Safe Harbor & Bolar Exemption: A Review of Case Law, Regulatory Reform, and Pre-Approval Strategy

With US courts continuing to refine the scope of § 271(e)(1) and the European Pharma Package proposing to extend and reshape Bolar exemptions across member states, this session examines the latest litigation and regulatory developments shaping how life sciences companies structure pre-approval activity on both sides of the Atlantic.

• Examine where the line is currently being drawn under § 271(e)(1), and what recent decisions including Jazz v. Avadel (Fed. Cir. May 2025) and Ascendis v. BioMarin (ITC, ongoing), tell us about the boundaries of protected pre-approval activity.
• How to structure pre-approval activity to make the most of safe harbor protection, and where its limitations continue to drive disputes.
• Discuss the European Pharma Package's proposed extension and reshaping of Bolar exemption means for originator and generic strategy, and how US companies are adapting their pre-approval strategies in response.