Health Law Highlights

USPTO Issues Training Materials to Examiners for Searching FDA and NIH Resources

From Knobbe Martens, by Joseph Mallon, Ashley Morales:

On March 20, 2024, the USPTO issued an alert about new training materials for patent examiners, developed to enhance searches for prior art in FDA and NIH databases. The training was first presented at the Biotechnology, Chemical, and Pharmaceutical Partnership Meeting on March 19, 2024.

The materials guide patent examiners on using various FDA and NIH resources to search for drug information. These resources include FDALabel, Drugs@FDA, and DailyMed. Examiners were also given guidance on how to use Google for searching

These materials were developed as part of the ongoing collaboration between the USPTO and the FDA, initiated by Executive Order 14036, which seeks to promote competition in the American economy. The goal is to balance the patent system to incentivize investments for life-saving drugs and biologics, while preventing its misuse to delay the introduction of affordable generic drugs and biosimilars.

The impact of these training materials on patent examination for brand-name drugs and biologics is yet to be seen. Further examiner training is expected under these ongoing collaboration initiatives.