Cross-Border Business Considerations in a Hatch-Waxman Scenario

April 23, 2018 2:45pm

David B. Abramowitz
Partner
Locke Lord LLP (Chicago, IL)

Lisa A. Jakob
Legal Director, IP Litigation
Merck & Company (Rahway, NJ)

Alyson L. Wooten
Counsel
Kilpatrick Townsend & Stockton LLP (Atlanta, GA)

  • Assessing circumstances in which cross-border business dealings may lead to Hatch-Waxman headaches
  • Evaluating potential liabilities of safe-harbor violations in connection with foreign manufacturers and finishers
  • Reviewing the FDA’s import ban list of foreign drug makers with a spotlight on China and India, relative to cGMP violations and potential loss of exclusivity
  • Analyzing the FDA warning letters for foreign sites land reviewing API manufacturer liability