AIPLA Comments on FDA Public Hearing on Facilitating Competition and Innovation in the Biological Products Workplace

AIPLA requests that before making changes related to the Federal Register Notice and Public Hearing, FDA consider possible implications on intellectual property rights, the patent litigation scheme provided by the Biologics Price Competition and Innovation Act of 2009 (BPCIA), and how that scheme compares with the patent litigation scheme provided by the Drug Price Competition and Patent Term Restoration Act of 1984 (referred to as the Hatch-Waxman Act).

AIPLA also requests that FDA provide detailed notice of any proposed changes related to the Federal Register Notice and Public Hearing and its reasons for proposing those changes, as well as opportunity for meaningful comment from AIPLA and other stakeholders.

Furthermore, taking into account the existing legislations, AIPLA further requests that the FDA undertake an analysis of the implications on intellectual property of any proposed changes that the FDA might implement, and publish the results for further public comments.