Broadcast Date: Wednesday, May 07, 2025
from 12:00 pm to 1:30 pm (ET)

Overview:

Discover recent developments in Hatch-Waxman litigation with a focus on Orange Book listings and the evolving complexities of patent law’s obviousness standard.

Join Jason A. Lief of Windels Marx Lane & Mittendorf, LLP for actionable insights and expert analysis tailored for legal and regulatory professionals.

 

Key Topics to Be Discussed

  • Orange Book Listings: Recent trends, legal challenges, and compliance strategies
  • Obviousness in Hatch-Waxman Cases
  • FDA’s Role in Hatch-Waxman Disputes
  • Practical Guidance for ANDA Filings
  • Case Law Updates

Credit:

Course Level:

Intermediate

 

Advance Preparation:

Print and review course materials

 

Method of Presentation:

Live Webcast

 

Prerequisite:

General knowledge of the Hatch-Waxman Act

 

Course Code:

1411414

 

Total Credit:

1.5

 

CLE Credits:

CA CLE 1.50 General - Approved Until: 05/07/2027

PA CLE 1.50 General - Approved Until: 05/07/2027

VT CLE 1:50 General - Approved Until: 12/31/2026

NJ CLE 1:50 General - Credits through Reciprocity

NY CLE 1:50 Areas of Professional Practice - Credits through Reciprocity

AR CLE 1:50 General - Credits through Reciprocity

CT CLE 1:50 General - Credits through Reciprocity

NH CLE 1.50 General – Meets the requirements of NH Supreme Court Rule 53

MO CLE 1.50 General - Approved Until: 05/07/2025

 

Pending CLE Application:

GA, TN, WI

 

Self-Apply:

AL, CO, DE, FL, ID, IL, IN, IO, KS, KY, LA, NC, ME, MN, MS, MT, NE, NV, NM, ND, OH, OK, OR, SC, TX, UT, VA, WA, WV, WY

 

If you’d like us to apply for CLE, you may opt to pay the CLE processing fee here.

 

No MCLE Requirements:

DC, MD, MA, MI, SD

 

Not Eligible for CLE:

AK, AZ, HI

Speaker Panel:

Jason A. Lief, Partner 
Windels Marx Lane & Mittendorf, LLP

Jason Lief is a premier patent trial lawyer with 25 years of experience. He has litigated and tried dozens of major patent and other intellectual property cases on behalf of some of the world’s most innovative and dynamic companies, often involving billion dollar products. Applying his legal and scientific training, Jason has established a reputation for winning outcomes and courtroom excellence.

Max H. Yusem, Of Counsel, Litigation Department
Paul Hastings, LLP

Max Yusem is an of counsel in the Litigation practice of Paul Hastings and is based in the firm’s New York office. His practice focuses on complex litigation with an emphasis on intellectual property matters in the fields of pharmaceuticals and biotechnology.

Mr. Yusem has experience litigating cases arising under the Hatch-Waxman Act on behalf of innovator companies and the Biologics Price Competition and Innovation Act (BPCIA). He has represented leading life science companies in high-stakes disputes in district court litigations, patent office proceedings, and arbitrations involving pharmaceutical compounds, formulations, and methods of treatment, which involved a wide variety of therapeutics, covering areas such as cardiovascular, diabetes, oncology, central and peripheral nervous systems, hormone replacement, and hemoglobinopathy.

Mr. Yusem has also consulted and represented clients in numerous other areas including antibody technology, genetic testing, microfluidic devices, and ethanol processing. He received his law degree, with honors, from George Washington University School of Law in 2013, where he served on the George Washington International Law Review. He earned a Bachelor of Arts from the Department of Psychological and Brain Sciences at Johns Hopkins University in 2008. Mr. Yusem is admitted to the New York State Bar.

Agenda:

Jason A. Lief, Partner

Windels Marx Lane & Mittendorf, LLP 

 

Max H. Yusem, Of Counsel, Litigation Department

Paul Hastings, LLP

Date & Time:

Wednesday, May 07, 2025

12:00 pm to 1:30 pm (ET)

A recording will be available to view 24-48 hours after the live date.

Materials:

Coming Soon.

Please check back again later.

Who Should Attend:

  • Intellectual Property Lawyers/Consultants
  • Patent Lawyers
  • Pharmaceutical Industry Lawyers and Executives
  • Regulatory Compliance Officers
  • Healthcare Providers

SPEAKERS

Jason A. LiefPartner 
Windels Marx Lane & Mittendorf, LLP
Max H. YusemOf Counsel, Litigation Department
Paul Hastings, LLP

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