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 will discuss pre-litigation considerations, including Orange Book patent listing, the interplay between patent and regulatory exclusivities, and pre-suit due diligence activities. We will 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.
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For more information, please email Jess Karas.