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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.

Fish has the premier patent litigation practice in the world, handling approximately 100% more patent cases than our nearest competitor. 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.

Learn more about our experience in the life sciences industry.

 

 


Featured Experience


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 Minute: Part 3

"Best practices for analyzing the Paragraph IV letter"

Highlights

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