Requires sponsors or holders of drug and biological products to provide and certify specified patent-related information to both the Food and Drug Administration (FDA) and the United States Patent and Trademark Office (USPTO). The measure defines what counts as “information material to patentability,” clarifies which patents are “applicable patents,” directs USPTO confidentiality protections, and changes enforcement rules by adding a nondisclosure defense in certain patent lawsuits.

The change is aimed at creating a formal information flow between product sponsors and federal agencies to improve patent transparency around drug and biologic approvals, while protecting confidential information and adjusting litigation tools and defenses.