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Bill116th CongressFiled Apr 29, 2019Health
H.R. 2375

Preserve Access to Affordable Generics and Biosimilars Act

Bill journey · stage 2 of 5

Under committee review

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What it doesSummary reported to house, part i (Dec 24, 2020)

Preserve Access to Affordable Generics and Biosimilars Act

This bill authorizes the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement is presumed to have anticompetitive effects and is a violation of this bill if the filer of the generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar.

An agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects.

When a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing, or sale of a drug, the manufacturers must certify that the material they have given the FTC concerning the agreement contains the complete agreement and any agreements related to that main agreement, including descriptions of any oral agreements or representations.

The bill imposes penalties for violations of this bill, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.

What just happenedDec 24, 2020

Placed on the Union Calendar, Calendar No. 576.

Who’s behind it

Rep. Nadler, Jerrold [D-NY-10](D-NY)Sponsor
4 cosponsors2 D2 R
Read on Congress.gov
4cosponsors2committees12actions2related bills11subjects
  1. Dec 24, 2020CalendarsH12410

    Placed on the Union Calendar, Calendar No. 576.

  2. Dec 24, 2020DischargeH12300

    Committee on Energy and Commerce discharged.

    Energy and Commerce Committee
  3. Dec 24, 2020Committee5500

    Committee on Energy and Commerce discharged.

    Energy and Commerce Committee
  4. Dec 24, 2020CommitteeH12200

    Reported by the Committee on Judiciary. H. Rept. 116-693, Part I.

    Judiciary Committee
  5. Dec 24, 2020Committee5000

    Reported by the Committee on Judiciary. H. Rept. 116-693, Part I.

    Judiciary Committee
  6. Apr 30, 2019Committee

    Ordered to be Reported by Voice Vote.

    Judiciary Committee
  7. Apr 30, 2019Committee

    Committee Consideration and Mark-up Session Held.

    Judiciary Committee
  8. Apr 30, 2019Committee

    Referred to the Subcommittee on Health.

    Health Subcommittee
  9. Apr 29, 2019IntroReferralH11100

    Referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

    Energy and Commerce Committee
  10. Apr 29, 2019IntroReferralH11100

    Referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

    Judiciary Committee
  11. Apr 29, 2019IntroReferralIntro-H

    Introduced in House

  12. Apr 29, 2019IntroReferral1000

    Introduced in House

Reported to House, Part IDec 24, 20208

Preserve Access to Affordable Generics and Biosimilars Act

This bill authorizes the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement is presumed to have anticompetitive effects and is a violation of this bill if the filer of the generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar.

An agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects.

When a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing, or sale of a drug, the manufacturers must certify that the material they have given the FTC concerning the agreement contains the complete agreement and any agreements related to that main agreement, including descriptions of any oral agreements or representations.

The bill imposes penalties for violations of this bill, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.

Introduced in HouseApr 29, 2019

Preserve Access to Affordable Generics and Biosimilars Act

This bill authorizes the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement is presumed to have anticompetitive effects and is a violation of this bill if the filer of the generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar.

An agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects.

When a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing, or sale of a drug, the manufacturers must certify that the material they have given the FTC concerning the agreement contains the complete agreement and any agreements related to that main agreement, including descriptions of any oral agreements or representations.

The bill imposes penalties for violations of this bill, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.

Preserve Access to Affordable Generics and Biosimilars Act — Informed