On demand

Life Sciences & Healthcare Innovation Program

Hatch-Waxman 101 for the Emerging Life Science Company

January 27, 2021
Event details
January 27, 2021
3:00 – 4:00 pm Eastern Standard Time

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

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