Affordable Prescriptions for Patients Act of 2023
This bill limits in certain instances the number of patents that a reference biological product manufacturer can assert in a patent infringement lawsuit against a company seeking to sell a biosimilar version.
Specifically, if the biosimilar manufacturer completes certain actions as part of an abbreviated pathway to get market approval, the bill limits, subject to exceptions and waivers, the number of certain types of patents that the reference product manufacturer may assert, such as patents filed more than four years after the reference product received market approval.
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