Summary: S.1416 — 116th Congress (2019-2020)All Information (Except Text)

There is one summary for S.1416. Bill summaries are authored by CRS.

Shown Here:
Introduced in Senate (05/09/2019)

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.