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.

Key topics discussed:

• Introduction to the Hatch-Waxman Act
• Exclusivity Incentives Under Hatch-Waxman
• Patent Certification and Litigation
• Case Studies: Teva v. GSK and Amarin v. Hikma
• FTC’s Role in Orange Book Listings
• Impact of the Inflation Reduction Act