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S. 1041119th Congress
Official title: Affordable Prescriptions for Patients Act
Introduced:
Read the official bill on Congress.govThe plain-language version leads. The official text is always the reference.
The bill caps brand-name biologic makers at generally 20 patents when suing biosimilar competitors for infringement.
45-second read · 4 questions answered below
The bill limits how many patents a brand-name biologic manufacturer can use to sue a biosimilar maker for infringement, generally capping it at 20 patents, with no more than 10 issued after a certain approval stage. Courts may allow more patents for good reason, such as significant product changes or withheld information by the biosimilar maker. The cap does not apply to patents covering new medical uses of the drug.
The bill mainly affects pharmaceutical companies that make original biologic drugs and those seeking to make biosimilar versions. It could indirectly affect patients and insurers.
Supporters argue reducing patent thickets could speed biosimilar competition and affect drug prices, while brand-name manufacturers may see the limits as restricting their ability to protect their inventions. The changes would apply only to new biosimilar applications filed after the law takes effect.
AI-drafted summary. Verify it against the official text before you act on it. Read the official bill on Congress.gov
Right now: it passed the Senate and now goes to the House. If the House changes it, it goes back to the Senate before reaching the President.
Latest action: — Held at the desk.