AIPLA Comments on FDA Public Hearing on Facilitating Competition and Innovation in the Biological Products Workplace
September 19, 2018
File Downloads
All documents are in PDF format.
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.
Upcoming Events
-
2026 AIPLA Virtual Corporate Practice Institute
January 13 to 20, 2026 | Up to 360 Minutes of CLE
The Corporate Practice Institute is not a bootcamp. This program provides in-depth insight for in-house corporate counsel and agents to learn about wide ranging legal issues affecting their practice from experienced practitioners. It is designed for experienced in-house attorneys and new in-house attorneys learning to manage new corporate environments and challenges not taught in law schools or private practice. The Institute also helps private practice attorneys, especially associates, prepare for potential in-house career moves. The program also provides valuable networking opportunities to connect with each other and learn from each other's experiences. This online, CLE-program spans two half-days, from Noon – 5:00 pm Eastern and includes 3 one-hour education sessions and a networking session each day. -
2026 Trade Secret Summit
March 26 to 27, 2026
The AIPLA Trade Secret Summit is the leading trade secret conference in the nation, with speakers from across the spectrum of private practitioners, in-house counsel, government, and academia, as well as fantastic networking opportunities. CLE credits will be available. -
2026 Spring Meeting - San Francisco, CA
May 13 to 15, 2026
We’re excited to welcome you to the 2026 AIPLA Spring Meeting, where innovation, technology, and intellectual property come together to shape the future. San Francisco is ready for your ideas, energy, and passion for IP! -
AIPLA 2026 Annual Meeting
October 29 to 31, 2026
Join us as we bring IP professionals together to learn and connect. More information coming soon! The 2026 Annual meeting will take place at the Westin Washington, DC, Downtown. Leadership Meetings on Wednesday, October 28. Programming scheduled October 29 - 31. -
2027 Spring Meeting - Denver, CO
May 6 to 8, 2027
We’re excited to welcome you to the 2027 AIPLA Spring Meeting, where innovation, technology, and intellectual property come together to shape the future. Denver is ready for your ideas, energy, and passion for IP!