Credits: 2.0 general credit hours
Description: IP attorneys who work in the life science space frequently encounter issues related to the US 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 product name reviews for proprietary names protected by trademarks, using patent information in FDA regulatory filings and vice versa, and related issues arising in patent litigation involving pharmaceuticals.
The members of our panel for this engaging interactive class have worked at FDA in various legal capacities; served as in-house attorneys involved in technology transfer for FDA-regulated products with related licensing, compliance, and trademark responsibilities; are or were FDA attorneys who have worked in IP firms or handled IP-related issues in FDA practices; and are or have been IP attorneys working with life science companies.
The panel will provide those who attend with practical tips for integrating FDA regulatory law into IP law practices for FDA-regulated products in hope that this class will be the springboard for future more in-depth FDA legal topics relevant to IP lawyers.
Faculty: Sara W. Koblitz, Hyman Phelps & McNamara PC and Brian J. Malkin, Teva Pharmaceuticals
Cosponsor: D.C. Bar Intellectual Property Law Community
Fees: $79 D.C. Bar Intellectual Property Law Community Members, $89 All Other D.C. Bar Communities Members, $99 D.C. Bar Members, $109 Government and Nonprofit Attorneys, and $129 Others
The D.C. Bar CLE Program now offers discounted group registration rates! For more information, contact the CLE Office at CLE@dcbar.org or 202-626-3488.