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

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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Declaratory Judgment Requirements Unchanged By Medicare Law, Court Says

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.

Declaratory Judgment Requirements Unchanged By Medicare Law, Court Says

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.

Waxman/Hatch Declaratory Judgment Reforms Are Focus Of Zoloft Appeal

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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