Intellectual Property Litigation partners Natasha Daughtrey and Joshua Weinger discus how, as of June 2023, over 3,500 advanced genetic therapies are under active development, with the FDA predicted to approve 10-20 products per year by 2025. Precommercialization gene or cell therapy companies often assume the safe harbor protects them from patent infringement suits. However, the law has evolved, and recent lawsuits by Regenxbio Inc. and the U.S. Court of Appeals' decision in Edwards Lifesciences v. Meril Life Sciences highlight ongoing disagreements. Gene and cell therapy developers should consider whether their potentially infringing use or product is FDA-approved, if it is closely tied to the approved product, if it could be a method of manufacturing, if it can be manufactured outside the U.S., if they can obtain research tools or analytical method patents, and be mindful of their public statements. More in Law360.