Navigating Hatch-Waxman and Biologic Litigation Amid the Coronavirus Pandemic

The Coronavirus pandemic is presenting unprecedented challenges to individuals and businesses around the world. Nevertheless, the essential business of making the world’s medicines continues. So too the litigation that is critical to the pharmaceutical industry’s pipelines. Several of Goodwin’s experts will discuss how courts and litigants have begun to address litigation in the current environment and issues both innovators and generic/biosimilar manufacturers need to consider as the industry enters uncharted waters.

Topics will include:

• Latest observations on the progress and scheduling of litigations in popular Hatch-Waxman and BPCIA venues like the Districts of Delaware and New Jersey;
• Possible effects on FDA reviews of pending and future submissions;
• Application of 30 month stays, 45 day complaint deadlines, exclusivity periods and patent dance exchange requirements;
• Impact of recent legislation and regulatory activity upon deadlines before the PTO and PTAB.

Goodwin's Elaine Blais, Srikanth Reddy and Daryl Wiesen will be panelists. 

CLE Credit Pending