Affordable Prescriptions for Patients Act

Limits and new rules for biosimilar patents

If enacted, this would set a 20-patent cap for lawsuits tied to an FDA biosimilar application filed after enactment. No more than 10 of those could be later-issued patents listed after the post-approval listing date in the biologics law. The cap would not cover patents on methods of using the drug for treatment, diagnosis, or prevention. The cap would apply only if the biosimilar maker completes the required patent information exchange, list sharing, negotiation, and notice steps in the biologics process. Courts would be able to raise the cap for good cause, such as missing information from the applicant, major changes to the product or process, or patent-office delays. The bill would also confirm that infringement in these cases would include patents on the drug, its uses, and the methods or products used to make it.