Affordable Prescriptions for Patients Act
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed Senate
- Passed House
- To President
- Became Law
Overview
The Affordable Prescriptions for Patients Act aims to reduce barriers to biosimilar drug development by limiting the number of patents that reference product manufacturers can assert against companies seeking to market biosimilar versions. Specifically, it restricts the number of patents a reference product manufacturer can use in an infringement lawsuit to a maximum of 20, with a limit of 10 patents filed more than four years after the original drug’s approval. This legislation seeks to encourage competition and potentially lower drug costs for patients.
Key provisions
- Limits the number of patents a reference product manufacturer can assert in an infringement lawsuit to 20.
- Limits the number of patents filed more than four years after the reference product’s approval to 10.
- Applies to lawsuits filed against companies seeking to market biosimilar versions of drugs.
- Allows a court to increase the patent limit if justice requires or for good cause.
- Excludes patents claiming methods for using the biologic drug.
- Requires the biosimilar manufacturer to complete specific actions under the abbreviated approval process.
- The limitation does not apply to patents covering methods of using the biologic drug for therapy, diagnosis, or prophylaxis.
- Provides a mechanism for the court to increase the patent limit if the biosimilar applicant fails to provide necessary information.
Who is affected
Bill text
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Sponsors
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4 on record
Primary sponsor
Cosponsors
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