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infringement based on its filing of an abbreviated new drug application — and consequently may have its ANDA approval withdrawn pursuant to § 271(e)(4)(A) — where the patent issued after U.S. Food and Drug Administration approval of the ANDA and was not subject to a Paragraph IV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 Univ. of New York v. Mylan Pharms. Inc., Nos. 09-184, 10-892 (D. Del. May 16, 2012) (Slip. Op.) ("Oracea Remedy Opinion"). Read the court's decision here. This ruling is another case in recent Federal Circuit and district court law clarifying the scope of § 271(e)(2)(A), a key tool for the enforcement of pharmaceutical patents under the Hatch-Waxman Act....

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