Think You Don’t Need to Worry About Patents Before Commercializing Your Gene or Cell Therapy Product? Think Again!

Many pre-commercialization gene or cell therapy companies are aware of the patents that could threaten their product after launch, but assume that they are protected from patent infringement suits before they obtain FDA approval and sell their products under the so-called “safe harbor.” In this webinar we will examine the recent cases filed by REGENXBIO asserting its patents related to adeno-associated virus (AAV) technology against several gene therapy developers, including instances where the allegedly infringing acts were before FDA approval or launch. We will discuss the current state of the law on when and how the safe harbor applies, as well as best practices for avoiding allegations of infringement during the development of a gene or cell therapy product.

CLE credit will be offered for California, Minnesota, New Jersey, New York and Pennsylvania.