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Hatch-Waxman

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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

Related Pages

Litigation Blog
Litigation

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March 31, 2022
Fish Attorneys Author IP Litigator Article, "Regenxbio v. Sarepta: Make Sure You’re Safely Within the Safe Harbor Before Using a 'Research Tool'"
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April 14th, 2022 | 1:30 pm EDT
Webinar | Viewing the Orange Book Under a Microscope: The Regulatory Framework & its Implications for Branded Drug Makers
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March 8, 2022
Orange Book 101
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January 20, 2022
Jenny Shmuel Named “Up and Coming Lawyer” by Massachusetts Lawyers Weekly
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REGENXBIO v. SAREPTA: Make Sure You’re Safely Within the Safe Harbor Before Using a “Research Tool”
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December 22, 2021
Fish Principal Chad Shear Authors Article for Life Sciences IP Review, "A Guide for Life Sciences Entrepreneurs"
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December 9th, 2021 | 1:30 pm EST
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November 9, 2021
Federal Circuit Clarifies Venue in Hatch-Waxman Actions in Celgene v. Mylan
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September 23, 2021
Fish Named “Intellectual Property Boutique Firm of the Year” by LMG Life Sciences
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September 3, 2021
Life Sciences Entrepreneur Sourcebook | Intellectual Property: What It Is and Why You Should Care
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September 13th, 2021 | 11:55 am EDT
Momentum: The Drug Patent Challenge Strategy Summit - Paragraph IV, Hatch-Waxman
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June 4, 2021
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