This seminar will consider the ways in which different legal regimes and agencies shape innovation in the biopharmaceutical sector, broadly understood to include therapeutic drugs, medical devices, and combination products such as GLP-1 injectors like Ozempic. Through readings comprised of scholarly articles, policy documents, and book excerpts, we will explore how various bodies of law—including patent, FDA, consumer protection, and antitrust—each influence the development of biopharmaceuticals. We will consider what constitutes meaningful innovation in the biopharmaceutical sector. We will study both moments when these systems operate in silos and when they collide, and consider how those dynamics affect innovation in the biopharmaceutical space.
Class discussions will evaluate the strengths and weaknesses of different institutional approaches and explore what kinds of structures best promote innovation. The course will also draw on select current events as case studies to illustrate the opportunities and challenges that arise when multiple institutions and domains regulate innovation simultaneously. Throughout the semester, students shall engage in theoretical, economic, and policy analysis.
Students will complete a final research paper on a topic agreed upon by the student and instructor. Class time will also be devoted to instructor-student meetings on paper development as well as to student paper presentations. No science background is necessary. There are no prerequisites.
Mehta, Prachi 