Intellectual property rights

Advanced IP: Innovation & Regulatory Policy for Pharma

Patents, and intellectual property rights more generally, are central features of the “information economy” and pharmaceuticals are widely understood to be the sector for which strong patent protection is most justified as an innovation policy. This topic examines in greater depth than is possible in a general patent or IP survey topic how patents work in their core area of significance. It provides, in other words, an opportunity to engage in an in-depth examination of a fundamental area of legal policy (innovation rules) in a central arena of its operation. Particular attention will be devoted to the following topics: (1) the non-obvious implications for the amount and direction of pharmaceutical innovation of the ways that general patent doctrines map onto the specific technological and economic features of drug innovation; (2) the intersection of patent protection with the regulatory-approval regime of the Food and Drug Administration (FDA); (3) the way FDA rules go beyond regulation directly to impact innovation incentives; (4) how patents/FDA rules combine with other regulatory and market features of the healthcare sector – such as insurance, the role of doctors as intermediaries between firms and the patients, and information asymmetries – to shape how specific ailments are focused on or neglected, how specific treatments are privileged or ignored and how drugs are promoted; (5) the international dimensions of pharmaceutical innovation and patent protection, in particular the role of the foregoing factors in providing challenges and opportunities with respect to the health crisis in the developing world; and (6) proposals for reforms or alternative innovation policies. Grading for the topic will comprise of regular topic participation, 2-3 short response papers (2-pages each) and a choice between a final take-home exam or paper. students and readers of this Legal Encyclopedia may satisfy the writing requirement in this topic.