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Generic Drug Manufacturers May Be Liable For Patent Infringement Under 35 U.S.C. § 271(e)(2)(A) In The Absence Of Paragraph IV Certification

May 22, 2012


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based on its filing of an Abbreviated New Drug Application ("ANDA") and consequently may have its ANDA approval withdrawn pursuant to § 271(e)(4)(A) where the patent issued after FDA approval of the ANDA and was not subject to a Paragraph IV certification.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 Courts 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.

Click here for a PDF of the full text

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