The Business of Pharmaceutical Patent Litigation: A Global Approach

April 29, 2019 2:00pm

What is it about?

2:00

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

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

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