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Expert Analysis

How Inter Partes Review Impacts Hatch-Waxman Exclusivity

Law360, New York ( February 27, 2013, 12:33 PM EST) -- The new inter partes review proceedings available under the America Invents Act present new and unique strategic advantages for generic drug challengers in Hatch-Waxman cases.[1] However, the Hatch-Waxman framework hinges on a complex paradigm in which district court litigation plays a central role. The decision to pursue an IPR, therefore, will depend in large part on how adjudication at the U.S. Patent and Trademark Office, as opposed to in district court, will impact the regulatory scheme. As a new and untested adversarial proceeding, there remain several areas of uncertainty as to the operation and consequences of IPR generally, and especially so in the complex Hatch-Waxman world....

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