Affordable Prescriptions for Patients Act of 2023

Bill: 118-s-150
Sponsor: Sen. Cornyn, John [R-TX]
Introduced: 2023-01-30 in the Senate
Policy area: Health
Subjects: Administrative remedies
Civil actions and liability
Competition and antitrust
Consumer affairs
Drug safety, medical device, and laboratory regulation
Federal Trade Commission (FTC)
Health care costs and insurance
Inflation and prices
Intellectual property
Judicial review and appeals
Manufacturing
Prescription drugs

Summary:
action_date: 2023-01-30
text: 

Affordable Prescriptions for Patients Act of 2023 

 
This bill prohibits product hopping by drug manufacturers, authorizes the Federal Trade Commission to enforce this prohibition, and imposes limits on patent litigation involving biological products. 
 
Generally, 
product-hopping
 describes a situation where, when the patents on a reference drug (or biological product) expire, the manufacturer switches to a follow-on product that is covered by a later-expiring patent. Under this bill, a 
follow-on product
 is a modified version of the reference drug that has an indication (what the drug is used for) that is identical or substantially similar to an indication of the reference drug.
 
The bill presumes product hopping has occurred when a reference drug manufacturer, after receiving notice that the Food and Drug Administration (FDA) has received an application to market a competing generic (or biosimilar) version, takes certain actions such as withdrawing the reference drug from the market and selling a follow-on product. 
 
A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition.
 
The bill also limits in certain instances the number of patents that a reference biological product manufacturer can assert in a patent infringement lawsuit against a company seeking to sell a biosimilar version. Specifically, if the biosimilar manufacturer completes certain actions as part of an abbreviated pathway to get FDA market approval, the bill limits, subject to exceptions and waivers, the number of certain types of patents that the reference product manufacturer may assert, such as patents filed more than four years after the reference product received market approval. 
 
 

action_date: 2023-03-01
text: 

Affordable Prescriptions for Patients Act of 2023 

 
This bill prohibits product hopping by drug manufacturers, authorizes the Federal Trade Commission to enforce this prohibition, and imposes limits on patent litigation involving biological products. 
 
Generally, 
product-hopping
 describes a situation where, when the patents on a reference drug (or biological product) expire, the manufacturer switches to a follow-on product that is covered by a later-expiring patent. Under this bill, a 
follow-on product
 is a modified version of the reference drug that has an indication (what the drug is used for) that is identical or substantially similar to an indication of the reference drug.
 
The bill presumes product hopping has occurred when a reference drug manufacturer, after receiving notice that the Food and Drug Administration (FDA) has received an application to market a competing generic (or biosimilar) version, takes certain actions such as withdrawing the reference drug from the market and selling a follow-on product. 
 
A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition.
 
The bill also limits in certain instances the number of patents that a reference biological product manufacturer can assert in a patent infringement lawsuit against a company seeking to sell a biosimilar version. Specifically, if the biosimilar manufacturer completes certain actions as part of an abbreviated pathway to get FDA market approval, the bill limits, subject to exceptions and waivers, the number of certain types of patents that the reference product manufacturer may assert, such as patents filed more than four years after the reference product received market approval. 
 
 

action_date: 2024-07-11
text: 

Affordable Prescriptions for Patients Act of 2023 

This bill limits in certain instances the number of patents that a reference biological product manufacturer can assert in a patent infringement lawsuit against a company seeking to sell a biosimilar version. 

Specifically, if the biosimilar manufacturer completes certain actions as part of an abbreviated pathway to get market approval, the bill limits, subject to exceptions and waivers, the number of certain types of patents that the reference product manufacturer may assert, such as patents filed more than four years after the reference product received market approval.

 

 


Legislative actions:
action_date: 2024-07-15
text: Held at the desk.
action_date: 2024-07-15
text: Received in the House.
action_date: 2024-07-12
text: Message on Senate action sent to the House.
action_date: 2024-07-11
text: Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S4537-4538)
action_date: 2024-07-11
text: Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
action_date: 2024-07-11
text: Measure laid before Senate by unanimous consent. (consideration: CR S4537-4538)
action_date: 2023-03-01
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 22.
action_date: 2023-03-01
text: Committee on the Judiciary. Reported by Senator Durbin without amendment. Without written report.
action_date: 2023-03-01
text: Committee on the Judiciary. Reported by Senator Durbin without amendment. Without written report.
action_date: 2023-02-09
text: Committee on the Judiciary. Ordered to be reported without amendment 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