Biologics Ethics Module: Understanding the Duties of Disclosure and Reasonable Inquiry

June 28, 2023 3:30pm

Josie Young
Groombridge, Wu, Baughman & Stone LLP

Kevin E. Noonan
McDonnell Boehnen Hulbert & Berghoff LLP

  • Revisiting the duties of disclosure and reasonable inquiry
    • Appreciating how inequitable conduct was found in Belcher Pharmaceuticals v. Hospira; Bruno Independent Living v. Acorn Mobility, and GS Cleantech Corp. v. Adkins Energy LLC
    • Formulating new strategies for timing USPTO and FDA submissions
  • Addressing Congress’s request for more transparency between the USPTO and the FDA
  • When will false or misleading communications about biosimilars amount to anticompetitive practices?
  • What constitutes acceptable access to samples of the reference product needed by the biosimilar?