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SIPO's Regulations

Provisional Provisions Concerning Entry Quarantine for Micro-Organisms(Viruses) and Culture Used for Patent Procedures .

1. Any  patent application filed by foreign applicants to China involving the deposit of micro-organism(viruses) and culture in the  deposit units designated by the Chinese Patent Office, shall in advance  entrust its or his foreign related patent agency to go through the formalities before the Ministry of Hygiene  or Ministry of Agriculture, Husbandry and Fishery for the application of entry licenses.

Micro-organisms(viruses) and culture relating to human beings or environmental hygiene shall be examined and approved by the Ministry of Hygiene; Micro-organisms(viruses) and culture relating to animals and plants shall be examined and approved by the Ministry of Agriculture, Husbandry and Fishery; Micro-organisms(viruses) and culture relating to diseases suffered  both by human beings and animals shall be examined and approved jointed by the Ministry of Hygiene and Ministry of Agriculture, Husbandry and Fishery after consultation. The examination and approval authority shall make a decision within one week after it receives the entry application for micro-organisms(viruses) and culture, and notify the  applicants accordingly. 

2. The examination and approval authority shall make the examination and approval according to the laws and  regulations promulgated by the State. Importing Micro-organisms(viruses)and culture  shall be packaged in absolute safe containers and shall not cause contamination of any kind.

3. Where going through the examination and approval formalities for the entry licenses, the foreign related patent agency shall submit the following to the examination and approval authority: name of the micro-organisms(viruses)and culture which is the subject of the application for entry of the country, source, quantity, use of such micro-organisms(viruses)and culture, and briefs concerning  whether such micro-organisms(viruses)and culture are dangerous to human beings or animals.

4. After the application is approved by the examination and approval authority, the foreign related patent agency may inform the foreign applicant applying for patent applications in China to mail or bring to China these micro-organisms(viruses) and culture.  The foreign related patent agency shall hand over to the Border Hygiene  and  Quarantine Department or Port Plant and Animal Quarantine Department the related certifying documents and the entry approval of  the examination and approval authority.  The Border Hygiene  and  Quarantine Department or Port Plant and Animal Quarantine Department shall make an inspection and grant the pass for the objects concerned. Where the Border Hygiene  and  Quarantine Department or Port Plant and Animal Quarantine Department finds that the importing micro-organisms(viruses) and culture are not in conformity with the accompanied documents, or where the package or container does not meet the requirements, the micro-organisms(viruses)and culture shall be returned, confiscated or destroyed.

5. The micro-organisms(viruses) and culture deposit units shall deposit the micro-organisms(viruses) and  culture in a proper way, insure their safe preservation, and take strict measures against its dissemination.

6. Where anyone applies for the use of the deposited micro-organisms(viruses) and culture for patent procedures for domestic exploitation, it or he, apart from abiding by the "Provisions Concerning the Deposit of Micro-Organisms for Patent Procedures" promulgate by the Chinese Patent Office, shall apply for the approval of the Ministry of Hygiene  or Ministry of Agriculture, Husbandry and Fishery.