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.