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American Conference Institute 5th Annual Paragraph IV Disputes Conference

Loeb & Loeb LLP is proud to sponsor the American Conference Institute's (ACI) Paragraph IV Disputes: Expert Insights on Hatch-Waxman Litigation Strategies for Brand Names and Generics Conference, where partner Mark Waddell will be on a panel titled "Comprehending the Newfound Significance of Inducement Actions in Paragraph IV Litigation."

From the conference website:

American Conference Institute’s Paragraph IV Disputes conference is the undisputed source for Hatch-Waxman litigation strategies for brand-names and generics. This event, which is widely recognized for setting the standards for Paragraph IV litigation and serves as the annual meeting place for the “who’s who” of pharmaceutical patent litigation is the single forum that brand name and generic companies can rely on for answers during this turbulent time in which the balance of power designed by the Hatch-Waxman Act may completely unravel. Come to this conference and get up-to-the minute information that you need to prepare for the new litigation confrontations to come.

Selected Agenda

Wednesday, May 4, 2011
9:45AM – 10: 45AM - Comprehending the Newfound Significance of Inducement Actions in Paragraph IV Litigation

  • Examining the relationship between inducement actions and Paragraph IV litigation
  • Defining inducement of infringement under current law
  • Exploring the significance of the Supreme Court’s grant of certiorari in Global Tech v. SEB and its potential impact on PIV-related inducement actions
    • mens rea requirements
    • indirect vs. direct infringement
  • AstraZeneca LP v. Apotex, Inc.: the role of Section 8 carve-outs and the inducement controversy vis-à-vis a Paragraph IV challenge
    • exploring the tension between the Orange Book listed use and the label
  • Orange Book listed methods of use patents vs. uses which are actually listed in the label
    • how does the failure to receive FDA approval to alter the label on the generic product constitute “requisite intent” to induce consumers to infringe the product’s intended use?

Stephen S. Rabinowitz, Fried, Frank, Harris, Shriver & Jacobson LLP

Stephen R. Auten, IPSandoz, Inc.
Steven J. Lee, Kenyon & Kenyon
Patricia Clarke Lukens, Johnson & Johnson, Law Department, Law Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Mark Waddell, Loeb & Loeb LLP