Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Congressional Research Service
Official summary
Version 00 · Introduced in Senate · May 22, 2019
Second Look at Drug Patents Act of 2019
This bill addresses the publication of drug patent information.
Drug manufacturers must submit patent information to the U.S. Patent and Trademark Office (USPTO) within 30 days following approval of a new drug application or an abbreviated new drug application. For patents issued after approval of an application, a drug manufacturer must submit the required patent information within 30 days of issuance. The USPTO must publish the patent information and invite requests for patent validity challenges.
The Food and Drug Administration must provisionally list in the Approved Drug Products with Therapeutic Equivalence Evaluations publication (commonly known as the Orange Book) a drug patent submitted to the USPTO in accordance with this bill until the Patent Trial and Appeal Board confirms the patent to be patentable or the patent is not challenged within a specific time frame.
Source last updated: Apr 21, 2025. Consult Congress.gov for the current record.
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