More Information About Making a Patent Deposit
Identity of materials
To ensure that ATCC is aware of all characteristics that may impact regulatory compliance in handling, storage and distribution, the following information is required for each item deposited. This information may be included on the patent deposit form or appended as necessary.
- Microorganisms: (bacteria, fungi, protozoa, etc.): The complete scientific name including genus and species, and the source of the material. The source of the material includes both the source of isolation (human, animal, plant, etc.) and the geographical location (U.S., France, etc.).
- Viruses: The name of the virus, whether it is a plant or animal virus, and the source including geographic location.
- Cell lines: The species of origin, such as human, mouse, monkey (type of monkey), etc., geographical source of isolation, and any known hazards associated with the line (HIV, EBV, etc.).
- Genetic materials: The name of the organism from which a vector, clone or library is derived. For clones and constructs the source of the DNA insert must be identified by species (e.g., human, mouse) or by scientific name if a microorganism or virus. When the source of the DNA is a microorganism or virus please provide the name of the gene and the identity of the host organism.
- Miscellaneous items: (seeds, embryos, insect eggs, etc.): The common name and scientific name of the source of the deposit, and the geographical source.
- Mixed cultures and consortia: Each component of the mixture must be identified.
Certificate of Deposit
A certificate of deposit is provided to the depositor immediately after the material is tested and found to be viable. A patent deposit number is assigned at this time. The deposit date is the date ATCC receives viable material.
Two copies of the certificate of deposit are provided to the depositor. If notarized certificate of deposit forms are required a fee of $100.00 for two notarized copies will be charged. If non notarized certificate of deposit forms are required a fee of $75.00 for two non notarized copies will be charged.
Please contact firstname.lastname@example.org for your certificate of deposit requests.
If the material is found nonviable, ATCC notifies the depositor and follows with a certificate of nonviability (form BP/9). If the material is found nonviable, there is no deposit. In this case, a deposit date is not issued, and no patent deposit number is assigned.
Microorganisms and cell lines may require approximately 3-4 weeks or longer for viability testing. Viruses, both animal and plant, and plant tissue cultures can require as long as 3 months (or longer in exceptional cases). High risk materials can require as long as 6 months or longer for viability to be determined.
ATCC strives to expedite processing of every deposit. ATCC will notify the depositor of the ATCC number immediately after a deposit is found viable.
Upon notification of your intention to deposit a culture with ATCC, we can assist you in obtaining the appropriate permits. The permit application forms will be forwarded to you. ATCC will apply for the permit and will advise the depositor when the permit is received.
Cell lines (including hybridomas), viruses, plant tissue cultures, and some seeds received from outside the United States may require an import permit from the U.S. Department of Agriculture (USDA). A Public Health Service (PHS) permit, available from the Centers for Disease Control and Prevention (CDC), is needed for importation of agents infectious to humans.
The USDA may require safety testing by USDA laboratories for some cell lines, hybridomas, and viruses before importation into the United States. The USDA performs in vitro testing of cells from Japan, Australia and Great Britain at a quoted price. In vivo tests are performed on cells and viruses from all other countries for a quoted price. The USDA does permit up to four cell lines, hybridomas or viruses to be tested in one in vivo test, which reduces the per item cost for testing. In many instances the USDA decides a permit is not necessary, but application still must be made. Do not send material until the USDA has made a decision.
Approximately four to six weeks should be allowed to obtain permits. Do not send the cultures until all pertinent permits are issued.
The depositor is ultimately responsible for the shipment of deposits to the ATCC and compliance with all applicable government regulations for the packaging and movement of the material. Delivery must be made directly to ATCC. We will not retrieve shipments from airports.
To ensure your material arrives safely and is handled appropriately, the following guidelines should be followed. When packaging vials, put all similarly labeled vials together in the package. The material should be clearly labeled and identified. The designation on the vial labels should agree with the strain designation that you have listed on the deposit forms. When shipping frozen material, use enough dry ice in an insulated shipping container to ensure the material is adequately frozen upon arrival at ATCC, taking into account any delays in transit.
