Patent Deposit

When you have a biomaterial with a pending patent application that's required to be deposited in a designated IDA repository, there are many steps. Don't worry. We're here to make the ATCC patent deposit process as seamless as possible. Here is some information to help you understand the next steps.

How to make a patent deposit

1. Fill out and submit the Patent Deposit Inquiry.
2. An ATCC representative will contact you within 10 business days to provide you with the Budapest Treaty Patent Deposit Form (BP/1 form) or the United States-only Non-Budapest Patent Deposit Form (Form 34).
3. You’ll fill out the appropriate form and then submit it to ATCC for review. Each deposit will need an individual deposit form.
4. ATCC will review your form and provide further instructions for shipment and depositing. NOTE: Do not ship deposit material prior to shipment authorization by ATCC as there will be delays in processing your patent deposit or your materials will be returned or destroyed in compliance with regulatory restrictions.
5. With ATCC’s approval, you can then ship your material to ATCC for deposit.
6. Once ATCC receives the material, you will receive an invoice.
7. We will then conduct viability testing.
8. The ATCC Patent Depository will provide the appropriate viability statement when testing is completed, which will make the deposit date and patent deposit numbers official.

Required patent documentation

Budapest Treaty Deposit Form (BP/1) must be completed for deposits to meet the requirements of The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure. A Budapest Treaty Deposit is required when additionally applying to the European Patent offices.

More information about the Budapest Treaty can be found through the World Intellectual Property Organization (WIPO). Rules for making biological deposits under the USPTO can be found on its website, as well.

US Patent Deposit Form 34 may be completed in lieu of the Budapest Treaty Deposit Form (BP/1) for patent deposits intended to be subject only to the rules of the USPTO. It is not necessary to complete Form 34 if you complete the BP/1 form. If both forms are completed, the BP/1 form supersedes Form 34.

Pricing

The ATCC Patent Depository service fee is $2,500 (USD) per deposit incurred at the time of receipt of a portion or all material. Please note that each deposit will need an individual deposit form. Payment for patent service will be invoiced after the receipt of the material, which can be paid by credit card, check, or wire transfer.

ATCC comprehensive patent services include:

• Pre-deposit assistance with forms and shipping
• Assignment of inbound tracking numbers for quicker receipt of patent deposit material
• Notification of patent material receipt
• Viability testing (one test, with one additional repeat if necessary)
• Certificate of deposit and a minimum of 30 years of storage
• Release of deposited material for distribution according to deposit rules
• Optional notification to depositors when deposit material is provided to third party

Additional Patent Deposit services, such as summaries of deposits, return of deposit material sample(s), additional copies of certificate of deposit, and destruction of deposit material, and their associated fees are available upon request.

See our Patent Requirements and Information section below for more details. To move forward in the patent deposit process, fill in and submit our Patent Deposit Inquiry form.

Types of microorganisms accepted

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.

• Agricultural seeds: The common name and scientific name of the source of the deposit and the geographical source.
• Cell lines: The species of origin, such as human, mouse, non-human primate, etc., geographical source of isolation, and any known hazards associated with the line (HIV, EBV, etc., and including genetically modified cell lines using plasmids with viral genes).
• Mixed cultures and consortia: Each component of the mixture must be identified.
• 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 (US, France, etc.).
• Viruses: The name of the virus 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 (US, France, 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 (eg, 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: The common name and scientific name of the source of the deposit and the geographical source.

How many samples to submit

For a valid deposit, we require:

• Seeds: 25 packets (25 seeds per packet)
• Cell lines: 25 cryopreserved vials from same harvest (2-6 million cells per vial)
• Mixed cultures and consortia: 25 cryopreserved or freeze-dried vials from same harvest (0.5 ml per vial)
• Microorganisms: 25 cryopreserved or freeze-dried vials from same harvest (0.5 ml per vial).
• Plasmids and vectors: 25 vials (100 ng per vial)
• Animal viruses: 25 cryopreserved or freeze-dried samples (1 ml per vial)
• Plant tissue cultures: 25 cryopreserved vials. Must be callus tissue. Seeds preferred

ATCC does not accept test tubes or other actively growing cultures. In order to help expedite viability testing, ATCC may request that growth medium be provided along with the deposits.

Permit Requirements

ATCC will assist in obtaining the appropriate regulatory permits. ATCC will apply for the permit and will advise the depositor when the permit is issued.

• Deposit materials to be shipped from outside the United States may require an import permit from various regulatory agencies, such as US Department of Agriculture (USDA) or Public Health Service (PHS).
• Deposit materials to be transferred within the United States may also require a transfer permit from various regulatory agencies, such as USDA.
• USDA may require safety testing by USDA laboratories for some cell lines, hybridomas, and microorganisms before importation into the United States. Testing fees may be issued from USDA to depositor.
• Approximately 4 or more weeks should be allowed to obtain permits.

Shipping Requirements

The depositor is ultimately responsible for the shipment of deposit material to ATCC, which includes 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. Do not ship deposit material prior to shipment authorization by ATCC.

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 must agree with the strain designation that is listed on the deposit form.
• When shipping cryopreserved material, use sufficient dry ice in an insulated shipping container to ensure the material’s viability is not compromised during movement, taking into account any delays in transit.

Certificate of Deposit

Two copies of the Certificate of Deposit is provided to the depositor 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 and its associated completed deposit form, following authorization of shipment from ATCC.

If the material is found nonviable, a deposit date is not issued and no patent deposit number is assigned. For nonviable material, ATCC provides a Certificate of Nonviability (form BP/9).

Replacement Deposit

If a culture or other biological material should become nonviable or compromised 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 3 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. ATCC, at its discretion, may also prepare additional samples from the depositor’s original material whenever necessary for the renewal of distribution stocks.

Availability of deposits

Requirements for availability of patent deposits is 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.