Tuesday, February 24, 2009

Federal Circuit Affirms Extension of 30-Month Stay Against Teva's Generic Evista

According to the post on Orange Book Blog:

Under the Hatch-Waxman Act, final FDA approval of an ANDA is automatically stayed for thirty months when a patent owner files suit for patent infringement within 45 days of receiving a Paragraph IV notice letter. The purpose of the stay is to allow the parties to litigate the patent infringement claims while the ANDA filer pursues FDA approval of its generic drug. Pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), a district court may shorten or lengthen the thirty–month stay if "either party to the action failed to reasonably cooperate in expediting the action."

The details can be read here.

the whole judgement can be read here.

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