Title: Biologic Patent Transparency Act
Policy area: Commerce

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.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 659 Introduced in Senate (IS)]

<DOC>






116th CONGRESS
  1st Session
                                 S. 659

 To provide for certain additional requirements with respect to patent 
                              disclosures.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 5, 2019

  Ms. Collins (for herself, Mr. Kaine, Mr. Portman, Mrs. Shaheen, Mr. 
Braun, and Ms. Stabenow) introduced the following bill; which was read 
 twice and referred to the Committee on Health, Education, Labor, and 
                                Pensions

_______________________________________________________________________

                                 A BILL


 
 To provide for certain additional requirements with respect to patent 
                              disclosures.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Biologic Patent Transparency Act''.

SEC. 2. PATENT DISCLOSURE REQUIREMENTS.

    (a) 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) Approved application holder listing requirements.--
                    ``(A) In general.--Beginning on the date of 
                enactment of the Biologic Patent Transparency Act, 
                within 30 days of approval of an application under 
                subsection (a) or (k), the holder of such approved 
                application shall submit to the Secretary a list of 
                each patent required to be disclosed (as described in 
                paragraph (3)).
                    ``(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, the holder of a biological 
                        product license that was approved under 
                        subsection (a) or (k) before the date of 
                        enactment of such Act shall submit to the 
                        Secretary a list of each patent required to be 
                        disclosed (as described in paragraph (3)).
                            ``(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, the 
                Secretary shall publish and make available to the 
                public a single, easily searchable, list that 
                includes--
                            ``(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' is any patent for which the 
        holder of a biological product license approved under 
        subsection (a) or (k), or a biological product application 
        approved under section 505 of the Federal Food, Drug, and 
        Cosmetic Act and deemed to be a license for a biological 
        product under this section on March 23, 2020, believes a claim 
        of patent infringement could reasonably be asserted by the 
        holder, or by a patent owner that has granted an exclusive 
        license to the holder with respect to the biological product 
        that is the subject of such license, if a person not licensed 
        by the holder engaged in the making, using, offering to sell, 
        selling, or importing into the United States of the biological 
        product that is the subject of such license.''.
    (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)) is amended by inserting 
``included in the list provided by the reference product sponsor under 
subsection (o)(1)'' after ``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)), including any updates 
        required under subparagraph (C) of that section, but was not 
        timely included in such list, may not bring an action under 
        this section for infringement of the patent.''.
    (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), as added by subsection 
(a).
    (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).
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