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Hatch-Waxman Image

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

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October 2, 2019
Fish & Richardson Receives Top Firm Rankings from LMG Life Sciences in Four Practice Areas
Press Release
News
September 6, 2019
Fish & Richardson Principal Susan Morrison Named 2019 “40 Under 40” Honoree by Delaware Business Times
Press Release
News
September 3, 2019
Brian Coggio Authors Article in Law360, “A District Court Split On Hatch-Waxman Venue Determinations”
Articles
News
May 21, 2019
Fish & Richardson Receives Top “Band 1” National Rankings for Intellectual Property and ITC Practices in Chambers USA 2019
Press Release
News
May 20, 2019
Fish & Richardson Attorneys Danielle (DJ) Healey and Dr. Tasha Francis Honored as “Influential Women in IP” by World Intellectual Property Review
Press Release
Fish Litigation Blog
May 3, 2019
Venue in Hatch-Waxman Actions is Governed by 28 U.S.C. § 1400(b) Not § 1391(b)
Author: Brian D. Coggio
IP Litigation
Life Sciences
News
March 4, 2019
Fish & Richardson Principal Chad Shear Named to “Intellectual Property Trailblazers” List by The National Law Journal
Press Release
News
January 16, 2019
Fish & Richardson Grows Firm With 14 Associates
Press Release
Fish Litigation Blog
September 11, 2018
Should Stockpiling Be Protected By The Hatch-Waxman Safe Harbor?
Author: Brian D. Coggio
IP Litigation
Life Sciences
News
August 6, 2018
Fish & Richardson Principals Juanita Brooks, Betsy Flanagan and Deanna Reichel Named to 2018 “Top 250 Women in Litigation” List
Press Release
News
August 2, 2018
Fish & Richardson Principal Joseph Warden Named Law360 2018 Life Sciences “Rising Star”
Press Release
News
May 22, 2018
Fish & Richardson Receives Top “Band 1” National Rankings for Intellectual Property and ITC Practices in Chambers USA 2018
Press Release
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