In order to meet the practical needs of examination of patent term extension, simplify administrative procedures and improve examination efficiency, the Taiwan Intellectual Property Office (TIPO) recently announced draft amendments to Articles 4 and 10 of the Regulations Governing the Determination of Patent Term Extension. The main points of the amendments are as follows:

1. The Specific Patent Agency may rely on documents that indicate the period of domestic and/or foreign clinical trials conducted for obtaining a marketing approval of drug from the central competent authority in charge of the business as criteria for determining the extension of the patent term. The Specific Patent Agency does not need to send the documents to the central competent authority for confirmation. (Amendment to Article 4, Paragraph 2 of the Regulations Governing the Determination of Patent Term Extension)

2. The implementation date of the amendment to Article 4 of the Regulations Governing the Determination of Patent Term Extension is specified. (Amendment to Article 10 of the Regulations Governing the Determination of Patent Term Extension)

Further explanations for the amendment to Article 4 of the Regulations Governing the Determination of Patent Term Extension are provided below.

1. During examination for marketing approval, the central competent authority in charge of the business shall confirm documents that indicate the period of domestic and/or foreign clinical trials and a data sheet for data exclusivity and domestic and/or foreign clinical trials submitted by an applicant. If there is any difference between the results confirmed by the central competent authority and the data sheet submitted by the applicant, the difference shall be corrected on the data sheet and approved by the central competent authority.

2. Since the central competent authority has confirmed the period of domestic and/or foreign clinical trials conducted for obtaining a marketing approval, the Specific Patent Agency can determine and calculate the period of domestic and/or foreign clinical trials based on the data sheet confirmed by the central competent authority. Hence, the proviso “sent by the Specific Patent Agency” in the current regulation is deleted. That is to say, after receiving the data sheet, the Specific Patent Agency does not need to send the data sheet to the central competent authority for confirmation.

3. If the Specific Patent Agency has doubts about the period of domestic and/or foreign clinical trials contained in the data sheet, the Specific Patent Agency can still send the data sheet to the central competent authority for confirmation.

(Translated based on News published on the TIPO’s website)

*Section Chief of International Patent Division at Tai E International Patent & Law Office