Foley Partners David Rosen, Jackie Wright Bonilla and Douglas Carsten will present a webcast for FOI Services, Inc., on “The Intersection of Patent & FDA Regulatory Professionals – An Introduction to Patent Law, Patent Litigation & the Interplay with the FDA Regulatory Process and More.” The webcast will take place on Wednesday, February 25, 2009, 12:00 p.m. – 1:30 p.m. CT.
The FDA’s drug approval process has been intertwined and significantly complicated by issues associated with patents, patent litigation and market exclusivity since the passage in 1984 of the Drug Price Competition Act and Patent Term Restoration. When developing and seeking approval for either a brand or a generic product, regulatory professionals need to have a working understanding of the impact of patent law, patent litigation, patent listing requirements for the listing of patents in the FDA’s Approved Drug Products List with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, and market exclusivity upon the approval of their products.
This webcast will explain the basics of obtaining patent protection and how to read an issued patent; provide information on preparing for the rigors of patent litigation; review listed patents and certifying patents to be listed in the Orange Book as well as a discussion on the intersection and impact of patent provisions and market exclusivity on the review and approval of both brand and generic drugs.
