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Hatch-Waxman

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Litigation

Post-Grant

Prosecution & Counseling

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

Related Pages

Litigation Blog
Litigation

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Fish Litigation Blog
November 13, 2020
Federal Circuit Panel Holds Hatch-Waxman Venue Under the Second Prong of § 1400(b) is Based on Actions Related to ANDA Submission
Authors: James Yang, Geoffrey D. Biegler
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November 10, 2020
Legal Alert: New Hatch-Waxman-Style Patent Law Formally Adopted by China’s National People’s Congress; to Take Effect June 1, 2021
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September 30, 2020
Christopher Green Named a 2020 “Georgia Trailblazer” by the Daily Report
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September 29, 2020
Fish & Richardson Receives Top Firm Rankings and 14 Principals Named 2020 “Life Sciences Stars” by LMG Life Sciences
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September 24, 2020
Fish & Richardson Named 2020 Intellectual Property Boutique Firm of the Year by LMG Life Sciences; Wins Patent Impact Case of the Year
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August 25, 2020
Geoff Biegler and Chad Shear Author The Recorder Article, "Hatch-Waxman Success: Start the Invention Story at the Beginning"
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August 12, 2020
Chad Shear Quoted in Managing Intellectual Property Article
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August 11, 2020
Fish & Richardson Featured in Nine Categories of the LMG Life Sciences Awards 2020 Shortlists
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August 10, 2020
Four Fish & Richardson Principals Named 2020 “Women Worth Watching in STEM” by Profiles in Diversity Journal
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August 7, 2020
Fish & Richardson Principals Juanita Brooks and Betsy Flanagan Named to 2020 “Top 250 Women in Litigation” List by Benchmark Litigation
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Fish Litigation Blog
June 22, 2020
FDA Seeks to Modernize the Orange Book
Authors: Cheryl Wang, Megan A. Chacon, Geoffrey D. Biegler
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June 4, 2020
Generic Drug Labeling and Induced Patent Infringement
Authors: Karrie Wheatley, Ph.D., Brian D. Coggio, Geoffrey D. Biegler
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