Orange Book Transparency Act of 2020

Bill: 116-hr-1503
Sponsor: full_name: Rep. Kelly, Robin L. [D-IL-2]
Introduced: 2019-03-05
Policy area: Health
Subjects: Administrative law and regulatory procedures

Congressional oversight

Drug safety, medical device, and laboratory regulation

Food and Drug Administration (FDA)

Government information and archives

Intellectual property

Prescription drugs
Latest action: action_date: 2021-01-05
text: Became Public Law No: 116-290.

Summaries:
action_date: 2019-03-05
action_desc: Introduced in House
text: <p><b>Orange Book Transparency Act of 2019</b></p> <p>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. </p> <p>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.</p>

action_date: 2021-01-05
action_desc: Public Law
text: <p><strong>Orange Book Transparency Act of 2020</strong></p>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. <p>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.</p>

tv_txt: I 116th CONGRESS 1st Session H. R. 1503 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.

1. Short title This Act may be cited as the Orange Book Transparency Act of 2019 . 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.

tv_txt: IB 116th CONGRESS 1st Session H. R. 1503 IN THE HOUSE OF REPRESENTATIVES AN ACT 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.

1. Short title This Act may be cited as the Orange Book Transparency Act of 2019 . 2. Orange Book (a) Submission of patent information for brand name drugs Paragraph (1) of section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) ) is amended to read as follows: (b) (1) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application— (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; (B) a full list of the articles used as components of such drug; (C) a full statement of the composition of such drug; (D) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (E) such samples of such drug and of the articles used as components thereof as the Secretary may require; (F) specimens of the labeling proposed to be used for such drug; (G) any assessments required under section 505B; and (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: (i) The applicant shall file with the application the patent number and the expiration date of— (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 (II) any patent which claims the method of using such drug. (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. Upon approval of the application, the Secretary shall publish the information submitted under subparagraph (H). The Secretary shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials required by subparagraph (A). . (b) 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) by inserting after the patent number and the expiration date of any patent which the following: fulfills the criteria in subsection (b) and ; (2) 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) 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) 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 (ii), (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 (ii), (iii), or (iv) of paragraph (5)(F) of this subsection; (IV) section 505A; (V) section 505E; or (VI) section 527(a). . (d) 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 notify within 14 days the Secretary in writing if either of the following occurs: (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. (II) A court issues a decision from which no appeal has been or can 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 paragraph (5)(B)(iv) 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. (e) Review and report Not later than 1 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) 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) 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. 3. GAO report to Congress (a) In general Not later than 1 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) Contents The Comptroller General shall include in the report under subsection (a)— (1) data on the number of— (A) 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) 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) 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) 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) 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) not listing the patents described in paragraph (1)(A) would delay the market entry of one or more such drugs; and (4) 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.

Passed the House of Representatives May 8, 2019. Karen L. Haas, Clerk.

tv_txt: IIB 116th CONGRESS 1st Session H. R. 1503 IN THE SENATE OF THE UNITED STATES May 9, 2019 Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions AN ACT 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.

1. Short title This Act may be cited as the Orange Book Transparency Act of 2019 . 2. Orange Book (a) Submission of patent information for brand name drugs Paragraph (1) of section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) ) is amended to read as follows: (b) (1) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application— (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; (B) a full list of the articles used as components of such drug; (C) a full statement of the composition of such drug; (D) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (E) such samples of such drug and of the articles used as components thereof as the Secretary may require; (F) specimens of the labeling proposed to be used for such drug; (G) any assessments required under section 505B; and (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: (i) The applicant shall file with the application the patent number and the expiration date of— (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 (II) any patent which claims the method of using such drug. (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. Upon approval of the application, the Secretary shall publish the information submitted under subparagraph (H). The Secretary shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials required by subparagraph (A). . (b) 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) by inserting after the patent number and the expiration date of any patent which the following: fulfills the criteria in subsection (b) and ; (2) 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) 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) 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 (ii), (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 (ii), (iii), or (iv) of paragraph (5)(F) of this subsection; (IV) section 505A; (V) section 505E; or (VI) section 527(a). . (d) 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 notify within 14 days the Secretary in writing if either of the following occurs: (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. (II) A court issues a decision from which no appeal has been or can 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 paragraph (5)(B)(iv) 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. (e) Review and report Not later than 1 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) 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) 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. 3. GAO report to Congress (a) In general Not later than 1 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) Contents The Comptroller General shall include in the report under subsection (a)— (1) data on the number of— (A) 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) 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) 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) 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) 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) not listing the patents described in paragraph (1)(A) would delay the market entry of one or more such drugs; and (4) 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.

