Pharmaceutical products present special challenges for companies and their multidisciplinary teams composed of business managers, scientists, attorneys, regulatory experts, and others. The reason for these challenges is that pharmaceuticals, unlike most other chemical products, sit at the intersection of patent and regulatory law. In this webinar Dr. Anthony Sabatelli, head of Dilworth IP’s Pharmaceutical and Biotech Patent Practice, will provide a basic introduction to the applicable patent and regulatory laws, focusing on their interplay over the product life cycle of a pharmaceutical product, from its inception in the lab, through R&D, human clinical testing, marketing, and eventual generic competition. Concepts such as patent term extension (35 USC 156), and the regulatory and market exclusivity periods granted upon approval of a NDA (21 USC 355) will be discussed. An example of a timeline for a pharmaceutical product will be presented to illustrate the fascinating interplay of these concepts and their importance for those multidisciplinary teams needing to make high stakes business decisions.
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About the Panelist
Dr. Anthony Sabatelli is a registered patent attorney and partner at Dilworth IP where he chairs the firm’s Pharmaceutical and Biotech group. Prior to joining Dilworth, Dr. Sabatelli was Vice President and in-house counsel at Rib-X Pharmaceuticals, Inc. (now Melinta Therapeutics, Inc.) and a member of their senior leadership team. Dr. Sabatelli held previous patent counsel positions at both Merck and at Procter & Gamble, where he originally began his career as a research chemist. He received his PhD in organic chemistry from Yale University and his JD degree from Salmon P. Chase College of Law. Dr. Sabatelli is an adjunct professor at the University of New Haven and an inventor on over a dozen patents.