9.1 This chapter addresses issues relating to the law and practice of challenging and enforcing gene patents in Australia. The chapter first outlines the procedures available to challenge Australian gene patents, both prior to the grant of a patent and after a patent has been sealed. The chapter then addresses the variety of ways in which gene patents may be enforced—from commercial negotiations to license a patent, to legal proceedings. The chapter also considers the factors that affect a patent holder’s decision as to which enforcement strategies it will pursue. An important issue is the ability of Australian patent holders to detect infringing activities. The chapter addresses mechanisms for monitoring compliance with patent rights, including through information made available by IP Australia. The chapter concludes with a discussion of insurance policies that provide coverage for the costs of patent litigation.