human cloning

APPENDIX C: EXCERPT FROM UNIVERSITY OF CALIFORNIA V. ELI LILLY AND CO. Source: U.S. Patent Quarterly 2d, Book 39, from “A. The ‘525 Patent” on pp. 1248–1254.

Some background information concerning research involving recombinant DNA must precede discussion of this issue. In the early 1970’s when experiments in the area of recombinant DNA were first contemplated many people, including some scientists, were concerned that such experiments might pose medical threats to humans. Tr. at 1295. The National Academy of Sciences eventually “called for a broad moratorium on all recombinant experiments until they could be . . . better reviewed by the scientific community.” Id. At a subsequent review of recombinant DNA research in 1975, it was suggested that experiments in that area might proceed if suitable guidelines were promulgated to govern the research. See Lilly Ex. 3547 at HG2 580773.

Consequently, the Recombinant DNA Molecule Program Advisory Committee, previously established by the Department of Health, Education, and Welfare’s National Institutes of Health (NIH), held its first meeting to develop safety guidelines. Id. Those guidelines were issued by the NIH on June 23, 1976, and published in the Federal Register on July 7, 1976. Tr. at 1296, 1298; Lilly Ex. 3731 at 000004; Lilly Ex. 3547. “The NIH Guidelines establish [ed] carefully controlled conditions for the conduct of experiments involving the production of [recombinant DNA] molecules and their insertion into organisms such as bacteria.” Lilly Ex. 3547 at HG2 580773. For example, the regulations classified types of biological containments (i.e., plasmids) and specified which ones could be used in certain recombinant DNA experiments. The regulations also governed the type of physical containment facilities (i.e., laboratories) in which scientists could conduct particular types of experiments. The safety guidelines mandated that no plasmid could be considered to fall within an approved classification until it had been certified by the NIH Recombinant DNA Advisory Committee. Tr. at 1301.

The guidelines also stipulated that any institution receiving NIH funds was to appoint a principal investigator. Under the guidelines, the principal investigator had certain responsibilities, including “supervising the safety performance of the staff to ensure that the required safety practices and techniques [were] employed” and “investigating and reporting in writing to the NIH Office of Recombinant DNA Activities and the institutional biohazards committee (or biosafety committee) any problems pertaining to operation and implementation of biological and physical containment safety practices and procedures, or equipment or facility failure.” Lilly Ex. 3547 at HG2 580791. The guidelines governed the conduct of all NIH supported research in the area of recombinant DNA. The research UC was conducting on rat insulin the research that formed the basis of the ‘525 patent was NIH-supported. Consequently, UC was to operate within the strictures of the safety guidelines.

By January of 1977, the NIH only had certified the plasmids denominated pSC101 and pCR1 for experiments with mammalian DNA. Tr. at 1301. According to Rutter, UC scientists H-32