If ANDA is Silent on Infringement, then Infringement is Assessed Based on the Product Likely to Be Sold; Courts Have Discretion to Consider Post-Trial ANDA Amendments

Ferring B.V. v. Apotex, Inc. et al.,__ F.3d __ (Fed. Cir, Aug. 22, 2014) (Lourie, DYK, Reyna) (D. Nev.: Jones) (3 of 5 stars)

Federal Circuit affirmed dismissal of Ferring's Hatch-Waxman infringement claim as moot after Apotex's amendment to its ANDA rendered it non-infringing.

The patents covered an extended-release drug and required that less than "about 70%" of the active ingredient dissolve after 45 minutes. Apotex filed an ANDA in 2010 that did not specify the dissolution rate but amended it in 2014 to require at least 75% dissolution at 45 minutes. The district court found that, although the 2010 ANDA infringed because its silence on the dissolution rate meant Apotex "could" sell an infringing product, the 2014 amended ANDA no longer infringed and thus dismissed the claim as moot.

2010 ANDA: Disagreeing with the district court, the Federal Circuit held the 2010 ANDA did not infringe because, under Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562 (Fed. Cir. 1997), the correct analysis when the ANDA is silent on infringement was whether the ANDA applicant "would likely sell an infringing composition pursuant to an approved ANDA," slip op. at 9. Ferring's admission that samples did not infringe and Apotex's own dissolution data showed that Apotex was not likely to sell an infringing product. By contrast, Sunovion Pharms., Inc. v. Teva Pharms., 731 F.3d 1271 (Fed. Cir. 2010), did not apply because it held that, when the ANDA specifies an infringing product, the defendant "could not avoid infringement by certifying that it would not infringe, overriding the language of its own ANDA." Id. at 8. Here, Apotex's 2010 ANDA "is silent with respect to the claim limitations of the patents-in-suit." No cross-appeal was necessary for the Federal Circuit to consider this issue because it was an alternate basis for not granting Ferring any relief.

2014 ANDA: The claim term "about 70%" was construed to mean "approximately 70%" rather than the ±10% margin Ferring advocated, and the 2014 amendment did not infringe under this construction because Ferring produced no evidence otherwise. The relevant statute did not prohibit assessing infringement based on the amendment because, "[f]or the purposes of section 271(e)(2), 'an application' means the ANDA as filed and all amendments to that application that have been allowed by the FDA." Slip. op. at 13. As in Bayer AG v. Elan Pharm. Res. Corp., 212 F.3d 1241 (Fed. Cir. 2000), the amendment here "shows Apotex is not permitted to sell an infringing product," and it was thus dispositive. Slip op. at 14. It did not matter that the amendment was made after trial, because the district court had discretion to consider it "guided by principles of fairness and prejudice to the patent holder." Id. at 15. There was no unfairness here because Apotex agreed to notify the court of any further amendments and no prejudice because Ferring never sought to reopen the record to introduce evidence the 2014 ANDA infringed.