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Ensuring robust and reliable biotech and pharmaceutical patents through examiner training on declaratory evidence
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 have 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 on searching publicly available FDA databases and examination of declaratory evidence of unexpected results.
“We are dedicated to continuous enhancement of our training and guidance in all areas of patent examination. This new training on declaratory evidence and our planned training and guidance on searching and unexpected results supports our commitment to ensuring the patent system incentivizes and protects the investments essential for bringing life-saving and life-altering drugs and biologics to market,” said Under Secretary of Commerce and Director of the USPTO Kathi Vidal.
To learn more, visit the USPTO-FDA Collaboration Initiatives webpage.
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