For a patent application involving utilization of biological materials that cannot be readily obtained by a person ordinarily skilled in the art through written description in the specification, the applicant generally needs to deposit the biological materials to satisfy the enablement requirement under the Patent Law.
Applicants intending to file such applications in multiple countries or regions would typically make an international deposit at an international depositary under the Budapest Treaty, enabling recognition of a single deposit across multiple jurisdictions.
However, Taiwan is not a member of the Budapest Treaty. Even if the patent applicant has deposited the biological materials at an international depositary authorized under the Budapest Treaty, when filing the same application in Taiwan, the applicant must still deposit the same biological materials with a domestic depositary, namely the Food Industry Research and Development Institute (FIRDI), and submit to TIPO a deposit and viability certificate issued by said domestic depositary within 4 months from the filing date of patent application or within 16 months from the earliest priority date, whichever is later. An applicant is exempted from the domestic deposit requirement only if the biological materials have been deposited at an officially recognized depositary in the United Kingdom, Japan or Korea pursuant to bilateral agreements between Taiwan and each of these three countries concerning the reciprocal recognition of deposits.
If a non-local patent applicant is required to make a domestic deposit, an import permit from a relevant Taiwan authority (e.g., the Customs Administration, the Ministry of Agriculture, the Ministry of Health and Welfare, etc., depending on the nature of the biological materials) would first be necessary before the biological material can be delivered transnationally. Due to differing regulations governing transnational delivery of various types of biological materials, the timeframe for the entire process depends on the properties of the biological materials and the applicable regulations, and can vary significantly. In some cases, the customs may impose additional quarantine requirements and/or other procedures, even if an import permit is in place, which can further delay the process. Moreover, the deposit and viability certificate is issued only after the biological materials pass a viability test performed by FIRDI, which takes additional time.
In addition to the time concerns, non-local patent applicants should also consider the financial implications. An official fee for depositing one common biological material at FIRDI is approximately US$1,200 to US$1,800, and a higher fee is required for biological materials with special properties. This is in addition to miscellaneous expenses such as transportation and customs clearance expenses.
Therefore, if non-local patent applicants intend to make an international deposit for a patent application to be filed in multiple countries or regions, including Taiwan, it may be advisable, where feasible, to make an international deposit in the United Kingdom, Japan or Korea. Doing so may help reduce both time and expense due to Taiwan’s reciprocal recognition arrangements with these countries.