How to Control the United States Pharmaceutical API Market Using Patents on New Synthetic Intermediate Compounds

Abstract

The multinational pharmaceutical industry now out-sources a much higher volume of active pharmaceutical ingredients from manufacturers in non-regulated markets such as Brazil, India and China. This economic change presents an opportunity for API manufacturers to potentially control the market in the United States for certain APIs, by capitalizing on a particular provision of US patent law. This paper reviews this law, examines several actual case studies under this law, and provides a check list of characteristics useful to identify the most valuable Active Pharmaceutical Ingredients (API) manufacturing opportunities.