Assessing Patent Protections Afforded Under the Safe Harbor Provision
Tuesday, August 19, 2025
Join Kirkland partners Tasha Gerasimow and Joseph Loy, along with Novartis Senior IP Counsel Jessica Lam, to explore patent protections and recent regulatory developments related to the safe harbor of the Hatch-Waxman Act. The safe harbor provision exempts certain uses of patented inventions related to FDA-regulated products from infringement. Our speakers explore the breadth of applicability of the safe harbor provision to numerous products (drugs, biologics, and medical devices) and activities. The program also covers implications for third-party entities (API suppliers, research tool providers) and provides key practice tips to ensure the safe harbor is available. Finally, the program examines recent regulatory developments for laboratory-developed test services likely to be impacted by the safe harbor provision. Don't miss this important program!
Ideal for IP counsel, regulatory teams, and innovators in biotech, pharma, and diagnostics.
You’ll learn how to:
- Apply the Safe Harbor provision to R&D and regulatory activity
- Determine whether research tools or third-party suppliers are protected
- Avoid pitfalls in stockpiling and basic research practices
- Understand the latest court rulings and regulatory developments
- Use best practices to strengthen your legal position
Speakers:
Tasha Gerasimow, Kirkland & Ellis
Jessica Lam, Novartis
Joseph Loy, Kirkland & Ellis
3rd BCLT Advanced Life Sciences Institute Series
Series Info | Resources | 3rd ALSI Subseries
Program Series:
Life sciences technologies continue to develop and evolve, regulatory agencies undergo rapid change, and the practice of life sciences law moves at an ever-increasing pace. To make sure you are up to date, the 3rd BCLT Advanced Life Sciences Institute series is mandatory viewing on key cutting-edge issues impacting your practice.
Disclaimer: All views or opinions expressed by any presenter during the course of this CLE is that of the presenter alone and not an opinion of the Oklahoma Bar Association, the employers, or affiliates of the presenters unless specifically stated. Additionally, any materials, including the legal research, are the product of the individual contributor, not the Oklahoma Bar Association. The Oklahoma Bar Association makes no warranty, express or implied, relating to the accuracy or content of these materials.