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Intellectual Property Office Amends the Examination Standards for "Patent Term Extension"
The Intellectual Property Office (IPO) announced on December 14, 2017 amendments of Chapter 11, Part II of the Patent Examination Guidelines, entitled "Examination Guidelines for Patent Term Extension." The amendments mainly include the following changes:
1. In the event the name of the market approve holder is inconsistent with that of the patentee, the applicant shall provide documentation that the two are the same legal entity or have an exclusive or non-exclusive authorization relationship. In addition, recordation of the license with the IPO is necessary.
2. The active ingredients in the first market approval shall be determined based on the active ingredient per se rather than the moiety having pharmacological effect (free base). The term "first market approval" means that obtained for the same active ingredient and the same use. In principle, different licenses obtained for different salts, esters or different hydrates of the same chemical moiety shall each be identified as a first market approval.
3. For determination of correlation between the patent scope and the first market approval, the "correspondence" relation originally specified in the Guidelines is redefined as "coverage." The relevant descriptions and examples in the Guidelines are amended accordingly. For the examination of an application for extension, the IPO requires that the active ingredients and use stated in the first license should be covered by the scope of the patent application. In the case of an invention patent for a product, the active ingredient contained in the first market approval should be covered by the scope of the product claims; in the case of a use invention patent, the active ingredients and use stated in the first market approval should be covered by the use claims. In the case of a manufacturing process for a product, the active ingredients contained in the first market approval should be covered by the process claims.
4. It is clarified that the commencement and conclusion dates of the foreign clinical trials are respectively the study initiation and study completion dates defined in the clinical trial report in line with ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use). In the case of applying for extension based on foreign clinical trial periods, the focus of the foreign clinical trial protocol should be stated, and the study initiation and completion dates as stated in the clinical trial report that conform to the ICH should be recorded as the commencement and conclusion dates of foreign clinical trial.
5. The conclusion of regulatory review of an application for agricultural chemical is redefined as the issue date recorded on the market approval for the agricultural chemical. Moreover, delay during regulatory review attributable to the applicant includes period from the issue date of approval of the "use methods and scopes" of agricultural chemical to completion of documents for regulatory review...
6. The requirement of submitting document(s) regarding allowance of patent term extension in foreign country(ies) is lifted.
7. The following stipulations are added: the period during regulatory review in which an interruption or delay in obtaining a market approval occurs due to "data inconsistent with the criteria for approving a market approval" is attributable to the applicant. In respect of applications for market approval of a drug or agricultural chemical, the documents and regulatory fees required for filing market approval are defined. Any delay during regulatory review in obtaining a market approval due to incomplete data, non-payment of fees, or data not in conformity with the requirements for obtaining a market approval during examination by the Department of Health and Welfare is in principle attributable to the applicant.
8. For an academic clinical trial converted into a clinical trial, the initiation date of the academic clinical trial is taken as the commencement date of the domestic clinical trial.
The IPO plans to announce implementation of the amended guidelines on 1 April 2018. Although the changes to the definition of the first market approval referred to in the preceding paragraph 2 relax the criteria on determination of first market approval, it also imposes a limitation on the scope of extension to the specific ingredients stated in the market approval according to the provisions of Article 56 of the Patent Act. In addition, the update of paragraph 7 may adversely impacts patentees by expanding the explanation of the "periods of delay attributable to the applicant."