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Executive Summary

GENETICS INSTITUTE EPO PATENT CASE WILL BE DECIDED BY DEC. 11, Massachusetts Federal Court Magistrate Patty Saris said Nov. 9 during the close of final oral arguments, which concluded 38 days of hearings on the erythropoietin patent dispute. In its final argument, Amgen contended that its scientist, Fu-Kuen Lin, PhD, was first to conceive the method of discovering the DNA sequence of EPO in 1982, and the first to isolate the DNA sequence for EPO in 1983. Until then, the company's attorneys (Alleghretti & Whitcoff, Chicago) maintained, no other company had the capability of producing EPO in significant quantities for pharmaceutical use. Genetics Institute/Chugai attorneys (New York firm of Morgan & Finnegan) countered that a Genetics Institute researcher, Edward Fritsch, PhD, was first in 1981 in conceiving a probing strategy that they say ultimately led to the isolation of the DNA sequence for EPO, even though the researcher did not actually isolate the DNA sequence until after the Amgen discovery. Furthermore, counsel for Genetics Institute/Chugai alleged that Amgen did not disclose at the time of patent filing, the "best mode" of EPO production (see following T&G). However, Amgen's counsel maintained that the company was not required to submit to the patent office the cell line that ultimately provided the best mode of production of EPO. In questions to the attorneys, Judge Saris indicated she had difficulty with two issues: * Without drawing conclusions, she questioned Amgen's motive for withholding the best mode of expressing EPO from the U.S. Patent and Trademark Office. "Why were some [cell lines] deposited and not the key one?" Saris asked. Chugai suggested that Amgen considered the cell line a trade secret and for that reason, decided not to submit the information to the PTO. * Saris also questioned whether Genetics Institute's scientists, despite being able to isolate EPO, knew enough prior to Amgen's patent submission to be able to produce the protein through recombinant technology. She indicated that she may interpret the validity of Genetics Institute's patent as being restricted to EPO purified from urine without including a claim for recombinant EPO. Amgen filed the suit in 1987, following the issuance of its patent for the DNA-sequence encoding EPO, the vector, and the transfected host cell used to produce EPO. The firm alleged that the production and sale of EPO by Genetics Institute and its licensee, Chugai, infringes the Amgen patent and that Genetics Institute's patent is invalid. Genetics Institute, which holds a patent for homogeneous EPO purified from urine, file Both sides have won preliminary rulings during the two-year case. In January 1988, then-presiding Judge William Young issued a partial summary judgement that found that Amgen had infringed Genetics Institute's patent on the grounds that Amgen's homogenous EPO, regardless of method, is described in Genetics Institute's patent. The same judge also required Genetics Institute to deposit up to $ 15 mil. in escrow in January 1989 for damages because of a reasonable likelihood that Amgen's patent is valid.

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