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Executive Summary

GENETICS INSTITUTE/CHUGAI's "BEST MODE" DEFENSE AGAINST AMGEN in the erythropoietin patent dispute between the companies was discussed by New York patent attorney Jennifer Gordon (Pennie & Edmonds) at a Nov. 6 Shearson Lehman Hutton health care conference in New York. With the "best mode" of production argument, Gordon elaborated, "Genetics Institute apparently thinks it has evidence that the inventors [of the Amgen product] had particular clones or particular vectors that they preferred for making EPO by recombinant means, and apparently, these preferred materials were not deposited [in support of the patent] as of a certain critical date." The best mode defense was among the issues raised by Genetics Institute and Chugai in oral arguments given Nov. 9 in Boston federal court (see preceding T&G). * Failure to provide the best mode for carrying out an invention, Gordon pointed out, was one of the arguments cited in Scripps Clinic v. Genentech. Decided in March, that suit involves patents for recombinant Factor VIII:C products. Gordon noted that one of the reasons the Scripps patent was found to be invalid was that the company failed to disclose a preferred monoclonal antibody for purification procedures which the inventors knew about. Scripps is appealing the decision. The U.S. Patent and Trademark Office, Gordon added, is proposing to amend the duty of disclosure standard for submission of patent information through proposed rule 57, published in the Federal Register last March. The proposed rule contains language that would make it easier for a patent applicant to determine what information is crucial to disclose.

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