About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline

LOG IN
LOG IN


73 U. Colo. L. Rev. 747 (2002)
An End to Gene Patents - The Human Genome Project Versus the United States Patent and Trademark Office's 1999 Utility Guidelines

handle is hein.journals/ucollr73 and id is 777 raw text is: AN END TO GENE PATENTS? THE HUMAN GENOME PROJECT VERSUS THE UNITED STATES PATENT AND TRADEMARK OFFICE'S 1999 UTILITY GUIDELINES MARY BREEN SMITH* INTRODUCTION Scientists working on the Human Genome Project (HGP) have recently determined the complete chemical structure of the human genome and have made the information available to the public. The human genome is a vast storehouse of informa- tion. It contains the complete genetic blueprint to build a human, coding for every chemical involved in the life process. In fact, the new human genomic information made available by the HGP promises to start a period of scientific advancement that will alter the way medicine is practiced far into the fu- ture.' Many entities, both public and private, seek to use the ge- netic information from the HGP to find new lifesaving drugs. These private entities include the pharmaceutical, biotechnol- ogy, and genomics industries. But the road from the HGP to a marketed drug is far from smooth. The costs of research and development are steep. In addition to the funds for years of re- search, companies must conduct clinical trials to prove the drug's efficacy and safety, as required for Food and Drug Ad- ministration (FDA) approval. These requirements can raise the cost of each new drug to hundreds of millions of dollars. Because of these expenses, companies involved in new drug de- velopment require considerable capital expenditure.2 * Candidate for Juris Doctor, University of Colorado School of Law, 2002; B.S., Biochemistry, University of California at Davis, 1987. The author also worked ten years as a laboratory researcher and two years as a patent agent in the biotechnology industry. Many thanks to Christopher G. Smith. 1. Elizabeth Silverman et al., Introduction to Genomics: An Investor's Guide (1996) (on file with author). 2. Bruce Lehman, Major Biotechnology Issues for the U.S. Patent and Trade- mark Office, 33 CAL. W. L. REV. 49, 50 (1996).