Synthesizing Human Insulin by Molly Nicholson With the Duke Institute for Genome Sciences & Policy Center for Genome Ethics, Law & Policy

Agenda  The players—Harvard, UCSF, Genentech  Basic timeline  Key hurtles  Individual strategies  Outcome  Conclusions  Sources and further research

The Players  University of California San Francisco  Genentech, Inc.  Harvard Biology Laboratories  Also…Eli Lilly and Company, Biogen, Novo Industri, Nordisk

Major Milestones January 1977Cloning of rat insulin October 1977Synthesis of human somatostatin May 1978 Expression of rat insulin in bacteria August 1978Synthesis of human insulin!

Key Factors  Open sharing of data  Government regulation  Relationship with the public and media  Intellectual Property  Business and Academia

The Harvard Biology Laboratories

Harvard  Moratorium on recombinant DNA research and P-3 laboratory facility  Patents  “Protein synthesis” (1983)  “Recombinant DNA molecule” (1986)  Biogen  The Midnight Hustler

University of California San Francisco ? William Rutter Chair of the Department of Biochemistry and Biophysics Howard Goodman Associate professor of Biochemistry Medical Sciences Building

UCSF The Rutter and Goodman Labs  pBR 322  Howard Goodman  Negotiations and agreements with Eli Lilly and Genentech, Inc.  Regents of the University of California v. Eli Lilly and Company (1990) Axel Ullrich

Genentech, Inc. UCSF and City of Hope National Medical Center Bob Swanson Founder of Genentech, Inc. Herbert Boyer Co-founder of Genentech, Inc., and UCSF professor of biochemistry

Genentech, Inc.  Difficulties separating from UCSF  Herb Boyer  Active recruiting  City of Hope lawsuit

Outcome  Genentech wins!  UCSF loses:  Weak patents  Harvard loses:  Fails to clone human insulin first

Conclusions  UCSF lost because:  Weak patent management and application  Lack of open data sharing led to tense working environment  Howard Goodman  Harvard lost because:  Government regulation

Sources  Stephen Hall, Invisible Frontiers: The Race to Synthesize a Human Gene (1987)  Judge Hugh S. Dillin’s Memorandum of Opinion re. Regents of the University of California v. Eli Lilly and Company  Oral histories collected by Sally Smith Hughes at UC Berkeley Libraries

Further Research Scheduled interviews with:  Walter Gilbert (Harvard)  John Baxter (UCSF) Administrators at the patent/technology transfer offices at UCSF, Harvard and Genentech

Questions?