Hatch Waxman Litigation

(262 Ratings)

Produced on: October 25, 2016

Course Format On Demand Audio

Taught by


Course Description

Time 90 minutes
Difficulty Intermediate

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


Ha Kung Wong

Fitzpatrick, Cella, Harper & Scinto

Ha Kung Wong practices general intellectual property law with an emphasis on complex patent litigation in pharmaceuticals and chemistry. Cases Mr. Wong has litigated include those related to proton pump inhibitors, anti-epileptic drugs and other pharmaceuticals. 

Representative Experience

·   AstraZeneca against Andrx, Genpharm, Dr. Reddy and Schwartz Pharma on patents relating to omeprazole  and its formulations.

·   Bristol-Myers Squibb against The Regents of the University of Michigan and Repligen Corp. and ZymoGenetics on patents relating to synthetic fusion proteins for regulating the immune system.

·   UCB against Mylan, Dr. Reddy, Sandoz and Cobalt on patents relating to levetiracetam, a leading epilepsy medicine.

·   GlaxoSmithKline against Barr Pharmaceuticals on patents relating to dutasteride, a leading BPH drug.

{C}{C}{C}·   {C}{C}{C}UCB and Celltech against KV Pharmaceutical on patents relating to methylphenidate hydrochloride, an ADHD medicine.


Mr. Wong currently is the Chair of the Recruiting Committee and also serves as faculty for NITA (the National Institute of Trial Advocacy).


J.D. cum laude, Notre Dame Law School, 1999

B.S. Chemistry, High Distinction, B.S. Biochemistry, University of Illinois Urbana-Champaign, 1996

Bar Admissions

State of New York, 2000; U.S. District Courts for the Southern and Eastern Districts of New York, 2001

Professional Activities

American Bar Association; New York Bar Association; New York Patent Law Association; American Chemical Society; New York Intellectual Property Law Association


·   While in law school, Mr. Wong served as Managing Editor for the Journal of Legislation and published, "The Extra in Extradition: Washington v. Pang's Impact on Extraditee Standing and Implicit Waiver," 24 J.Legis 111 (1998).

·   Published, Wong, H. & Lau, D., "Combine and conquer: handling biotech combination inventions in the wake of KSR," Nat. Biotechnol. 27, 446-448 (2009).

·   Published, Wong, H. & Saha, S., "Obvious to Try? The Slippery Slope of Biotechnology," Bloomberg Law Reports, Vol. 4, No. 19, 8-11 (May 10, 2010).

·   Published, Wong, H. & Gupta, V., "Recent legislation impacts development of biologics," Financier Worldwide, (November 2010).

·   Published, Wong, H. & McMahon, D., "Preparing for uncertainties in biosimilars litigation," Financier Worldwide, pg. 37-8 (January 2011).

·    Published, Wong, H., Pierson, R.W., Wang, S., "Trade Secret Law Reform: Could an Amended Economic Espionage Act Overcome Inconsistencies in the Current State Law System?" Bloomberg Law Reports, Intellectual Property, Vol. 6, No. 3, 21-6 (January 17, 2012).

·   Published, Wong, H & Pierson, R.W., "Conducting an IP Audit When Laws Change", New York Law Journal (May 9, 2012)

John W. Kirkland

Fitzpatrick, Cella, Harper & Scinto

Professional Experience

John W. Kirkland’s practice focuses on patent litigation with an emphasis in the chemical, biotechnology and pharmaceutical arts. Prior to law school, Mr. Kirkland was employed by Merck & Co. as a scientist.


While in law school, Mr. Kirkland served as a Notes and Comments Editor of the Arts and Entertainment Law Journal, was a Heyman Scholar and a member of the Intellectual Property Law Students Association.


Awards and Recognition

Mr. Kirkland is listed as a Rising Star in Intellectual Property in the 2014 issue of Super Lawyers: New York Metro Edition.



J.D., Benjamin N. Cardozo School of Law, 2004

B.A., Molecular Biology and Biochemistry, magna cum laude, Phi Beta Kappa, Rutgers University,1998


Bar Admissions

U.S. Patent and Trademark Office, 2003; State of New Jersey, 2004; State of New York, 2005; U.S. District Courts for the Southern and Eastern Districts of New York, 2006


Professional Activities

New York Intellectual Property Law Association


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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