Affordable Prescriptions for Patients Act

The Affordable Prescriptions for Patients Act would modify patent rules in disputes between biologic drug manufacturers and companies seeking to sell biosimilar alternatives. Under current law, biosimilar manufacturers can use an abbreviated approval process with the FDA. This bill would limit which patents the original drug manufacturer can assert in lawsuits against biosimilar competitors, specifically excluding patents filed more than four years after the original drug received market approval. Courts could increase these limits if they determine justice requires it.

If enacted, this bill could potentially lower costs for consumers by making it easier for biosimilar manufacturers to bring cheaper alternatives to market. Biosimilars are substantially similar to original biologic drugs but typically cost less. By restricting the patents that original manufacturers can use defensively, the bill aims to reduce legal barriers that might otherwise delay or prevent biosimilar competition. The bill has passed committee review and is eligible for a floor vote in the Senate.