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Executive Summary

FIRST IL-2 U.S. PATENT ISSUES: ROCHE HAS EXCLUSIVE RIGHTS under an agreement with patent holder Ajinomoto. "Roche is not aware of any recombinant interleukin-2 in the clinic that is produced by a method that does not fall within the issued claims," Roche VP and Chief Patent Counsel Jon Saxe commented in an April 19 press release. The patent (No. 4,738,927), Roche said, "covers genetic engineering techniques including novel DNA sequences and organisms containing such DNA." The company is maintaining that it will have the right "in the U.S. and many other countries to exclude others from making, using or selling recombinant human IL-2 produced using such techniques." Immunex, the Seattle-based biotech firm, assisted Roche in the development of IL-2. Under the 1981 research agreement, Immunex conducted preclinical research, with Roche responsible for the molecular development of the lymphokine product. Roche's relationship with Ajinomoto evolved from work by Immunex founders Christopher Henney and Steven Gillis with the Japanese firm prior to the formation of Immunex. "This development is an important one for Immunex," CEO Stephen Duzan commented in a separate, same-day release. "The patent confirms the leadership position of Immunex and Hoffmann-LaRoche in the commercial development of IL-2." The product is currently is clinical development in several U.S. centers for treatment of various types of cancer including malignant melanoma, renal cell cancer and colon cancer. Immunex received payment for early development of the protein, retains the right to manufacture a portion of the IL-2 sold by Roche, and will receive royalties on any worldwide sales. The action by the U.S. Patent & Trademark Office apparently clouds the position of Cetus, whose IL-2 product, Proleukin, is currently in Phase III development in the U.S. and pending approval in certain European countries. Cetus has filed for patents in the U.S., basing its position on muteins, or slightly altered formulations of the natural molecule. Whether Cetus will be excluded from taking its product to market likely will depend on a cross-licensing agreement, such as the one between Schering and Roche covering alpha interferon, or will be settled in court.

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