April 1, 2024

20 March 2024 USPTO Alert: USPTO ensures robust and reliable patents through examiner training on searching for prior art in FDA and NIH databases

Takeaways:  FDA databases may contain useful information about the patentability of drugs and validity of drug patents.  Also, remember that documents submitted to FDA and NIH may be material to patentability and, if so, should be disclosed to the USPTO in an Information Disclosure Statement.

USPTO training materials were presented at the Biotechnology, Chemical, and Pharmaceutical Partnership Meeting on March 19, 2024 to help examiners navigate U.S. Food and Drug Administration (FDA) and National Institute of Health (NIH) databases and search non-patent literature on drugs, formulations, and their methods of treatment/use. The following databases are already available to examiners and choosing which database(s) to search depends upon field availability, preference, and case specifics: FDALabel; Drugs@FDA; DailyMed & DailyMed Archive (NIH); and Google search of FDA.gov domains(s).

FDALabel is accessible via https://nctr-crs.fda.gov/fdalabel/ui/search and allows for full-text and structure searching of FDA-approved drug product labeling.

Drugs@FDA is accessible via https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm and contains the most recent labeling submitted to the FDA that may not be FDA approved.

DailyMed is accessible via https://dailymed.nlm.nih.gov/dailymed/ and contains labeling, submitted to the FDA by companies, for FDA-approved products and additional products regulated, but not approved, by the FDA. DailyMed archives can be accessed via the same website.

Google “FDA.gov” – a Google search can be forced to target specific web domains by including “site:” in the search query. For example: “site:fda.gov”

Detailed instructions on navigating each database’s search capabilities can be found in the USPTO training materials.

Note, old FDA documents are archived at https://archive-it.org/organizations/1137. FDALabel, DailyMed, and the DailyMed Archive contain drug labels/inserts only. FDA Label and DailyMed contain current drug labels, while the DailyMed Archive contains retired drug labels. The DailyMed Archive is considered best used to obtain a label with a good priority date after perusing current labels. Although there is overlap, many biological and vaccines fall under different guidance and are therefore not in Drugs@FDA.

Following these training materials, examiners will be able to search and utilize results from FDA and NIH websites and resources; narrow searches to specific dates, drugs, and product sheets; and perform a complete and correct search for a drug, use, dose, or formulation in compliance with the Examiner PAP, MPEP, and best practices.