What risks does an applicant take when relying on evidence of accessibility other than a deposit?
When an applicant relies on evidence of accessibility other than a deposit to show that a biological material is known and readily available, they take on certain risks. According to MPEP 2404.01:
“Those applicants that rely on evidence of accessibility other than a deposit take the risk that the patent may no longer be enforceable if the biological material necessary to satisfy the requirements of 35 U.S.C. 112 ceases to be accessible.”
This means that if the biological material becomes inaccessible in the future, it could affect the enforceability of the patent. The MPEP further explains:
“Such a defect cannot be cured by reissue after the grant of a patent.”
Therefore, applicants should carefully consider the long-term availability of the biological material when deciding whether to rely on evidence of accessibility or make a deposit.
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