How should non-Taiwanese patent applicants deposit biological materials?

Regarding the microbial preservation and survival procedures, due to the existence of the Budapest Treaty, countries around the world generally comply with the biological material deposit procedures, which provides convenience for PCT international applications. However, since Taiwan is not a member of the treaty, even if the biological material is deposited in accordance with the Budapest Treaty, the applicant in Taiwan still needs to deposit it locally in a depository recognized by the Taiwan Intellectual Property Office. At present, there is only one qualified institution in Taiwan that is applicable to the preservation and survival of microorganisms involved in patent applications, which is the Food Industry Development Research Institute (FIRDI) in Hsinchu, Taiwan. According to regulations, the applicant must clearly submit the deposit and survival certificate to the Intellectual Property Office within 4 months from the date of the patent application, otherwise the patent application process may be affected due to failure to submit relevant certificates in time.

From a corporate strategy perspective, patent applicants should not only consider the deposit of biological materials, but also understand in advance the administrative approvals involved in imports, such as obtaining permits from the Customs Administration, the Ministry of Agriculture, or the Ministry of Health and Welfare. Based on field experience, the specific approval time is uncertain, and some biological materials may encounter obstacles in import permits. In addition, customs quarantine procedures will further delay the completion of the deposit. In addition, FIRDI needs 3 to 4 weeks after receiving the sample to confirm the culturability and survival of the material before issuing the necessary certification documents.

The cost of depositing and maintaining microorganisms at FIRDI is approximately US$1,200-1,800. The storage cost may be high if special biological materials are involved, as well as possible transportation and customs clearance costs.