The rapid growth of generic drug companies has instigated increased enforcement and litigation activities in the pharmaceutical industry, further complicating the nature of the Hatch-Waxman Act and posing more risks of infringement.

Because of this, the Congress continues to strengthen its efforts in facilitating the regulatory approval of generic pharmaceuticals. Similarly, drug companies need to be well-versed with all legislative process as well as anticipated policy changes surrounding this area of law. Preparing a comprehensive monitoring plan is also important to navigate the emerging developments.

In this LIVE Webcast, a panel of key thought leaders and practitioners will offer a discussion of the latest developments as well as critical issues surrounding the Hatch-Waxman Act. This interactive course will provide helpful insights to help your company deal with patent challenges.

Key topics include:

  • Hatch-Waxman Act: Legal Overview
  • Emerging Legal Issues
  • Regulatory Strategies for Patent Challenges
  • Recent Notable Cases
  • An Outlook of What’s Ahead


Course Level:




Print and review course materials


Method of Presentation:

Live Webcast



General knowledge of Hatch-Waxman Act


Course Code:



NY Category of CLE Credit:

Areas of Professional Practice


Total Credit:

1.0 CLE

Speaker Panel:

Giancarlo Scaccia, Associate
Greenberg Traurig LLP

Giancarlo Scaccia is an associate in Greenberg Traurig’s Intellectual Property Practice. Giancarlo has wide-ranging litigation and trial experience across diverse industries, but focuses his practice on pharmaceutical patent litigation, including ANDA/Hatch-Waxman matters. Giancarlo also represents clients in post-grant proceedings and due diligence investigations. While in law school, Giancarlo clerked as an Alexander Fellow with the Honorable Susan D. Wigenton in the U.S. District Court for the District of New Jersey.

John Claud, Assistant Director, Consumer Protection Branch
U.S. Department of Justice

John Claud is an Assistant Director at the Consumer Protection Branch of the U.S. Department of Justice. He has litigated numerous civil and criminal matters relating to violations of the Food, Drug, and Cosmetic Act and other statutes, and is the coordinator of CPB’s national oversight of FDCA criminal cases. Before joining DOJ, John was an associate at Cadwalader, Wickersham & Taft. He started his career as an Assistant District Attorney in the Manhattan D.A.’s Office. John is a graduate of Trinity College (Ct.), holds a master’s degree from the University of Colorado, and is a cum laude graduate of the Catholic University of America Columbus School of Law.


Date & Time:

Thursday, March 03, 2022

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

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


Coming Soon.

Please check back again later.

Who Should Attend:

  • Patent Attorneys
  • Pharmaceutical Industry Lawyers
  • Patent Licensing Attorneys
  • FDA Attorneys
  • In-House Counsel
  • General Counsel


Giancarlo ScacciaAssociate
Greenberg Traurig LLP
John ClaudAssistant Director, Consumer Protection Branch
U.S. Department of Justice



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