What are the requirements for releasing biological material deposits to the public?
What are the requirements for releasing biological material deposits to the public?
The requirements for releasing biological material deposits to the public are detailed in MPEP 2410.01. The key requirement is:
“All restrictions on availability to the public of the deposited material will be irrevocably removed upon the granting of a patent disclosing the deposit.”
This means that once a patent is granted, the biological material must be made available to the public without any restrictions. The MPEP further states:
“The deposit must be maintained for the life of the patent, and the depository must agree to furnish samples of the deposit to those persons who are legally entitled to receive them under 37 CFR 1.808(b).”
To ensure compliance with these requirements, the following steps must be taken:
- For deposits not made under the Budapest Treaty, a contract between the depositor and depository must be in place ensuring unrestricted permanent availability.
- All restrictions on access must be irrevocably removed upon granting of the patent.
- The deposit must be maintained in a viable and contamination-free condition.
- Samples must be furnished upon request to those legally entitled to receive them.
These requirements ensure that the public has access to the biological materials necessary to fully understand and potentially reproduce the patented invention, which is a fundamental principle of the patent system.
To learn more: