Faster Generic Drug Access: Protecting Competition and Lowering Prescription Costs.
This law aims to reduce prescription drug costs by accelerating the market entry of cheaper generic and biosimilar alternatives. It creates a legal 'safe harbor,' protecting generic manufacturers from patent infringement lawsuits if they market their drugs only for uses that are not patented, using restricted 'skinny labels.' This change is expected to increase competition and lower prices for consumers, leading to personal savings.
Key points
Generic drug makers can launch products by excluding patented uses from their labeling, without being sued for infringing the patent on that specific method of use.
The goal is to boost market competition, leading directly to lower prices for many prescription medications for patients.
The protection applies only if the generic company does not promote the drug for the specific patented condition or use.
Introduced
Additional Information
Print number: 119_HR_6485
Sponsor: Rep. Cline, Ben [R-VA-6]