What is the legal basis for exemption from replacement deposits?

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Source: FAQ (MPEP-Based) BlueIron Update: 2024-09-30 5 Rules 5 Related FAQs This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice. 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. Related Rules from the Manual of Patent Examining Procedure 5 rules Collapse Replacement Deposit Not Required for National Security, Health, or Environmental Safety Reasons MPEP 2407.05 No Replacement Deposit If Samples Cannot Be Furnished Outside Jurisdiction Due to National Security, Health, or Environmental Safety Reasons MPEP 2407.05 Prohibited Access to Patent Applications Except PTAB Proceedings MPEP 1002.02(b) Access to Firm's Patent Applications for Registered Members with Signatory Power MPEP 104 Required Procedure for Making PTO Board Decisions Public MPEP 103 Other Related FAQs 5 FAQs Collapse How does the Budapest Treaty relate to exemptions from replacement deposits? What are the specific conditions for exemption from replacement deposits? What happens if a depository cannot furnish samples due to jurisdicti...