[1] Whether a patented invention for which the term of a patent may be extended pursuant to Article 53(2) and (3) of the former Patent Act includes a pharmaceutical invention subject to an import license in addition to the item license for manufacture (affirmative)

[2] The method of distinguishing the binding act from the discretionary act, the discretionary act or the discretionary act, and the method of judicial review of each act

[1] (A) Article 9-2(1)1 of the former Enforcement Decree of the Patent Act (wholly amended by Presidential Decree No. 13078, Aug. 28, 1990; hereinafter the same) upon delegation of Article 53(2) and (3) of the former Patent Act (wholly amended by Act No. 4207, Jan. 13, 1990); Article 9-2(1)1 of the former Enforcement Decree of the Patent Act (wholly amended by Presidential Decree No. 13078, Aug. 28, 1990; hereinafter the same) provides for the invention of a drug subject to marketing approval for the extension of the term of a patent right, and does not explicitly

(B) Considering the purport of the extension system of the term of a patent, there is no difference in that both a drug that is subject to marketing approval and a drug that is subject to marketing approval are prohibited from working the patented invention in the process of obtaining permission through activity, safety test, etc., and the delegation clause merely provides that the term of a patent may be extended where long-term testing, such as activity, safety, etc. necessary for obtaining permission or registration is required, and the drug that is subject to marketing approval is not subject to extension of the term of a patent.

Article 27(1) of Annex 1C to the Marrakesh Agreement Establishing the World Trade Organization, which entered into force on January 1, 1995 after the enforcement of Article 9-2(1)1 of the former Enforcement Decree of the Patent Act, provides that “patents shall be granted and patent rights shall enjoy without discrimination on the basis of the place of invention, technical field, import of products, or domestic production,” and Article 9-2(1)1 of the former Enforcement Decree of the Patent Act does not fully allow the extension of the term of a pharmaceutical product subject to import approval as provided for in Article 9-2(1)1 of the former Enforcement Decree of the Patent Act.

The former Enforcement Decree of the Patent Act (amended by Presidential Decree No. 16852, Jun. 23, 2000; hereinafter “Enforcement Decree of the Patent Act of 2000”) amended on June 23, 200 does not have a separate transitional provision prohibiting retroactive application of Article 7 subparag. 1, which included an invention subject to marketing approval for drugs subject to registration for extension of term extension, and thus, even a patent invention for which an application for marketing approval was filed prior to the entry into force of Article 27(1) of the Intellectual Property Agreement was included in the subject of extension after July 1, 200, the enforcement date of the above Act

(C) Comprehensively taking into account the legislative purport of the delegation clause, etc., the contents of the intellectual property agreement entered into force after the enforcement of the delegation clause, and the amendment of the Enforcement Decree of the Patent Act in 2000, a patented invention for which the term may be extended by the delegation clause can be interpreted as including not only the manufacture permit but also the drug invention subject to the import permit. Article 9-2(1)1 of the former Enforcement Decree of the Patent Act does not stipulate Article 34(1) of the Pharmaceutical Affairs Act concerning the import permit of drugs. It can be deemed that legislative deficiencies are insufficient

[2] When the administrative act is classified into the so-called binding act, the act of discretionary discretion, and the act of discretionary discretion or the act of discretionary discretion in relation to the existence and scope of discretionary discretion, the division shall be determined by considering all the circumstances, such as the stay, form and text of the relevant laws and regulations, the main purpose and characteristics of the administrative sector to which the relevant act belongs, and the individual nature and type of the relevant act itself. Judicial review on the two so classified shall be based on the method of determining the legitimacy of the judgment made by the administrative agency in light of its conclusion in light of the fact-finding and the interpretation and application of the relevant laws and regulations in the case of the former. In the latter case, the court shall only examine whether the pertinent act is a deviation or abuse of discretionary power without drawing the conclusion of the original office, taking into account the possibility of determining the public interest based on the discretion of the administrative agency, and the examination of whether the act is deviation or abuse of discretionary power is subject to misunderstanding of facts, violation of the principle of proportionality and equality, and the purpose or denial of the relevant act.

