Acceptable Depository

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;

ply 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

. 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

nt 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

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/

.

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