Biosimilars: Navigating the 271(e) “Safe Harbor” and 271(g) Exceptions to Patent Infringement

September 9, 2020 | 12:00 PM - 1:00 PM


U.S. patent law provides two exceptions to patent infringement that particularly impact biosimilar manufacturers:

  1. The law provides a “safe harbor” from infringement when the use of a patented invention is “reasonably related” to developing information to submit to FDA to support approval of a new drug.
  2. The law provides a carve-out from infringement based on foreign use of a process patent to make an imported product if the product is “materially changed by subsequent processes” before importation into the United States.

This webinar will discuss how these important exceptions to infringement apply to biosimilar products, and how courts have determined what potentially infringing activities qualify for the protections.