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Waxman/Hatch Declaratory Judgment Reforms Are Focus Of Zoloft Appeal

This article was originally published in The Pink Sheet Daily

Executive Summary

The Federal Circuit Court of Appeals will hear arguments from Teva and Pfizer Oct. 7 on the impact of Medicare Modernization Act provisions on an ANDA filer’s ability to seek a court order declaring it does not infringe an innovator’s patent.

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Impact Of Waxman/Hatch Reforms On Declaratory Judgments Questioned By Judges

Federal Circuit judges hearing oral arguments in Teva's lawsuit against Pfizer on a Zoloft patent express skepticism that the Medicare Modernization Act relaxed the standards for a generic company to bring a declaratory judgment action against an innovator.

Impact Of Waxman/Hatch Reforms On Declaratory Judgments Questioned By Judges

Federal Circuit judges hearing oral arguments in Teva's lawsuit against Pfizer on a Zoloft patent express skepticism that the Medicare Modernization Act relaxed the standards for a generic company to bring a declaratory judgment action against an innovator.

Zoloft Patent Dispute: FTC Wants Teva’s Declaratory Judgment Case Against Pfizer Restored

The case could create “the first appellate precedent regarding whether there is a justiciable ‘controversy’” when a subsequent ANDA filer sues a brand manufacturer for a declaratory judgment on noninfringement, the commission says in an amicus brief in support of Teva.

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