Patent Depository System

January, 2008
Patent & Trademark Attorney
Kazuya Hasegawa

1. Introduction

One of remarkable systems in relation to biotechnology field is a “depository system”. The depository system is stated in Regulations Under Patent Law Articles 27-2 and 27-3. The depository system is a system for meeting the enablement requirement (Patent Law Article 36-4) of an invention in such a manner that an applicant deposits microorganisms of the invention, for which a patent application is to be filed, at a designated depository institution so that other parties request a sample of the deposited microorganisms. It also can be said that the depository system is related to the purpose of the Patent Law itself in which an exclusive license is to be granted for a prescribed period as a compensation for disclosure of the invention.

Regulations Under Patent Law Article 27-2 (1) “An applicant who is to file an patent application on an invention related to a microorganism shall attach to the application a copy of the most recent viability statement issued by the international depositary authority stated in the Treaty Article 2 (viii), which is stated in Rule 7 of Regulations Under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure (hereinafter, referred to as “the Treaty”), or a statement in attestation of the fact that the microorganisms are deposited within a period designated by the Commissioner of the Patent Office, except for the case where the microorganisms are readily available to a person skilled in the art related to the invention

Regulations Under Patent Law Article 27-3(1) “A person who is to perform the invention related to the microorganisms which are deposited according to the preceding article for the purpose of examination or study can request a sample of the microorganisms on the following conditions. ……”

In recent years, as genetic engineering has been developed, the invention for which the patent application is to be filed can be specified by base sequence or amino-acid sequence, or useful compounds can be produced by gene-recombination technology. Thereby, it has been sometimes said that a necessity of the depository system is decreased1). However, in a food industry or the like, consumers take a cautious stance on the gene-recombination technology. Therefore, under present circumstances, microorganisms having useful characters are produced by classical breeding techniques such as hybridization, mutation, or the like. Moreover, in some cases, the microorganisms are distributed in the marketplace. Thus, it is assumed that the needs to obtain a patent on the microorganisms produced by the classical breeding techniques are still high.
The following describes details about the depository system, which is still useful for obtaining a patent in the biotechnology field.

2. Depository Procedure in Japan

Outline of the depository procedure in Japan is as follows. As for more details of the depository procedure, please refer to:
“http://www.nbrc.nite.go.jp/npmd/how-to_depo.html”, or
“http://unit.aist.go.jp/ipod/ci/procedures/deposit/new_deposit/new_deposit.html”.
With the view toward the Budapest Treaty: Code of Practice 1998, the domestic depository procedure was altered from April 1, 20042).

(1) Submit a designated depository application, a specification of conditions of microorganism, and a microorganism to a depository institution designated by the Commissioner of the Patent Office and an international depositary authority according to the Budapest Treaty (hereinafter, referred to as a “depository institution*”.
(2) If the depository application and the specification of conditions of microorganism are satisfied, receive a “receipt” after it is confirmed that the deposited microorganism has a prescribed figure and number.
(3) Receive a “viability statement” as soon as it is confirmed that the microorganism to be deposited is viable as a result of its viability test.

When a patent application is to be filed on an invention related to a microorganism which is not easily available to a skilled person, the microorganism, for which the application is to be filed, should be specified in the description and the like by an accession number described in the viability statement, and the patent application should be accompanied with a “copy of the viability statement” issued in the depository procedure. If the microorganism is sufficiently explained in the description, and the description contains (1) the name of the international depositary authority, (2) the date of receipt, and (3) the reference number, it is also possible to file the patent application at the time when the “receipt” is issued.
Until March 31, 2004, the viability statement is issued as soon as the depository application and the microorganism are received. However, from April 1, 2004, the viability statement is issued after the viability test2).

　*1 Depository Institutions:
AIST International Patent Organism Depositary (IPOD: http://unit.aist.go.jp/ipod/ci/index.html), and
NITE Patent Microorganisms Depositary (NPMD: http://www.nbrc.nite.go.jp/npmd/)

3. Matter of Caution in relation to the Procedure

(1) In Japan, the depository procedure shall be performed prior to filing the patent application (Regulations Under Patent Law Article 27-2 (1)). On the contrary, in the United States, the depository procedure shall be performed until the payment for the issue fee (37 CFR 1.809(b) (1)). In Europe, as well as in Japan, the depository procedures shall be performed prior to filing the patent application (EPC Rule 28(1) (a)).
(2) At the time when the receipt is issued, it is possible to file the patent application. However, a copy of the viability statement shall be submitted to the Patent Office as soon as the viability statement is issued (Regulations Under Patent Law Article 27-2(2)).
(3) In a case where the patent application is filed with a receipt, if the result of the viability tests of the deposited microorganism is negative, the microorganism is considered not to be deposited on the date described in the receipt2). In this case, the microorganism shall be resubmitted to the depository institution (at this time, a new receipt is issued). However, the microorganism described in a viability statement which is issued after resubmission is considered different from the microorganism specified by a reference number of the initial receipt described in the description of the patent application. Therefore, if the applicant submits a copy of the viability statement, its validity is not accepted. Also, even if the applicant files a declaration of priority in such a manner to specify the microorganism by an accession number, and submits the copy of the viability statement to the Patent Office, the applicant cannot obtain advantages of the priority in relation to the microorganism specified by the accession number. Accordingly, though there is a temporal restriction, the patent application should be filed after receiving the viability statement.

4. Closing

In Japan, because we have poor underground resources, technologies for producing materials (material production technologies) have been a foundation of our domestic industries. From such situation of resources, a fermentation technology for producing soybean paste, soy sauce, rice wine, and the like by using microorganisms has drawn attention as one of the material production technology through the ages and been developed. Nowadays, not only in a food industry, but also the fermentation technology with the microorganisms is used as means of producing useful materials such as medical goods or the like. Thus, the fermentation technology is one of critical technologies for the domestic industries. Moreover, these days, because depletion of oil resources has become a concerned problem, production of biofuel, which is alternative to the oil resources, becomes more important. Therefore, I believe that in the future, the fermentation technology will draw more and more attention because the fermentation technology is effective for producing the biofuel. The fermentation technology in Japan has a long history, and needless to say, has advantages with respect to foreign countries. In this way, the fermentation technology is, for Japan, “intellectual resources” alternative to the “underground resources”. In order to further develop this “intellectual resources” from here on, it is important to protect the “intellectual resources”, and furthermore, the legal systems for effectively utilizing the “intellectual resources” become significant. One of the legal systems for protecting the “intellectual resources” is the Patent Law. It is the microorganisms that are essential for inventions related to the fermentation technology. In this column is described the depository system which is necessary for obtaining a patent on the inventions related to the microorganisms. I hope that the depository system will keep effectively utilized both internationally and domestically, and the fermentation technology as our “intellectual resources”, eventually the domestic industries, will have been further developed.


1) “Theory and Problems in Patent Examination and Appeal” under the editorship of Minoru Takeda published by Japan Institute of Invention and Innovation
2) Japan Patent Office Website “Alterations in the domestic depository system”
http://www.jpo.go.jp/tetuzuki/t_tokkyo/shutsugan/kitaku_kokunai.htm