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Executive Summary

GENENTECH PROTROPIN PATENT COVERS DNA PROCESS used in the production of the human growth hormone, Genentech maintains. Hoffmann-LaRoche and Hormone Research Foundation sued Genentech for patent infringement in California District Court on Sept. 5. Genentech contends that it has a process patent covering DNA production of Protropin. According to Genentech, the Roche suit is based on a patent held by Hormone Research that covers only human growth hormone synthesized through chemical means. The Roche suit asserts that Genentech is infringing Hormone Research's December 1974-issued patent entitled "Synthetic Human Growth-Promoting and Lactogenic Hormones and Method of Producing Same." According to the complaint, Hormone Research, a not-for-profit research group based in Berkeley, California, granted Roche exclusive rights to the patent in 1982. The patent was filed in 1971. The complaint alleges that Genentech is infringing the patent by "conducting clinical trials on synthetic human growth hormone formulated in pharmaceutical preparations designated 'Protropin' and submitting [an NDA for the product] to obtain arpproval . . . for the commercial manufacture, use or sale of such pharmaceutical preparations before the expiration of [Hormone Research's patent] and/or by making, using and/or selling pharmaceutical preparations designated 'Protropin' as well as synthetic human growth hormone that is used in formulating such compositions." Protropin (methionyl human growth hormone) was approved in October 1985. In less than three months of marketing in 1985, Genentech reported Protropin sales of approximately $5 mil. With sales of approximately $17 mil. during the first six months of 1986, Protropin volume is annualizing at between $30-$40 mil. Roche and Hormone Research are requesting that Genentech be "permanently restrained and enjoined from further infringement of U.S. Patent 3,853,833." The suit also seeks a damage award "to compensate plaintiffs for defendant's infringement of said patent." Genentech noted in a press release that it "had previously rejected Roche's offer of a license under the patent because the company does not believe the patent is infringed."

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