Preservation measures of biological materials used in patent procedures

Chapter I General Provisions Article 1 These Measures are formulated in accordance with the Patent Law of People's Republic of China (PRC) and the Detailed Rules for the Implementation of the Patent Law of People's Republic of China (PRC) (hereinafter referred to as the Detailed Rules for the Implementation of the Patent Law) in order to standardize the procedures for the preservation of biological materials used in patent procedures and the provision of samples. Article 2 The biological material preservation unit is responsible for preserving the biological materials used in the patent procedure, and providing the preserved biological material samples to the units or individuals that have the right to obtain the samples. Article 3 Foreigners, foreign enterprises or other foreign organizations that have no habitual residence or business office in China shall entrust a legally established patent agency to handle relevant affairs in accordance with these Measures. Chapter II Preservation of Biological Materials Article 4 Where biological materials are submitted for preservation in accordance with the provisions of Article 24 of the Detailed Rules for the Implementation of the Patent Law, the patent applicant shall submit the biological materials to the preservation unit, and attach a request for preservation, stating the following items:

(1) The biological materials requested to be preserved are used for the purpose of patent procedures, and the preservation shall not be withdrawn within the preservation period specified in Article 9 of these Measures;

(2) The name and address of the patent applicant;

(3) Describe in detail the conditions required for the cultivation, preservation and survival test of the biomaterial; When a mixed culture of two or more biomaterials is preserved, its components and at least one method to check the existence of each component should be explained;

(4) the identification symbol given to the biomaterial by the patent applicant, and the classification, naming or scientific description of the biomaterial;

(5) Declaring that the biomaterial has or may have characteristics that are harmful to health or the environment, or declaring that the patent applicant does not know that the biomaterial has such characteristics. Article 5 The preservation unit shall not undertake the obligation to recheck the biological characteristics of the biological materials requested for preservation. Where the patent applicant requests to review the biological characteristics and classification of the biomaterial, it shall sign a separate contract with the preservation unit when submitting the preserved biomaterial. Article 6 After receiving the biological materials and the preservation request, the preservation unit shall issue a written preservation certificate to the patent applicant, which shall be sealed by the preservation unit and signed by the person in charge. The preservation certificate shall include the following contents:

(a) the name and address of the preservation unit;

(2) The name and address of the patent applicant;

(3) the date of receipt of the biological materials;

(4) the identification symbol given to the biomaterial by the patent applicant, and the classification, naming or scientific description of the biomaterial;

(five) the preservation number given by the preservation unit. Article 7 Under any of the following circumstances, the biological material preservation unit shall not preserve it and notify the patent applicant:

(a) the biological material does not belong to the category of biological materials accepted by the preservation unit;

(2) The nature of the biomaterial is so special that the technical conditions of the preservation unit cannot preserve it;

(3) When the preservation unit receives the preservation request, it cannot accept the biological material for other reasons. Article 8 After receiving the biological materials and the preservation request, the preservation unit shall conduct the survival test in time and issue a written survival certificate to the patent applicant, which shall be sealed by the preservation unit and signed by the person in charge. The survival certificate shall record whether the biological materials are alive or not, and include the following items:

(a) the name and address of the preservation unit;

(2) The name and address of the patent applicant;

(3) the date of receipt of the biological materials;

(four) the preservation number given by the preservation unit;

(5) Date of feasibility test.

During the preservation period, according to the request made by the patent applicant or patentee at any time, the preservation unit shall conduct a survival test on the biological material and issue a written survival certificate sealed by the preservation unit and signed by the person in charge. Article 9 The shelf life of biological materials used in patent procedures shall be at least 30 years, counting from the date when the preservation unit receives the biological materials. Where a preservation unit receives a request for samples of biological materials before the expiration of the preservation period, it shall keep them for at least another five years from the date of the request. During the period of preservation, the preservation unit shall take all necessary measures to keep the biological materials preserved by it alive and free from pollution. Article 10 Before the publication of a patent application involving preserved biological materials, the preservation unit shall be responsible for keeping the biological materials and related information confidential, and shall not provide samples and information of the biological materials to any third party. Article 11 In case of death or pollution of biological materials during preservation, the preservation unit shall promptly notify the patent applicant or patentee. If the applicant for a patent or the patentee resubmits the biological material identical to the original biological material within 4 months from the date of receiving the above notice, the preservation unit shall continue to preserve it. Chapter III Provision of Samples of Biological Materials Article 12 During the preservation period, the preservation unit shall provide samples of biological materials at the request of the patent applicant or patentee for the preservation of biological materials and the units or individuals permitted by them.

Where the right to apply for a patent or the patent right is transferred, the right to request samples of biological materials and the right to allow others to obtain samples of biological materials shall be transferred together.

Where the right to apply for a patent or the patent right is transferred, the assignee shall promptly notify the preservation unit of the transfer of the right to apply for a patent or the patent right.