FDA Law for IP Lawyers

IP Lawyers who work in the life science space frequently encounter issues related to the U.S. Food and Drug Administration's (FDA's) regulation of medical and consumer products. Examples include patent term extension applications, new product applications submitted in discovery related to patent litigation, listing patents in FDA's Orange Book and related exclusivity questions for product life cycle management, patent exchanges in biosimilar litigation, FDA's product name reviews for proprietary names protected by trademarks, and using patent information in FDA regulatory filings and vice versa, and related issues arising in patent litigation involving pharmaceuticals. The program includes lawyers who have worked at FDA in various legal capacities, in-house attorneys involved in technology transfer for FDA-regulated products with related licensing, compliance, and trademark responsibilities, as well as FDA lawyers working in IP firms or handling IP-related issues in FDA practices, and IP lawyers working with life science companies. In this program, the speakers will provide practical tips for integrating FDA regulatory law into IP law practices for FDA-regulated products and hopes that this program will be the springboard for future more in-depth FDA legal topics relevant to IP lawyers.

Speakers

Sara Koblitz, Esq., Hyman, Phelps & McNamara, P.C.

Janet B. Linn, Esq., Tarter Krinsky & Drogin LLP

Brian Malkin, Esq., Arent Fox LLP