[1] Article 53(2) and (3) of the former Patent Act (wholly amended by Act No. 4207, Jan. 13, 1990; see current Article 89(1)); Article 9-2(1)1 of the former Enforcement Decree of the Patent Act (wholly amended by Presidential Decree No. 13078, Aug. 28, 1990; see current Article 7 subparag. 1); Article 7 subparag. 1 of the former Enforcement Decree of the Patent Act (wholly amended by Presidential Decree No. 17246, Jun. 27, 2001); Article 7 subparag. 2 of the former Enforcement Decree of the Patent Act / [2] Article 1 of the Administrative Litigation Act (general administrative disposition] and Article 27 of the former Enforcement Decree of the Patent Act

[2] Supreme Court Decision 98Du17593 delivered on February 9, 2001 (Gong2001Sang, 652)

Noartis AG (Attorneys Lee Jae-de et al., Counsel for the plaintiff-appellant)

The Commissioner of the Korean Intellectual Property Office

SDRB Co., Ltd. (former trade name before the alteration: SKKK Co., Ltd.) (Law Firm SPP et al., Counsel for the plaintiff-appellant-appellant)

SKKK Co., Ltd. (Law Firm Spah, Attorneys Gyeong-chul et al., Counsel for the plaintiff-appellant)

Seoul High Court Decision 2013Nu48417 decided May 16, 2014

All appeals are dismissed. The costs of appeal are assessed against the Defendant’s Intervenor, and the remainder are assessed against the Defendant. The motion to resume the proceedings is dismissed. The costs incurred by the motion to resume the proceedings are assessed against the requester to resume the proceedings.

The grounds of appeal by the Defendant and the Intervenor joining the Defendant (hereinafter referred to as the “ Intervenor”) are examined together.

1. Details of the instant disposition

According to the reasoning of the lower judgment and the record, the following circumstances are revealed.

A. On September 15, 2003, the Plaintiff filed an application with the Commissioner of the Korea Food and Drug Administration for approval of a clinical trial plan for import approval of the special drug “explose Nos. 5 (Liberag 5)” (hereinafter “the instant drug”) on January 14, 2004, and obtained approval from the Commissioner of the Korea Food and Drug Administration for a clinical trial to assess safety, internal medicine, etc. of the instant drug. On September 14, 2007, the Plaintiff was notified by the Commissioner of the Korea Food and Drug Administration of the outcome of the examination of safety and effectiveness, standards, and test method. On November 20, 207, the Plaintiff obtained an import approval of the instant drug (hereinafter “instant permission”).

B. On April 23, 2012, the Plaintiff filed an application with the Defendant for the extension of the patent term of the instant patent on the ground of the instant permission under Article 53 of the former Patent Act (amended by Act No. 3891, Dec. 31, 1986; wholly amended by Act No. 4207, Jan. 13, 1990; hereinafter “the Patent Act of 1987”); Article 12199 of the Enforcement Decree of the Patent Act (amended by Presidential Decree No. 12199, Jul. 1, 1987; hereinafter “Enforcement Decree of the Patent Act of 1987”); Article 9-3 of the former Enforcement Decree of the Patent Act (amended by Presidential Decree No. 13078, Aug. 28, 199; hereinafter “the Enforcement Decree of the Patent Act”); based on the name “the patent right to the instant patent invention subject to extension of the patent term of the claim 1; hereinafter “the extension application”).

C. On April 28, 2013, the Defendant, based on the Patent Act and the Enforcement Decree of the Patent Act in 1987, and the former Regulations on the Operation of the Extension System of the Term of Patent Right (amended by the Korean Intellectual Property Office Notice No. 2009-18, Aug. 24, 2012; hereinafter “instant Notice”), approved non-approval of the instant application for extension on the following grounds (hereinafter “instant Disposition”).

(1) Article 53(2) of the Patent Act of 1987 does not constitute “the case where it requires a long-term test for activation, safety, etc. necessary for permission, etc.”

