In a case where foreign company A, a patentee of the patent invention, “5HT2C receptor control system,” filed an application for registration of extension of the term of a patent right with the requirement of 385 days for permission for import of narcotics, etc., which is a drug for embodying the patent, but the examiner of the Korean Intellectual Property Office rendered a decision to reject the application for registration of extension on the ground that the above drug granted permission pursuant to Article 18 of the former Narcotics Control Act and Article 34 of the Enforcement Rule of the same Act is not subject to extension of the term of patent right, the case holding that the above drug can be interpreted as included in the patent invention for which the term of patent may be extended under Article 89(1)

A foreign company, which is the patentee of a patented invention, “5HT2C receptors control system, was required to obtain permission for import of narcotics, etc., which is a medicine for the purpose of embodying the patented invention, and applied for registration of extension of the term of a patent right. However, the decision of rejection was made on the ground that the above drug granted permission for marketing pursuant to Article 18 of the former Narcotics Control Act (amended by Act No. 1331, May 18, 2015; hereinafter “former Narcotics Control Act”) and Article 34 of the former Enforcement Rule of the Narcotics Control Act (amended by Ordinance of the Prime Minister No. 1192, Sep. 21, 2015) is not subject to extension of the term of patent rights.

The case interpreting Article 89(1) of the former Pharmaceutical Affairs Act (amended by Act No. 13096, Jan. 28, 2015; hereinafter the same) as the “approval for items under the former Pharmaceutical Affairs Act” is deemed to have no intrinsic and substantial difference from the “approval for items” inasmuch as the patented invention for which patent duration may be extended pursuant to Article 89(1) of the former Patent Act (amended by Act No. 13114, Jan. 28, 2015; hereinafter the same) is identical to the “approval for items” and the data submitted for such approval are in substance the same procedures and contents as those prescribed by the former Pharmaceutical Affairs Act, and thus, the scope and purpose of the extension of patent term is determined to have no substantial difference with the “approval for items under the former Pharmaceutical Affairs Act” and Article 9(1)1 of the former Enforcement Decree of the Patent Act (amended by Act No. 13096, Jan. 28, 2015; hereinafter the same).

Article 89(1) of the former Patent Act (Amended by Act No. 13096, Jan. 28, 2015); Article 31, 42, and 55 of the former Pharmaceutical Affairs Act (Amended by Act No. 13114, Jan. 28, 2015); Article 2 subparag. 3(d) of the former Narcotics Control Act (Amended by Act No. 1331, May 18, 2015); Articles 18, 21, and 57 of the former Enforcement Decree of the Patent Act (Amended by Presidential Decree No. 26494, Aug. 19, 2015); Articles 7, 32, and 34 of the former Enforcement Rule of the Narcotics Control Act (Amended by Ordinance of the Prime Minister No. 1192, Sep. 21, 2015);

에자이 알앤드디 매니지먼트 가부시키가이샤(エ일ザイ·ア일ル·アンド·ディ일·マネジメント주식회사) (소송대리인 변호사 강경태 외 1인)

The Commissioner of the Korean Intellectual Property Office

May 24, 2019

1. The Korean Intellectual Property Tribunal’s decision on the case No. 2016 Won1645 on December 22, 2017 shall be revoked.

2. The costs of the lawsuit are assessed against the defendant.

The same shall apply to the order.

1. Basic facts

A. The patented invention of this case (No. 1)

(i) Name of the invention: 5HT2C receptors control systems;

2) The international filing date/priority claim date/registration date/registration number: April 11, 2003/ April 12, 2002/ March 5, 2008 (patent registration number omitted)

3) A patentee: The plaintiff

4) Claims

【Request 1 to 116】 (Dismissal)

【Request 117】 Chemical I compound or its pharmaceutically permitted salt

A person shall be appointed.

