Preserve Access to Affordable Generics and Biosimilars Act

Bill: 118-s-142
Sponsor: Sen. Klobuchar, Amy [D-MN]
Introduced: 2023-01-30 in the Senate
Policy area: Health
Subjects: Administrative law and regulatory procedures
Civil actions and liability
Competition and antitrust
Contracts and agency
Federal Trade Commission (FTC)
Intellectual property
Judicial review and appeals
Licensing and registrations
Manufacturing
Marketing and advertising
Prescription drugs

Summary:
action_date: 2023-01-30
text: 

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 and secure final approval for 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.

action_date: 2023-03-01
text: 

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 and secure final approval for 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.


Legislative actions:
action_date: 2023-03-01
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 20.
action_date: 2023-03-01
text: Committee on the Judiciary. Reported by Senator Durbin with an amendment in the nature of a substitute. Without written report.
action_date: 2023-03-01
text: Committee on the Judiciary. Reported by Senator Durbin with an amendment in the nature of a substitute. Without written report.
action_date: 2023-02-09
text: Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
action_date: 2023-01-30
text: Read twice and referred to the Committee on the Judiciary.
action_date: 2023-01-30
text: Introduced in Senate