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CETUS GAINING AMGEN's INTERLEUKIN-2 PATENT RIGHTS

Executive Summary

CETUS GAINING AMGEN's INTERLEUKIN-2 PATENT RIGHTS under a settlement announced April 4. "Amgen will assign all its U.S. and foreign patent rights to Cetus and each company will have the rights to separately develop, manufacture and market its respective form of IL-2," the release states. "The rights are royalty free throughout the world except for the U.S., where Cetus will receive a royalty from Amgen and Ortho on sales of IL-2 by Amgen's licensee, Ortho." The settlement makes Cetus the apparent winner in IL-2 patent litigation dating back to the summer of 1986. With its R&D efforts focused more on erythropoietin and other cell growth factors, however, Amgen probably viewed settlement for a lower-priority product as a more attractive alternative to litigation. Amgen was the first to file suit in San Francisco Federal Court, claiming that three Cetus patents covering mutein formulations of recombinant IL-2 were invalid and infringed on the product under development by Amgen. In September 1986, Cetus, which said it was the only company to hold U.S. patents for rDNA-produced IL-2, filed a countersuit against Amgen in the same court, seeking injuctive relief and treble damages. Cetus' principal competitor in the development of the recombinant lymphokine product remains Immunex and worldwide licensee Roche. While Cetus bases its patent position on muteins, or slightly altered formulations of the original molecule, Immunex and Roche are developing a natural sequence IL-2 product. There has been no patent litigation between Cetus and either Roche or Immunex on IL-2. Both products are still in clinical trials. "Our settlement proves that some patent disputes in our industry can be resolved on a business basis in the best interests of both parties," Amgen President George Rathman commented. His remarks were echoed by Cetus President Robert Fildes, who said the settlement "heralds a positive new direction for the biotechnology industry."
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