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Executive Summary

UPJOHN's MINOXIDIL PATENT INFRINGEMENT SUIT v. RIAHOM CORP. charges that Riahom is "making, using and/or selling compositions for the treatment of baldness" that contain a salt of minoxidil. Upjohn filed suit against the Delaware-based Riahom in Delaware Federal Court May 6 seeking preliminary and permanent injunctions to block Riahom from further infringement of its minoxidil patent 4,139,619. The suit against Riahom, which names the company's president J. P. Utsick, states that the defendants have not responded to a notice of infringement "but have, on information and belief, continued a nationwide campaign to enroll 500 exclusive distributors for their infringing composition, in violation of [Upjohn's] patent rights and without seeking FDA approval." Riahom's composition is sold under the name Rivixil in the U.S. Upjohn also charges that Riahom has made false claims in promoting and advertising Rivixil, including "claims that Rivixil is patented, that Rivixil is a cosmetic, not a drug, that said compositions are proven safe and easy to use, that distribution and sale of Rivixil does not require prior approval of the FDA as a drug product and that Rivixil may be sold without a physician's prescription." The suit asserts that "in fact, on information and belief, Rivixil is not patented in the U.S. The drug is subject to FDA approval, has not been approved by FDA and requires a physician's prescription for sale." Upjohn submitted an NDA for a topical formulation of minoxidil, trademarked Regaine in December. The company intends to market the hair growth product as an Rx drug.

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