Extension of Patent Right Term becomes Possible for Therapeutic Psychotropic Drugs

Extension of Patent Right Term becomes Possible for

Therapeutic Psychotropic Drugs

-Partial revision of Enforcement of Patent and Utility Model Acts will be implemented as of July 14, 2020-




The Korean Intellectual Property Office (KIPO) announced they will improve the system for extending patent and utility model right terms by adding narcotics that have been approved by the Ministry of Food and Drug Safety to the objects of extension of term of patent right, and such system will be implemented as of July 14, 2020.



In the case that a patent application is registered, the term of existence of the patent right is up to 20 years from the filing date of the application in principle, and after that, such invention can be implemented by anyone as the patent right will have expired.



However, in order to manufacture and sell pharmaceuticals and pesticides, it is necessary to go through additional lengthy approval/registration procedures by the Ministry of Food and Drug Safety or the Rural Development Administration, so even if such a patent application is registered, there is the drawback that the patented technology cannot be used during the period of waiting for approval or registration, and accordingly, the period in which this kind of patent can be implemented becomes relatively short.



Accordingly, KIPO has operated a system that extends the term of a patent right by the period required for product approval or registration (for up to 5 years), but until now the only objects have been a pharmaceutical approved by the Ministry of Food and Drug Safety based on the Pharmaceutical Affairs Act or an agricultural pesticide registered with the Rural Development Administration based on the Agrochemicals Control Act.



However, despite the fact that pharmaceuticals such as narcotic analgesics are subject to approval by the Ministry of Food and Drug Safety based on the Narcotics Management System before manufacture and sale, such patent right was not included in the objects of extension of term of patent right and thus many have felt that it was against system fairness.



Consequently, KIPO has revised the Enforcement Decree of the Patent Act so that the term of a patent right can be extended in the case that it takes time for a pharmaceutical to be approved such as a narcotic analgesic, and it applies to all applications for registration of extended patent term filed after July 14, 2020.



Meanwhile, the above revision of the Enforcement Decree of the Patent Act and Utility Model Act also includes matters of adjusting the detailed standard regarding the period to be excluded from an extension when the term of a patent or utility model right is extended based on a KIPO examination delay as well as matters of recognizing depository institutions for microorganisms agreed to with other countries.



When the registration of the establishment of a patent or utility model right is delayed beyond the date when four years have lapsed after the date of a patent application or the date when three years have lapsed after a request for the examination of an application is made, whichever is later, the term of the relevant patent or utility model right may be extended as much as the delayed period; however, a period delayed due to an applicant during an examination procedure shall be excluded from an extension of term of right.



This system is to compensate for a shortened term of patent right when a patent examination is excessively delayed and thus the patent registration is delayed, and said system was introduced in 2012 under the Korea-US FTA, with the kind of delayed period caused by an applicant being stipulated by domestic patent law according to the patent system of each country.



In Korea, there are 49 situations prescribed by law in which examination can be delayed due to an applicant, but some periods delayed due to an applicant, such as a period in which examination is delayed because the applicant has not submitted documents necessary for the examination, are omitted from the regulation, so there has been a problem that such period could not be excluded from an extended period.


Accordingly, by supplementing the period that was omitted in the relevant regulations in accordance with the purpose of extensions for patent rights, KIPO improved the extension of patent and utility model right period system by adding only periods in which examination is delayed even though the applicant has made sufficient efforts.



Meanwhile, in the case of filing a patent application for a microorganism in a foreign country, in order to be able to deposit microorganisms in a depository institution designated through an agreement with a foreign country, KIPO added recognition of microorganism depository institutions in Korea.



Previously, in order to file a patent application for a microorganism in a foreign country, in the case of countries that have joined the applicable international treaty*, the microorganism could simply be deposited with an International Depository Authority (IDA)** in Korea, but in the case of filing an application in a country that had not joined the treaty, the applicant had to deposit the microorganism directly.


* 「The Budapest Treaty on the International Approval of Deposit of Microorganisms in Patent Procedures」 ('80.8. Entry into Force)

** The 4 institutions that have acquired the status of an International Depository Authority under the guarantee of the Korean government in accordance with the Budapest Treaty are the Korean Collection for Type Cultures (KCTC), the Korean Culture Center of Microorganisms (KCCM), the Korea Cell Line Research Foundation (KCLRF) and the Korean Agricultural Culture Collection (KACC)



In this process, since the cost of transporting and depositing microorganisms abroad is expensive, domestic companies were burdened in the case of filing microbial patents in countries that do not participate in the international treaty such as Taiwan and Thailand, but in the future, it is anticipated that there will be a significant cost reduction effect when filing a patent application with a designated depository institution in Korea per the treaty.



<Cost for depositing microorganisms with depository institutions in major countries>



The Chief of the Patent Examination Policy Bureau of KIPO said, “This revision of the Enforcement Decree of the Patent Act and Utility Model Act will resolve the problems that some pharmaceuticals for treatment such as narcotic analgesics could not be extended for term of patent right, and we expect that it will also be helpful to related industries as applicants who desire to file patent applications abroad become able to deposit microorganisms more conveniently and safely."



[Source: KIPO]


#KIPO #IntellectualProperty #Microorganism #DepositingCost #TherapeuticPsychotropicDrug #PatentRightTerm #Patent


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