상기 식에서, R₁은 H 또는 알킬이고; R₂는 알킬, -CH₂-O- 알킬, -OH 또는 －CH₂OH이고; 는 H이거나; R₂ 및 는 함께 －CH₂-CH₂-를 형성하고; R₃은 할로겐, 퍼할로알킬, CN, , , , 아릴 또는 헤테로아릴이고, 상기 아릴은 알킬, 할로겐, 퍼할로알킬 및 알콕시로부터 선택된 2개 이하의 치환기로 치환될 수 있고, 상기 헤테로아릴은 할로겐 및 알킬로부터 선택된 2개 이하의 치환기로 치환될 수 있고; R₄는 H, 할로겐, 퍼할로알킬, CN, , , , , OH, 아릴 또는 헤테로아릴이고, 상기 아릴은 알킬, 할로겐, 퍼할로알킬 및 알콕시로부터 선택된 2개 이하의 치환기로 치환될 수 있고, 상기 헤테로아릴은 할로겐 및 알킬로부터 선택된 2개 이하의 치환기로 치환될 수 있거나; R₃ 및 R₄는 이들이 부착된 원자와 함께 1개의 O 원자를 갖는 5 또는 6원 헤테로시클릭 고리를 형성할 수 있고; 각각의 는 독립적으로 알킬, 알케닐, 아릴, 헤테로아릴, 아릴 알킬, 헤테로아릴 알킬, 퍼할로알킬 또는 알릴이고; 은 H 또는 알킬이되, 단 이 H 이외의 것일 경우, R₄는 H일 수 없고; R₁ 및 R₂가 메틸이고, R₄가 H일 경우, R₃은 또는 일 수 없고; R₁ 및 R₂가 메틸이고, R₄가 H일 경우, R₃은 이미다졸, 치환된 이미다졸 또는 이미다졸 유도체일 수 없으며; 여기서, “아릴”은 3 내지 14개의 탄소 원자를 가진 모노시클릭 또는 폴리시클릭 방향족기를 나타내고, “헤테로아릴”은 O, N 또는 S와 같은 1 내지 4개의 비탄소 원자를 포함하는 아릴기를 나타내고, “아릴 알킬”은 아릴 치환기를 포함하는 알킬을 나타내고, “헤테로아릴 알킬”은 헤테로아릴 치환기를 포함하는 알킬을 나타내고, “치환된 이미다졸”은 하나 이상의 치환기를 포함하는 이미다졸로부터 유도된 라디칼을 나타내고, “이미다졸 유도체”는 융합된 고리들 중 하나가 이미다졸인 융합된 고리계를 나타낸다.

【Request 18, 122 through 124, 126, 127, 148 through 150, 154, 155, 160 through 170】

【Request 119 through 121, 125, 128 through 147, 151 through 153, 156, 157, 163 through 166】

【Request 158, 159, 167 through 169】 (Dismissal)

B. Product license of the instant medicine (Evidence A No. 1 and 7)

1) Date of obtaining permission, etc.: February 2, 2015

2) Details of permission: No. 1 of the Import License No. 1 of narcotics (hereinafter “instant item approval”).

(iii) The name of an active ingredient: (R-8-chloro-1-Meethyl-2,3,4,5-tetradyd-1H-3-benchlorates;

(d) Item name: Lorcaslerin Hydroide Hydroides;

(v) Product name: Belviq Table

6) Efficacy and effectiveness: A method of assistance to the Food and Campaign Act for the purpose of controlling the body of a patient, among those whose physical quantity index (BMI) is not less than 30 km/m of square, or which are not less than 27 km/m of liquid mass index (e.g., high blood pressure, abnormal geological blood transfusion, and Type 2 urology) with other risk factors (e.g., high blood pressure, abnormal blood transfusion, and Type 2 urology);

(c) Details of the trial decision (Evidence A through 4);

1) On April 29, 2015, the Plaintiff filed an application for registration of extension of the term of a patent right (application number omitted; hereinafter referred to as “application for registration of extension”) with the claims subject to extension under Article 117, 118, 122 through 124, 126, 127, 148 through 150, 154, 155, 160 through 162, and 170 of the instant patent invention on the ground that the requirements of 385 days for the marketing approval of the instant case took place.

2) On August 20, 2015, the Korean Intellectual Property Office examiner notified the Korean Intellectual Property Office examiner of the opinion that “The term “the”, which is a drug subject to registration for extension, is not an item license pursuant to Article 31(2) and (3) of the Pharmaceutical Affairs Act or Article 42(1) of the Enforcement Rule of the same Act, and obtained an item license pursuant to Article 18 of the Narcotics Control Act (hereinafter “Narcotic Drugs Control Act”) and Article 34 of the Enforcement Rule of the same Act. Thus, the instant pharmaceutical invention does not constitute a pharmaceutical invention under Article 7 subparag. 1 of the Enforcement Decree of the Patent Act, and the practice of the patented invention is not recognized as unnecessary to obtain permission under Article 89(1) of the Patent Act.

3) On November 19, 2015, the Plaintiff asserted that, “Article 7 subparag. 1 of the Enforcement Decree of the Patent Act” provides that “a pharmaceutical product that has obtained marketing approval pursuant to Article 31(2) and (3) or 42(1) of the Pharmaceutical Affairs Act is “a drug that has been granted marketing approval pursuant to Article 31(1) of the Pharmaceutical Affairs Act,” but in light of the purpose and purpose of the patent term extension system, the Plaintiff asserted that, “the instant pharmaceutical product invention is an invention subject to extension of patent term, not the meaning of excluding the instant pharmaceutical product, i.e.

