Intellectual Property Rights and Regulatory Considerations Throughout Drug Repurposing

Repurposing existing drugs has been proposed to develop novel therapeutic approaches that are less risky, less expensive, and need less time than inventing new drugs. To successfully repurpose a pharmaceutical product, it is necessary to consider and include intellectual property and regulatory exclusivities. Patent protection strategies that cover new formulations, indications, and methods of use may give effective and long-term product exclusivity even when a patent does not protect the underlying active pharmaceutical ingredient (API), original formulations, indications, and methods of use. These patent strategies should be used cautiously, together with repurposed pharmaceutical formulations. To assist in repurposing, it is important to examine the obstacles that the repurposing community faces so that novel methods will be suggested to overcome the associated challenges. This book chapter covers drug regulatory and intellectual property rights (IPR) related aspects of drug repurposing. The goal is to help practitioners understand regulatory issues for drugs or product modifications and the repositioning of existing substances. The regulatory background and examples of drug modifications that use sponsor research and public information to seek new drug application (NDA) clearance for small molecules are also provided.