Life Sciences & Healthcare Innovation Program
Hatch-Waxman 101 for the Emerging Life Science Company
Event summary
This program is targeted at innovative life science companies that have filed, or will soon file, NDA or 505(b)(2) applications and are anticipating their first Hatch-Waxman litigation. We discuss pre-litigation considerations, including Orange Book patent listing, the interplay between patent and regulatory exclusivities, and pre-suit due diligence activities. We also discuss Hatch-Waxman litigation mechanics, including Notice Letters, 30-month stays of FDA ANDA approval and lawsuit timing.
This webinar is part of our Life Sciences & Healthcare Innovation Program, Cooley’s 14th annual event in conjunction with the J.P. Morgan Healthcare Conference.
For more information, please email Jess Karas.
Related contacts
This content is provided for general informational purposes only, and your access or use of the content does not create an attorney-client relationship between you or your organization and Cooley LLP, Cooley (UK) LLP, or any other affiliated practice or entity (collectively referred to as “Cooley”). By accessing this content, you agree that the information provided does not constitute legal or other professional advice. This content is not a substitute for obtaining legal advice from a qualified attorney licensed in your jurisdiction and you should not act or refrain from acting based on this content. This content may be changed without notice. It is not guaranteed to be complete, correct or up to date, and it may not reflect the most current legal developments. Prior results do not guarantee a similar outcome. Do not send any confidential information to Cooley, as we do not have any duty to keep any information you provide to us confidential. This content may be considered Attorney Advertising and is subject to our legal notices.