The Business of Pharmaceutical Patent Litigation: A Global Approach

April 29, 2019 2:00pm

Tashica Williams Amirgholizadeh
Patent Litigation Counsel
Gilead Sciences (Foster City, CA)

Phil Carey
Senior Counsel, Patent Litigation

Serge Ilin-Schneider

Serge Ilin-Schneider
General Counsel
Wockhardt USA & Morton Grove Pharmaceuticals (Troy Hills, NJ)

Nathaniel Lipkus
Osler, Hoskin & Harcourt LLP

Deepro R. Mukerjee
KattenMuchinRosenman LLP (New York, NY)

David Silverstein
Axinn, Veltrop & Harkrider LLP (New York, NY)

Kevin Zive
VP, Global IP
Apotex (Toronto, ON)

Track Moderator

George Johnston
Intellectual Property, Gibbons P.C.(Newark, NJ)


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


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


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