What is the significance of a Budapest Treaty deposit for biological materials in patent applications?

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Source: FAQ (MPEP-Based) BlueIron Update: 2024-09-29 10 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. A Budapest Treaty deposit can be significant for biological materials in patent applications, but it doesn’t automatically ensure that the material is considered known and readily available. According to MPEP 2404.01 : “Even a deposit made under the Budapest Treaty and referenced in a United States or foreign patent document would not necessarily meet the test for known and readily available unless the deposit was made under conditions that are consistent with those specified in these rules.” The key conditions include: All restrictions on accessibility must be irrevocably removed by the applicant upon granting of the patent (with one possible exception under 37 CFR 1.808(b)). The deposit must have been necessary to overcome a rejection under 35 U.S.C. 112. The record must clearly indicate that the deposit was made under the Budapest Treaty and meets all accessibility requirements. Therefore, while a Budapest Treaty deposit can be valuable, it’s important to ensure it meets all the specific requirements outlined in the USPTO rules to be considered known and readily available. Related Rules from the Manual of Patent Examining Procedure 10 rules Collapse Requirement for Known and Readily Available Biological Material MPEP 2404.01 Required Biological Material Must Be Known and Readily Available MPEP 2404.01 Biological Material Must Be Known and Readily Available MPEP 2404.01 Required Indicia for Known and Readily Available Biological Materials MPEP 2404.01 Permitted Deposit Made Under Budapest Treaty Must Be Accessible MPEP 2404.01 Commercial Availability as Known and Readily Available Evidence MPEP 2404.01 Material Known and Readily Available Must Be Described Adequately MPEP 2404.01 Deposited...