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What’s New for Hatch-Waxman Litigation: Exploring Trends, Updates, and Critical Issues


Level: Intermediate
Runtime: 110 minutes
Recorded Date: May 17, 2022
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Agenda

Key topics include:
  • Hatch-Waxman Litigation Post-COVID
  • Impact of Changes in Venue for Hatch-Waxman Litigation
  • Regulatory and Litigation Impact of Carve-Outs
  • Economic Issues Associated With an “at-risk” Launch
  • Factors to Consider When Analyzing Commercial Success
  • Recent Notable Cases
Runtime: 1 hour, 50 minutes
Recorded: May 17, 2022

For NY - Difficulty Level: For both newly admitted & experienced attorneys

For NY - Difficulty Level: Both newly admitted and experienced attorneys

Description

As the COVID-19 crisis stretches into its third year, brands and generic drug companies will likely see the impact of continued regulatory developments in the Hatch-Waxman space.

Moreover, recent notable cases further reveal key takeaways and unresolved issues which drug companies should be wary of. Among the salient developments involve changes in venue for a Hatch-Waxman Act case — highlighting the need for concerned practitioners to stay close to the venue issue as it remains to be a focus of the Federal courts.

In this program, a panel of key thought leaders and practitioners will offer an in-depth look at the critical developments and issues surrounding Hatch-Waxman litigation. This course will provide helpful insights to help your company deal with patent challenges.

This program was recorded on May 17th, 2022.

Provided By

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Panelists

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Andrew Wasson

Partner
Haug Partners

Andrew Wasson is a partner and Chair of Haug Partners’ FDA practice in the New York office. Andrew has a broad range of experience in both the brand and generic side of pharmaceuticals, especially with respect to issues involving intellectual property law and regulatory law. Having grown up with a father who is a patent lawyer, Mr. Wasson has been involved in patents in one way or another for the better part of his life and has the advantage of being able to deal with complex patent law concepts in a very natural way. Mr. Wasson is registered to practice before the U.S. Patent and Trademark Office and has published extensively in both scientific and legal literature. Mr. Wasson serves as an Adjunct Lecturer of Entrepreneurship & Innovation at the Hynes Institute for Entrepreneurship & Innovation at Iona College.

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Sean Sheridan

Principal
Charles River Associates

Dr. Sean Sheridan is a principal in the Life Sciences Practice at CRA. He has served as an expert witness in cases brought before federal and state courts, the Patent Trial and Appeal Board, the International Trade Commission, and arbitration tribunals.
Dr. Sheridan has developed numerous economic analyses related to the evaluation of commercial success and the quantification of damages in patent infringement and trade secret misappropriation cases, including analyses quantifying lost profits, reasonable royalties, and unjust enrichment. He has also provided financial consulting services for a variety of non-litigation purposes including transaction due diligence, license negotiations, and strategic decision-making. The engagements he has worked on span a wide range of industries and products, including pharmaceuticals, recombinant therapeutic proteins, vaccines, gene editing, medical devices, diagnostics, research tools, electronic health records, and many others outside of the life sciences.

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Giancarlo Scaccia

Associate
Greenberg Traurig LLP

Giancarlo Scaccia is an associate in Greenberg Traurig’s Intellectual Property Practice. Giancarlo has wide-ranging litigation and trial experience across diverse industries, but focuses his practice on pharmaceutical patent litigation, including ANDA/Hatch-Waxman matters. Giancarlo also represents clients in post-grant proceedings and due diligence investigations. While in law school, Giancarlo clerked as an Alexander Fellow with the Honorable Susan D. Wigenton in the U.S. District Court for the District of New Jersey.

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Alison J. Baldwin

Partner
Faegre Drinker Biddle & Reath LLP

With 20 years of experience in pharmaceutical and agricultural matters, Alison Baldwin is uniquely equipped to advance your most complex intellectual property goals. Whether you Eat it, Drink it, Wear it, Smoke it or Drive it, Alison’s extensive background in biotechnology and plant science brings a vital perspective to your project.
An experienced litigator with dozens of pharmaceutical and biotechnology cases under her belt, Alison advocates for clients in all stages of trial across a range of venues. Her experience in federal district court, the International Trade Commission, the Patent Trial and Appeal Board — along with private arbitration proceedings — informs her strategic guidance for clients in every phase of their case.


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