Broadcast Date: Monday, December 18, 2023
from 12:00 pm to 1:30 pm (ET)
Overview:
The pharmaceutical labeling carve-out regulations remain a source of complexity in several cases. The Hatch-Waxman Act created a way for the Food and Drug Administration (FDA) to approve generic drugs even if they omit information about protected use to encourage competition among generic products. However, following the Teva v. GSK ruling, businesses must exercise caution and recognize the intricate relationship between Orange Book listed use patents, reference listed drug’s prescribing information, and promotional labeling and other related activities.
Furthermore, as other skinny-labeling-related cases continue to emerge which emphasize the need for legal professionals, businesses and other practitioners to remain up to date with recent developments to successfully navigate this area of law.
Join distinguished experts Jason A. Lief (Windels Marx) and Ha Kung Wong (Venable LLP) for an in-depth discussion on the latest developments impacting Hatch-Waxman litigation. The speakers will share valuable insights, including practical advice and strategies, to help navigate the dynamic legal landscape in this field.
Key topics include:
- Hatch-Waxman Act: Latest Issues and Challenges
- Examining the Pharmaceutical Labeling Carve-Out Regulations
- Analyzing The implications of the Teva v. GSK ruling
- Other Skinny-Labeling-Related Cases
- Practical Tips and Compliance Strategies
- What Lies Ahead
Credit:
Course Level:
Intermediate
Advance Preparation:
Print and review course materials
Method of Presentation:
On-Demand Webcast
Prerequisite:
General knowledge of the Hatch-Waxman Act
Course Code:
1410857
NY Category of CLE Credit:
Areas of Professional Practice
Total Credits:
1.5 CLE
How to Claim CLE Credits Per State:
https://knowledgewebcasts.com/how-to-claim-cle-credits-per-state/
CLE State Requirements:
https://knowledgewebcasts.com/cle-state-requirements/
CPE State Requirements:
Speaker Panel:
Ha Kung Wong, Partner
Venable LLP
Ha Kung Wong practices general intellectual property (IP) law with an emphasis on complex patent and trade secret litigation, as well as IP transactions and contract negotiations for mergers, acquisitions, vendor agreements, and collaborations in pharmaceuticals, biologics, chemistry, medical devices, digital health, and artificial intelligence. Cases Ha Kung has litigated include those related to proton pump inhibitors, anti-epileptic drugs, anti-tussives, ADHD medications, injectable microspheres, RNAi products, antibiotics, and other pharmaceuticals. Ha Kung also has extensive experience with inter partes review, post-grant review, IP counseling, pre-suit investigations, licensing, and due diligence, including patent strength and freedom-to-operate analyses.
Jason A. Lief, Partner
Windels Marx
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.
Agenda:
Segment 1
Ha Kung Wong, Partner
Venable LLP
- Impact of Skinny Labels/Carve-Outs on Hatch-Waxman Litigation
- Inflation Reduction Act Impact on Hatch-Waxman Litigation & Settlement
- Inter Partes Review and Post Grant Review Impact (including Statistics) on Orange Book Listed Patents
Segment 2
Jason A. Lief, Partner
Windels Marx
- Experts – Practice Tips on Selection and Use in Hatch Waxman Cases
- Qui Tam Case
- FTC and Orange Book
Date & Time:
Monday, December 18, 2023
12:00 pm to 1:30 pm (ET)
Who Should Attend:
- Patent and Intellectual Property Lawyers
- Biotechnology Lawyers
- FDA Lawyers
- Patent Agents
- Patent Professionals from Pharmaceutical/Drug Manufacturing
- Pharmaceutical Executives
- Generic Drug Manufacturers
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