② Since “the first permission” has already been obtained for the same effective ingredients, it does not constitute “where permission is necessary for executing patented inventions” under Article 9-2(1)1 of the Enforcement Decree of the Patent Act, 1987 (Article 3(3) of the Notice of this case).

(3) In cases of item permission for import, it shall not be subject to extension prescribed by the Enforcement Decree of the Patent Act of 1987.

④ Since a patent right is an application for extension after it loses its effect, it is subject to return (Article 2(3) of the Notice).

⑤ The application period for the extension of the Enforcement Decree of the Patent Act in 1987 was limited.

2. As to the grounds of appeal regarding the subject matter of patent duration extension approval

A. Article 53 of the Patent Act of 1987 provides for a system that allows the Commissioner of the Korean Intellectual Property Office to obtain permission or registration under other Acts and subordinate statutes in order to work a patented invention and extend the term of a patent in cases where a long-term test of activation, safety, etc. necessary for such permission or registration needs to be conducted (Paragraph 2). Moreover, the subject matter, requirements, and other necessary matters of a patented invention for which the term may be extended shall be prescribed by Presidential Decree (Paragraph 3) (hereinafter “instant delegation provision”).

According to delegation, Article 9-2 (1) of the Enforcement Decree of the Patent Act of 1987 provides that "an invention for which the term of a patent may be extended shall be limited to an invention falling under any of the following subparagraphs," and subparagraph 1 provides that "an invention of a medicine subject to an item approval under Article 26 (1) of the Pharmaceutical Affairs Act for the purpose of executing a patented invention" and subparagraph 2 of Article 8 of the Agrochemicals Control Act provides that "an invention of a pesticide or an agrochemical product subject to registration under Articles 8 (1) and 9 (1) of the Agrochemicals Control Act for the purpose of executing a patented invention" (hereinafter "Article 9-2 (1) 1 of the Enforcement Decree of the Patent Act of 1987")

At the time of the enforcement of the instant provision, there were “manufacturing marketing approval” (Article 26(1)) and “import marketing approval” (Article 34(1) and (3) of the former Pharmaceutical Affairs Act (amended by Act No. 4486, Dec. 31, 1991; hereinafter “former Pharmaceutical Affairs Act”) in the marketing approval to work a patented invention under the former Pharmaceutical Affairs Act (amended by Act No. 4486, Dec. 31, 1991) at the time of the implementation of the instant provision. The instant provision only prescribes the invention of a pharmaceutical product subject to marketing approval for the extension of the patent term extension application, and does not explicitly stipulate the invention of

B. We examine the interpretation of the delegation clause of this case as well as the marketing approval of drugs, and also whether the invention of drugs subject to import approval can be seen as subject to the extension approval of term extension.

(1) As long as the interpretation of administrative laws does not deviate from the ordinary meaning of the language and text, it does not exclude the teleological interpretation that takes into account the legislative intent and purpose, etc. (see Supreme Court Decision 2006Du11590, Sept. 20, 2007, etc.). Therefore, in interpreting the meaning of the subject of approval for extension of patent term, it is reasonable to suggest that the interpretation conforms to it by taking into account the legislative intent, purpose, and contents of the improved legislation

(2) In order to implement an invention of a medicine, etc., a patent holder shall obtain permission, etc. in accordance with the Pharmaceutical Affairs Act, etc. to promote public health and sanitation and ensure safety and effectiveness. In order to obtain such permission, a patent holder shall suffer disadvantages in executing the patented invention in the process of obtaining such permission, etc. Therefore, the Patent Act has established a system for extending the term of a patent for a period during which the patented invention could not be worked in order to relieve such disadvantages and protect and encourage the invention of a medicine, etc. under the Pharmaceutical Affairs Act (see, e.g., Supreme Court Decision 2017Hu844, 851, 868, 875, Nov. 29, 2017). Considering the purport of such extension system, both a medicine subject to marketing approval and an imported medicine subject to marketing approval are not different in that the patented invention can not be worked in the process of obtaining the license through an examination of activation, safety, etc., and the delegation provision of this case does not require an extension of the term of a patent.

