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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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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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Fish & Richardson Principals Juanita Brooks and Betsy Flanagan Named to 2020 “Top 250 Women in Litigation” List by Benchmark Litigation
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June 22, 2020
FDA Seeks to Modernize the Orange Book
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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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May 22, 2020
Fish Attorneys Author Law360 Article, "How Pandemic-Related Delays Affect Hatch-Waxman Litigants"
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February 11, 2020
Fish Named Law360 Life Sciences Practice Group of the Year
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January 14, 2020
Fish & Richardson Named Law360 Life Sciences and International Trade Practice Group of the Year
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December 18, 2019
Fish & Richardson is the U.S. Patent Elite’s Top Law Firm for Litigation Over the Past Decade
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October 2, 2019
Fish & Richardson Receives Top Firm Rankings from LMG Life Sciences in Four Practice Areas
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