Double Dosing: How Brand-Name Pharmaceutical Manufacturers Manipulate Patent Rules to Extend Market Exclusivity

Authors

Elizabeth Hertzberg, Washington and Lee University School of LawFollow

Abstract

A robust patent system is important for spurring innovation, but it is not without risk. Because a patent owner has exclusivity over the patented subject matter for a specific term, there is incentive to extend that monopoly however possible. Identical subject matter is unpatentable, but obvious variants of an existing patent may be allowed if the applicant agrees to the same expiration date for both patents. This agreement is called a terminal disclaimer. While patents tied together with terminal disclaimers may not necessarily lead to unjust patent term extensions, an army of terminal disclaimers directed at one invention presents a different problem: it creates a patent thicket. This problem is especially prevalent in the pharmaceutical industry. When brand-name drug manufacturers create patent thickets, they often deter competition from generic manufacturers because the cost of cutting through significant numbers of patents can be extremely high. The consumers ultimately suffer.

The United States Patent and Trademark Office (USPTO) recently attempted to curtail this kind of patent gamesmanship. The USPTO’s proposed rule would have allowed challengers to invalidate entire patent groups by striking one claim of one patent in the group. Though the proposal ultimately failed for reasons explored in this Note, it did seek to address the seemingly growing threat of dense patent thickets. This Note suggests two alternative solutions: adopting an improvement patent model and banning direct-to-consumer (DTC) pharmaceutical advertising. The improvement patent model would require inventors who apply for minor improvements to their original invention to relinquish exclusivity over the prior invention to allow competitors to practice the patented material. A ban on DTC advertising would decrease the financial incentive brand-name manufacturers have to extend their monopolies by decreasing the often artificial demand for their products.

Recommended Citation

Elizabeth Hertzberg, Double Dosing: How Brand-Name Pharmaceutical Manufacturers Manipulate Patent Rules to Extend Market Exclusivity, 82 Wash. & Lee L. Rev. 1521 (2025).
Available at: https://scholarlycommons.law.wlu.edu/wlulr/vol82/iss4/8