By Kevin E. Noonan — A fractured affirmance of a district court decision to dismiss an infringement action under 35 U.S.C. § 271(e)(1) was the occasion for the Federal Circuit to illustrate the continued debate over the scope of the safe harbor enacted as part of the Hatch-Waxman Act in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. The case arose over a brief (one week) importation of two transcatheter heart valve systems (Class III medical devices, subject to regulatory approval by FDA) by Meril in conjunction with attendance by their representatives at a medical conference. These representatives were instructed…