4) On February 17, 2016, the Korean Intellectual Property Office examiner rendered a decision to reject the instant application for registration of a patent on the ground that “Article 7 subparag. 1 of the Enforcement Decree of the Patent Act clearly stipulates that the subject matter of patent term extension registration is an invention of a drug subject to permission pursuant to Articles 31 and 42 of the Pharmaceutical Affairs Act, and that no drug licensed pursuant to the Narcotics Control Act is provided, and thus, “the instant drug, which is a drug granted permission pursuant to Article 18 of the Narcotics Control Act and Article 34 of the Enforcement Rule of the same Act, is not subject to extension of patent term” (hereinafter “instant disposition”).

5) On March 18, 2016, the Plaintiff filed a petition for a trial against the foregoing decision of refusal with the Intellectual Property Tribunal, and the Intellectual Property Trial and Appeal Board rendered a trial ruling dismissing the Plaintiff’s petition (hereinafter “instant trial ruling”) on December 22, 2017, on the ground that “the invention of a drug for which a license was granted under Article 18 of the Narcotics Control Act does not constitute an invention of a drug for which a license was granted under Article 7 subparag. 1 of the Enforcement Decree of the Patent Act.” Thus, the instant patent invention cannot be deemed an invention of a drug for which a license was granted under Article 7 subparag. 1 of the Enforcement Decree of the Patent Act.”

