What is the significance of ‘publicly available material’ in biological patent applications?

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Source: FAQ (MPEP-Based) BlueIron Update: 2024-09-30 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. ‘Publicly available material’ plays a crucial role in determining whether a biological material deposit is necessary for a patent application. According to MPEP 2404.02 : “No deposit is required, however, where the required biological materials can be obtained from publicly available material with only routine experimentation and a reliable screening test.” The significance of publicly available material is that: It can eliminate the need for a biological deposit It demonstrates that the biological material is accessible to those skilled in the art It supports the enablement requirement of the patent application It can reduce costs and simplify the patent application process Applicants should clearly identify and describe any publicly available sources of the biological material in their patent application to potentially avoid the need for a deposit. Related Rules from the Manual of Patent Examining Procedure 10 rules Collapse Publicly Available Biological Material Not Requiring Deposit MPEP 2404 Permitted Patent Application May Reference Biological Material Deposit MPEP 2404 Permitted Deposited Biological Material Is Considered Readily Available Regardless of Access Conditions MPEP 2404 No Deposit When Routinely Obtainable MPEP 2404.02 Required Deposit Not Required Unless Necessary for Patentability MPEP 2404 Biological Material Must Be Known and Readily Available MPEP 2404.01 Required Deposit Required for Undue Experimentation MPEP 2404.02 Required Current Availability Satisfies Biological Material Requirement MPEP 2404.01 Deposit of Biological Material Permitted for Invention Relying on Such Material MPEP 2404 Description of Biological Material Must Be Adequate MPEP 2404.01 Permitted Othe...