Passed the House of Representatives May 8, 2019. Cheryl L. Johnson, Clerk.

tv_txt: IB Union Calendar No. 25 116th CONGRESS 1st Session H. R. 1503 [Report No. 116–47] 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 May 2, 2019 Additional sponsors: Mr. Ruiz , Mr. Rush , Mr. Pallone , Mrs. Dingell , Ms. Eshoo , Mr. Kennedy , Ms. Matsui , Mrs. Craig , Ms. Clarke of New York , Mr. Van Drew , Mr. Walden , Ms. Schakowsky , and Ms. Mucarsel-Powell May 2, 2019 Reported with an amendment, committed to the Committee of the Whole House on the State of the Union, and ordered to be printed Strike out all after the enacting clause and insert the part printed in italic For text of introduced bill, see copy of bill as introduced on March 5, 2019 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.

1. Short title This Act may be cited as the Orange Book Transparency Act of 2019 . 2. Orange Book (a) Submission of patent information for brand name drugs Paragraph (1) of section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) ) is amended to read as follows: (b) (1) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application— (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; (B) a full list of the articles used as components of such drug; (C) a full statement of the composition of such drug; (D) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (E) such samples of such drug and of the articles used as components thereof as the Secretary may require; (F) specimens of the labeling proposed to be used for such drug; (G) any assessments required under section 505B; and (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: (i) The applicant shall file with the application the patent number and the expiration date of— (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 (II) any patent which claims the method of using such drug. (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. Upon approval of the application, the Secretary shall publish the information submitted under subparagraph (H). The Secretary shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials required by subparagraph (A). . (b) 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) by inserting after the patent number and the expiration date of any patent which the following: fulfills the criteria in subsection (b) and ; (2) 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) 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) 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 (ii), (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 (ii), (iii), or (iv) of paragraph (5)(F) of this subsection; (IV) section 505A; (V) section 505E; or (VI) section 527(a). . (d) 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 notify within 14 days the Secretary in writing if either of the following occurs: (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. (II) A court issues a decision from which no appeal has been or can 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 paragraph (5)(B)(iv) 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. (e) 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) 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) 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. 3. GAO report to Congress (a) 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) Contents The Comptroller General shall include in the report under subsection (a)— (1) data on the number of— (A) 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) 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) 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) 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) 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) not listing the patents described in paragraph (1)(A) would delay the market entry of one or more such drugs; and (4) 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.

May 2, 2019 Reported with an amendment, committed to the Committee of the Whole House on the State of the Union, and ordered to be printed

tv_txt: 116th CONGRESS 2d Session H.R. 1503 In the Senate of the United States, December 7, 2020. Amendment:

