1. Short title
This Act may be cited as the “Second Look at Drug Patents Act of 2020”.
Second Look at Drug Patents Act of 2020
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to the listing of patents in the Orange Book.
2. Amendments
Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended—
in subsection (b)(1), in the fifth sentence, by inserting “, subject to the conditions under subsection (j)(7)(A)(iii)(II) being met” before the period;
in subsection (c)(2), at the end of the third sentence, by inserting “subject to the conditions under subsection (j)(7)(A)(iii)(II) being met” before the period; and
in subsection (j)(7)(A)(iii)—
by striking “When patent” and inserting “(I) When patent”;
by inserting “, subject to subclause (II),” after “, include”; and
by adding at the end the following:
“(II) The Secretary shall include patent information on the list pursuant to subclause (I) if the following conditions are met:
“(aa) If the patent has been issued as of the date on which the application is approved under subsection (c), the sponsor, within 30 days of the date of such approval, shall submit to the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (referred to in this clause as the “Director”) a notification that the sponsor has filed with the Secretary information about the patent as required under subsection (b)(1) or (c)(2), as applicable.
“(bb) If the patent is issued after the date on which the application is approved under subsection (c), the sponsor, not later than 30 days after the date on which the patent is issued, shall submit to the Director a notification that the sponsor has filed with the Secretary information about the patent as required under subsection (c)(2).
“(cc) Upon receipt of a notification under item (aa) or (bb), as applicable, the Director shall publish, not later than 30 days of such receipt, in the Official Gazette of the United States Patent and Trademark Office, and on an internet website that the Director shall establish, maintain, and operate, a notification with respect to the patent, requesting that any person that is eligible to file a request described in section 311(b) of title 35, United States Code, file such a request.”