Patent term extension strategies in the pharmaceutical industry

Article type: Research Article

Authors: Bhat, Vasanthakumar N.

Affiliations: Lubin School of Business, Pace University, New York, NY, USA

Abstract: The purpose of this paper is to discuss patent term extension strategies for pharmaceutical companies in the United States. Market exclusivity acquired through patents can yield higher prices and profits for pharmaceutical products. Therefore, pharmaceutical companies use a variety of strategies to increase market exclusivity of their products. Some of the strategies discussed in this paper include one-year extension of time to file for patent under the Paris convention, patent term restoration allowed by the Waxman-Hatch Act, orphan drug exclusivity, pediatric exclusivity, the 30-month stay provision and so on. Even though, the strategies discussed in this paper are for the United States, they may be applicable to most European countries, Australia, New Zealand, Japan, and Canada with minor modifications as similar pharmaceutical regulations exist in these countries.

Keywords: patents, generics, pharmaceuticals, market exclusivity, Paris convention

Journal: Pharmaceuticals, Policy and Law, vol. 6, no. 0, pp. 109-122, 2005