What is the legal basis for exemption from replacement deposits?
The legal basis for exemption from replacement deposits of biological materials is provided in the Code of Federal Regulations and is referenced in the Manual of Patent Examining Procedure (MPEP). Specifically:
“The provisions of 37 CFR 1.805(h) indicate that a replacement deposit is not required even though the depository cannot furnish samples, under certain conditions, to those requesting a sample outside of the jurisdiction where the depository is located.”
This regulation is part of the broader framework governing biological deposits in patent applications. The MPEP also notes that this provision is consistent with international agreements, stating: “See also Article 5 of the Budapest Treaty.” The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure provides international standards for biological deposits.
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