I 
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 subse-
quently 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 Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Biologic Patent Trans-
parency 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: 
VerDate Sep 11 2014 
02:36 Oct 30, 2019
Jkt 099200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H4850.IH
H4850
kjohnson on DSK79L0C42 with BILLS
‘‘(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 Trans-
parency Act, within 30 days of approval of an 
application under subsection (a) or (k), the 
holder of such approved application shall sub-
mit to the Secretary a list of each patent re-
quired to be disclosed (as described in para-
graph (3)). 
‘‘(B) 
PREVIOUSLY
APPROVED
OR
LI-
CENSED 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 de-
scribed in paragraph (3)). 
VerDate Sep 11 2014 
02:36 Oct 30, 2019
Jkt 099200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H4850.IH
H4850
kjohnson on DSK79L0C42 with BILLS
‘‘(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 bio-
logical product under section 505 of the 
Federal Food, Drug, and Cosmetic Act 
that is deemed to be a license for the bio-
logical product under this section on 
March 23, 2020, shall submit a list of each 
patent required to be disclosed (as de-
scribed 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 
VerDate Sep 11 2014 
02:36 Oct 30, 2019
Jkt 099200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H4850.IH
H4850
kjohnson on DSK79L0C42 with BILLS
‘‘(II) the date of approval of a 
supplemental application for the bio-
logical product; and 
‘‘(ii) any patent, or any claim with re-
spect to a patent, included on the list pur-
suant to this paragraph with respect to the 
biological product subsequently determined 
to be invalid or unenforceable, within 30 
days of a determination of patent inva-
lidity. 
‘‘(2) PUBLICATION OF INFORMATION.— 
‘‘(A) IN GENERAL.—Within 1 year of the 
date of enactment of the Biologic Patent Trans-
parency 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 Cos-
metic Act and deemed to be a license for 
the biological product under this section on 
March 23, 2020; 
VerDate Sep 11 2014 
02:36 Oct 30, 2019
Jkt 099200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H4850.IH
H4850
kjohnson on DSK79L0C42 with BILLS
‘‘(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 appli-
cation 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 li-
cense 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 sec-
tion with respect to each such biological 
product, and the date on which such exclu-
sivity expires; 
VerDate Sep 11 2014 
02:36 Oct 30, 2019
Jkt 099200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H4850.IH
H4850
kjohnson on DSK79L0C42 with BILLS
‘‘(vii) information regarding any de-
termination related to biosimilarity or 
interchangeability for each such biological 
product; and 
‘‘(viii) information regarding approved 
indications for each such biological prod-
uct, in such manner as the Secretary de-
termines appropriate. 
‘‘(B) UPDATES.—Every 30 days after the 
publication of the first list under subparagraph 
(A), the Secretary shall revise the list to in-
clude— 
‘‘(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 in-
formation described in clauses (i) through 
(viii) of subparagraph (A); and 
‘‘(ii) any updates to information pre-
viously published in accordance with sub-
paragraph (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 prod-
VerDate Sep 11 2014 
02:36 Oct 30, 2019
Jkt 099200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H4850.IH
H4850
kjohnson on DSK79L0C42 with BILLS
uct license approved under subsection (a) or (k), or 
a biological product application approved under sec-
tion 505 of the Federal Food, Drug, and Cosmetic 
Act and deemed to be a license for a biological prod-
uct 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, sell-
ing, or importing into the United States of the bio-
logical 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 INFRINGE-
MENT.—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 
VerDate Sep 11 2014 
02:36 Oct 30, 2019
Jkt 099200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H4850.IH
H4850
kjohnson on DSK79L0C42 with BILLS
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 con-
strued to require or allow the Secretary of Health and 
Human Services to delay the licensing of a biological prod-
uct under section 351 of the Public Health Service Act 
(42 U.S.C. 262). 
Æ 
VerDate Sep 11 2014 
02:36 Oct 30, 2019
Jkt 099200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6301
E:\BILLS\H4850.IH
H4850
kjohnson on DSK79L0C42 with BILLS