40 CFR 95.3 - Findings prior to application to Attorney General.
The Administrator, or the Administrator's designee, may apply to the Attorney General for a mandatory patent license pursuant to section 308 of the Act (42 U.S.C. 7608) either in response to a petition under § 95.2 or on the Administrator's or designee's own initiative, only after expressly finding that each one of the following mandatory criteria is met:
(a) The application is for a patent license covering no more than one patent;
(b) The party to whom the proposed patent license is to be granted has presented the Administrator or designee with evidence that such party has made reasonable efforts to obtain a patent license from the patent owner with terms similar to the license terms to be proposed in the application to the Attorney General;
(c) The patent under which a patent license is sought in the application to the Attorney General is being used or is intended for public or commercial use;
(e) The patented technology is not otherwise reasonably available, and there are no other reasonable alternatives for accomplishing compliance with sections 111, 112 or 202 of the Act (42 U.S.C. 7411, 7412 or 7521); and
(f) The unavailability of a mandatory patent license may result in a substantial lessening of competition or a tendency to create a monopoly in any line of commerce in any section of the United States.