Orphan Business Models: Toward a New Form of Intellectual Property
Vol. 124 No. 6
Drug companies will often have insufficient incentives to undertake clinical testing on drugs ineligible for patent protection. The Orphan Drug Act combats this problem by providing a limited term of exclusivity to companies willing to shepherd a drug through FDA approval. This strategy is a form of intellectual property protection that might be applicable in many contexts beyond drugs, but the literature has not previously addressed the design and potential scope of such protection