New York, NY

American Conference Institute’s (ACI’s) Paragraph IV Disputes conference helps both brand name and generic pharmaceutical companies make sense of changing industry dynamics precipitated by the patent cliff and other factors such as patent reform, regulatory shifts and recent and pending case law.

Our faculty of respected and renowned counsel for branded and generic pharmaceutical companies will provide insights on all facets of Paragraph IV litigation: pre-litigation concerns — the commencement of suit — final adjudication and every step in between. Sessions will address the key elements of Paragraph IV litigation in addition to some of the most pressing and recent controversies in this area, including:

  • The impact of patent reform on Hatch-Waxman litigation
  • The boundaries of 271(e)(1) relative to infringing pre vs. post market activities
  • New obviousness considerations in light of recent decisions and the AIA
  • The potential effects of FDASIA and the GAIN Act on Paragraph IV Challenges
  • Exclusivity concerns for brands as well as generics
  • New rulings in divided infringement and inducement of infringement
  • Damages theories relative to launching at risk
  • The further evolution of the inequitable conduct ruling post-Therasense

Lisa M. Ferri
Christopher J. Kelly
For more information please, click here.