Bill > HR1503

This bill, the Orange Book Transparency Act of 2020, aims to modernize the "Orange Book" - a list maintained by the Food and Drug Administration (FDA) that contains information about patents and exclusivities for brand-name drugs. The key provisions include: 1) Requiring drug manufacturers to submit additional patent information when filing a new drug application, including patent numbers, expiration dates, and information on whether the patent claims the drug substance, drug product, or a method of using the drug. 2) Requiring drug manufacturers to submit patent information within 30 days of a drug's approval or patent issuance, and specifying that only certain types of patents must be submitted. 3) Directing the FDA to list any applicable exclusivity periods for each drug in the Orange Book. 4) Requiring drug manufacturers to notify the FDA within 14 days if a patent is cancelled or invalidated, and directing the FDA to update the Orange Book accordingly. 5) Requiring the FDA and the Government Accountability Office to review and report on the types of patent information that should be included in or removed from the Orange Book. The goal of these changes is to improve transparency around the patents and exclusivities associated with brand-name drugs, which can impact the timing of generic drug approvals and market entry.

Business and Industry, Health and Social Services

https://www.congress.gov/bill/116th-congress/house-bill/1503/all-info