(3) Article 27(1) of the Marrakesh Agreement Establishing the World Trade Organization, which entered into force on January 1, 1995, following the enforcement of the instant provision, provides that “Any patent shall be granted and patent rights shall be enjoyed without discrimination on the import or domestic production of the invention site, technical field, product, or product” (hereinafter referred to as the “intellectual Property Agreement”). However, a patent may constitute discrimination based on the import or domestic production of the product, unless the extension of the duration of the pharmaceutical product subject to import approval is permitted as a whole, as provided in the instant provision.

Ultimately, Article 7 Subparag. 1 of the former Enforcement Decree of the Patent Act (amended by Presidential Decree No. 16852, Jun. 23, 2000; hereinafter “Enforcement Decree of the Patent Act, 2000”) amended on June 23, 200, added “Article 34(1) of the Pharmaceutical Affairs Act” to “Article 34(1) of the Enforcement Decree of the Patent Act, which included an invention subject to marketing approval of drugs subject to registration of extension, thereby eliminating discrimination against the provisions

(4) The Enforcement Decree of the Patent Act in 2000 does not have any separate transitional provisions prohibiting retroactive application of Article 7(1) and thus, even a patent invention for which import license was granted after an application was filed prior to the entry into force of Article 27(1) of the Intellectual Property Agreement, the patent application for registration of extension was included in the subject of extension after July 1, 200, the enforcement date of the above Enforcement Decree.

At the time of the amendment of the Enforcement Decree of the Patent Act in 2000, there were only cases of application for registration of extension since the first application for registration of extension was filed in 1999, and there was no one case of extension approval until 2005 even after the amendment. Meanwhile, on March 15, 2006, the Defendant opened an “Industrial Property Council on Application for Registration of Extension” on the ground that the Defendant would include not only the application for registration of extension but also the extension application in the application for registration of extension as an extension. After the Defendant decided to include the imported pharmaceutical product in the subject of extension approval, the Defendant has granted 30 or more applications for extension of the imported pharmaceutical product from 1999 to the time of closing

C. In full view of the legislative purport of the instant delegation clause, etc., including the contents of the intellectual property agreement entered into force after the enforcement of the instant delegation clause, and the amendment of the Enforcement Decree of the Patent Act in 2000, a patented invention for which the term may be extended pursuant to the delegation provision of the instant case can be interpreted as including not only the manufacture permit but also the drug invention subject to import permit. The fact that the instant provision does not stipulate Article 34(1) of the Pharmaceutical Affairs Act regarding the import permit of drugs is insufficient legislation.

Thus, among the disposition grounds of this case, the part that is not subject to extension as prescribed by the Enforcement Decree of the Patent Act in 1987 is illegal as it is against the delegation provisions of this case.

Therefore, although the reasoning of the lower judgment is somewhat inappropriate, the lower court’s conclusion that the instant disposition was unlawful is justifiable, and contrary to what is alleged in the grounds of appeal, the lower court did not err by misapprehending the principle of equality under the Constitution, the separation of powers, the limit of delegated legislation, and the presumption of judgment, or by failing to exhaust all necessary

3. As to the ground of appeal on the observance of the extension period of this case

A. The lower court determined as follows.

According to Article 53(1) of the Patent Act of 1987 and Article 9-3(1) of the Enforcement Decree of the Patent Act of 1987, the period for submitting an application for approval for extension of the patent term expires from the third anniversary before the expiration date of the patent term to the expiration date of the patent term. On April 21, 2012, which is the expiration date of the patent term of the instant patent invention. However, Article 14 subparag. 4 of the former Patent Act (amended by Act No. 7871 of Mar. 3, 2006) provides that "if the last day of the patent-related procedure falls on an official holiday (including the Workers' Day and Saturdays due to the Designation of Workers' Day), the period shall expire on the next day, and Article 6 proviso to Article 6 of the Addenda of the former Patent Act of the former Patent Act (amended by Act No. 11117 of Dec. 2, 2011) and proviso to Article 1 of the former Patent Act (amended by Act).

