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Draft Proposal for "Guidelines for Taiwan-Japan Cooperation on Deposit of Biological Materials in Relation to Patent Procedure"

On November 20, 2014, Taiwan and Japan signed a Memorandum of Understanding with respect to cooperation on deposit of biological materials in relation to patent procedure. The purpose of the Memorandum was to eliminate the need for patent applicants to make duplicate deposits in each country. To implement a framework for Taiwan-Japan biological material deposit cooperation, on May 14, 2015 the Taiwan Intellectual Property Office (TIPO) announced draft "Guidelines on Taiwan-Japan Cooperation on Deposit of Biological Materials in Relation to Patent Procedure" (hereinafter referred to as the "Guidelines").
Taiwan is not a signatory to the Budapest Treaty, and as such does not enjoy mutual recognition of foreign depository institutions. Article 27 of the Patent Act requires an applicant filing a patent application for invention involving a biological material to make a deposit of the biological material with the Bio-resource Collection and Research Center under Food Industry Research and Development Institute no later than the filing date; no deposit is required if the biological material involved is easily obtainable by a person with ordinary skill in the particular field in question. The same Article also provides that, in the event that the biological material concerned has been deposited in a foreign depository recognized by the patent authority prior to filing the patent application for invention, the applicant is exempted from the requirement of making a deposit no later than the filing date of the application. Therefore, even if prior to filing of an application the biological material has been deposited with an international depository institution recognized by the Budapest Treaty, it should still be deposited with a depository institution in Taiwan in compliance with the Patent Act.
With respect to deposit of biological materials in Taiwan, Article 27, Paragraph 5 of the Patent Act provides that: "If an applicant has deposited the biological material in a depository designated by a foreign country in its territory with which the ROC recognizes the effects of deposits based on reciprocity, and if the applicant has submitted the certificate(s) of deposit issued by the said foreign depository, the applicant is exempted from the requirement of making a deposit in the ROC." Following the signing of the Memorandum between Taiwan and Japan on November 20, 2014, which removes the need to make duplicate deposits of biological materials in both Taiwan and Japan, the TIPO released its draft Guidelines on May 14, 2015, the most salient provisions of which are as follows: (1) Clarification is given on the scope of effectiveness of mutual recognition of deposit as a result of result cooperation between Taiwan and Japan, and the depository institution designated by the patent authority; (2) As designated depositories are unable to distrubte samples of deposit biological material, provisions are made with respect to procedure for re-submission; subject who performs such submission; requirements  to the effect that the original deposit date is regarded as the deposit date, and exceptions which disallow re-submission; (3) Requirements are stipulated for restrictions on import and export of biological materials; (4) Qualifications are described for designated depository institutions; (5) Requirements are defined for the relevant patent authority to ensure transfer of biological materials and complementary measures to be taken by it upon the designated depository institution ceasing the execution of its assignment; (6) Provisions are indicated for handling of the patent authority upon the designated depository's refusal to accept deposit of a particular type of biological material;(7) It is effectively stipulated that applications for deposit of biological materials, re-submission procedure, and deposit of biological materials are irrevocable; (8) Causes for refusal by a depository institution to accept deposit of biological materials and process such submission are established;(9) Duration of deposit of biological materials with a designated depository institution and confidentiality regulations are defined; and (10) Qualifications are provided for sub-licensing of biological materials and sub-licensing procedure for sub-licensing by applicants with different qualifications.
Upon implementation of the Guidelines, patent applicants in Taiwan and Japan with biological material inventions can follow these provisions to avoid needing to make duplicate deposits of such materials in Taiwan and Japan.