How do we protect biomedical research in the evolving intellectual property environment?

The turn of the 21st century saw a flurry of commentary on the need to better protect experimental uses of patented subject matter, particularly in biomedicine. This chapter examines the causes for these concerns in three jurisdictions: the United States (US), Europe and Australia. It shows a divergence in approaches to addressing these concerns, with Europe having statutory provisions protecting both research on and non-commercial research with patented subject matter, Australia solely protecting research on, and the US relying on the common law, which has progressively narrowed protected uses. Lack of protection for research uses of data, know how and materials adds to the problem. We argue that this problem still exists, and we should not shy away from attempting to solve it. A robust, internationally harmonised ‘research on’ exception is an important first step. Other strategies for protecting research with patented subject matter also need to be explored.