To get a patent in the United States, the Patent Act requires patent applicants to include enough written information that a person of ordinary skill in the art could make and use the invention. This description, commonly known as “enablement,” is an essential component of the intellectual property system, which aims to create an incentive to innovate while delivering the benefits of the innovation to the public. With biological materials, a person may need access to the physical biological material the inventor has created in order to make and use it. In these cases, the applicant deposits the material with any International Depositary Authority, as established under the Budapest Treaty (37 CFR 1.803). While a biological deposit is not mandatory by default, a patent examiner may determine that a deposit is necessary to meet the enablement requirement.
In the United States, there are two recognized depositories that accept seeds and plant tissue deposits for patent purposes: The American Tissue Type Collection (ATCC) and the National Center for Marine Algae and Microbiota (NCMA). Additional seed varieties are available from International Depositary Authorities in other nations. (Other depositories that accept seeds include the China Center for Type Culture Collection, China General Microbiological Culture Collection Center, International Patent Organism Depositary (Japan), Korean Agricultural Culture Collection, Korean Collection for Type Cultures, and National Collections of Industrial, Food, and Marine Bacteria (United Kingdom).
The patent applicant is responsible for depositing the material to the depository under contract terms that ensure that the seed or plant tissue is kept viable and available for the life of the patent and beyond (37 CFR 1.806). Once a United States patent is granted, the applicant must remove all restrictions on the availability of the patent deposit material to the public (37 CFR 1.808). In a patent application, information about where the deposit has been made is usually stated under a separate header labeled “Deposit Information” See example on page 11 of PDF
Both the ATCC and the NCMA are recognized under the Budapest Treaty as International Depositary Authorities, which eliminates the need for patent applicants to deposit biological material in each country where patent protection is sought. The Budapest Treaty includes a secrecy obligation that prevents any International Depositary Authority from stating whether something was deposited under the Treaty and also from releasing any information about the deposits made under the Treaty until a requestor can demonstrate their legal right to access the material (Rule 9.2). For this reason, a person who wishes to access a patent deposit material from a depository must obtain a certificate from the United States Patent and Trademark Office (USPTO) to verify that they are entitled to access the deposit. The certificate verifies that the deposit was required to “enable” the invention, and that a patent has been granted and thus should be made available without restriction.
Anyone wishing to access seeds or plant material from an International Depositary Authority should take the following steps:
- Locate the deposit information in the patent of interest.
- Fill out form BP/12.
- Contact a director of USPTO Technology Center 1600 to submit the form BP/12. If the USPTO determines that the requestor is entitled to access the deposited material, the form will be signed by a USPTO official and returned to the requestor.
- Create an account with the International Depositary Authority that holds the desired material.
- Submit a signed request for the material accompanied by the signed form BP/12.
Patent deposit material deposited under the Budapest Treaty is required to match the description of the invention in the patent application, and it must be kept viable and available for the effective life of the patent, or at least 30 years and at least 5 years after the most recent request for the furnishing of a sample of the deposit was received by the depository (37 CFR 1.806). Any issues with the viability of the seed should be reported to the depository keeping the material.
Please note that receipt of a patent deposit material does not imply a right to use that material if it is still covered by a patent in force. Deposits are made available to enable the invention; however, patent law allows patent owners to exclude others from making, using, offering to sell, or selling the claimed invention for a limited term. Deposits accessed from an International Depositary Authority may still be subject to patent restrictions.