How long must a biological material deposit be maintained for patent purposes?

The duration of a biological material deposit for patent purposes is specified in the USPTO regulations. According to MPEP 2404.01, which references 37 CFR 1.806:

“The term of deposit is “at least thirty (30) years and at least five (5) years after the most recent request” for a sample; the agreement sufficiently ensures that the deposit will be “available beyond the enforceable life of the patent”.”

This requirement is designed to ensure that the biological material remains accessible for a significant period, including:

  • A minimum of 30 years from the date of deposit
  • At least 5 years after the most recent request for a sample
  • Beyond the enforceable life of the patent

The MPEP further notes that “unless there is a reasonable basis to believe that the biological material will cease to be available during the enforceable life of the patent, current availability would satisfy the requirement.” This approach balances the public interest in accessing the material with the practical considerations of long-term storage and maintenance.

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Topics: MPEP 2400 - Biotechnology, MPEP 2404.01 - Biological Material That Is Known And Readily Available To The Public, Patent Law, Patent Procedure
Tags: biological material, Deposit, Duration, Public Accessibility