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Executive Summary

Schering-Plough is alleging that Interferon Sciences' genetically engineered genital herpes treatment Alferon Gel infringes the company's alfa interferon patent in a suit filed March 21 in Delaware federal court. The suit charges Interferon Sciences with infringement and "inducing or contributing to the infringement" of Biogen's U.S. patent #4,530,901. Schering has licensed the Biogen patent since 1985 and markets the recombinant alfa-2 interferon worldwide under the tradename Intron A. The product is marketed in the U.S. for the treatment of Kaposi's sarcoma, hairy cell leukemia and venereal warts. Interferon Sciences began filing its Product Licensing Application for Alferon Gel in May 1987 and expects to submit the "balance" of its clinical trial results "in the very near future." The suit also charges Interferon Sciences Development Corp., Anheuser-Busch and its subsidiary Busch Biotech with patent infringement. Busch Biotech takes Interferon Sciences' genetically engineered yeast and grows it into a crude lysate, which Interferon Sciences then purifies. Through its biotech subsidiary, Anheuser-Busch has provided over $ 11 mil. in financial backing to Interferon Sciences since 1983. The suit does not involve Interferon Sciences' naturally derived Alferon N Injection. The company reached a licensing accord with Hoffmann-LaRoche on March 7, 1988 to prevent patent infringement suits against the product as it neared the market. The PLA for Alferon N is currently pending at FDA.

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