Patent holder notification
Executive Summary
FDA proposes amending notice of certification of patent invalidity or noninfringement requirements to permit delivery by express mail, messenger, delivery service, electronic mail and facsimile, in addition to registered and certified mail, "provided that verification of receipt is obtained." FDA is also proposing that applicants submit a copy of the notice to the agency with the delivery receipt. The proposed rule responds to a citizen petition submitted Feb. 4, 1997 by McKenna & Cuneo on behalf of the National Pharmaceutical Alliance ("The Pink Sheet" Aug. 11, 1997, T&G-3)...