Ministry of Economic Affairs Scraps Provision in Regulations for Ratifying Extension of Patent Term Requiring Applicants to Provide Foreign Documents as Proof of Extension Approval Source: Taiwan Intellectual Property Office The Ministry of Economic Affairs (the “MOEA”) announced on April 11 that it had amended the Regulations for Ratifying Extension of Patent Term (the “Regulations”), realizing structural goal of patent term extensions and simplifying the process for extending patent terms. The amendments took effect on April 1st. The MOEA explained in the reasons for the amendment that the domestic and/or foreign clinical trials or tests conducted for the purpose of obtaining approval by an applicant for a drug or agricultural chemical respectively from the competent authority shall be limited to those sent by the patent agency to the competent authority and confirmed to be necessary by the latter for issuing such an approval. Also, when the applicant bases on the period of foreign clinical trials and applies for a patent term extension, whether or not an application for patent term extension was granted outside of Taiwan shall not be considered, It is not necessary to provide the documents of foreign patent term extension approval as proof. Therefore, one of the Paragraphs in Articles 5 and 7, which stipulates that the applicant must provide foreign document(s) as proof of application in order to obtain regulatory approval have been deleted. Furthermore, regarding field tests undertaken to receive approval from the regulatory in charge of agricultural chemicals, information from at least three field tests conducted outside of Taiwan or information from tests conducted domestically must be provided in accordance with Article 5 of the "Pesticide Field Testing Guidelines." However, it was originally stipulated that while the applicant needs to conduct more than one field test, the calculation of duration of the tests can be combined only when there is a sequential relation among all tests. Otherwise, the longest period of time in one of the tests took place shall prevail. And, so as to implement the purpose of the patent term extension system and also to safeguard the rights and interests of applicants, the amendment of the Regulations removes language in Article 6 which stipulates that for field tests of no sequential relations, only the longest time period on one of the tests may be adopted in applying for an extension.