D. Relevant Notes 1) Statutes

본문내 포함된 표 [1] 구 특허법(2015. 1. 28. 법률 제13096호로 개정되기 전의 것) 제89조(허가 등에 따른 특허권의 존속기간의 연장) ① 특허발명을 실시하기 위하여 다른 법령에 따라 허가를 받거나 등록 등을 하여야 하고, 그 허가 또는 등록 등(이하 “허가 등”이라 한다)을 위하여 필요한 유효성·안전성 등의 시험으로 인하여 장기간이 소요되는 대통령령으로 정하는 발명인 경우에는 제88조 제1항에도 불구하고 그 실시할 수 없었던 기간에 대하여 5년의 기간까지 그 특허권의 존속기간을 한 차례만 연장할 수 있다(이하 ‘이 사건 위임조항’이라 한다). [2] 구 특허법 시행령(2015. 8. 19. 대통령령 제26494호로 개정되기 전의 것) 제7조(허가 등에 따른 특허권의 존속기간의 연장등록출원 대상 발명) 특허법 제89조 제1항에서 “대통령령이 정하는 발명”이란 다음 각호의 어느 하나에 해당하는 발명을 말한다(이하 ‘이 사건 시행령 조항’이라 한다). 1. 특허발명을 실시하기 위하여 「약사법」 제31조 제2항·제3항 또는 제42조 제1항에 따라 품목허가를 받아야 하는 의약품[신물질(약효를 나타내는 활성부분의 화학구조가 새로운 물질을 말한다. 이하 이 조에서 같다)을 유효성분으로 하여 제조한 의약품으로서 최초로 품목허가를 받은 의약품으로 한정한다]의 발명 2. 특허발명을 실시하기 위하여「농약관리법」제8조 제1항, 제16조 제1항 및 제17조 제1항에 따라 등록하여야 하는 농약 또는 원제의 발명 [3] 구 약사법(2015. 1. 28. 법률 제13114호로 개정되기 전의 것) 제31조(제조업 허가 등) ① 의약품 제조를 업으로 하려는 자는 대통령령으로 정하는 시설기준에 따라 필요한 시설을 갖추고 총리령으로 정하는 바에 따라 식품의약품안전처장의 허가를 받아야 한다. ② 제1항에 따른 제조업자가 그 제조(다른 제조업자에게 제조를 위탁하는 경우를 포함한다)한 의약품을 판매하려는 경우에는 총리령으로 정하는 바에 따라 품목별로 식품의약품안전처장의 제조판매품목허가(이하 “품목허가”라 한다)를 받거나 제조판매품목 신고(이하 “품목신고”라 한다)를 하여야 한다. ③ 제1항에 따른 제조업자 외의 자가 제34조 제1항에 따라 임상시험계획의 승인을 받아 임상시험을 실시한 의약품을 제조업자에게 위탁제조하여 판매하려는 경우에는 총리령으로 정하는 바에 따라 식품의약품안전처장에게 위탁제조판매업신고를 하여야 하며, 품목별로 품목허가를 받아야 한다. 제42조(의약품 등의 수입허가 등) ① 의약품 등을 수입하려는 자(이하 “수입자”라 한다)는 총리령으로 정하는 바에 따라 품목마다 식품의약품안전처장의 허가를 받거나 신고를 하여야 한다. 허가받은 사항 또는 신고한 사항을 변경하려는 경우에도 또한 같다. 제55조(중독성·습관성 약품) 인체에 중독성이나 습관성으로 작용할 염려가 있는 의약품의 제조·관리 등에 필요한 사항은 따로 법률로 정한다. [4] 구 마약류 관리에 관한 법률(2015. 5. 18. 법률 제13331호로 개정되기 전의 것) 제2조(정의) 이 법에서 사용하는 용어의 뜻은 다음과 같다. 1. “마약류”란 마약·향정신성의약품 및 대마를 말한다. 2. “마약”이란 다음 각 목의 어느 하나에 해당하는 것을 말한다. (중략) 3. “향정신성의약품”이란 인간의 중추신경계에 작용하는 것으로서 이를 오용하거나 남용할 경우 인체에 심각한 위해(위해)가 있다고 인정되는 다음 각 목의 어느 하나에 해당하는 것으로서 대통령령으로 정하는 것을 말한다. 가. 오용하거나 남용할 우려가 심하고 의료용으로 쓰이지 아니하며 안전성이 결여되어 있는 것으로서 이를 오용하거나 남용할 경우 심한 신체적 또는 정신적 의존성을 일으키는 약물 또는 이를 함유하는 물질 나. 오용하거나 남용할 우려가 심하고 매우 제한된 의료용으로만 쓰이는 것으로서 이를 오용하거나 남용할 경우 심한 신체적 또는 정신적 의존성을 일으키는 약물 또는 이를 함유하는 물질 다. (가)목과 (나)목에 규정된 것보다 오용하거나 남용할 우려가 상대적으로 적고 의료용으로 쓰이는 것으로서 이를 오용하거나 남용할 경우 그리 심하지 아니한 신체적 의존성을 일으키거나 심한 정신적 의존성을 일으키는 약물 또는 이를 함유하는 물질 라. (다)목에 규정된 것보다 오용하거나 남용할 우려가 상대적으로 적고 의료용으로 쓰이는 것으로서 이를 오용하거나 남용할 경우 (다)목에 규정된 것보다 신체적 또는 정신적 의존성을 일으킬 우려가 적은 약물 또는 이를 함유하는 물질 (중략) 4. “대마”란 대마초[칸나비스 사티바 엘(Cannabis sativa L)]와 그 수지(수지) 및 대마초 또는 그 수지를 원료로 하여 제조된 모든 제품을 말한다. 다만 대마초의 종자(종자)·뿌리 및 성숙한 대마초의 줄기와 그 제품은 제외한다. (중략) 제6조(마약류취급자의 허가 등) ① 마약류취급자가 되려는 다음 각호의 어느 하나에 해당하는 자로서 총리령으로 정하는 바에 따라 제1호·제2호 및 제4호에 해당하는 자는 식품의약품안전처장의 허가를 받아야 하고, 제3호에 해당하는 자는 특별시장·광역시장·도지사 또는 특별자치도지사(이하 “시·도지사”라 한다)의 허가를 받아야 하며, 제5호에 해당하는 자는 시장·군수 또는 구청장(자치구의 구청장을 말한다. 이하 같다)의 허가를 받아야 한다. 허가받은 사항을 변경할 때에도 또한 같다. 1. 마약류수출입업자:「약사법」에 따른 수입자로서 식품의약품안전처장에게 의약품 품목허가를 받거나 품목신고를 한 자 2. 마약류제조업자 및 마약류원료사용자:「약사법」에 따라 의약품 제조업의 허가를 받은 자 제18조(마약류 수출입의 허가 등) ① 마약류수출입업자가 아니면 마약 또는 향정신성의약품을 수출입하지 못한다. ② 마약류수출입업자가 마약 또는 향정신성의약품을 수출입하려면 총리령으로 정하는 바에 따라 다음 각호의 허가 또는 승인을 받아야 한다. 1. 품목마다 식품의약품안전처장의 허가를 받을 것. 허가받은 사항을 변경할 때에도 같다. 2. 수출입할 때마다 식품의약품안전처장의 승인을 받을 것. 승인받은 사항을 변경할 때에도 같다. 제21조(마약류 제조의 허가 등) ① 마약류제조업자가 아니면 마약 및 향정신성의약품을 제조하지 못한다. ② 마약류제조업자가 마약 또는 향정신성의약품을 제조하려면 총리령으로 정하는 바에 따라 품목마다 식품의약품안전처장의 허가를 받아야 한다. 허가받은 사항을 변경할 때에도 또한 같다. 제57조(다른 법률의 적용) 마약 및 향정신성의약품의 제조·관리 등에 관하여 이 법에 규정된 것을 제외하고는「약사법」을 적용한다. [5] 구 마약류 관리에 관한 법률 시행규칙(2015. 9. 21. 총리령 제1192호로 개정되기 전의 것) 제32조(수출입·제조품목허가신청 등) ① 마약류 관리법 제18조 제2항 제1호, 제21조 제2항 또는 제24조 제2항에 따라 마약·향정신성의약품 또는 한외마약의 수입 또는 제조품목허가를 받으려는 자는 별지 제34호 서식에 따른 신청서(전자문서로 된 신청서를 포함한다)에 다음 각호의 구분에 따른 서류(전자문서로 된 서류를 포함한다)를 첨부하여 식품의약품안전처장에게 제출하여야 한다. 1. 사람에게 사용할 것을 목적으로 하는 경우:「의약품 등의 안전에 관한 규칙」제4조 및 제12조에 따른 서류. 다만「의약품 등의 안전에 관한 규칙」제5조 제1항 각호의 어느 하나에 해당하는 경우에는 같은 규칙 제5조 제2항·제3항 및 제12조에 따른 서류를 제출하여야 한다.

