Bill > S150

This bill, the Affordable Prescriptions for Patients Act of 2023, amends the Federal Trade Commission Act to prohibit "product hopping," a practice where pharmaceutical companies make minor changes to their drugs to extend their patent exclusivity and delay generic competition. The key provisions of the bill include: 1. Allowing the reference product sponsor (the company that developed the original drug) to assert up to 20 patents against a biosimilar applicant, with no more than 10 of those patents having issued after a certain cutoff date, in an effort to limit the ability of the reference product sponsor to prolong patent exclusivity. 2. Allowing the court to increase the number of patents the reference product sponsor can assert in certain circumstances, such as if the biosimilar applicant fails to provide required information or if there is a material change to the biosimilar product. 3. Exempting patents that claim a method of using the drug product, such as an indication or method of treatment, from the patent limitation. 4. Increasing the Medicare Improvement Fund by $1.8 billion to help fund Medicare-related improvements. The goal of the bill is to facilitate more timely access to lower-cost biosimilar drugs by limiting the ability of reference product sponsors to extend their exclusivity through minor changes to their products.

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https://www.congress.gov/bill/118th-congress/senate-bill/150/all-info