CRA is a proud sponsor of the conference focusing on the intersection of intellectual property and the biopharmaceutical industry, and will explore the law, politics, and business of life sciences.
Sean Sheridan is a speaker during the session titled “Biopharma Patent Litigation Updates: Hatch-Waxman, BPCIA, and Beyond.”
The pharmaceutical patent litigation landscape continues to evolve, with court decisions and regulatory actions shaping strategies for both brand and generic companies. This panel will provide an up-to-the-minute review of critical developments, including Orange Book disputes and Hatch-Waxman litigation for small molecules—highlighting cases including Teva v. Amneal and recent FTC enforcement trends. Panelists will also examine Purple Book litigation under the BPCIA for biologics, with attention to proposed reforms such as the Affordable Prescriptions for Patients Act and ETHIC Act. The discussion will also address the scope of the safe harbor for generics to avoid infringement liability, including examination of the decision in Jazz v. Avadel, ongoing debates over “skinny labels,” and legislative efforts like the Big Savings Act and Prompt Approval of Safe Generic Drugs Act. Finally, the panel will explore new restrictions on “pay-for-delay” and other settlement arrangements under measures such as the Preserve Access to Affordable Generics & Biosimilars Act. Attendees will leave with a clear understanding of the latest legal and policy shifts—and what they mean for pharma IP litigation strategies going forward.
For more information on this event, click here.