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Public Law116th CongressHealth
H.R. 1503Became Law

Orange Book Transparency Act of 2020

This bill became law

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What it doesSummary public law (Jan 5, 2021)

Orange Book Transparency Act of 2020

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.

What just happenedJan 5, 2021

Became Public Law No: 116-290.

Who’s behind it

Rep. Kelly, Robin L. [D-IL-2](D-IL)Sponsor
13 cosponsors12 D1 R
Read on Congress.gov
13cosponsors2committees37actions1amendments2related bills7subjects
  1. Jan 5, 2021President

    Became Public Law No: 116-290.

  2. Jan 5, 2021BecameLaw36000

    Became Public Law No: 116-290.

  3. Jan 5, 2021President

    Signed by President.

  4. Jan 5, 2021BecameLaw36000

    Signed by President.

  5. Dec 24, 2020Floor

    Presented to President.

  6. Dec 24, 2020President28000

    Presented to President.

  7. Dec 10, 2020ResolvingDifferencesH41931

    Motion to reconsider laid on the table Agreed to without objection.

  8. Dec 10, 2020ResolvingDifferencesH41610

    On motion that the House agree to the Senate amendment Agreed to without objection. (text: CR H7130-7131)

  9. Dec 10, 2020NotUsed19500

    Resolving differences -- House actions: On motion that the House agree to the Senate amendment Agreed to without objection.(text: CR H7130-7131)

  10. Dec 10, 2020FloorH8D000

    Mrs. Dingell asked unanimous consent to take the bill, H.R. 1503 from the Speaker's Table and agree to the Senate amendment. (consideration: CR H7130-7131)

  11. Dec 10, 2020ResolvingDifferencesH40110

    Mrs. Dingell asked unanimous consent that the House agree to the Senate amendment.

  12. Dec 8, 2020Floor

    Message on Senate action sent to the House.

  13. Dec 7, 2020Floor

    Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S7242-7243)

  14. Dec 7, 2020Floor17000

    Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.(text of amendment in the nature of a substitute: CR S7242-7243)

  15. Dec 7, 2020Discharge

    Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.

    Health, Education, Labor, and Pensions Committee
  16. Dec 7, 2020Committee14500

    Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.

    Health, Education, Labor, and Pensions Committee
  17. Dec 7, 2020Floor

    Measure laid before Senate by unanimous consent. (consideration: CR S7244)

  18. May 9, 2019IntroReferral

    Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

    Health, Education, Labor, and Pensions Committee
  19. May 8, 2019FloorH38310

    Motion to reconsider laid on the table Agreed to without objection.

  20. May 8, 2019FloorH37300

    On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 422 - 0 (Roll no. 187). (text: CR H3486-3487)

  21. May 8, 2019Floor8000

    Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 422 - 0 (Roll no. 187).(text: CR H3486-3487)

  22. May 8, 2019FloorH30000

    Considered as unfinished business. (consideration: CR H3491)

  23. May 8, 2019FloorH37220

    At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.

  24. May 8, 2019FloorH8D000

    DEBATE - The House proceeded with forty minutes of debate on H.R. 1503.

  25. May 8, 2019FloorH30000

    Considered under suspension of the rules. (consideration: CR H3486-3488)

  26. May 8, 2019FloorH30300

    Ms. Eshoo moved to suspend the rules and pass the bill, as amended.

  27. May 2, 2019CalendarsH12410

    Placed on the Union Calendar, Calendar No. 25.

  28. May 2, 2019CommitteeH12200

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-47.

    Energy and Commerce Committee
  29. May 2, 2019Committee5000

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-47.

    Energy and Commerce Committee
  30. Apr 3, 2019Committee

    Ordered to be Reported (Amended) by Voice Vote.

    Energy and Commerce Committee
  31. Apr 3, 2019Committee

    Committee Consideration and Mark-up Session Held.

    Energy and Commerce Committee
  32. Mar 27, 2019Committee

    Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .

    Health Subcommittee
  33. Mar 27, 2019Committee

    Subcommittee Consideration and Mark-up Session Held.

    Health Subcommittee
  34. Mar 6, 2019Committee

    Referred to the Subcommittee on Health.

    Health Subcommittee
  35. Mar 5, 2019IntroReferralH11100

    Referred to the House Committee on Energy and Commerce.

    Energy and Commerce Committee
  36. Mar 5, 2019IntroReferralIntro-H

    Introduced in House

  37. Mar 5, 2019IntroReferral1000

    Introduced in House

Public LawJan 5, 202149

Orange Book Transparency Act of 2020

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.

Introduced in HouseMar 5, 2019

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.

Orange Book Transparency Act of 2020 — Informed