What are the requirements for a biological deposit to be accepted for patent purposes?
For a biological deposit to be accepted for patent purposes, it must meet specific requirements as outlined in the Manual of Patent Examining Procedure (MPEP). According to MPEP 2411.01:
“Where a deposit is required to satisfy 35 U.S.C. 112, a deposit must be made in accordance with these regulations. See 37 CFR 1.802. A deposit accepted in any International Depositary Authority (IDA) under the Budapest Treaty shall be accepted for patent purposes if made under conditions which comply with 37 CFR 1.806 and 37 CFR 1.808(a) concerning term of deposit and permissible conditions on access once the patent is granted.”
In summary, the deposit must be:
- Made in accordance with 37 CFR 1.802
- Accepted in an International Depositary Authority (IDA) under the Budapest Treaty
- Compliant with 37 CFR 1.806 regarding the term of deposit
- Compliant with 37 CFR 1.808(a) concerning permissible conditions on access once the patent is granted
These requirements ensure that the deposited biological material is properly maintained and accessible for the purposes of patent disclosure and enablement.
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