[Reasons for Recognition] Unsatisfy, Gap evidence Nos. 1 through 4, 7, Eul evidence No. 1, the purport of whole pleadings

2. The parties' assertion

A. The plaintiff

For the following reasons, it is reasonable to view that the instant pharmaceutical product is included in the subject matter of extension of patent term as stipulated in the instant delegation provision. Therefore, the instant trial decision, which maintained the instant disposition rejecting the instant application for registration of extension, as deemed lawful, should be revoked as it is unlawful.

1) Psychotropic drugs under the Narcotics Control Act are also used for the purpose of diagnosis, treatment, mitigation, or prevention of human beings or animals, and the provisions related to marketing approval under the Narcotics Control Act stipulate that the provisions related to marketing approval under the Pharmaceutical Affairs Act shall be followed as they are. Therefore, it is unreasonable to exclude “psychotropic drugs” under the Narcotics Control Act, even though there is no difference between the general medicines and psychotropic drugs under the Pharmaceutical Affairs Act in the test and procedure, permitting agency, required period, etc. necessary to obtain “ marketing approval” and the psychotropic drugs under the Narcotics Control Act, even though they are not different from

2) Unless the part related to the marketing approval of psychotropic drugs under the Narcotics Control Act is prescribed in the Enforcement Decree of the instant case, it constitutes error due to omission or lack of legislation. Therefore, if the delegation provision of the instant case and the enforcement decree of the instant case are interpreted systematically, purposeological and legally, it may be deemed that the subject of extension of the term under the delegation provision of the instant case constitutes “psychotropic drugs approved under the Narcotics Control Act,” and thus, the instant disposition rejecting an application for registration of extension of the term of patent rights with respect to the instant drug is unlawful.

3) both the “approval for items under the Narcotics Control Act” and the “approval for items under the Pharmaceutical Affairs Act” constitute “permission for use as a medicine,” and there is no difference in that the relevant patented invention has been recognized as useful as a medicine. Therefore, the exclusion of the instant medicine from the scope of delegation under the Narcotics Control Act solely on the ground that the “approval for items under the Narcotics Control Act” was not expressly provided for in the Enforcement Decree of the instant case from the scope of delegation under the instant delegation provision, and it is in violation of the principle of equality under Article 11(1) of the Constitution, and the restriction on the Plaintiff’s property right and freedom of business, etc., and infringement on the essential contents of the right under Article 37(2) of the Constitution.

B. Defendant

For the following reasons, the instant trial ruling is legitimate, and thus, the Plaintiff’s claim seeking revocation is without merit.

1) Various permissions for narcotics, etc. under the Narcotics Control Act are prohibited in principle as it is harmful or unreasonable to the general public. However, such prohibition is an administrative act that allows the pertinent act to be lawfully conducted by exceptionally cancelling such prohibition, while permissions for medicines under the Pharmaceutical Affairs Act is an administrative act that gives the possibility of the pertinent act by releasing general prohibition under the Acts and subordinate statutes. Accordingly, it cannot be deemed that permissions for items under each Act have the same legal nature in all respects.

2) An administrative disposition regarding the registration of extension of a patent term constitutes a beneficial administrative disposition involving extension of a patent right to a patentee, and a third party constitutes an indive administrative act restricting the right to freely practice the patented invention during the extended period. Administrative laws and regulations that serve as the basis for an indive administrative act should be strictly construed and applied. If the text of the law itself consists of relatively clear concepts, in principle, other interpretation methods need not be applied or should be limited.

3) Whether to extend the term of a patent under Article 89 of the Patent Act belongs to the discretion of an administrative agency. As such, an invention requiring a long period of time due to an examination necessary for permission, etc. is not subject to extension of the term of a patent. The instant provision explicitly stipulates that the instant provision is an invention of a drug under Article 31(2) and (3) or 42(1) of the Pharmaceutical Affairs Act, but does not stipulate an invention of a drug subject to marketing approval for the Narcotics Control Act. Thus, it is evident that an invention subject to extension of the term of a patent falls under an invention under Article 18 of the Narcotics Control Act.

