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Executive Summary

ALZA/MMD BEGIN SHIPPING NICODERM NICOTINE PATCH DEC. 13, the same day a San Francisco Federal court lifted a temporary restraining order barring shipment and sale of the 24-hour transdermal nicotine smoking cessation patch, which was approved by FDA on Nov. 7. After the ruling was announced, Marion Merrell Dow said it would begin shipping Nicoderm "immediately" and that its smoking-cessation patch would be in pharmacies across the U.S. before New Year's day, in time for New Year's stop-smoking resolutions. The company plans to run consumer print, television and radio advertisements for Nicoderm in early 1992. The temporary restraining order had been granted Nov. 21 in response to a request by Elan Corp. and its U.S. marketing partner Lederle in a Nov. 20 patent infringement suit against the Alza/Marion Merrell Dow team. The suit alleged that Nicoderm infringed Elan's patent 4,943,435 for a prolonged activity nicotine patch ("The Pink Sheet" Nov. 25, T&G-4). The TRO was granted pending a decision on Elan/Lederle's preliminary injunction request, which the court also denied on Dec. 13. The patent litigation "will be resolved by the court at a later date," MMD said. No trial date has been set. MMD and Alza said they "vigorously dispute" the patent infringement allegation. Due to the delay caused by the restraining order, Nicoderm will closely follow Ciba-Geigy's Habitrol patch onto the market. Habitrol was approved Nov. 27. Ciba-Geigy said shipments of the product are under way and Habitrol will be in pharmacies across the country by the week of Dec. 23 ("The Pink Sheet" Dec. 9, T&G- 1). Ciba-Geigy escaped an immediate threat to Habitrol's introduction on Dec. 11 when a Newark, N.J. federal court denied Elan/Lederle's request for a temporary restraining order against the product. Elan/Lederle's request was part of the two companies' counterclaim against Ciba-Geigy, which sued them for patent infringement on Dec. 2. Ciba-Geigy also had requested a temporary restraining order against Elan/Lederle's ProStep patch, which is unapproved, but that request was denied on Dec. 11 as well. The Newark federal court is scheduled to rule on Elan/Lederle's request for a preliminary injunction on Dec. 20 and on Ciba- Geigy's request on Jan. 28. Ciba-Geigy's suit against Elan and Lederle further clouds the nicotine patch litigation picture, with all four competitors involved in at least one patent infringement suit each. In addition to its suit against Elan and Lederle, Ciba-Geigy sued Alza/MMD on Nov. 27 ("The Pink Sheet" Dec. 9, T&G-2). Elan/Lederle also have a suit pending against Cygnus Therapeutic Systems alleging that Nicotrol 16, which was codeveloped with Kabi Pharmacia and uses Cygnus' matrix technology, infringes Elan's 4,946,853 method patent ("The Pink Sheet" May 20, T&G-4). Nicotrol 16 is to be marketed by Warner-Lambert.

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