Affordable Prescriptions for Patients Act

This bill proposes to limit the number of patents a biologic drug manufacturer can assert in lawsuits against companies seeking to market lower-cost biosimilar versions of their products. These limits would apply to specific types of patents, such as those filed more than four years after the original drug received approval, provided the biosimilar manufacturer meets certain information-sharing requirements. Courts would retain the authority to increase these patent limits if justice requires or if there is good cause shown.

This bill primarily affects manufacturers of biologic drugs and companies seeking to market biosimilar versions of those drugs. It also impacts the federal court system, which is granted the authority to adjust patent assertion limits based on the interests of justice or good cause. Additionally, the legislation affects the Food and Drug Administration's abbreviated approval process for biosimilar products.

• Limits on patent assertions in biologic drug litigation. The bill restricts the number of patents a biologic drug manufacturer can assert in lawsuits against companies seeking to market biosimilar versions of their products.
• Criteria for patent limitations. The limits apply to specific patents, such as those filed more than four years after the original biologic received market approval, provided the biosimilar manufacturer shares certain product information.
• Exemptions for specific patent types. The restriction on the number of assertable patents does not apply to patents that claim certain methods for using the biologic drug.
• Judicial discretion for patent limit increases. A court may increase the number of patents allowed in a lawsuit if it determines that justice requires it or if there is good cause for the increase.

The bill modifies the existing legal framework governing the abbreviated Food and Drug Administration approval process for biosimilar drugs by placing new limits on the number of patents a biologic manufacturer can assert during infringement litigation.

The bill aims to facilitate the market entry of lower-cost biosimilar drugs by limiting the number of patents a biologic drug manufacturer can assert during infringement litigation. It establishes these limits for specific patent types, such as those filed more than four years after the original drug's approval, provided the biosimilar manufacturer follows certain information-sharing requirements.