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.
Daniel Hoppe
Aaron Clay
Sophie Wang
Sophie Wang is a Partner in Litigation and is Co-Head of the IP Litigation practice. She is a first-chair trial lawyer who represents biotech, pharmaceutical, and technology companies in complex and high stakes intellectual property and commercial disputes across the country. Sophie is a go-to resource for clients in the life sciences industry, including for “bet-the-company” patent litigation (including Hatch-Waxman and biosimilar litigation), post-grant review (PGR) and inter partes review (IPR) proceedings before the United States Patent Trial and Appeal Board (PTAB), trade secrets litigation, and contract, licensing, and other commercial disputes. She also routinely advises clients on the management of their US and global patent and litigation strategies, including regularly consulting with counsel before the EPO and in the UK, Germany, and other foreign jurisdictions.