On March 20, 2024, The USPTO issued an alert, notifying practitioners that the USPTO had developed training materials for patent examiners regarding searching for prior art in FDA and NIH databases.[1] The new training materials were presented to the public at the Biotechnology, Chemical, and Pharmaceutical Partnership Meeting, held in person at the USPTO headquarters in Alexandria, Virginia, and at the USPTO Silicon Valley Regional Office in San Jose, California, on March 19, 2020.[2]
The training materials provide guidance to patent examiners regarding various FDA and NIH resources available to search for drug information.[3] These resources include FDALabel, a “web-based database maintained by FDA, allowing for full-text and structure searching of FDA-approved drug product labeling,” Drugs@FDA, a database containing information about FDA-approved products including prescription and over-the-counter brand-name and generic drug products, and therapeutic biological products, and DailyMed, a database containing labels submitted to the FDA for certain FDA-approved products, as well as some products regulated but not approved by the FDA.[4] In the training materials, examiners were informed about products, information, and search features available for each database.[5] Examiners were also provided with guidance regarding how to use Google to search FDA.gov.[6]
These new training materials were prepared as part of ongoing collaboration initiatives between the USPTO and the FDA to ensure that patent examiners have the necessary information to determine whether to grant patent rights to an applicant.[7] These initiatives were created as a result of Executive Order 14036, on “Promoting Competition in the American Economy,” which stated that “too often, patent and other laws have been misused to inhibit or delay – for years and even decades – competition from generic drugs and biosimilars, denying American’s access to lower-cost drugs.”[8] The goal of these initiatives is to ensure that the patent system incentivizes and protects investments made to bring life-saving and life-altering drugs and biologics to the market, while also ensuring that the patent system is not used to improperly delay bringing affordable generic drugs and biosimilars to market.[9]
How this training material will affect patent examination for brand-name drugs and biologics remains to be seen. However, it is expected that additional examiner training will be provided pursuant to the ongoing collaboration initiatives between the FDA and USPTO.
[1] USPTO ensures robust and reliable patents through examiner training on searching for prior art in FDA and NIH databases, available at https://www.uspto.gov/subscription-center/2024/uspto-ensures-robust-and-reliable-patents-through-examiner-training (last visited March 22, 2024).
[3] TC 16000 Examiner training using FDA and NIH databases to search drugs, formulations , and their methods of treatment and use, available at https://www.uspto.gov/sites/default/files/documents/using_fda_and_nih_databases.pdf?utm_campaign=subscriptioncenter&utm_content=&utm_medium=email&utm_name=&utm_source=govdelivery&utm_term= (last visited March 22, 2024).
[4] Id. at 4, 16, 25, 34.
[7] USPTO ensures robust and reliable patents through examiner training on searching for prior art in FDA and NIH databases, available at https://www.uspto.gov/subscription-center/2024/uspto-ensures-robust-and-reliable-patents-through-examiner-training (last visited March 22, 2024).
[8] Executive Order on Promoting Competition in the American Economy, available at https://www.whitehouse.gov/briefing-room/presidential-actions/2021/07/09/executive-order-on-promoting-competition-in-the-american-economy/ (last visited March 22, 2024).
[9] USPTO-FDA Collaboration Initiatives, available at https://www.uspto.gov/initiatives/fda-collaboration?utm_campaign=subscriptioncenter&utm_content=&utm_medium=email&utm_name=&utm_source=govdelivery&utm_term=(last visited March 22, 2024).
