Clarifying Infringement Liability Under Hatch-Waxman

Law360, New York (May 23, 2012, 1:17 PM EDT) -- On May 16, 2012, Judge Leonard P. Stark of the United States District Court for the District of Delaware held that a generic drug manufacturer may be liable under 35 U.S.C. § 271(e)(2)(A) for patent infringement based on its filing of an abbreviated new drug application — and consequently may have its ANDA approval withdrawn pursuant to § 271(e)(4)(A) — where the patent issued after U.S. Food and Drug Administration approval of the ANDA and was not subject to a Paragraph IV certification. See Research Found. of State...
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