ACI’s 13th Annual Paragraph IV Disputes

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.