In an Issue of First Impression, the Federal Circuit Finds Infringement as a Matter of Law Despite a Sworn Certification Promising No Infringement
By JOSEPH M. OMALLEY, JR., ERIC W. DITTMANN, DAVID M. CONCA, & NICHOLAS A. TYMOCZKO
In a September 26th precedential ruling addressing an issue of first impression, the Federal Circuit held that a “so-called certification pledging not to infringe cannot override the conclusion that when a drug manufacturer seeks FDA approval to market a generic compound within the scope of a valid patent, it is an infringement as a matter of law.” Sunovion Pharms., Inc. v. Teva Pharms. USA, Inc., No. 2013-1335, Slip Op. at 15 (Fed. Cir. Sept. 26, 2013). The Federal Circuit’s decision ensures that generic drug manufacturers will not be able to avoid patents through unilateral representations to courts and provides innovators with certainty in defending their most-important products against infringement.