Biologic Patent Transparency Act

To provide for certain additional requirements with respect to patent disclosures. 1. Short title This Act may be cited as the Biologic Patent Transparency Act 2. Patent disclosure requirements (a) In general Section 351 of the Public Health Service Act ( 42 U.S.C. 262 (o) Additional requirements with respect to patents (1) Approved application holder listing requirements (A) In general Beginning on the date of enactment of the Biologic Patent Transparency Act (B) Previously approved or licensed biological products (i) Products approved under section 351 of the PHSA Not later than 30 days after the date of enactment of the Biologic Patent Transparency Act (ii) Products approved under section 505 of the FFDCA Not later than 30 days after March 23, 2020, the holder of an approved application for a biological product under section 505 of the Federal Food, Drug, and Cosmetic Act that is deemed to be a license for the biological product under this section on March 23, 2020, shall submit a list of each patent required to be disclosed (as described in paragraph (3)). (C) Updates The holder of a biological product license approved under subsection (a) or (k) shall submit to the Secretary a list that includes— (i) any patent first required to be disclosed (as described in paragraph (3)) after the submission under subparagraph (A) or (B), as applicable, within 30 days of the earlier of— (I) the date of issuance of such patent by the United States Patent and Trademark Office; or (II) the date of approval of a supplemental application for the biological product; and (ii) any patent, or any claim with respect to a patent, included on the list pursuant to this paragraph with respect to the biological product subsequently determined to be invalid or unenforceable, within 30 days of a determination of patent invalidity. (2) Publication of information (A) In general Within 1 year of the date of enactment of the Biologic Patent Transparency Act (i) the official and proprietary name of each biological product licensed under subsection (a) or (k), and of each biological product application approved under section 505 of the Federal Food, Drug, and Cosmetic Act and deemed to be a license for the biological product under this section on March 23, 2020; (ii) with respect to each biological product described in clause (i), each patent submitted in accordance with paragraph (1); (iii) the date of licensure and application number for each such biological product; (iv) the marketing status, dosage form, route of administration, strength, and, if applicable, reference product, for each such biological product; (v) the licensure status for each such biological product, including whether the license at the time of listing is approved, withdrawn, or revoked; (vi) any period of any exclusivity under subsection (k)(7)(A) or subsection (k)(7)(B) of this section or section 527 of the Federal Food, Drug, and Cosmetic Act, and any extension of such period in accordance with subsection (m) of this section with respect to each such biological product, and the date on which such exclusivity expires; (vii) information regarding any determination related to biosimilarity or interchangeability for each such biological product; and (viii) information regarding approved indications for each such biological product, in such manner as the Secretary determines appropriate. (B) Updates Every 30 days after the publication of the first list under subparagraph (A), the Secretary shall revise the list to include— (i) (I) each biological product licensed under subsection (a) or (k) during the 30-day period; and (II) with respect to each biological product described in subclause (I), the information described in clauses (i) through (viii) of subparagraph (A); and (ii) any updates to information previously published in accordance with subparagraph (A). (3) Patents required to be disclosed In this section, a patent required to be disclosed . (b) Disclosure of patents Section 351(l)(3)(A)(i) of the Public Health Service Act ( 42 U.S.C. 262(l)(3)(A)(i) included in the list provided by the reference product sponsor under subsection (o)(1) a list of patents (c) Restriction on claims of patent infringement Section 271(e) of title 35, United States Code, is amended by adding at the end the following: (7) The owner of a patent that should have been included in the list described in section 351(o)(1) of the Public Health Service Act ( 42 U.S.C. 262(o)(1) . (d) Regulations The Secretary of Health and Human Services may promulgate regulations to carry out subsection (o) of section 351 of the Public Health Service Act ( 42 U.S.C. 262 (e) Rule of construction Nothing in this Act, including an amendment made by this Act, shall be construed to require or allow the Secretary of Health and Human Services to delay the licensing of a biological product under section 351 of the Public Health Service Act ( 42 U.S.C. 262

Summary: Biologic Patent Transparency Act This bill requires the holder of a license to market a biologic drug to disclose all patents believed to be covering that drug. The bill also directs the Department of Health and Human Services  (HHS) to make such information publicly available. (Biologics are drugs produced through natural processes or isolated from natural sources.) The holder of a market approval license for a biologic product shall submit a list to HHS of all patents that the holder reasonably believes would be infringed by an unauthorized person making, using, offering to sell, selling, or importing that product. The license holder shall update HHS as to any relevant patents granted after the initial submission and as to listed patents that were later invalidated or rendered unenforceable. If a patent that should have been listed was not timely disclosed to HHS, the patent holder may not sue for infringement of that patent. HHS shall publish an easily searchable list of all biologics that have received market approval or for which an application for approval has been filed. The list shall contain information including (1) the official and proprietary name of the product, (2) the patents the license holder has listed under this bill, (3) whether various market exclusivity periods apply to the product, and (4) information about whether the product is interchangeable with another biologic product.