Barr Laboratories, Inc. v. Thompson

How courts have described this case

Verbatim parenthetical descriptions written by other courts when citing this decision. Ranked by citation-network relevance.

• concluding that the plaintiffs ANDA with a delayed effective date was a tentative approval
• holding statutory amendment was not “impermissibly retroactive” because plaintiff did not have sufficiently vested legal right under prior statutory language
• upholding FDA determi- nation under 21 C.F.R. § 314.105(a) that ANDA approval before patent expiration was tentative, not final
• explaining, with respect to cross-motions for summary judgment, that “the court shall grant summary judgment only if one of the moving parties is entitled to judgment as a matter of law upon material facts that are not genuinely disputed”
• “Significant events occurring prior to the effective date can, and often must, delay the effective date of ANDA approvals.”
• apply- ing Chevron to FDA letter ruling

Source: CourtListener parenthetical corpus (CC0).