Affordable Prescriptions for Patients Act of 2019
This bill prohibits product hopping by drug manufacturers. Product hopping is presumed when a drug manufacturer engages is a hard switch or a soft switch. A hard switch occurs when, after a manufacturer receives notice of an application for a generic drugs, either, (1) the manufacturer obtains removal of a drug from the Food and Drug Administration’s approved drug list or the drug is moved to the discontinued products list, and the manufacturer markets or sells a follow-on product; or (2) a manufacturer announces the withdrawal or discontinuance of a listed drug, or the manufacturer destroys the inventory of a listed drug in a manner that impedes generic drug competitors, and the manufacturer markets or sells a follow-on product. A follow-on product is a changed, modified, or reformulated version of a manufacturer’s already-approved drug or biological product that still treats the same medical condition.
A soft switch occurs when a manufacturer receives notice of an application for a generic drugs, takes other actions that impede generic drug competitors, and the manufacturer markets or sells a follow-on product.
A drug manufacturer may rebut a presumption of product hopping by demonstrating that its conduct was not intended to limit competition.
This bill also limits the number of patents that may be included in infringement claims brought by approved biological product license holders against applicants for a biosimilar product license.
Affordable Prescriptions for Patients Act of 2019
Bill journey · stage 2 of 5
Under committee review
What it doesSummary reported to senate (Jun 28, 2019)
Affordable Prescriptions for Patients Act of 2019
This bill prohibits product hopping by drug manufacturers. Product hopping is presumed when a drug manufacturer engages is a hard switch or a soft switch. A hard switch occurs when, after a manufacturer receives notice of an application for a generic drugs, either, (1) the manufacturer obtains removal of a drug from the Food and Drug Administration’s approved drug list or the drug is moved to the discontinued products list, and the manufacturer markets or sells a follow-on product; or (2) a manufacturer announces the withdrawal or discontinuance of a listed drug, or the manufacturer destroys the inventory of a listed drug in a manner that impedes generic drug competitors, and the manufacturer markets or sells a follow-on product. A follow-on product is a changed, modified, or reformulated version of a manufacturer’s already-approved drug or biological product that still treats the same medical condition.
A soft switch occurs when a manufacturer receives notice of an application for a generic drugs, takes other actions that impede generic drug competitors, and the manufacturer markets or sells a follow-on product.
A drug manufacturer may rebut a presumption of product hopping by demonstrating that its conduct was not intended to limit competition.
This bill also limits the number of patents that may be included in infringement claims brought by approved biological product license holders against applicants for a biosimilar product license.
What just happenedJun 28, 2019
Placed on Senate Legislative Calendar under General Orders. Calendar No. 132.
Who’s behind it
- Reported to SenateJun 28, 2019
- Introduced in SenateMay 9, 2019
- Jun 28, 2019Calendars
Placed on Senate Legislative Calendar under General Orders. Calendar No. 132.
- Jun 28, 2019Committee
Committee on the Judiciary. Reported by Senator Graham with an amendment in the nature of a substitute. Without written report.
Judiciary Committee - Jun 28, 2019Committee14000
Committee on the Judiciary. Reported by Senator Graham with an amendment in the nature of a substitute. Without written report.
Judiciary Committee - Jun 27, 2019Committee
Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
Judiciary Committee - May 9, 2019IntroReferral
Read twice and referred to the Committee on the Judiciary.
Judiciary Committee - May 9, 2019IntroReferral10000
Introduced in Senate
Affordable Prescriptions for Patients Act of 2019
This bill prohibits patent thicketing and product hopping by drug manufacturers. In general, patent thicketing occurs when a drug manufacturer obtains new patents related to a previously-patented drug, biological product, or underlying chemical composition that extends the manufacturer’s market exclusivity for that drug without demonstrating that the new patents serve a meaningful purpose other than limiting competition from generic drug manufacturers.
Product hopping is presumed when a drug manufacturer obtains removal of a drug from the Food and Drug Administration’s approved drug list, discontinues a drug, or markets a reformulation of an already-approved drug during a certain period after which the manufacturer has been notified that a competing drug manufacturer has applied for generic drug approval. These practices are not considered product hopping if the manufacturer demonstrates that the drug was removed from the approved-drug list for safety reasons. Or, in the case of a drug reformulation, the manufacturer shows that the modified product provides a significant health benefit, is the option least likely to reduce competition, and is based on substantial financial considerations unrelated to limiting competition.
The Federal Trade Commission may penalize violating manufacturers and bring claims in federal court to prohibit the conduct and provide restitution.