[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4850 Introduced in House (IH)]
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116th CONGRESS
1st Session
H. R. 4850
To provide for certain additional requirements with respect to patent
disclosures.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
October 23, 2019
Ms. Spanberger (for herself and Mr. Reed) introduced the following
bill; which was referred to the Committee on Energy and Commerce, and
in addition to the Committee on the Judiciary, for a period to be
subsequently determined by the Speaker, in each case for consideration
of such provisions as fall within the jurisdiction of the committee
concerned
_______________________________________________________________________
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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