Originally published by Drug Delivery: Principles and Applications
Shahnam Sharareh and Wansheng Jerry Liu authored the chapter, "Intellectual Property and Regulatory Issues in Drug Delivery Research" in the Drug Delivery: Principles and Applications publication.
This chapter discusses the basis of patent laws and Food and Drug Administration (FDA) regulations that drug manufacturers must be mindful of before developing a patent strategy. For pharmaceutical and drug delivery research, patent procurement strategy is an integral part of any commercial drug formulation research projects. In the United States, before any drug formulation reaches the market, it must meet the safety and efficacy criteria by the Food, Drug, and Cosmetics Act (FDCA) as enforced by the FDA. The new drug application (NDA) approval process under the FDCA essentially requires applicants to substantiate safety and efficacy of a drug product through well-controlled human clinical trials. Manufacturers of drug products with a potential long-market life should consider managing patent term and regulatory exclusivities as part of their strategies to maximize their product's life cycle and market success in the face of scientific uncertainty.
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