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based on its filing of an Abbreviated New Drug Application ("ANDA") and consequently may have its ANDA approval withdrawn pursuant to § 271(e)(4)(A) where the patent issued after FDA approval of the ANDA and was not subject to a Paragraph IV certification.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