Lilly v. IPPI

Executive Summary

Lilly v. IPPI: Oncovin-manufacturer Lilly met with FDA to discuss agency approval of International Pharmaceutical Products Inc.'s vincristine. According to an agency memo of the meeting, Lilly's Washington counsel urged FDA to rescind approval of the generic anticancer agent on the grounds that IPPI still had not satisfied patent certification and notification requirements. FDA previously rescinded approval of IPPI's ANDA for vincristine until the generic company submitted Lilly patent information ("The Pink Sheet" Feb. 2, T&G-5). The memo reports that FDA Chief Counsel Thomas Scarlett replied "he was not prepared to recommend that IPPI's approval be rescinded a second time but that FDA will try to improve its procedures for handling patent filings and certifications".