PLAY RECORDING

Broadcast Date: Tuesday, May 17, 2022
from 3:00 pm to 5:00 pm (ET)

Overview:

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 LIVE Webcast, 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 interactive course will provide helpful insights to help your company deal with patent challenges.

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

Credit:

Course Level:

Intermediate

 

Preparation:

Print and review course materials

 

Method of Presentation:

On-Demand Webcast

 

Prerequisite:

General knowledge of Hatch-Waxman Act

 

Course Code:

149393

 

NY Category of CLE Credit:

Areas of Professional Practice

 

Total Credit:

2.0 CLE

Speaker Panel:

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.

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.

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.

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.

Agenda:

SEGMENT 1:

Giancarlo Scaccia, Associate

Greenberg Traurig LLP

  • Has there been a rebound in the number of ANDA litigations and ANDAs approved post-COVID?
  • Safe Harbor – evaluating Regenxbio Inc. v. Sarepta

SEGMENT 2:

Alison J. Baldwin, Partner

Faegre Drinker Biddle & Reath LLP

  • The changes in the venues allowed in H-W litigations and the anticipated increased use of MDLs as a result
  • The recent changes in the use of parallel proceedings at the PTAB
  • The continued impact of invalidity challenges under 35 USC 112 on H-W strategies

SEGMENT 3:

Sean Sheridan, Principal

Charles River Associates

  • Factors to consider when analyzing the commercial success of a patented pharmaceutical product: Identifying and quantifying indicators of commercial success
  • Economic factors relating to the nexus between the claimed invention and the commercial success of a patented pharmaceutical product
  • Economic issues associated with the “at-risk” launch of a generic drug prior to the conclusion of Hatch-Waxman litigation: Factors influencing “at-risk” launch decisions
  • Evaluating potential damages attributable to an at-risk launch

SEGMENT 4:

Andrew WassonPartner

Haug Partners

  • Focusing on the GSK-Teva litigation, which would include: A regulatory primer on carve-outs and FDA practice
  • Analyzing the separate strand of the Federal Circuit’s inducement jurisprudence
  • Bringing them together with a deep dive into the longstanding GSK-Teva saga and current status
  • An analysis of other recent skinny label cases
  • Best practices and guidance for strategies around method patents taking into account the above

Materials:

Download Course Materials

Who Should Attend:

  • Patent Attorneys
  • Pharmaceutical Industry Lawyers
  • Patent Licensing Attorneys
  • FDA Attorneys
  • In-House Counsel
  • General Counsel

SPEAKERS

Giancarlo ScacciaAssociate
Greenberg Traurig LLP
Alison J. BaldwinPartner
Faegre Drinker Biddle & Reath LLP
Sean SheridanPrincipal
Charles River Associates
Andrew WassonPartner
Haug Partners

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