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Executive Summary

Roche is fortifying its rDNA interleukin-2 patent position via agreement with Ajinomoto, the Japanese Foundation for Cancer Research, and U.S. research partner, Immunex, in preparation for an upcoming showdown with other biotech firms developing recombinant interleukin-2, the firm indicated in a Nov. 19 press release. Under the agreement with Ajinomoto, Roche is licensing "the rights that will accrue to Ajinomoto as a result of the original cloning in 1982 of the human gene for IL-2 (interleukin-2)," the release notes. With the Ajinomoto agreement, Roche is looking to gain the trump card in future patent disputes over rDNA-derived interleukin-2.Roche expects Ajinomoto to receive a broad patent for its groundbreaking work that covers marketing and manufacturing of recombinant interleukin-2. At present, there are a number of firms with active rDNA-derived interleukin-2 research programs, including Sandoz, Cetus, Biogen, and Collaborative Research. Roche, Biogen, Collaborative Research and Cetus have entered clinicals with recombinant interleukin-2. In taking steps to shore up its interleukin-2 patent position, Roche is anticipating the same kind of patent struggle that is shaping up in the recombinant interferon area. Biogen, Roche's competitor in the race to get alpha-interferon to the market, was issued a broad patent for first cloning the protein last August from the European Patent Office. Roche immediately challenged that patent, maintaining that the Roche/Genentech team was the first to successfully produce the nature protein now used in clinicals. Immunex Clarifies License Agreement With Roche, Settles Dispute With Ajinomoto Ajinomoto, Roche explained, has filed for patent rights to interleukin-2 based on the pioneer work of Dr. Taniguchi, who, while working under a license agreement with Ajinomoto and the Japanese Foundation for Cancer Research in 1982, became the first scientist to clone and publish the genetic sequence for the human IL-2 gene. Roche VP and biotechnology patent law specialist Jon Saxe said his firm believes that, "based on the work of Dr. Taniguchi and his collaborators, Ajinomoto will gain basic patent rights to expression of the human IL-2 gene, to recombinant organisms containing that gene and to recombinant protein." He added: "Gaining the rights to inventions of Taniguchi and his collaborators was considered important for the continuation of our own pioneering clinical work with the protein." Roche rDNA-derived interleukin-2 is currently undergoing clinical testing for AIDS (Acquired Immune Deficiency Syndrome) at the Natl. Institutes of Health. These trials, which began March 1, 1984, "have shown that interleukin-2 is apparently well tolerated at the dosage given," Roche said. The firm added that it "soon" plans "to inaugurate additional trials in AIDS patients as well as in cancer patients whose immune systems have been suppressed by the disease or by chemotherapeutic treatments." In a separate Nov. 19 press release, Immunex noted that a series of interleukin-2 patent agreements were signed between the three firms -- Roche, Ajinomoto, and Immunex. In addition to the Roche/Ajinomoto agreement, under which Roche gets an exclusive license to the Japanese firm's patent position on IL-2 in return for royalties, separate agreements between Roche and Immunex and between Ajinomoto and Immunex have also been concluded. Immunex noted that its agreement with Roche "clarified certain terms of license agreements between Immunex and Roche and its U.S. subsidiary concerning worldwide marketing rights." Under Immunex' agreement with Ajinomoto, the two firms waived rights for claims against each other as a result of the termination of a consulting agreement in 1981.

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