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.

Regulators must ensure that innovative health research is safe and undertaken in accordance with laws, ethical norms and social values, and that it is translated into clinical outcomes that are safe, effective and ethically appropriate. But they must also ensure that innovative health research and translation (IHRT) is directed towards the most important health needs of society. Through the patent system, regulators provide an incentive-based architecture for this to occur by granting a temporary zone of exclusivity around patented products and processes. The first part of this chapter outlines this regulatory role of patents in IHRT. The chapter then considers the ways in which patentees choose to use their patent rights in IHRT, and the scope for government intervention. The chapter then explores recent actions by patentees that indicate a willingness to moderate the use of their patent rights by engaging in self-regulation and other forms of collaborative regulation. Finally, the chapter concludes with a call for greater government oversight of patent use in IHRT. It is argued that private organisations should not have absolute discretion in deciding how to employ their patents in areas such as health, but that they must be held to account in exercising their state-sanctioned monopoly rights.