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H.R. 1503 — what changed

Orange Book Transparency Act of 2020

From Introduced in House to Reported in House. 1 section amended and 1 added between Introduced in House and Reported in House.

Sec. 2 Orange Book

(a)
changed Patents—Submission of patent information for brand name drugs— Clause (iii) Paragraph (1) of section 505(j)(7)(A) 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) 355(b)) is amended to read as follows:

changed “(iii)“(b)

changed “(I) When patent information submitted under subsection (b) or (c) respecting a drug included on “(1) Any person may file with the list is Secretary an application with respect to be published by any drug subject to the Secretary, provisions of subsection (a). Such persons shall submit to the Secretary shall, in revisions made under clause (ii), include such information for such drug.as part of the application—

changed “(II) The Secretary—“(A) full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use;

changed “(aa) shall include on the list, from such patent information respecting “(B) a drug, drug substance (including active ingredient) patents, drug product (including formulation and composition) patents, and method full list of use patents; andthe articles used as components of such drug;

changed “(bb) may choose to include on the list additional patent information respecting “(C) a full statement of the drug.composition of such drug;

changed “(III) The Secretary shall not include on the list any patent to the extent such patent claims “(D) 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 full description of the approved application for a drug to submit, for purposes other than methods used in, and the list under this paragraph, patent information respecting a device that is facilities and controls used for for, the delivery manufacture, processing, and packing of the drug.”such drug;

added “(E) such samples of such drug and of the articles used as components thereof as the Secretary may require;

added “(F) specimens of the labeling proposed to be used for such drug;

added “(G) any assessments required under section 505B; and

added “(H) patent information, with respect to each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug, and consistent with the following requirements:

added “(i) The applicant shall file with the application the patent number and the expiration date of—

added “(I) any patent which claims the drug for which the applicant submitted the application and is a drug substance (including active ingredient) patent or a drug product (including formulation and composition) patent; and

added “(II) any patent which claims the method of using such drug.

added “(ii) If an application is filed under this subsection for a drug and a patent of the type described in clause (i) which claims such drug or a method of using such drug is issued after the filing date but before approval of the application, the applicant shall amend the application to include such patent information.”

(b)
added Conforming changes to requirements for subsequent submission of patent information— Section 505(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is amended—
(1)
added by inserting after “the patent number and the expiration date of any patent which” the following: “fulfills the criteria in subsection (b) and”;
(2)
added by inserting after the first sentence the following: “Patent information that is not the type of patent information required by subsection (b) shall not be submitted.”; and
(3)
added by inserting after “could not file patent information under subsection (b) because no patent ” the following: “of the type required to be submitted in subsection (b)”.
(c)
renumbered was (3) 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—

added “(I) clause (ii), (iii), or (iv) of subsection (c)(3)(E) of this section;

removed “(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;

added “(III) clause (ii), (iii), or (iv) of paragraph (5)(F) of this subsection;

removed “(III) clause (iii) or (iv) of paragraph (5)(F) of this subsection;

“(IV) section 505A;

“(V) section 505E; or

“(VI) section 527(a).”

(d)
added Removal of invalid patents—
(c)
removed Removal of invalid patents—
(1)
renumbered was (4)(2) 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)

added “(i) The holder of an application approved under subsection (c) for a drug on the list shall notify within 14 days the Secretary in writing if either of the following occurs:

added “(I) The Patent Trial and Appeals Board issues a decision from which no appeal has been or can be taken that a patent for such drug is invalid.

added “(II) A court issues a decision from which no appeal has been or can be taken that a patent for such drug is invalid.

removed “(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:

removed “(I) The Patent Trial and Appeals Board issues a decision that a patent for such drug is invalid.

removed “(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

added “(II) not before the expiration of any 180-day exclusivity period under paragraph (5)(B)(iv) that relies on a certification described in paragraph (2)(A)(vii)(IV) that such patent was invalid.”

removed “(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)
renumbered was (4)(3) 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.
(e)
renumbered was (5) 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)
added solicit public comment regarding 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)
added transmit to the Congress an evaluation of such comments, including any recommendations about the types of patent information that should be included on or removed from such list.
(1)
removed 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)
removed 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.

Sec. 3 GAO report to Congress

added
(a)
added In general— Not later than one year after the date of enactment of this Act, the Comptroller General of the United States (referred to in this section as the “Comptroller General”) shall submit to the Committee on Energy and Commerce of the House of Representatives a report on the patents included in the list published under section 505(j)(7) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(j)(7)), including an analysis and evaluation of the types of patents included in such list and the claims such patents make about the products they claim.
(b)
added Contents— The Comptroller General shall include in the report under subsection (a)—
(1)
added data on the number of—
(A)
added patents included in the list published under paragraph (7) of section 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(j)), that claim the active ingredient or formulation of a drug in combination with a device that is used for delivery of the drug, together comprising the finished dosage form of the drug; and
(B)
added claims in each patent that claim a device that is used for the delivery of the drug, but do not claim such device in combination with an active ingredient or formulation of a drug;
(2)
added data on the date of inclusion in the list under paragraph (7) of such section 505(j) for all patents under such list, as compared to patents that claim a method of using the drug in combination with a device;
(3)
added an analysis regarding the impact of including on the list under paragraph (7) of such section 505(j) certain types of patent information for drug product applicants and approved application holders, including an analysis of whether—
(A)
added the listing of the patents described in paragraph (1)(A) delayed the market entry of one or more drugs approved under such section 505(j); and
(B)
added not listing the patents described in paragraph (1)(A) would delay the market entry of one or more such drugs; and
(4)
added recommendations about which kinds of patents relating to devices described in paragraph (1)(A) should be submitted to the Secretary of Health and Human Services for inclusion on the list under paragraph (7) of such section 505(j) and which patents should not be required to be so submitted.