The United States Patent and Trademark Office (USPTO) works closely with the U.S. Food and Drug Administration (FDA) on a number of collaboration initiatives, including providing training to patent examiners so they have the key information needed when deciding whether to grant patent rights.
As part of our commitment to ensure robust and reliable patent rights for biotech and pharmaceutical inventions, we developed USPTO training materials on declaration practice under 37 CFR §1.132. These training materials were presented to the public at the Biotechnology, Chemical, and Pharmaceutical Partnership Meeting on March 28, 2023.
We also plan to provide additional examiner training and guidance this year to biotech and pharmaceutical patent examiners on searching publicly available FDA databases and examination of declaratory evidence of unexpected results.
To learn more, visit the USPTO-FDA Collaboration Initiatives webpage.