ACI's 13th Annual Paragraph IV Disputes

Event Information


Monday, April 29, 2019


2:00 pm


The Business of Pharmaceutical Patent Litigation: A Global Approach


The Conrad New York
New York

Delivery Method

Upcoming Events - In Person


What is it about?

2:00 pm

  • Understanding the Importance of Aligning Legal and Business Functions for Global Patent Litigation Planning
  • Utilizing business functions such as operations, business development and life cycle management to advance product portfolio acquisitions and IP protections
  • Understanding the importance of global portfolio planning from the get go
  • Responding in kind to continued growth on a global scale by building a team structure that is sustainable on a long-term basis to address IP litigation around the world
  • Assessing common international business scenarios encountered by both brand name and generic manufacturers which may lead to patent and/or exclusivity loss
  • Identifying potential safe-harbor violation liabilities related to foreign manufacturers and finishers
  • Considering FDA warning letters relative to foreign manufacturing sites and reviewing related manufacturer liability
    • 180-day exclusivity forfeiture

2:45 pm

  • Managing Global Pharmaceutical Patent Litigation: International and Domestic Considerations
  • Building a global litigation team
  • Selecting the right foreign outside counsel
  • Coordinating with outside counsel to establish litigation strategies and timelines relative to anticipated ANDA litigation and related international patent challenges
  • Coordinating multi-jurisdictional proceedings

3:30 pm

  • Exploring Matters of International Trade and Impacting the Value of Pharmaceutical Patents
  • Analyzing the IP provisions of the United States-Mexico-Canada Agreement (USMCA) that will have a direct impact on Hatch-Waxman litigation
  • Exploring controversies relative to patent term adjustment provisions to compensate for patent office “unreasonable delay” in issuing a patent
  • Assessing the impact and dangers of other applicable treaties on the Hatch-Waxman landscape
    • Evaluating the threat of compulsory licensing and finding diplomatic remedies

For more information with regards to the conference, please click here.