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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!
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Previous Program(s)
Assessing Patent Protections Afforded Under the Safe Harbor Provision
BCLT Life Sciences Law & Policy Center
Tuesday, August 19, 2025 | 1:00 p.m. (PT) | B-CLE
0.75 General CLE Credit Available
Recording | 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
Examining Written Description
BCLT Life Sciences Law & Policy Center
Tuesday, August 26, 2025 | 1:00 p.m. (PT) | B-CLE
1.00 General CLE Credit Available
Recording | Resources | Speaker Bios & Contact Info
The written description requirement under 35 U.S.C. § 112 continues to shape the outcome of high-stakes patent litigation. In this engaging and practical session, Kiley White of Tensegrity Law Group unpacks the latest Federal Circuit and district court decisions, highlighting how state of the art knowledge, expert testimony, and claim drafting strategies can make—or break—your case. Whether you represent patentees or challengers, you’ll leave with concrete tools to strengthen your litigation and prosecution approaches.
You’ll learn how to:
- Navigate broad and genus claim challenges
- Use expert testimony effectively without overstepping
- Draft specifications that withstand § 112 scrutiny
Speakers:
Kiley White, Tensegrity Law Group
3rd BCLT Advanced Life Sciences Institute Subseries
Royalty Finance, the UCC and Issues of Recharacterization
Three-Part Virtual Series
Recordings | Subseries Information | Resources
In this three-part virtual series, BCLT & Gibson, Dunn & Crutcher have partnered issues originally raised in a Law 360 article written by Gibson Dunn attorneys, Todd Trattner and Ryan Murr, entitled How Biotech Cos. Can Utilize Synthetic Royalty Financing. Gibson Dunn attorneys explored, in depth, royalty finance, looking at synthetic royalties, the treatment of synthetics under the UCC, and the risks of a sale of a synthetic royalty being recharacterized as a loan in bankruptcy. The aim of this virtual speaker series is to educate biotechnology stake holders (investors, entrepreneurs, companies, and their attorneys) on best practices for monetizing and investing in a synthetic royalty so that they may embark on such transactions with greater certainty.
For anyone with an interest in how modern biotechnology companies raise capital, this series will help you optimize your rights and reduce your risks. Don’t miss it!