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Recommendations for Statutory Reform of the Patent Term Extension System to Increase Public Accountability and Fight Soaring Drug Prices

Ethan Lin '21

Christopher Morten, editor

Executive Summary

In the past 40 years, patent protections on pharmaceutical drugs have effectively lengthened to nearly double the standard 20-year monopoly intended by patent law. The lengthening of patent monopolies has contributed to skyrocketing pharmaceutical drug prices and healthcare costs. A significant driver of this trend has been the patent term extension (PTE) provision of the Hatch-Waxman Act, 35 U.S.C. § 156, which allows drug companies to delay the expiration dates of already-issued patents on prescription drugs, lengthening their patent monopolies. This paper suggests legislative reforms to the PTE provision to restrict improper patent term extensions and make the patent system more democratic and transparent to the public.