4) Even though the invention related to narcotics is excluded from the scope of extension of the patent term due to the violation of the principle of equality under the Constitution, its unconstitutionality is not to eliminate its effect by the court directly taking legislative measures, but to require the administrative agency having legislative power over the relevant statutes to enact a separate legislation in the future, and then to remove the unconstitutionality according to such amendment legislation. Even if the enforcement decree of this case is judged unconstitutional and unlawful, an application for extension of the patent term cannot be filed until the amendment of "including an invention related to narcotics, etc." is enacted. Thus, the issue of whether the enforcement decree of this case excludes the invention of narcotics, etc. does not directly affect the trial, but it cannot be recognized as the premise of trial accordingly.

3. Whether the trial decision of this case is unlawful

(a) The nature of permission for items under Articles 18 and 21 of the Narcotics Control Act;

In light of the following circumstances, “approval for items” under the Narcotics Control Act, which is the instant medicine, is identical to the “approval for items” under the Pharmaceutical Affairs Act, and the kinds and requirements of data to be submitted for the same purpose, and the procedures and details of the reporting for items approval are in accordance with the same procedures and contents as those prescribed under the Pharmaceutical Affairs Act, and thus, there is no substantial difference from the “approval for items” under the Pharmaceutical Affairs Act.

1) The purpose of the Narcotics Control Act and the Pharmaceutical Affairs Act is to contribute to the improvement of national health (Article 1 of each Act). Article 55 of the Pharmaceutical Affairs Act provides that “The matters necessary for the manufacture, management, etc. of drugs that might lead to the improvement of national health shall be separately determined by other Acts,” and Article 57 of the Narcotics Control Act provides that “The Narcotics Control Act shall be enacted to prevent harm and danger to the health due to misuse or abuse of narcotics, psychotropic drugs, marijuana, and basic substances by ensuring the proper handling, management, etc. of narcotics, etc. (Article 1)” and “The Pharmaceutical Affairs Act shall be applied to the manufacture, management, etc. of narcotics and psychotropic substances except as otherwise provided for in this Act,” and the Narcotics Control Act appears to be related to the special law of the Pharmaceutical Affairs Act in the manufacture, management, etc. of psychotropic substances.

2) The Narcotics Control Act classifys narcotics into narcotics, psychotropic drugs, and marijuana (Article 2 of the Narcotics Control Act), and psychotropic drugs, among which they are classified into four levels depending on the degree of harm and injury. The term “rocarin” of the main ingredient of the instant drug is “(d)” (i.e., “psychotropic drugs”), which is the lowest stage of causing physical dependence and mental dependence on the “psychotropic drugs” (Article 2 subparag. 3) of the Narcotics Control Act, and is used for medical treatment in a relatively less and less likely to be misused or abused than those provided for in subparagraph (c) (Article 2 subparag. 3) of the said Act, and thus constitutes “drugs or substances containing them, which are less likely to cause physical or psychological dependence than those provided for in subparagraph (c) where they are misused or abused (Article 8 of the said Act). The term “rocarin” of the instant drug, which is the main ingredient of the instant drug, is currently used as a treatment medication with a general medicine like clinical medicine (Article 1(a) of the said Act).

3) According to Article 6(1) of the Narcotics Control Act, an exporter, importer, or manufacturer of narcotics is defined as “an importer or manufacturer under the Pharmaceutical Affairs Act, who has obtained marketing approval or filed a report with the Minister of Food and Drug Safety.” Therefore, the subject entitled to marketing approval of the psychotropic drugs to which the instant drug belongs is substantially the same as the subject entitled to marketing approval under the Pharmaceutical Affairs Act.

4) According to Article 32 of the Enforcement Rule of the Narcotics Control Act, where a person who intends to obtain marketing approval of narcotics, including psychotropic drugs, intends to use them for others, the documents to be submitted to the Minister of Food and Drug Safety shall be as stated in the Pharmaceutical Affairs Act, and “documents pursuant to Articles 4 and 12 of the Regulations on the Safety of Drugs, Etc.” should be submitted in the same manner as the “Pharmaceutical Affairs Act”. Therefore, the documents to be submitted for marketing approval of psychotropic drugs are practically the same as those to be submitted for marketing approval under the Pharmaceutical Affairs Act.

5) The provisions on clinical trials, registration of raw materials, marketing approval, reporting, and examination necessary for marketing approval under the Pharmaceutical Affairs Act and marketing approval under the Narcotics Control Act are all dealt with based on the same provisions and contents.

Article 1 (Purpose) of the Regulations on Approval of Plans for Clinical Tests of Drugs / [1] The purpose of this Decree is to prescribe the detailed matters concerning the methods, scope, requirements, scope of exemption, procedures and standards for approval of plans for clinical trials of drugs pursuant to Article 34 (7) of the Pharmaceutical Affairs Act and Articles 24 and 30 of the Regulations on Safety of Drugs, etc., and Article 57 of the Narcotics Control Act to ensure the appropriateness in the affairs of approval of plans for clinical trials of drugs. [2] The purpose of Article 1 (Purpose) of the Regulations on Registration of Drugs / [2] Articles 31-2 and 42 of the Pharmaceutical Affairs Act, Articles 15 and 17 of the Regulations on the Safety of Drugs, etc., Articles 52 and 33 of the Enforcement Rule of the same Act, the items subject to registration, preparation of registration data, scope of data, requirements for submission, scope of exemption, standards for disposal of narcotics, etc., the purpose of Article 13 (Purpose of Examination and Management of Drugs) of the Pharmaceutical Affairs Act.

