37 CFR 1.803 Acceptable depository.
- (a) A deposit shall be recognized for the purposes of these regulations if made in
- (1) any International Depositary Authority (IDA) as established under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, or
- (2) any other depository recognized to be suitable by the Office. Suitability will be determined by the Commissioner on the basis of the administrative and technical competence, and agreement of the depository to comply with the terms and conditions applicable to deposits for patent purposes. The Commissioner may seek the advice of impartial consultants on the suitability of a depository. The depository must:
- (i) Have a continuous existence;
- (ii) Exist independent of the control of the depositor;
- (iii) Possess the staff and facilities sufficient to examine the viability of a deposit and store the deposit in a manner which ensures that it is kept viable and uncontaminated;
- (iv) Provide for sufficient safety measures to minimize the risk of losing biological material deposited with it;
- (v) Be impartial and objective;
- (vi) Furnish samples of the deposited material in an expeditious and proper manner; and
- (vii) Promptly notify depositors of its inability to furnish samples, and the reasons why.
- (b) A depository seeking status under paragraph (a)(2) of this section must direct a communication to the Commissioner which shall:
- (1) Indicate the name and address of the depository to which the communication relates;
- (2) Contain detailed information as to the capacity of the depository to comply with the requirements of paragraph (a) (2) of this section, including information on its legal status, scientific standing, staff and facilities;
- (3) Indicate that the depository intends to be available, for the purposes of deposit, to any depositor under these same conditions;
- (4) Where the depository intends to accept for deposit only certain kinds of biological material, specify such kinds;
- (5) Indicate the amount of any fees that the depository will, upon acquiring the status of suitable depository under paragraph (a) (2) of this section, charge for storage, viability statements and furnishings of samples of the deposit.
- (c) A depository having status under paragraph (a)(2) of this section limited to certain kinds of biological material may extend such status to additional kinds of biological material by directing a communication to the Commissioner in accordance with paragraph (b) of this section. If a previous communication under paragraph (b) of this section is of record, items in common with the previous communication may be incorporated by reference.
- (d) Once a depository is recognized to be suitable by the Commissioner or has defaulted or discontinued its performance under this section, notice thereof will be published in the Official Gazette of the Patent and Trademark Office.
37 CFR 1.803 indicates that a depository will be recognized as acceptable for the purposes of these regulations if it is either an International Depositary Authority (IDA) established under the Budapest Treaty, or if it is a depository recognized as suitable by the Commissioner. After the effective date of these regulations, a deposit of biological material which is made in a depository which is not recognized as acceptable under this regulation will not be considered as satisfying the requirements of 35 U.S.C. 112. See Ex parte Humphreys, 24 USPQ2d 1255 (Bd. Pat. App. & Int. 1992). On the other hand, if a deposit is not required to satisfy the requirements of 35 U.S.C. 112, it is permissible to make reference to such a deposit even though it may not be in a depository or made under the conditions which are acceptable under these regulations. As new depositories are recognized as suitable by the Commissioner, their identity will be announced in the Official Gazette.
An organization may be recognized as suitable by the Office if the procedure and conditions specified in 37 CFR 1.803(a)(2) and 37 CFR 1.803(b) are followed. Generally, it is not the intention of the Office to recognize as suitable any organization where the need for a suitable depository for patent purposes is being met by depositories recognized as IDAs under the Budapest Treaty. Suitability will be judged by the Commissioner, based on need and the information supplied by the organization seeking status, and information obtained from other sources that may be consulted.
While there is a desire to provide flexibility to a patent applicant in selecting an appropriate depository, these rules are not intended to permit each patent applicant to become its own depository since both the patent owner and the public have an interest in the continued availability and accessibility of the deposit during the enforceable life of the patent, and the public has a continuing interest in its availability when the patent is no longer enforceable. The concept of a depository independent of the control of the depositor or an IDA as an acceptable depository is based on the need and desire to ensure the safe and reliable storage of a deposited biological material under circumstances that are substantially free of the opportunity for intentional mishandling or negligent handling of the deposited material. The use of an independent depository or internationally recognized depository will tend to preserve the integrity of the deposit process against those that may accidentally alter the deposited material, may wish to tamper with the deposited material or may wish to resume control of its availability when the patent is no longer enforceable, and will tend to preserve the interest of the public in the access to the biological material once the term of the patent expires.
When a depository having status under 37 CFR 1.803(a)(2) seeks to change the kinds of biological materials that it will accept and maintain for the purposes of these rules, a communication requesting such a change should be directed to the Commissioner containing the information requested in 37 CFR 1.803(b). When such a change is requested, the requesting depository should provide a complete list of the kinds of biological materials it will accept.
37 CFR 1.803(d) indicates that once a depository is recognized as suitable for the purposes of this rule, or has defaulted or discontinued its performance under this section, notice thereof will be published in the Official Gazette of the Patent and Trademark Office. The mere fact that a deposit has been made in an IDA recognized under the Budapest Treaty does not mean that the terms of the deposit meet either the requirements of the Budapest Treaty or the deposit regulations. Many of the depositories recognized under the Budapest Treaty have many different arrangements under which biological material may be stored.
The World Intellectual Property Organization (WIPO) publishes a Guide to the Deposit of Micro-organisms under the Budapest Treaty (WIPO Publication No. 661 (E)) on the procedures and requirements concerning the deposit of biological material, including procedures for obtaining a sample of deposited material, in each of the international depository authorities. The Guide and a list of current IDAs under the Budapest Treaty are available at www.wipo.int/treaties/en/registration/budapest/.