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Title IV — Patent Disclosure Requirements

H.R. 3947 · 116th Congress · Jul 24, 2019 · Lineage

IV Patent Disclosure Requirements

Sec. 401 Patent disclosure and transparency requirements

(a)
In general—
(1)
In general— Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended by adding at the end the following:

“(o) Additional requirements with respect to patents

“(1) Publication of information

“(A) In general—Within 1 year of the date of enactment of the Biologic Patent Transparency Act, the Secretary shall publish and make available to the public a single, easily searchable list that includes—

“(i) the proper and proprietary name of each biological product licensed or deemed to be licensed under subsection (a) or (k);

“(ii) the date of approval and application number for each such biological product;

“(iii) the marketing status, dosage form, route of administration, strength, and, if applicable, reference product, for each such biological product;

“(iv) the licensure status for each such biological product, including whether the license at the time of listing is approved, withdrawn, or revoked;

“(v) for each such biological product that is a reference product for which an exclusivity period applies, and for which the Secretary has determined the dates of such exclusivity period, under subsection (k)(7)(A) or subsection (k)(7)(B) of this section or under section 527 of the Federal Food, Drug, and Cosmetic Act, including any extension of such exclusivity period in accordance with subsection (m) of this section, the date on which such exclusivity period expires;

“(vi) any determination of biosimilarity or interchangeability for each such biological product; and

“(vii) 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 (vii) of subparagraph (A); and

“(ii) any updates to information previously published in accordance with subparagraph (A).”

(2)
Public listing of patent information—
(A)
In general— The Secretary of Health and Human Services shall include in the recommendations transmitted to Congress under section 744I(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–53(f)) recommendations with respect to the collection and publication of patent information in the list described in section 351(o) of the Public Health Service Act (42 U.S.C. 262), as added by paragraph (1).
(B)
Development— In developing recommendations under subparagraph (A), the Secretary of Health and Human Services may consult with the Federal Trade Commission, the Director of the United States Patent and Trademark Office, and the Federal Trade Commission, in addition to the entities listed in section 744I(f)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–53(f)(1)).
(b)
Rule of construction— Nothing in this section, including the amendment made by this section, shall be construed to require or allow the Secretary of Health and Human Services to delay the review or approval of a biologic license application under section 351 of the Public Health Service Act (42 U.S.C. 262).

Sec. 402 Antitrust exemption for health insurance issuers To negotiate wholesale acquisition prices of prescription drugs purchased from drug manufacturers

(a)
Exemption— It shall not be a violation of the antitrust laws for one or more health insurance issuers or their designated agents to jointly negotiate wholesale acquisition prices of a prescription drug with a manufacturer of a prescription drug with regards to the reimbursement policies of the insurers of the manufacturer’s drugs so long as no single wholesale acquisition price is jointly determined between the insurance issuers or their designated agents.
(b)
Definitions— For purposes of this section:
(1)
Antitrust laws— The term antitrust laws has the meaning given it in subsection (a) of the 1st section of the Clayton Act (15 U.S.C. 12(a)), except that such term includes section 5 of the Federal Trade Commission Act (15 U.S.C. 45) to the extent such section 5 applies to unfair methods of competition.
(2)
Health insurance issuer— The term health insurance issuer has the meaning given that term in section 2791(b) of the Public Health Service Act (42 U.S.C. 300gg–91(b)).
(3)
Health maintenance organization— The term health maintenance organization means—
(A)
a federally qualified health maintenance organization (as defined in section 300e(a) of title 42 of the Code of Federal Regulations),
(B)
an organization recognized under State law as a health maintenance organization, or
(C)
a similar organization regulated under State law for solvency in the same manner and to the same extent as such a health maintenance organization.
(4)
Manufacturer— The term manufacturer means anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a prescription drug.
(5)
Prescription drug— The term prescription drug means a drug for human use subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)).
(c)
Effective date— This section shall take effect on the date of the enactment of this Act but shall not apply with respect to conduct that occurs before such date.

Sec. 403 Fair treatment of Medicare part B billing codes for the prescribing of biosimilars

Section 1847A of the Social Security Act (42 U.S.C. 1395w–3a) is amended by adding at the end the following new subsection:

“(h) Use of certain codes—Notwithstanding any previous provision of this section, for purposes of payment of biological biosimilar product the Secretary of Health and Human Services shall assign a uniform Common Procedure System code to describe all such products that share a common reference product.”