You are invited to join us at the Food and Drug Law Journal 2022 Symposium – a virtual event. George O’Brien, partner in Mayer Brown’s Life Science Industry Group, will discuss his forthcoming paper “FDA and the PTO: Is There a Role Beyond ‘Ministerial’ for FDA in Administering the Orange Book and other Aspects of the Hatch-Waxman Patent Regime?” on November 3rd.

The panel will address:

  • The implications of recent correspondence between FDA and the PTO addressing impacts of patents on competition;
  • Use Codes, Section viii statements and labeling carve outs, and the potential impact of the GSK v. Teva decision;
  • Recent litigation regarding the listing of certain medical device and REMS patents, and FDA’s response; and
  • Novel issues related to patent term extension that are awaiting FDA decisions.

The panel will be held virtually on Thursday, November 3, 2022
11:20 a.m. –12:35 p.m. EDT

To learn more and to register, please visit the event webpage.