The United States leads the world in novel biomedical innovation, thanks in large part to its strong research universities, talented researchers, efficient drug approval processes, and a pricing system that enables companies to earn sufficient revenues to reinvest in future generations of innovation. Yet two other factors are indispensable: First, world-leading public and private investment in life-sciences research and development (R&D) activity, with these public and private investments playing unique yet complementary roles in America’s life-sciences innovation system. Second, effective technology transfer and commercialization policies that enable federally funded basic life-sciences research, often taking place at U.S. universities, to lead to research discoveries and inventions that can be patented and licensed to private-sector entities, which then undertake the risky, complex, and expensive process of bringing innovative new medicines and therapies to market. Underpinning this successful ecosystem is bipartisan legislation that gives universities rights to intellectual property (IP) generated from federal funding: the Bayh-Dole Act. Since its introduction in 1980, the act has played a catalytic role in stimulating innovation across many sectors, and especially in the life-sciences. However, calls made by some to use Bayh-Dole “march-in right” provisions to control drug prices threaten to undermine this successful ecosystem and reduce the pace of American biopharmaceutical innovation.
