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Hatch-Waxman

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For more than a century, Fish has helped life sciences companies through waves of change within their industries by providing comprehensive advice and guidance to protect proactively their intellectual property and other assets.

Our practice includes Hatch-Waxman and other patent litigation for leading pharmaceutical companies, appellate victories that have had broad-ranging impact on the development of patent law, and several of the most significant patent cases of the past decade.

When representing innovator drug companies, we pursue multiple strategies to maximize returns on our clients’ investments during market exclusivity periods.

We do this by taking an interdisciplinary approach— ensuring that all scientific issues are understood fully throughout the product development and protection process. From the earliest stages of Hatch-Waxman litigation, we bring together the best team within the ranks of our firm to strategize the best course of action that will achieve our clients’ objectives.

This fully integrated approach—everything from pre-suit investigations to PTO actions, Orange Book tactics, Title I strategies of the Hatch-Waxman Act, ANDA filings (especially certification requirements pursuant to Paragraph IV), and FDA affairs—has proven invaluable to our clients in pharmaceutical litigation. Hatch-Waxman may be the door to the courthouse, but once in front of a judge or jury, you must still litigate the underlying science, and it is there that the Fish differential becomes evident.

We consistently deploy legal strategies and tactics that leverage our intellectual property, litigation, regulatory practices and technical expertise to achieve results for our pharmaceutical and life sciences clients. See below for our most recent client representation in the Hatch-Waxman industry.

Learn more about our experience in the life sciences industry.

 



Hatch-Waxman Minute: Part 1

"You've been handed a Paragraph IV letter, now what?"

Hatch-Waxman Minute: Part 2

"Retaining documents once the Paragraph IV letter is received"

Hatch-Waxman Series

Hatch-Waxman Minute
Parts 3-7

Highlights

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Fish Litigation
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May 22, 2018
Fish & Richardson Receives Top “Band 1” National Rankings for Intellectual Property and ITC Practices in Chambers USA 2018
Press Release
Fish Litigation Blog
March 6, 2018
Law360: Searching For 'Act Of Infringement' Under Hatch-Waxman
<i>Law360:</i> Searching For 'Act Of Infringement' Under Hatch-Waxman
Authors: Brian D. Coggio, Ron Vogel
IP Litigation
Life Sciences
News
January 18, 2018
Fish & Richardson Named Law360 Life Sciences Practice Group of the Year
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News
October 13, 2017
11 Fish & Richardson Principals Named 2017 "Life Sciences Stars" by LMG Life Sciences
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Fish Litigation Blog
October 9, 2017
Venue Over An ANDA Defendant: D. Del. Weighs In
Venue Over An ANDA Defendant: D. Del. Weighs In
Author: Kelly Allenspach Del Dotto
Life Sciences
News
October 3, 2017
High-Stakes Gilead Case Lands Fish & Richardson Principals Juanita Brooks and Jon Singer on The Recorder’s List of Litigation Game Changers
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Fish Litigation Blog
September 20, 2017
Law360: A Review Of Willfulness Findings In Hatch-Waxman Actions
<i>Law360</i>: A Review Of Willfulness Findings In Hatch-Waxman Actions
Authors: Brian D. Coggio, Ron Vogel
IP Litigation
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September 19, 2017
Fish & Richardson Named 2017 General Patent Litigation Firm of the Year, Inter Partes Review Firm of the Year, and IP Boutique Firm of the Year by LMG Life Sciences
Press Release
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August 10, 2017
Susan Morrison Named 2017 “Woman Worth Watching in STEM” by Profiles in Diversity Journal
Media Mention
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May 3, 2017
Two Fish & Richardson Attorneys Named to "2017 Best Attorneys" List
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April 3, 2017
Q&A with Susan Morrison: Patent Lawyer and Scientist Inspiring Women in STEM
Q&A with Susan Morrison
Author: Susan Morrison (Coletti)
Hatch-Waxman
Litigation
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March 31, 2017
A Big Year Is Expected in Life Sciences Patent Litigation
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