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Dear Clients and Friends,
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To cope with the implementation of the newly amended Taiwan Patent Act taking effective on 1 January 2013, the Ministry of Economic Affairs (i.e. the MOEA) jointly promulgated the amended Regulation Ratifying Extension to Patent Term ("Regulation") on 28 December 2012 with the Department of Health ("DOH") and the Council of Agriculture ("COA"); the Regulation took effect on 1 January 2013. The major changes include the following:
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I.
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Adjustment of the number of the Concerned Provision in the "Regulation"
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According to Paragraph 3, Article 52 of the old Patent Act, the MOEA is authorized to jointly promulgate a regulation governing matters related to patent term extension together with the DOH and the COA. In the amended Patent Act, such article was renumbered as Paragraph 5, Article 53, which was reflected in the amended Regulation (Article 1 of the amended Regulation).
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II.
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Time period of Conducting Domestic or Clinical Trials or Field Trials
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1.
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The provisions related to the time period for conducting domestic and overseas clinical trials for pharmaceutical products were originally provided in Items 1 and 3, respectively, under Paragraph 1, Article 4 of the old Regulation. Considering that the regulations regarding registration of pharmaceutical products are not different from those for domestic and overseas clinical trials, the time period for conducting domestic and overseas clinical trials are now jointly regulated under Item 1, Paragraph 1, Article 4 of the amended Regulation, and the original Item 3 was deleted (Paragraph 1, Article 4 of the amended Regulation).
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Similarly, the provisions related to the time period for conducting domestic and overseas field trials of agricultural chemicals were originally provided in Items 1 and 3, respectively, under Paragraph 1, Article 6 of the old Regulation. Considering that the regulations regarding registration of agricultural chemicals are not different from those for domestic and overseas field trials, the time period for conducting domestic and overseas field trials are now jointly regulated under Item 1, Paragraph 1, Article 6 of the amended Regulation and the original Item 3 was deleted. It is clarified in the amended Regulation that the specific trial eligible for patent term extension is limited to field trials because usually only the fieldtrials are taken into consideration when reviewing an application for patent term extension (Paragraph 1, Article 6 of the amended Regulation).
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2.
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The time period for conducting domestic and overseas clinical trials of pharmaceutical products or that for conducting domestic and overseas field trials of agricultural chemicals, which are eligible for patent term extension , should be limited to that determined the DOH or COA to be necessary for the grant of such registration permit (Paragraph 2, Article 4 and Paragraph 2, Article 6 of the amended Regulation).
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3.
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The phrase, "the time period for failure to take actions needed for obtaining a permit" (a period that should be deducted from the extended term) is fine-tuned as "the inaction period attributable to the applicant" (Paragraph 3, Article 4 and Paragraph 4, Article 6 of the amended Regulation).
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III.
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List regarding Domestic and Overseas Trials
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It is newly added that, when applying for patent term extension for a patent covering a pharmaceutical product or the manufacture process thereof, or a patent covering an agricultural chemical or the manufacture process thereof, a "list" of the time period for conducting the trials involved, as well as the dates of the commencement and conclusion of such trials should be submitted. It is clarified in the amendment reasons that the above-mentioned evidentiary documents are not limited to those issued by government agencies; documents prepared and issued by the trial organization will suffice. It is also clarified that the newly added requirement for submitting a "list" as stated above is aimed to facilitate the IPO's review of the application for patent term extension, and the IPO may forward such list for the DOH or the COA for verification. Please note that the name of the domestic and overseas trials and the dates of the commencement and conclusion of such trials should be specified in the list. Regarding how to determine the dates of the commencement and conclusion of trials, It will be further regulated in the Patent Examination Guidelines on Extension to Patent Term (Articles 5 and 7 of the amended Regulation).
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IV.
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Commencement Date and the Ending Date of "Time Period for Not Being Able to Practice the Patent Due to Seeking a Permit"
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1.
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For a trial commencing prior to the publication date of the concerned patent, the commencement date of "the time period for not being able to practice a patent due to seeking a permit" is added into the amended Regulation for clarification. The above-mentioned time period should start from "the date on which the trial begins" (Paragraph 1, Article 8 of the amended Regulation).
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2.
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During the review process of registration for pharmaceutical products and agricultural chemicals, there are "grant date of permit ", "date of notification for collecting a permit" and "date of receiving a permit" for pharmaceutical products, and "date of notifying permit grant", "date of applicant's processing for registration," and "date of issuing a permit". In the past, these different dates have become very confusing when the IPO determined the ending date of "the time period for not being able to practice a patent due to seeking a permit". For clarification, the amended Regulation states that the ending date of "the time period for not being able to practice a patent due to seeking a permit" is "the day prior to the date of collecting a permit", which will be further regulated in the Patent Examination Guidelines on Extension to Patent Term (Paragraph 2, Article 8 of the amended Regulation).
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V.
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Determination of "Extended Term" for Patent Term Extension
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Where the "requested term for extension" listed in a written application for patent tem extension is longer than the "term for extension" allowed after the IPO's review of the said application, the IPO will issue an official notification to the applicant and ask the applicant to file a response. If the response to be filed is considered groundless, the IPO will grant the extension period according to its previous opinion. On the other hand, if the IPO considers that the allowable extension term is longer than the "requested term" listed in the initial written application, it will still grant the allowable duration as stated above (Article 9 of the amended Regulation).
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We hope that you find the above information helpful. If you have any questions or need our assistance, please do not hesitate to contact us.
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