Green Griffith partners, Chris Griffith and Emer Simic, were featured invitees at the 8th Annual Generic International Summit, in Shanghai on April 19-20, 2018.
(Shanghai) — This year’s Annual Generic International Summit focused on a variety of topics pertinent to international generic pharma companies, including IP and regulatory issues, formulation technology and marketing. Chris presented on the “Interplay Between FDA Exclusivity, PTAB/IPRs and Hatch-Waxman Litigation on the Filing and Approval of 505(b)(2) Applications and ANDAs.” The presentation discussed IP and regulatory issues associated with seeking and obtaining FDA marketing approval for 505(b)(2) NDAs and ANDAs, and provided strategies for success, including whether, when and how to best use the federal courts and/or PTAB (via IPRs) to address obstacles to FDA approval.
