Understanding the US Safe Harbor, and Regulatory and Research Safe Harbors in the EU/Canada

This webinar has ended.


Appreciating the scope of protection afforded by the Section 271(e)(1) Hatch-Waxman Safe Harbor is vital to pharmaceutical and biotech firms. Moreover, a general understanding of the protections available in the EU and Canada also allows multinational organizations to conduct their research and development efforts in the most infringement-free environment. Fish attorneys Brian Coggio and Ron Vogelspoke about these protections and strategies for doing business in light of them in this one-hour webinar. Topics included:

  • What is the Safe Harbor and its origins and scope?
  • What is the impact of recent rulings?
  • What pre- and post-approval activities are protected under the Safe Harbor?
    • API suppliers
    • Stockpiling
    • Research tools
  • How do the Bolar Exception and Bolar Exemption affect research and development efforts in the EU and Canada?
  • What is the broad European research exemption?

If you are interested in gaining a better understanding of the domestic and multinational protections available to pharmaceutical or biotech companies, this complimentary webinar is for you.