is different from the use of the drug that is claimed in the asserted patent. In ruling on the motions, the district court noted that, as far as Alcon was concerned, Allergan had presented sufficient evidence to present a triable issue of fact with regard to induced infringement, or had at least presented sufficient evidence to proceed to discovery. 5 Allergan, 200 F.Supp.2d at 1225, 63 USPQ2d at 1431. The district court did not make a similar finding with respect to B & L. The district court, nevertheless, granted Alcon's and B & L's motions. Addressing Allergan's claim of induced infringement, the court held that the filing of an ANDA does not provide a predicate for a method of use patent holder to sue an ANDA applicant for induced infringement. Id. at 1232, 63 USPQ2d at 1437. The court viewed section 271(e)(2) as being symmetrical with section 271(e)(1), which, as noted above, allows a generic drug manufacturer to use a patented drug in order to prepare an application for FDA approval without liability for infringement. The court therefore 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). The court stated that, had section 271(e)(1) not been enacted, Allergan could have sued Alcon for infringement for using its patent in the development of a generic drug. It could not, however, sue Alcon for inducing infringement because there was yet to be any third-party infringement and thus the question of inducing infringement would be entirely too speculative. Id. at 1231, 63 USPQ2d at 1436. Under these circumstances, the district court concluded, allowing a patentee to bring a claim for inducing infringement under [s]ection 271(e)(2) runs afoul of the `case or controversy' requirement of Article III [of the Constitution]. Id. at 1232, 63 USPQ2d at 1437. The district court rejected Allergan's direct cause of action claim on the ground that section 271(e)(2) does not expand the traditional grounds of patent infringement; it requires the same inquiry as any other infringement suit. Id. at 1227, 63 USPQ2d at 1433. 21 Allergan now appeals the district court's grant of Alcon's and B & L's motions for summary judgment. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).