Patenting Germs? USPTO Updates Forms for Storing Tiny Life Forms
Published Date: 3/9/2026
Notice
Summary
The USPTO is asking for your thoughts on renewing a form that helps patent applicants deposit biological materials, like tiny living things, when applying for patents. This update won’t cost you money but aims to keep paperwork easy and clear. If you want to share your ideas, make sure to comment by April 8, 2026!
Analyzed Economic Effects
4 provisions identified: 0 benefits, 4 costs, 0 mixed.
Estimated Paperwork Burden and Costs
The USPTO estimates 1,501 annual respondents and 1,501 annual responses for this information collection, with each response taking about 1 to 5 hours. The total estimated annual respondent burden is 1,505 hours and the total estimated annual non-hourly cost burden is $4,306,511. Comments on the collection are due by April 8, 2026.
Information You Must Give When Depositing Biologicals
If you submit a patent application that includes a biological material capable of self-replication, you must provide documentation to the USPTO showing compliance with 37 CFR 1.801–1.809. When a deposit is not made under the Budapest Treaty, you must submit a viability statement that includes the depository name and address, depositor name/address, deposit date, deposit identity and accession number, viability test date, sampling procedure (if not done by the depository), and a statement the deposit can reproduce.
What to Report if a Deposit Fails or Changes
If a deposited biological sample is lost, contaminated, or cannot self-replicate, you must notify the USPTO in writing with particulars and, if the patent has already issued, request a certificate of correction. You may also be required to submit verification statements or written notifications that an acceptable deposit will be made after the effective filing date.
Rules to Become a USPTO-Recognized Depository
Institutions that want USPTO recognition as a suitable depository under 37 CFR 1.803(a)(2) must submit detailed information about their name/address, legal status, scientific standing, staff, facilities, the types of biological material they will accept, availability conditions, and any fees they will charge for storage, viability statements, and supplying samples.
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