Patents and the Pharmaceutical Industry: Curbing the Abusive Practices Employed by Blockbuster Drug Companies to Prolong Market Exclusivity

Authors

Kelley Chandler, J.D., Cornell Law School, 2020

Keywords

Hatch-Waxman Act, Evergreening, Product Hopping, Pharmaceutical patents, Patent law

Abstract

Patent law in the pharmaceutical space presents unique challenges. Interactions between patent terms, the FDA, the drug development process, and the need for quality medical solutions create a complex dynamic which leads to uncertainty. This uncertainty makes it difficult to discern between solutions which might be effective, and solutions which will spawn new challenges where they so intently sought to eliminate old ones. Although Hatch-Waxman was a success in many ways, in other ways it has proven to frustrate the purposes behind its enactment. The suggestions presented here are a sound starting point for alleviating some of the burden plaguing the pharmaceutical market due to the misuse and misapplication of the patent laws. While there is no simple way forward, "it is imperative that the law regulating pharmaceuticals be vigilantly analyzed." It can "literally be a matter of life and death."

Recommended Citation

Chandler, Kelley (2019) "Patents and the Pharmaceutical Industry: Curbing the Abusive Practices Employed by Blockbuster Drug Companies to Prolong Market Exclusivity," Cornell Journal of Law and Public Policy: Vol. 29: Iss. 2, Article 5.
Available at: https://scholarship.law.cornell.edu/cjlpp/vol29/iss2/5