B. Examining the reasoning of the lower judgment in light of the relevant statutes and the records, including the duly admitted evidence, the lower judgment partially inappropriate, but the conclusion that the lower court rendered is acceptable. In so doing, contrary to what is alleged in the grounds of appeal, the lower court did not err by misapprehending the legal doctrine on the period for submitting an application for an extension

4. As to the Defendant’s grounds of appeal on the deviation and abuse of discretion regarding the extension approval requirements

A. When an administrative act is classified into the so-called binding act, the act of discretionary discretion, and the act of discretionary discretion or the act of discretionary discretion in relation to the existence and scope of discretionary discretion, the division shall be determined by considering all the following factors: (a) the stay and form of laws and regulations on the basis of the pertinent act; (b) the language and text thereof; (c) the main purpose and characteristics of the administrative sector to which the pertinent act belongs; and (d) the individual nature and type of the pertinent act itself. Judicial review on the two separate types of acts shall be based on the method of determining the legitimacy of the judgment made by the administrative agency in light of its conclusion based on the fact-finding and the interpretation and application of the relevant laws and regulations in the case of the former; and (c) the determination of whether there is deviation or abuse of discretionary power on the basis of the discretion of the administrative agency without drawing the conclusion of the original body; and (d) the determination of whether such discretion is deviation or abuse should be subject to the determination of facts, the principle of proportionality and equality; and (e) the purpose and motive of the pertinent act.

B. The lower court determined to the following purport based on the factual basis as indicated in its reasoning.

(1) Although it appears that the patented invention of this case requires a long period of time in the examination of activation, safety, etc. for obtaining permission, the defendant merely presumed that the prior permission on the patented invention of this case was granted to the same active ingredient, and the activation and safety of the patented invention of this case was also confirmed, without examining how the actual period of the examination, such as safety conducted by the plaintiff, was actually required.

(2) Article 3(3) of the Notice of this case cited by the Defendant as the ground for the instant disposition provides that the extension is recognized only for the first permission in the case where multiple permissions are granted. The patented invention is an invention for the use of medicine. The patented invention is an invention for the use of medicine, and the patented invention is a substance invention for a compound, and the patent application of this case is another separate patent, and the patent application of this case was subject to the instant permission in order to practice the patented invention. Thus, there is no room to apply Article 3(3) of the Notice of this case.

(3) Article 7 of the Enforcement Decree of the Patent Act (amended by Presidential Decree No. 24491, Apr. 3, 2013) (amended by Presidential Decree No. 24491, Apr. 3, 2013) does not apply to the instant patent invention for which an application for extension was filed before April 3, 2013, the effective date, for which only the first marketing approval was granted, among the medicines

(4) Therefore, in light of the purport of the extension of the patent term, it is reasonable to deem the instant disposition to exceed the discretionary power granted to the Defendant.

C. Examining the reasoning of the lower judgment in light of the aforementioned legal principles and records, the lower court’s conclusion is justifiable, and contrary to what is alleged in the grounds of appeal, there were no errors by misapprehending the legal principles on deviation and abuse of discretionary power, or by failing to exhaust all necessary deliberations.

5. As to the ground of appeal on the violation of the duty of explanation and cadastral duty

According to the records, with respect to the unconstitutionality and illegality of the provision of this case, the court below asserted the grounds for violation of the principle of equality, etc. and held a trial on this part.

Therefore, we cannot accept the allegation in the grounds of appeal that the court below committed an act of incompetence against the defendant or intervenors without making any doubt as to the unconstitutionality or illegality of the provision of this case and without giving an opportunity for pleading.

6. As to the grounds of appeal on whether to add the grounds for disposition

In an appeal litigation seeking the revocation of an administrative disposition, a disposition agency may not claim a ground for disposition on the ground that it is based on the initial disposition and its basic facts are different from the facts without identity (see Supreme Court Decision 2016Du44186, Aug. 29, 2017, etc.).

