Assessing Patent Protections Afforded Under the Safe Harbor Provision
Topic(s)
Biotechnology and Life Sciences
|
Patent Litigation
|
Patent Prosecution
DESCRIPTION
Assessing Patent Protections Afforded Under the Safe Harbor Provision
3rd BCLT Advanced Life Sciences Institute Series
BCLT Life Sciences Law & Policy Center
Tuesday, August 19, 2025 | 1:00 p.m. | B-CLE
0.75 General CLE Credit Available
Program Info | Resources | Speaker Bios & Contact Info
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.
Catch up on our three-part exploration of royalty financing for life sciences companies, and check out two new program launches: (1) updates on the application of safe harbor provisions and FDA laboratory test regulation, and (2) key developments in the law related to patent disclosure.
The Advanced Life Sciences Institute will be launched virtually through B-CLE. You do not want to miss this special event!
Registration is free and available to all, and CLE will be offered.
Presented by
This course is available to students for free.