Hatch-Waxman 101 for the Emerging Life Science Company

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 .. Read more 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.