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ON “DOMESTIC” AND “INTERNATIONAL” DEPOSIT OF BIOMATERIALS
Linda Liu & Partners
When an applicant applies for a biomaterial-related patent in his own country such as Japan, he is sometimes obligated to deposit the biomaterial with a depositary institution of his country. In order to get a patent in some other countries, the applicant has to “convert” the domestic deposit into an international deposit. Such conversion, however, may cause the biomaterial to be deemed not to have been deposited when the application enters China, thereby leading to a defect of insufficient disclosure.
The reason for this trouble is that the SIPO only accepts a deposit with an international depositary authority recognized by the Budapest Treaty. Hence, the date on which a biomaterial is first deposited with a qualified international depositary authority (hereinafter referred to as international deposit date) or the date when a domestic deposit is converted into an international deposit (hereinafter referred to as conversion date) is accepted by the SIPO. In contrast, the date when the biomaterial sample is deposited with a domestic depositary institution is will not be relevant and therefore not be accepted. In the event that the conversion date is later than the filing data of the application (or the priority date where priority is claimed), the biomaterial sample will be deemed by the SIPO not to have been deposited due to a violation of the provision of “depositing a sample of the biological material before, or at the latest, on the date of filing (or the priority date where priority is claimed)”. As a result, the patent application will be considered to have a defect that the description is not sufficiently disclosed.
To have a better understanding of this issue, see a patent application below.
As shown in Chart 1, the application, relevant to a biomaterial, was filed on November 1, 2008 in China, and it has a Japanese priority date of February 1, 2008; the biomaterial was deposited on January 1, 2008 in Japan, and the domestic deposit was converted into an international deposit on October 1, 2008.
Since the SIPO accepts only an international deposit acknowledged by the Budapest Treaty, the conversion date, i.e. October 1, 2008, was accepted as the qualified deposit date. This date, however, was later than the priority date. In accordance with Rule 25 of the Implementing Regulations of the Chinese Patent Law1 and the SIPO’s Guidelines for Examination2, the biomaterial was deemed not to have been deposited. Without the biomaterial, one skilled in the art would not carry out the invention on the basis of the description. The description therefore was considered insufficiently disclosed.
To overcome the above defect, two solutions are available at present:
1. Abandon the priority
As a result of the abandonment, the conversion date is earlier than the filing date. The deposit will be accepted, thereby overcoming the problem of insufficient disclosure. However, this causes the disadvantage that the art prior to the filing date rather than the priority date will be considered in the determination of novelty and inventiveness.
2. Retain the priority
The determination of novelty and inventiveness may not be adversely affected, but the description will have the defect of insufficient disclosure because the biomaterial is deemed not to have been deposited. Hence, the technical solution concerning the biomaterial will not be protected.
Obviously, both solutions will bring unfavorable influence on the applicant’s interests. To avoid the problem above, the applicant of an international application concerning biomaterials or an application intended to enter China in the future may consider direct depositing the biomaterials with a qualified international depositary authority.
It is hoped that the above brief introduction to “domestic” and “international” deposit will give readers some helpful information. Any comments or discussions are welcome!
* 1. Rule 25 of the Implementing Regulations of the Chinese Patent Law:
Where an invention for which a patent is applied for concerns a new biological material which is not available to the public and which cannot be described in the application in such a manner as to enable the invention to be carried out by a person skilled in the art, the applicant shall, in addition to the other requirements provided for in the Patent Law and these Implementing Regulations, go through the following formalities:
(1) depositing a sample of the biological material with a depositary institution designated by the Patent Administration Department under the State Council before, or at the latest, on the date of filing (or the priority date where priority is claimed), and submit at the time of filing or at the latest, within four months from the filing data, a receipt of deposit and the viability proof from the depository institution; where they art not submitted with the specified time limit, the sample of the biological shall be deemed not to have been deposited;
(2) giving in the application document relevant information of the characteristics of the biological material;
(3) indicating, where the application relates to the deposit of the biological material, the request and the description the scientific name (with its Latin name) and the title and address of the depositary institution, the date on which the sample of the biological material was deposited and the accession number of the deposit; where, at the time of filing, they are not indicated, they shall be supplied within four months from the date of filing; where after the expiration of the time limit they art not supplied, the sample of the biological material shall be deemed not to have been deposited.
2. Point (4) in section 9.2.1 of chapter 10 in part II of the SIPO’s Guidelines for Examination:
The depositary institutions designated by the SIPO refer to the international authorities for biological material samples acknowledged by the Budapest Treaty.