That the bill from the House of Representatives (H.R. 1503) entitled An Act 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. , do pass with the following Strike all after the enacting clause and insert the following: 1. Short title This Act may be cited as the Orange Book Transparency Act of 2020 . 2. Orange Book modernization (a) Submission of patent information for brand name drugs (1) In general Paragraph (1) of section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) ) is amended to read as follows: (b) (1) (A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application— (i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use; (ii) a full list of the articles used as components of such drug; (iii) a full statement of the composition of such drug; (iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (v) such samples of such drug and of the articles used as components thereof as the Secretary may require; (vi) specimens of the labeling proposed to be used for such drug; (vii) any assessments required under section 505B; and (viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that— (I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or (II) claims a method of using such drug for which approval is sought or has been granted in the application. (B) If an application is filed under this subsection for a drug, and a patent of the type described in subparagraph (A)(viii) is issued after the filing date but before approval of the application, the applicant shall amend the application to include the patent number and expiration date. . (b) Subsequent submission of patent information (1) In general Section 505(c)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c)(2) ) is amended— (A) by inserting before the first sentence the following: Not later than 30 days after the date of approval of an application submitted under subsection (b), the holder of the approved application shall file with the Secretary the patent number and the expiration date of any patent described in subsection (b)(1)(A)(viii), except that a patent that is identified as claiming a method of using such drug shall be filed only if the patent claims a method of use approved in the application. If a patent described in subsection (b)(1)(A)(viii) is issued after the date of approval of an application submitted under subsection (b), the holder of the approved application shall, not later than 30 days after the date of issuance of the patent, file the patent number and the expiration date of the patent, except that a patent that claims a method of using such drug shall be filed only if approval for such use has been granted in the application. ; (B) in the first sentence following the sentences added by subparagraph (A), by striking which claims the drug for which and all that follows through of the drug. and inserting described in subsection (b)(1)(A)(viii). ; (C) in the second sentence following the sentences added by subparagraph (A), by inserting after could not file patent information under subsection (b) because no patent the following: of the type for which information is required to be submitted in subsection (b)(1)(A)(viii) ; and (D) by adding at the end the following: Patent information that is not the type of patent information required by subsection (b)(1)(A)(viii) shall not be submitted under this paragraph. . (2) Updating list 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 by striking (b) or . (c) 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 any exclusivity period that is applicable, for which the Secretary has determined the expiration date, and for which such period has not yet expired, under— (I) clause (ii), (iii), or (iv) of subsection (c)(3)(E); (II) clause (iv) or (v) of paragraph (5)(B); (III) clause (ii), (iii), or (iv) of paragraph (5)(F); (IV) section 505A; (V) section 505E; (VI) section 527(a); or (VII) subsection (u). . (d) Orange book updates with respect to invalidated patents (1) Amendment 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) In the case of a listed drug for which the list under subparagraph (A)(i) includes a patent for such drug, and any claim of the patent has been cancelled or invalidated pursuant to a final decision issued by the Patent Trial and Appeal Board of the United States Patent and Trademark Office or by a court, from which no appeal has been, or can be, taken, if the holder of the applicable application approved under subsection (c) determines that a patent for such drug, or any patent information for such drug, no longer meets the listing requirements under this section— (i) the holder of such approved application shall notify the Secretary, in writing, within 14 days of such decision of such cancellation or invalidation and request that such patent or patent information, as applicable, be amended or withdrawn in accordance with the decision issued by the Patent Trial and Appeal Board or a court; (ii) the holder of such approved application shall include in any notification under clause (i) information related to such patent cancellation or invalidation decision and submit such information, including a copy of such decision, to the Secretary; and (iii) the Secretary shall, in response to a notification under clause (i), amend or remove patent or patent information in accordance with the relevant decision from the Patent Trial and Appeals Board or court, as applicable, except that the Secretary shall not remove from the list any patent or patent information 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). . (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. (e) Review and report Not later than 1 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) solicit public comment regarding the types of patent information that should be included on, or removed from, the list under section 507(j)(7) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(7) ); and (2) transmit to Congress a summary of such comments and actions the Food and Drug Administration is considering taking, if any, in response to public comment pursuant to paragraph (1) about the types of patent information that should be included or removed from such list. (f) GAO report to congress (1) In general Not later than 2 years 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 Health, Education, Labor, and Pensions of the Senate and 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) ) that claim an active ingredient or formulation of a drug in combination with a device that is used for delivery of such drug, including an analysis of such patents and their claims. (2) Content The Comptroller General shall include in the report under paragraph (1)— (A) data on— (i) the number of 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) ) that claim the active ingredient or formulation of a drug in combination with a device that is used for delivery of the drug, and that together claim the finished dosage form of the drug; and (ii) the number of claims with respect to each patent included in the list published under such section 505(j)(7) 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; (B) an analysis of the listing of patents described in subparagraph (A)(ii), including the timing of listing such patents in relation to patents described in subparagraph (A)(i), and the effect listing the patents described in subparagraph (A)(ii) has on market entry of one or more drugs approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act as compared to the effect of not listing the patents described in subparagraph (A)(ii); and (C) recommendations about which kinds of patents relating to devices described in subparagraph (A)(i) should be submitted to the Secretary of Health and Human Services for inclusion on the list under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act and which patents should not be required to be so submitted in order to reduce barriers to approval and market entry. (g) Conforming amendments Section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) is amended— (1) in subsection (c)(3)(E), by striking clause (A) of subsection (b)(1) each place it appears and inserting subsection (b)(1)(A)(i) ; and (2) in subsection (j)(2)(A)(vi), by striking clauses (B) through (F) of subsection (b)(1) and inserting clauses (ii) through (vi) of subsection (b)(1)(A) .

Secretary

tv_txt: I One Hundred Sixteenth Congress of the United States of America At the Second Session Begun and held at the City of Washington on Friday, the third day of January, two thousand and twenty H. R. 1503 AN ACT 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.