6) According to the result of the fact-finding conducted on April 2, 2019 by the Ministry of Food and Drug Safety of this Court on the Ministry of Food and Drug Safety (hereinafter “Food and Drug Administration”), the Food and Drug Center, which is a permitting agency, responded to the following: “The food and Drug Center, has no difference in manufacturing or importing drugs, and the examination and procedure of marketing approval and permission under Article 31(2) and (3) or Article 42(1) of the Pharmaceutical Affairs Act. For reference, except as otherwise provided for in the Narcotics Control Act concerning the manufacture and management of narcotics and psychotropic drugs pursuant to Article 57 of the Narcotics Control Act. The processing period of the item subject to permission for narcotics complies with the processing period stipulated in the Regulations on Safety of Drugs, etc., which is subordinate statutes to the Pharmaceutical Affairs Act, and thus, the legal processing period is the same, and the period of submission of supplementary documents for the item applied for, and the period of examination for addition may vary for each item.”

7) The Patent List of Drugs stipulated in Article 50-2 of the Pharmaceutical Affairs Act, along with the patent for other general pharmaceutical products, is also registered as to “,” which is the instant pharmaceutical product (see the Integrated Information System of Drugs (htps://nedrug. Ss.go.go/infd)).

B. Whether the invention of the instant drug subject to marketing approval under the Narcotics Control Act is subject to extension of patent term under the interpretation of the delegation provision of this case

1) Criteria for determination

As long as the interpretation of administrative law does not deviate from the ordinary meaning of the language and text, it does not preclude the teleological interpretation that takes into account the legislative intent and purpose, etc. (see Supreme Court Decision 2006Du11590, Sept. 20, 2007). In interpreting the meaning of the subject of extension of patent term, it is reasonable to respect the legislative purpose and purpose as much as possible and to make it consistent with it (see Supreme Court Decision 2014Du3702, Oct. 4, 2018).

2) Specific determination

In light of the following circumstances, a patented invention for which the patent term may be extended under the delegation clause of this case may be interpreted not only to include not only the invention of a drug subject to marketing approval under Articles 31 and 42 of the Pharmaceutical Affairs Act, but also the invention of a psychotropic drug falling under Article 2 subparag. 3 (d) of the Narcotics Control Act, which is subject to marketing approval under Articles 18 and 21 of the Narcotics Control Act. The fact that the enforcement decree of this case does not stipulate an invention of a psychotropic drug falling under Article 2 subparag. 3 (d) of the Narcotics Control Act, which is subject to marketing approval under Articles 18 and 21 of the Narcotics Control Act, can be deemed legislative deficiencies.

A) In order to implement an invention of a medicine, etc., permission, etc. is required to promote public health and sanitation and ensure stability and effectiveness of the invention. A patentee is prohibited from working a patented invention in the process of obtaining such permission, etc. The Patent Act established a system for extending the term of a patent by the period during which a patented invention could not be worked in order to remedy such situation and to protect and encourage the invention of a medicine, etc. (see Supreme Court Decision 2018Hu844, 851, 868, 875, Nov. 29, 2017, etc.). Considering the purport of the patent term extension system, there is no difference in that both a medicine subject to permission under the Pharmaceutical Affairs Act and a psychotropic drug subject to permission for items under the Narcotics Control Act, i.e., the psychotropic drug cannot be worked in the process of obtaining permission, etc. after undergoing an examination of activation, safety, etc., and Article 18(1) of the Patent Act does not require the extension of the term of a patent right.

B) The instant delegation provision only allows the extension of the patent term to “where a long-term test on activation, safety, etc. necessary for permission, registration, etc. under other Acts and subordinate statutes needs to be conducted,” and does not differentiate between pharmaceutical products on the grounds of differences in the nature of a drug, other than active and safety, etc., that is, physical and mental dependence, etc. In addition, the instant delegation provision merely delegates the delegation of the subject matter and requirements of a patented invention meeting the requirements prescribed under the mother Act, and does not delegate the delegation of either “type of permission or registration” or “scope of other Acts and subordinate statutes” to implement a patented invention, but does not delegate the authority to exclude part of an invention which is subject to extension of the patent term under the instant delegation provision.

