ANDA Litigation and The America Invents Act


This session is critical for understanding how The America Invents Act will impact ANDA Litigation. This course starts with a thorough review of provisions relating to Abbreviated New Drug Applications. Topics illuminated include restoration of patent term; requirements for filing ANDA applications (e.g. in terms of active ingredients and bioequivalency); and, Paragraph IV certifications.

The seminar continues by providing insight as to how aspects of the AIA will affect ANDA. These discussion points include inter-partes review; post-grant review; supplemental examination; derivation proceedings; defenses; and, patent prosecution issues. The program concludes by delving into an analysis of recent litigation that intersects with the AIA and ANDA.




About the Course:

The following are among the issues that reviewed:

  • What are the incentives for filing for ANDA?
  • How will interference be impacted by the AIA?
  • Does the AIA raise or lower the bar for the issue of obviousness? How can potential obvious challenges be drafted around?
  • How does the AIA influence earlier use defenses?
  • What is the status of the best mode necessity under the AIA? 
  • What should you know about the intersection of prophetic experiment and the written description requirement?
  • What are the standards for pursuing post-grant review?
  • What role does lead compound analysis play in ANDA and patent challenges under the AIA?
  • What are the fee schedules like in terms of filing for inter-partes review and supplemental examinations?

Course Length: Approx. 1.5 hours

About Author: Robert D. Katz, Partner, Eaton Van Winkle

Robert D. Katz has been practicing intellectual property law for over 30 years, and his practice has encompassed virtually every aspect of intellectual property law. He has been the first chair in a large number of patent, trademark, copyright, unfair competition, and trade secret cases including jury trials, and has also handled arbitrations and mediations. He has obtained and opposed preliminary injunctions and briefed and argued appeals in State and Federal Courts throughout the country.

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