A deep dive into patent law and exclusivity in the United States

The pharmaceutical industry is critical to the progress of science in researching, developing and introducing new therapies that improve the health and quality of life for patients around the globe. This continued progress requires an extensive amount of funding and financial risk due to the complexity and unpredictability of basic research, clinical trials and the approval process, which result in many failed drugs for every success. It is estimated that it takes about 10 to 15 years, with an average cost of US$1–2 billion, for each new drug product to be approved for therapeutic use (D Sun, W Gao, H Hu, S Zhou, Why 90% of clinical drug development fails and how to improve it?Acta Pharm Sin B 2022, 12(7):3049–62). Accordingly, exclusivity – provided by a robust patent portfolio and regulatory statutes – is essential in order to recoup the massive investments incurred during research, development and regulatory approval of pharmaceutical products. These exclusivities are also critical in providing and maintaining resources for the further development of other therapies in a company’s pipeline.