FTC Seeks Appeals Court Rehearing Of Zoloft Declaratory Judgment Case
This article was originally published in The Pink Sheet Daily
Executive Summary
Federal Circuit panel's decision requiring Teva to establish a "reasonable apprehension" of being sued by Pfizer ignores Waxman/Hatch's recognition that generic firms may overcome ANDA approval "bottlenecks" by obtaining a court decision, Federal Trade Commission says in an amicus brief.
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A divided federal appeals court says the Waxman/Hatch reforms did not lift the requirement that an ANDA filer bringing a declaratory judgment demonstrate a “reasonable apprehension” of being sued for infringement. The ruling comes in a dispute between Teva and Pfizer over a Zoloft patent.
Zoloft Patent Dispute: FTC Wants Teva’s Declaratory Judgment Case Against Pfizer Restored
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