When is a deposit of biological material not necessary for patent applications?

Question

Accepted Answer

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. A deposit of biological material is not necessary for patent applications when the required biological materials can be made or isolated without undue experimentation. This is explicitly stated in MPEP 2404.02 : “Applicant may show that a deposit is not necessary even though specific biological materials are required to practice the invention if those biological materials can be made or isolated without undue experimentation.” This means that if the biological materials needed for the invention can be obtained through routine procedures and without excessive effort, a deposit may not be required. Related Rules from the Manual of Patent Examining Procedure 10 rules Collapse Deposit of Biological Material Permitted for Invention Relying on Such Material MPEP 2404 Publicly Available Biological Material Not Requiring Deposit MPEP 2404 Permitted Patent Application May Reference Biological Material Deposit MPEP 2404 Permitted Deposit Not Needed for Isolated Materials Without Undue Experimentation MPEP 2404.02 Required Deposited Biological Material Is Considered Readily Available Regardless of Access Conditions MPEP 2404 Description of Biological Material Must Be Adequate MPEP 2404.01 Permitted Availability of Biological Material Must Be Known and Accessible MPEP 2404.01 Permitted Deposit Required for Undue Experimentation MPEP 2404.02 Required Deposit Not Required Unless Necessary for Patentability MPEP 2404 Requirement for Established Known Biological Material MPEP 2404.01 Other Related FAQs 5 FAQs Collapse How can an applicant demonstrate that a biological material deposit is not necessary? What is the significance of &#8216;publicly available material&#8217; in biological patent applications? H...