Section 271(e)(1) of Title 35 U.S. Code

Section 271(e)(1) of Title 35 U.S. Code provides a legal exception that protects certain activities related to developing and testing new drugs or medical methods from patent infringement claims. Specifically, it allows researchers and companies to conduct experiments necessary to obtain regulatory approval (like FDA approval) without being sued for infringing on existing patents. This encourages innovation by enabling testing and demonstrating the safety and effectiveness of new products before bringing them to market, without the risk of patent litigation during these research phases.