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