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Hatch Waxman Litigation

(349 reviews)

Produced on October 25, 2016

$ 99 Intellectual Property and Patent In Stock
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Course Information

Time 1h 30m
Difficulty Intermediate
Topics covered in this course: Intellectual Property Patent

Course Description

The Hatch-Waxman Act, formally, the Drug Price Competition and Patent Term Restoration Act of 1984, P.L. 98-417, provides an expedited process for generic drug approval and has successfully created a strong and vibrant generic drug industry. Join Fitzpatrick Partner Ha Kung Wong and Fitzpatrick Of Counsel John Kirkland as they walk through the intricacies of the Act, discuss industry trends and the development of the law regarding induced infringement. Mr. Wong and Mr. Kirkland also explore how the Leahy-Smith America Invents Act (AIA), signed into law in 2011, has impacted Hatch-Waxman litigation.

Learning Objectives:

  1. Understand the Hatch-Waxman Act, including: Generic approval process; exclusivities available for brand and generic drugs; certifications available to generic drug applications; forfeiture of generic exclusivities; patent term extension; and framework for litigation
  2. Comprehend the intricacies of induced infringement
  3. Discuss the AIA and Hatch-Waxman litigation
  4. Gain best practices and tips

Credit Information

After completing this course, Lawline will report your attendance information to {{ accredMasterState.state.name }}. Please ensure your license number is filled out in your profile to ensure timely reporting. For more information, see our {{ accredMasterState.state.name }} CLE Requirements page . After completing this course, {{ accredMasterState.state.name }} attorneys self-report their attendance and CLE compliance. For more information on how to report your CLE courses, see our {{ accredMasterState.state.name }} CLE Requirements FAQ .


Ha Kung Wong

Venable LLP

Ha Kung Wong practices general intellectual property law with an emphasis on complex patent and trade secret litigation in pharmaceuticals, biologics and chemistry. Cases Ha Kung has litigated include those related to proton pump inhibitors, anti-epileptic drugs, anti-tussives, psychotropic agents, siRNA and other pharmaceuticals. Mr. Wong also has extensive experience with inter partes review (IPR), post grant review (PGR), intellectual property counseling, pre-suit investigations, licensing and due diligence.

Mr. Wong is the recipient of the 2017 ILO Client Choice Individual Award for Intellectual Property in New York, was named to The National Law Journal’s 2017 inaugural list of Elite Boutique Trailblazers and was recognized as a 2018 LMG Life Sciences Star. He serves as faculty for NITA (the National Institute of Trial Advocacy) and Lawline, and has been named a Furthered 40 by Lawline for his contributions. He is also an Advisory Board Member for The Center for Biosimilars.

John W. Kirkland

Alkermes, Inc.

John Kirkland is Director of Intellectual Property at Alkermes, Inc. in Waltham, Massachusetts. At Alkermes, Mr. Kirkland has responsibility for all aspects of U.S. patent disputes, in both judicial and administrative tribunals. Prior to joining Alkermes, Mr. Kirkland was Counsel at Fitzpatrick, Cella, Harper & Scinto, where he advised clients in all aspects of intellectual property matters, including disputes arising under the Hatch Waxman Act. 


Ariela Y.

Amazing! I love these two speakers.

James A.

Very enjoyable. Mixed Hatch Waxman and other approaches to give a very complete picture.

Stephanie S.

excellent presenters

Lawrence B.

Best presenters out of all of my online courses over the past years. Hire these guys full time. Good work!

Robert H.

First CLE I have watched this year that was entertaining and provided informational material.

Regan M.

These guys are my favorite! Keep them coming back. Their humor keeps me interested

Susan T.

Presenters made this seminar enjoyable

James B.

It was nice that the presenters tried to inject some humor.

catherine m.


Valerie N.

This was a great presentation -- well organized, informative, and fun to listen to. Thank you!

Julie A. B.

Pleasant, easy-to-understand, enjoyable program. Effective and effortless use of humor moves the dialogue along.

Donna A.

Great program

Tom H.

Great use of humor and general back and forth dialogue between the two presenters to help make a potentially dry topic interesting

Amanda A.

I liked the humor component of this presentation.

Nina S.

Very entertaining and informative! Thanks!

Jeffrey W.

Thank you, informative (and entertaining!)

Colleen K.

These presenters are amazing - makes it very easy to listen to somewhat technical information.

Michael G.

Great Speakers!

Jill W.

Entertaining & informative!! These guys should do more CLE's!!!

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