Converting to Budapest Treaty
Only the original depositor of patent material may convert their deposit to meet the requirements of the Budapest Treaty. If Viability of the deposit has been confirmed before the conversion another viability test is not required, however a Budapest deposit form must be completed and the usual fee paid. The fee is the same as for new deposits, but if the fee for patent storage is already paid, it is not charged again. For deposits made before January 1, 1981, a deposit date of January 1, 1981 (the date ATCC was recognized as an International Depository Authority), becomes the deposit date for Budapest Treaty purposes. Deposits made after January 1, 1981, have a deposit date of the conversion of the deposit, provided viability is confirmed. Deposits under the Budapest Treaty also meet USPTO requirements.
If a culture or other biological material should become nonviable or be destroyed during the effective term of the deposit, it is the responsibility of the depositor to replace it. The Budapest Treaty permits replacement of a deposit which was originally found viable and later became nonviable as long as 1) the replacement is made within three months from the notification of nonviability, and 2) the replacement has the same characteristics as the original deposit. The deposit retains the same patent deposit number and deposit date.
However, the Budapest Treaty makes no provisions for replacements of material that was originally viable and later found to have different characteristics than those originally defined. In this case, a supplemental deposit may be made, and a new deposit date and number will be assigned. All requesters of the original deposit may be notified of the supplemental deposit and given a choice as to which to purchase, as long as both deposits are freely available.
Timely arrival of patent deposit material at ATCC is critical to establishing the desired deposit date. Reliance on delivery services to transport the material to ATCC on time and in a viable state is risky. Therefore, through our interim storage service, material intended for patent deposit can be placed into a safekeeping deposit at ATCC until the intended date of patent deposit.
While in safekeeping the material will be handled under the same terms and conditions of propriety and confidentiality as other safe deposit material (see below). When a patent deposit date is desired, the material in interim storage can be converted to a patent deposit simply by notifying ATCC. Viability testing of material received for interim storage can be performed upon receipt, and although retesting is necessary when converted to patent deposit, this can provide insurance that the earliest possible patent deposit date will be obtained. The interim storage service provides a means of ensuring that your material is received by the ATCC patent depository promptly and in viable condition. The date of deposit for patent purposes will be the date of transfer from interim storage, not the date it was received for interim storage.
ATCC also offers safe deposit services for those valuable biological materials for which patent protection has not been sought. Both cGMP-compliant and standard safe deposit services are available. Materials are stored in liquid nitrogen in strict confidence, and the depositor retains all proprietary rights. Multiple year agreements are available, along with restricted distribution only after depositor approval. If patent protection is sought at a later date, the biological material can be transferred to the Patent Depository by the original depositor. Click here for more details.
Availability of Deposits
Requirements for availability of patent deposits are determined by the rules in the country in which the patent application is filed. Generally, ATCC is required to make patent materials available only after the issuance of a pertinent patent. Prior to that time, the deposit need only be made available to a requester if 1) the Commissioner of the USPTO (in accordance with 35 USC 122) issues a decision to release such deposit; 2) the patent office of another country issues such a decision to release the deposit to a particular requester; or 3) the original depositor requests in writing that the deposit be released to a particular requester.
Although in the United States availability of the deposited material is required only after the issuance of a patent, in Europe availability is made possible with European Patent Office (EPO) approval upon publication of the patent application. The requester must agree to use the biological material for experimental purposes only, and not to make the material available to a third party before the application is refused or withdrawn or the patent expires. There is also an option during the European patent filing process by which an inventor may choose, for a certain period of time, to have the biological material made available only through an expert.
It is the responsibility of the depositor to inform ATCC of the issuance of pertinent patents. ATCC urges depositors to diligently inform us when the patent issues and which deposits to release.
Use of Patent Cultures
The deposit of a culture in ATCC does not grant to ATCC a license, either express or implied, to infringe the patent, and ATCC's release of cultures to others does not grant them a license, either express or implied, to infringe the patent. Recipients of cultures from ATCC are so informed using the following disclaimer in ATCC catalogs and reference guides: "This material is cited in a U.S. and/or other Patent and may not be used to infringe the patent claims."