1. Short title This Act may be cited as the Orange Book Transparency Act of 2020 . 2. Orange Book modernization (a) Submission of patent information for brand name drugs (1) In general Paragraph (1) of section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) ) is amended to read as follows: (b) (1) (A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application— (i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use; (ii) a full list of the articles used as components of such drug; (iii) a full statement of the composition of such drug; (iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (v) such samples of such drug and of the articles used as components thereof as the Secretary may require; (vi) specimens of the labeling proposed to be used for such drug; (vii) any assessments required under section 505B; and (viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that— (I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or (II) claims a method of using such drug for which approval is sought or has been granted in the application. (B) If an application is filed under this subsection for a drug, and a patent of the type described in subparagraph (A)(viii) is issued after the filing date but before approval of the application, the applicant shall amend the application to include the patent number and expiration date. . (b) Subsequent submission of patent information (1) In general Section 505(c)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c)(2) ) is amended— (A) by inserting before the first sentence the following: Not later than 30 days after the date of approval of an application submitted under subsection (b), the holder of the approved application shall file with the Secretary the patent number and the expiration date of any patent described in subsection (b)(1)(A)(viii), except that a patent that is identified as claiming a method of using such drug shall be filed only if the patent claims a method of use approved in the application. If a patent described in subsection (b)(1)(A)(viii) is issued after the date of approval of an application submitted under subsection (b), the holder of the approved application shall, not later than 30 days after the date of issuance of the patent, file the patent number and the expiration date of the patent, except that a patent that claims a method of using such drug shall be filed only if approval for such use has been granted in the application. ; (B) in the first sentence following the sentences added by subparagraph (A), by striking which claims the drug for which and all that follows through of the drug. and inserting described in subsection (b)(1)(A)(viii). ; (C) in the second sentence following the sentences added by subparagraph (A), by inserting after could not file patent information under subsection (b) because no patent the following: of the type for which information is required to be submitted in subsection (b)(1)(A)(viii) ; and (D) by adding at the end the following: Patent information that is not the type of patent information required by subsection (b)(1)(A)(viii) shall not be submitted under this paragraph. . (2) Updating list 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 by striking (b) or . (c) 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 any exclusivity period that is applicable, for which the Secretary has determined the expiration date, and for which such period has not yet expired, under— (I) clause (ii), (iii), or (iv) of subsection (c)(3)(E); (II) clause (iv) or (v) of paragraph (5)(B); (III) clause (ii), (iii), or (iv) of paragraph (5)(F); (IV) section 505A; (V) section 505E; (VI) section 527(a); or (VII) subsection (u). . (d) Orange book updates with respect to invalidated patents (1) Amendment 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) In the case of a listed drug for which the list under subparagraph (A)(i) includes a patent for such drug, and any claim of the patent has been cancelled or invalidated pursuant to a final decision issued by the Patent Trial and Appeal Board of the United States Patent and Trademark Office or by a court, from which no appeal has been, or can be, taken, if the holder of the applicable application approved under subsection (c) determines that a patent for such drug, or any patent information for such drug, no longer meets the listing requirements under this section— (i) the holder of such approved application shall notify the Secretary, in writing, within 14 days of such decision of such cancellation or invalidation and request that such patent or patent information, as applicable, be amended or withdrawn in accordance with the decision issued by the Patent Trial and Appeal Board or a court; (ii) the holder of such approved application shall include in any notification under clause (i) information related to such patent cancellation or invalidation decision and submit such information, including a copy of such decision, to the Secretary; and (iii) the Secretary shall, in response to a notification under clause (i), amend or remove patent or patent information in accordance with the relevant decision from the Patent Trial and Appeals Board or court, as applicable, except that the Secretary shall not remove from the list any patent or patent information 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). . (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. (e) Review and report Not later than 1 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) solicit public comment regarding the types of patent information that should be included on, or removed from, the list under section 507(j)(7) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(7) ); and (2) transmit to Congress a summary of such comments and actions the Food and Drug Administration is considering taking, if any, in response to public comment pursuant to paragraph (1) about the types of patent information that should be included or removed from such list. (f) GAO report to congress (1) In general Not later than 2 years 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 Health, Education, Labor, and Pensions of the Senate and 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) ) that claim an active ingredient or formulation of a drug in combination with a device that is used for delivery of such drug, including an analysis of such patents and their claims. (2) Content The Comptroller General shall include in the report under paragraph (1)— (A) data on— (i) the number of 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) ) that claim the active ingredient or formulation of a drug in combination with a device that is used for delivery of the drug, and that together claim the finished dosage form of the drug; and (ii) the number of claims with respect to each patent included in the list published under such section 505(j)(7) 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; (B) an analysis of the listing of patents described in subparagraph (A)(ii), including the timing of listing such patents in relation to patents described in subparagraph (A)(i), and the effect listing the patents described in subparagraph (A)(ii) has on market entry of one or more drugs approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act as compared to the effect of not listing the patents described in subparagraph (A)(ii); and (C) recommendations about which kinds of patents relating to devices described in subparagraph (A)(i) should be submitted to the Secretary of Health and Human Services for inclusion on the list under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act and which patents should not be required to be so submitted in order to reduce barriers to approval and market entry. (g) Conforming amendments Section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) is amended— (1) in subsection (c)(3)(E), by striking clause (A) of subsection (b)(1) each place it appears and inserting subsection (b)(1)(A)(i) ; and (2) in subsection (j)(2)(A)(vi), by striking clauses (B) through (F) of subsection (b)(1) and inserting clauses (ii) through (vi) of subsection (b)(1)(A) .

Speaker of the House of Representatives. Vice President of the United States and President of the Senate.