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Executive Summary

QUAD CONSIDERING SALE OF PRESERVATIVE-FREE LIQUID VINCRISTINE that differs in formulation from Lilly's recently patented liquid ready-to-use vincristine which includes preservatives. The company said it is reviewing the validity of the patent issued to Lilly Oct. 28 for its liquid vincristine product Oncovin and will decide in the next two weeks whether or not to market a new liquid formulation. Quad has been marketing a liquid vincristine since May 1986. Lilly filed a patent infringement suit against Quad in Indianapolis federal court the same day it was granted a patent for Oncovin. The suit charges that the Par subsidiary "aggressively marketed its ready-to-use vincristine formulation" with the knowledge that Lilly's patent for the product would issue. Lilly said the patent gives it exclusive rights to liquid vincristine. "Lilly has given written notice to Quad of the existence of its application for the patent, the fact that the patent would issue, and the content of the allowed claims," the suit states. It maintains that Quad "has represented to the FDA and to the public that its ready-to-use vincristine formulation is identical to Lilly's." Lilly asked the court to enjoin Quad from infringing the patent, and to order Quad to recall the formulation. Lilly also asked for treble damages to compensate for the alleged infringement. Another firm involved in the liquid vincristine market, LyphoMed, has decided that the best defense is a good offense. The firm filed suit in the federal court of Chicago Oct. 30 seeking a declaratory judgment against Lilly. LyphoMed said it is seeking to have the court "hold Lilly's patent invalid and unenforceable because, among other reasons, Lilly misleadingly used data to support its patent application and withheld important data from the patent office which would have resulted in denial of Lilly's patent." "LyphoMed received an ANDA approval for liquid vincristine in September. Adria also markets the formulation under a licensing agreement with Quad. Quad said it has not decided whether to license its new liquid formulation to Adria and noted that the decision would be based on the validity of Lilly's patent.

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