Upcoming Free Webinar on Patent and Regulatory Issues for Pharmaceuticals
Dr. Anthony Sabatelli, head of Dilworth IP’s Pharmaceutical and Biotech Patent Practice, will be hosting the second of this year’s Dilworth IP Webinar Seminars. This session, entitled At the Intersection of Patent and Regulatory Law – Navigating the Challenges for Pharmaceuticals, will address the special challenges pharmaceutical products present for companies and their multidisciplinary teams. These challenges exist because pharmaceuticals, unlike most other chemical products, sit at the intersection of patent and regulatory law. In this webinar, Dr. Sabatelli 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.