ODA and GAIN: The Key to Promoting Innovation


  • Tej Singh


Medicine has greatly advanced in recent decades, but has it reached its peak? With increasing costs for getting the Federal Drug Administration’s (“FDA”) approval and for performing clinical trials, pharmaceutical companies and drug companies are hesitant to research and develop drugs that do not have a significant market despite protections offered through patents. For example, companies are more reluctant to research and develop drugs for rare diseases and drugs for antibiotic-resistant strains of microorganisms as there is not enough demand for such drugs, even if the drug is able to obtain a patent. Pharmaceutical drug developers rely strongly on the patent system and regulatory incentives in developing drugs. The patent system, for example, allows the drug developer to control the market for a certain period of time so that it can recover its drug development costs and get rewarded for its innovative efforts. Because drugs for rare diseases and antibiotic resistant strains of pathogens have such a small market and affect a limited number of people, pharmaceutical developers often lack incentives to research and develop such drugs. However, regulations such as the Orphan Drug Act (“ODA”) and Generating Antibiotic Incentives Now (“GAIN”) Act attempt to provide incentives to pharmaceutical developers for rare diseases, also called orphan diseases, and antibiotic resistant ailments. However, are these incentives enough? Is the current patent system still working for all pharmaceuticals? This paper seeks to address these questions and other issues concerning the pharmaceutical industry and its relationship to the patent system, specifically related to the Orphan Drug Act and Generating Antibiotic Incentives Now.


Author Biography

Tej Singh

JD, University of San Diego School of Law