Title: Orange Book Transparency Act of 2020
Policy area: Health

Summary:
Orange Book Transparency Act of 2019
This bill modifies requirements for the Food and Drug Administration (FDA)	to list and publish drug patent and exclusivity information. Specifically, the FDA must include on its list certain patent information and must specify each drug exclusivity period that has not concluded.
The holder of an approved drug application must notify the FDA when a listed patent is invalidated by a court or by the Patent Trial and Appeal Board. The FDA must remove invalidated patents from its list, subject to the 180-day drug exclusivity period.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1503 Introduced in House (IH)]

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116th CONGRESS
  1st Session
                                H. R. 1503

 To amend the Federal Food, Drug, and Cosmetic Act regarding the list 
 under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act, 
                        and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 5, 2019

Ms. Kelly of Illinois introduced the following bill; which was referred 
                to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act regarding the list 
 under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act, 
                        and for other purposes.

    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 ``Orange Book Transparency Act of 
2019''.

SEC. 2. ORANGE BOOK.

    (a) Patents.--Clause (iii) of section 505(j)(7)(A) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is amended to read 
as follows:
    ``(iii)(I) When patent information submitted under subsection (b) 
or (c) respecting a drug included on the list is to be published by the 
Secretary, the Secretary shall, in revisions made under clause (ii), 
include such information for such drug.
    ``(II) The Secretary--
            ``(aa) shall include on the list, from such patent 
        information respecting a drug, drug substance (including active 
        ingredient) patents, drug product (including formulation and 
        composition) patents, and method of use patents; and
            ``(bb) may choose to include on the list additional patent 
        information respecting the drug.
    ``(III) The Secretary shall not include on the list any patent to 
the extent such patent claims a device that is used for the delivery of 
the drug. Notwithstanding the preceding sentence, the Secretary may 
require (under other applicable provisions of law) the holder of the 
approved application for a drug to submit, for purposes other than the 
list under this paragraph, patent information respecting a device that 
is used for the delivery of the drug.''.
    (b) Listing of Exclusivities.--Subparagraph (A) of section 
505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(7)) is amended by adding at the end the following:
    ``(iv) For each drug included on the list, the Secretary shall 
specify each exclusivity period that is applicable and has not 
concluded under--
            ``(I) clause (iii) or (iv) of subsection (c)(3)(E) of this 
        section;
            ``(II) clause (iv) or (v) of paragraph (5)(B) of this 
        subsection;
            ``(III) clause (iii) or (iv) of paragraph (5)(F) of this 
        subsection;
            ``(IV) section 505A;
            ``(V) section 505E; or
            ``(VI) section 527(a).''.
    (c) Removal of Invalid Patents.--
            (1) In general.--Section 505(j)(7) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is amended by 
        adding at the end the following:
    ``(D)(i) The holder of an application approved under subsection (c) 
for a drug on the list shall promptly notify the Secretary in writing 
if either of the following occurs:
            ``(I) The Patent Trial and Appeals Board issues a decision 
        that a patent for such drug is invalid.
            ``(II) A court issues a decision from which no appeal may 
        be taken that a patent for such drug is invalid.
    ``(ii) The holder of an approved application shall include in any 
notification under clause (i) a copy of the decision described in 
subclause (I) or (II) of clause (i).
    ``(iii) The Secretary shall remove from the list any patent that is 
determined to be invalid in a decision described in subclause (I) or 
(II) of clause (i)--
            ``(I) promptly; but
            ``(II) not before the expiration of any 180-day exclusivity 
        period under clause (iv) or (v) of paragraph (5)(B) that relies 
        on a certification described in paragraph (2)(A)(vii)(IV) that 
        such patent was invalid.''.
            (2) Applicability.--Subparagraph (D) of section 505(j)(7) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355(j)(7)), as added by paragraph (1), applies only with 
        respect to a decision described in such subparagraph that is 
        issued on or after the date of enactment of this Act.
    (d) Review and Report.--Not later than one year after the date of 
enactment of this Act, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall--
            (1) review the types of patent information that should be 
        included on the list under section 507(j)(7) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)); and
            (2) report to the Congress on the results of such review, 
        including any recommendations about the types of patent 
        information that should be included on or removed from such 
        list.
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