Navigating Exclusivity, Patent Challenges, and Regulatory Nuances
This course provides a comprehensive overview of the Hatch-Waxman Act and its profound impact on the pharmaceutical industry. Participants will gain insights into the balance of interests between generic and innovator drug companies, the intricacies of exclusivity incentives, and the critical legal battles that shape the landscape of drug approvals. Led by expert attorney Sara Koblitz from Hyman Phelps & McNamara P.C., the course delves into recent case studies such as Teva v. GSK and Amarin v. Hikma, exploring their implications for patent litigation and regulatory strategy. Additionally, the course covers the Federal Trade Commission's (FTC) evolving role in challenging Orange Book listings and the potential impacts of the Inflation Reduction Act on Hatch-Waxman litigation.
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Director at Hyman, Phelps & McNamara, P.C.
Sara W. Koblitz advises FDA-regulated clients on a range of issues with a particular focus on Hatch-Waxman patent and exclusivity, biosimilars, and the Orange Book. She helps drug and device manufacturers in various stages of product development and guides clients through the applicable regulatory requirements with respect to applications and submissions, device classification, potential exclusivities, promotional issues, and post-marketing requirements. Ms. Koblitz also counsels cosmetics, food, and dietary supplement clients, with experience regarding genetically modified foods, medical foods, food labeling, and dietary supplement claims and substantiation. Ms. Koblitz has authored several Citizen Petitions and has worked extensively with litigators and experts in preparation for depositions and trials. She has worked with companies of all sizes, from start-ups to Fortune 500 companies. Ms. Koblitz also has experience in export control and other areas of regulatory law. Prior to joining Hyman Phelps & McNamara, Ms. Koblitz practiced at a major intellectual property firm, where she counseled clients on the Hatch-Waxman Act and other areas of FDA regulation. Prior to that, she worked on general FDA regulatory matters at an AmLaw 100 firm. While in law school, Ms. Koblitz clerked at the FDA Office of Policy and the Humane Society of the United States.
