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Indiana Law Journal

Document Type

Article

Publication Date

Spring 2023

Publication Citation

98 Indiana Law Journal 1181 (2023)

Abstract

The U.S. biotechnology industry got its start and grew to maturity over roughly three decades, beginning in the 1980s. During this period genes were patentable, and many gene patents were granted. University researchers performed basic research— often funded by the government—and then patented the genes they discovered with the encouragement of the Bayh-Dole Act, which sought to encourage practical applications of basic research by allowing patents on federally funded inventions and discoveries. At that time, when a researcher discovered the function of a gene, she could patent it such that no one else could work with that gene in the laboratory without a license. She had no right, however, to control genes in nature, including in human bodies. Universities licensed their researchers’ patents to industry, which brought in significant revenue for further research. University researchers also used gene patents as the basis for obtaining funding for start-up enterprises spun out of university labs. It was in this environment that many of today’s biotechnology companies started. In 2013, the Supreme Court held that naturally occurring genes could no longer be patented. This followed a 2012 decision that disallowed patents on many diagnostic processes. These decisions significantly changed the intellectual property protections in the biotechnology industry. Nevertheless, the industry has continued to grow and thrive. This Article investigates two questions. First, if some form of exclusive rights still applied to genes, would the biotech industry be even more robust, with more new entrants in addition to thriving, well-established companies? Second, does the current lack of protection for gene discoveries incentivize keeping such discoveries secret for the many years that it can take to develop a therapeutic based thereon—to the detriment of patients who could benefit from knowledge of the genetic associations, even before a treatment is developed? The Article concludes by analyzing what protection for discovering genetic associations, if any, will most increase social welfare.

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