C) As seen earlier, “approval for items under the Narcotics Control Act” and “approval for items under the Pharmaceutical Affairs Act” do not have any essential difference between the permitting agency, documents, type and contents of the target test, required period, etc., and it is difficult to view the delegation provision of this case and the enforcement decree of this case as not including “approval for items under the Narcotics Control Act” with respect to the instant drugs, and thus, it constitutes discrimination in violation of the principle of equality under Article 11(1) of the Constitution, if the extension of the duration of the instant drugs is not permitted in entirety with respect to the instant drugs, such as the instant drugs.

D) In particular, “the instant medicine” was partially amended on November 25, 2013, the Plaintiff filed an application for marketing approval pursuant to Article 42(1) of the Pharmaceutical Affairs Act as the first drug under the Pharmaceutical Affairs Act at the time of filing an application for marketing approval, and the consultation response was completed on October 10, 2014, and the consultation response was completed as to the quality and response of GMP data on January 6, 2015 (Evidence No. 7), but the “the Enforcement Decree of the Narcotics Control Act” was partially amended on December 23, 2014 (Evidence No. 8), and the Plaintiff again filed an application for marketing approval under Article 2 subparag. 3(d) of the Narcotics Control Act with respect to the instant pharmaceutical drug, which is an effective ingredient for marketing approval, and the Plaintiff again filed an application for marketing approval for the instant pharmaceutical drug, other than the instant pharmaceutical drug, pursuant to Article 2 subparag. 1(d) of the Enforcement Rule of the Narcotics Control Act, and subsequently filed an application for marketing approval for import approval for the instant pharmaceutical drug.

E) In general, the designation of psychotropic drugs is designated prior to the permission for items of drugs, but it is also designated as psychotropic drugs after the permission for items of drugs under the Pharmaceutical Affairs Act (Evidence A, No. 11, No. 15, No. 18). On the contrary, at the time of the permission for items, there may be cases where the designation of psychotropic drugs under the Narcotics Control Act was changed after the designation as a general medicine under the Pharmaceutical Affairs Act. However, under the extension of the patent term extension system, in cases where the “general medicine under the Pharmaceutical Affairs Act” and “psychotropic drugs under the Narcotics Control Act” are handled differently from the “psychotropic drugs under the Pharmaceutical Affairs Act” in the extension of the patent term extension system, it may cause inequality between the instability in operating the patent

F) In order to introduce the patent term extension system in 1987, the Korean Intellectual Property Office, which was the competent authority promoting the amendment of the statutes, submitted to the National Assembly by the Korean Intellectual Property Office for the purpose of the introduction of the patent term extension system, there were no discussions on the content that the recovery period would not exceed five years, including only the period required for the domestic test procedure, and the activation of domestic clinical trials (Evidence A No. 6), and that psychotropic drugs are likely to cause mental and physical dependence. Furthermore, there seems to have been no discussions on the content that excludes psychotropic drugs from the subject of extension of patent term due to discrimination with other pharmaceutical inventions during the process of the introduction of the patent term extension system and the transition process. Therefore, it is difficult to view that the legislators’ legislative intent of the amendment of the Enforcement Decree of the instant provision of the Patent Act partly excluded the invention on psychotropic drugs under the Narcotics Control Act from the invention subject to extension of patent term.

C. Whether the instant disposition is lawful

Therefore, among the grounds for the instant disposition, the part that “the instant drug that obtained marketing approval pursuant to Article 18 of the Narcotics Control Act and Article 34 of the Enforcement Rule of the same Act shall not be subject to extension of the patent term” was committed against the delegated provisions and is unlawful.

D. Sub-determination

Since the instant disposition rejecting the instant application for registration of extension is unlawful, the instant decision that deemed the instant disposition lawful is also unlawful.

4. Conclusion

Therefore, the plaintiff's claim of this case seeking the revocation of the trial decision of this case is justified and it is so decided as per Disposition.

[Attachment] Claims for Patented Invention of this case: omitted

Judges Lee Jae-hee (Presiding Judge)

1) The provisions of the former Act and subordinate statutes, which were enforced at the time of the application for registration of the instant extension, are merely the same as those of the provisions of the current Act and merely the difference between the extent of modification of some phrases that are not related to the issues of the instant case, and thus, under convenience, the former Act and subordinate statutes are omitted and the name

2) When a person takes a drug for a long time and suspends the administration of the drug, it is considered that the drug has a great influence by mental disorder. To this end, in the event of non-smoking, tobacco is likely to be physically disturbed, and it does not cause any special physical obstacle.

Note 3) When a drug was taken for a long time and the administration was suspended, it is also called mental or physical displeasure, and search clinic. If it was used for a long time to ambin, it would be mentally ambin, and if it was discontinued, it would be likely that it would interfere with the normal function of telegraph transmission, such as ambin, ambin, stopath, personnel inequality, and anxiety.

4) Dod Dod Mact Pact Pactic e (Standards for the manufacture and quality control of excellent medicines).