For reasons indicated in its holding, the lower court determined that the Defendant’s assertion to the effect that the instant application for extension of patent term was lawful since it was a lump sum of the unreasonable extension strategy beyond the scope permitted by the Patent Act cannot be added to the grounds for disposition depending on the grounds and basic factual relations which were used as the grounds for the instant disposition at the time of the instant disposition, and it is difficult to view that there was an intention to delay the Plaintiff’s permission procedure in light of the progress of the procedure for granting the permission

Examining the reasoning of the lower judgment in light of the aforementioned legal principles and records, the lower court’s aforementioned determination is justifiable, and contrary to what is alleged in the grounds of appeal, there were no errors in the misapprehension of legal doctrine regarding

7. As to the ground of appeal on the ground for invalidation of the patent invention of this case

In the reasoning of a written judgment, it is sufficient to indicate the judgment on the party’s allegations and other means of offence and defense to the extent that it can be recognized that the text is fair, and there is no need to determine all the parties’ allegations or means of offence and defense (see Article 208(2) of the Civil Procedure Act). Even if no specific and direct judgment on a party’s allegations is indicated in the judgment, if it is possible to know that the allegations were accepted or rejected in light of the overall purport of the reasons for the judgment, it cannot be deemed an omission of judgment. Even if the decision was not actually made, if it is obvious that the assertion would be rejected even if the decision was not made, there is no error of omission of judgment due to the lack of influence on the conclusion of the judgment (see, e.g., Supreme Court Decision

The lower court determined to the effect that the patented invention of this case is not denied inasmuch as ordinary technicians could not easily cite the patented invention of this case as the patented invention of this case, by readily recognizing the light absorption with the active elements of the patented invention of this case and the effects in the event of light inclusion. In so determining, the purport of rejecting the assertion that the instant disposition rejecting the extension of the duration of the patented invention of this case is legitimate as a result of the invalidation of the patent registration, on the grounds that the patented invention of this case has grounds for invalidation of the patent registration. In addition, even in light of the relevant legal principles and records, the lower court’

Therefore, the lower judgment did not err by omitting judgment on the grounds for invalidation of registration or failing to exhaust all necessary deliberations, contrary to what is alleged in the grounds of appeal.

8. As to the ground of appeal on the ruling of assessment

When an administrative disposition is unlawful, the court may render a judgment that, in principle, the revocation or alteration of such unlawful disposition is not exceptionally permitted in cases where it is extremely inappropriate for the public welfare, and thus, the revocation or alteration of such unlawful disposition is considerably inappropriate. Therefore, the application of an assessment judgment should be limited under extremely strict requirements. In determining whether it is considerably inappropriate for the public welfare, the necessity for cancellation or alteration of such unlawful or unreasonable administrative disposition and the situation against public welfare that may arise from such revocation or alteration should be compared and determined whether such disposition is applied (see Supreme Court Decision 2009Du8359, Dec. 10, 2009, etc.).

In this case, it is difficult to find out circumstances to recognize the necessity of the ruling of assessment, and thus, the ground of appeal against this cannot be accepted.

9. As to a request for continuation of proceedings

According to the records, the Intervenor, as of December 1, 2017, after the end of the period for filing a statement of grounds of appeal, divided the company into a method of transferring the business part of the business part to the applicant for the continuation of the proceedings, and submitted a written application for the continuation of the proceedings in this case. However, when the proceedings of the court of final appeal are declared without pleading at the same stage, it is not necessary to have the newly incorporated company take over the proceedings (see, e.g., Supreme Court Decision 2012Du27794, Feb. 27, 2014). Accordingly, the application for the continuation of proceedings by the applicant for the continuation of proceedings is rejected.

10. Conclusion

Therefore, all appeals are dismissed, and the remainder of the costs of appeal are assessed against the intervenor, and the remainder is assessed against the defendant. The request for the continuation of proceedings by the requester is dismissed, and the costs are assessed against the requester. It is so decided as per Disposition by the assent of all participating Justices on the bench.

Justices Lee Ki-taik (Presiding Justice)