Alert

Paragraph IV Litigation, IPRs, and New Settlement Risks

Interplay Between Paragraph IV Litigation and IPRs, Multiple Generic Challengers, Key Issues in IPRs

Recording of a 90-minute premium CLE webinar with Q&A


Conducted on Tuesday, March 31, 2020

Recorded event now available

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Program Materials

This CLE webinar will guide counsel on pharmaceutical-related patent challenges from strategy to settlement. The panel will discuss the interplay between Paragraph IV litigation and post-grant proceedings, and where multiple generic challengers fit in the exclusivity scheme. The presenters will also examine critical issues in Inter partes review (IPR) challenges involving pharmaceutical patents. Finally, the presenters will discuss new risks to settlement in light of the changing landscape surrounding antitrust review of pharmaceutical patent settlements.

Description

IPR proceedings are a powerful tool for companies to challenge pharmaceutical patents. The number of pharmaceutical-related challenges using the IPR process should continue to climb, given the advantages that IPRs offer compared to district court litigation, as well as the increasing number of abbreviated new drug applications filed with the FDA.

All of this is based on the lower standard of proof and a panel of judges with technical expertise as compared to the federal district courts. As a result, the IPR process is an attractive option for challenging pharmaceutical patents over litigating them in federal court. IPR challenges alone or in conjunction with district court litigation are becoming increasingly common concerning pharmaceuticals.

And should companies instead wish to litigate with the prospect of settlement in mind, ever changing legal rules at both the federal and state levels impact strategy and decision making.

Listen as our authoritative panel of patent attorneys and litigators examines the interplay between Paragraph IV litigation and post-grant proceedings. The panel will also discuss critical issues in post-grant challenges involving pharmaceutical patents as well as how pharmaceutical patents fare in post-grant challenges. The panel will then guide counsel on new risks to patent litigation settlements given evolving law.

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Outline

  1. Interplay between Paragraph IV litigation and IPRs
  2. Multiple generic challengers and exclusivity
  3. Pharmaceutical patents in post-grant challenges
  4. Key issues in post-grant challenges involving pharmaceutical patents
  5. New risks to pharmaceutical patent settlements

Benefits

The panel will review these and other key issues:

  • Where do multiple generic challengers fit into the exclusivity scheme?
  • How do pharmaceutical patents fare in post-grant challenges in comparison to all patents?
  • What are the crucial issues in post-grant challenges involving pharmaceutical patents?
  • What are potential strategies for pharmaceutical companies looking to settle and mitigate risk?

Faculty

Bliss, Travis
Travis W. Bliss, Ph.D.

Partner
Panitch Schwarze Belisario & Nadel

Dr. Bliss counsels a variety of clients ranging from individual inventors to small businesses to Fortune 500 companies...  |  Read More

Dunston, Erin
Erin M. Dunston

Partner
Panitch Schwarze Belisario & Nadel

Ms. Dunston focuses on inter partes reviews, interferences, district court litigation, opinions, and prosecution...  |  Read More

Hirschhorn, Philip
Philip L. Hirschhorn

Partner
Panitch Schwarze Belisario & Nadel

Mr. Hirschhorn has represented clients in Hatch-Waxman (Paragraph IV) litigations, has worked in diverse industries...  |  Read More

Pereira, Aaron
Aaron L.J. Pereira
Attorney
Panitch Schwarze Belisario & Nadel

Mr. Pereira’s practice encompasses intellectual property litigation and counseling, with specific expertise in...  |  Read More

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