In the years following FDA approval of direct-to-consumer, genetic-health-risk/DTCGHR testing, millions of people in the US have sent their DNA to companies to receive personal genome health risk information without physician or other learned medical professional involvement. In Personal Genome Medicine, Michael J. Malinowski examines the ethical, legal, and social implications of this development. Drawing from the past and present of medicine in the US, Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercial personal genome sequencing and testing sectors and to assess their impact on the future of US medicine. Written in relatable and accessible language, the book also proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.

Chapter 14 covers legal issues arising in the context of academic research and technology transfer. A brief history of university technology development and the Bayh-Dole Act of 1980 are given, followed by a discussion of various issues that have arisen under the Act. The Act’s effect on ownership of IP is discussed with reference to Stanford v. Roche (2011). Its requirements for royalty sharing and US manufacturing are discussed. The area of march-in rights is illustrated through the dispute over Fabryzyme. Next focus shifts to the role of university technology transfer offices (TTOs) and ways that universities have attempted to shape university technology transfer over the years, including through the 2007 Nine Points document and the highlighting of issues such as reserved rights, limits on exclusivity, socially-responsible licensing and price controls. Next, other forms of university technology development agreement are discussed, including sponsored research and materials transfer agreements. The chapter concludes with a discussion of university policies relating to copyright.