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The USPTO-FDA Collaboration: Laying the Foundation for the Life Sciences Industry and Beyond
November 15, 2022 @ 12:00 pm - 1:00 pm
In 2021, President Biden called for action “to help ensure the patent system, while incentivizing innovation, does not also unjustifiably delay generic drug and biosimilar competition beyond that reasonably contemplated by applicable law.” In response, the USPTO and the FDA have begun an unprecedented collaboration that the USPTO believes will “strengthen our patent system for all technologies.” This webinar will explore the first steps of that collaboration and possible next steps, including:
- The USPTO’s notice on duties of disclosure and reasonable inquiry, particularly with respect to statements made to the FDA.
- The FDA’s (and some senators’) concerns about continuation practice and the USPTO’s request for comments on that issue.
- The role of the PTAB in the collaboration, including the interplay between post grant proceedings at the PTAB and Orange-book listed patents and biologic patents.
- The webinar will include a diverse panel of stakeholders, including Deputy Chief Judge Mike Tierney and Deputy Commissioner Bob Bahr of the USPTO and former FDA Chief Counsel Stacy Amin.
Mike Tierney – Deputy Chief Judge, USPTO
Bob Bahr – Deputy Commissioner, USPTO
Mehran Arjomand – Partner, Morrison Foerster
Stacy Amin – Former FDA Chief Counsel, Partner, Morrison Foerster
Dr. Jean Nguyen – Associate, Morrison Foerster