Opinion ID: 772062
Heading Depth: 2
Heading Rank: 5

Heading: Biovail's Motion for Vacatur and Remand

Text: 35 Biovail has moved for vacatur and remand on the ground that Andrx did not advise Biovail of several (eleven) amendments filed to the ANDA after the close of discovery, and which were not made known to Biovail until after trial and decision and only shortly before scheduled appellate argument. It is an abuse of the judicial role for Andrx to ask us to review on appeal what should have been made known, and adequately explored, at trial. Under 21 U.S.C. § 355(j)(2)(B), there is an obligation to disclose the filing of an ANDA, as well as its content, to the patent holder and other interested parties. See 5 C.F.R. § 314.95 (2000). The obligation to inform the parties, and the trial court, as to any material amendment to the ANDA continues throughout the litigation that is artificially provoked under Paragraph IV. Andrx's failure to disclose the amendments it filed to the ANDA after the close of discovery constitutes a violation of that obligation. 36 However, in the interest of bringing this case to closure, we have reviewed the texts of these amendments, which have been provided in response to the motion now before us. We conclude that the amendments do not show reversible error in the district court's decision that infringement does not lie.