The Affordable Prescriptions for Patients Act (S. 1416), introduced by Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT), was approved unanimously by the Judiciary Committee last week, as amended.
- As originally drafted, the bill would have granted the Federal Trade Commission (FTC) the ability to bring an antitrust action against a drugmaker for filing lawful, valid patents on improvements to a product. This version would have greatly reduced the incentive for making any post-approval improvements to a product and exposed manufacturers to significant liability for doing so.
- Following interventions from key members on the Committee, the broad FTC anti-patent authority as originally proposed was struck from the bill and replaced with a change to the “patent dance” under the Biologics Price Competition and Innovation Act.
- The legislation now places a 20-limit cap – only on certain patents that are filed more than 4 years after approval of an innovative biologic drug – that a branded biologic maker can claim in litigation. In return, biosimilar applicants will have to follow all steps of the “patent dance”— something they currently don’t have to do. While far from perfect, this greatly mitigates the damage that would have been done by the original version of the bill.
What’s next: Further changes are expected as the bill advances through the legislative process.
Drug pricing continues to be one of the few areas of bipartisan agreement, and momentum is building around reforms that will significantly alter the drug cost and innovation ecosystem