Cross-Border Business Considerations in a Hatch-Waxman Scenario: The Global Approach to Pharmaceutical Patent Litigation

September 22, 2022 2:00pm

Mary Morry
Merck & Company

Domnick A. Conde

Dominick A. Conde
Venable LLP

Andrea Tiglio
Associate General Counsel, IP Legal
Senior Director IP

Astellas Pharma US

When considering cross-border biopharmaceutical patent matters, there are multiple factors in play. It is critical to understand the patent landscape in the relevant countries, the differences in patent laws in various jurisdictions, and the timing of litigation. Topics of discussion will include:

  • Assessing common international business scenarios encountered by both brand name and generic manufacturers
  • Identifying potential safe-harbor concerns related to foreign manufacturers and finishers
  • Building and managing a winning global litigation team
  • Understanding the importance of aligning legal and business functions for global patent litigation planning
  • Managing global pharmaceutical patent litigation
  • Exploring matters of international trade and impacting the value of pharmaceutical patents