(영문) 서울고등법원 2014. 5. 16. 선고 2013누48417 판결

2. On April 28, 2013, the disposition that the Defendant rendered against the Plaintiff for the extension of the term of a patent (patent registration number 3 omitted) to the Plaintiff is revoked.

3. Of the total costs of litigation, the part resulting from the participation is borne by the Intervenor joining the Defendant, and the remainder is borne by the Defendant.

Purport of claim and appeal

The same shall apply to the order.

Reasons

1. Basic facts

The following facts do not conflict between the parties, or can be acknowledged by comprehensively taking into account the overall purport of the pleadings as follows: Gap evidence 1, Gap evidence 2, Eul evidence 3, Eul evidence 4, Gap evidence 5, Gap evidence 6, Gap evidence 28, Gap evidence 40, Gap evidence 64, Gap evidence 65, Gap evidence 66, Eul evidence 1, Eul evidence 3, Eul evidence 5, Gap evidence 66, Eul evidence 1, and Eul evidence 3.

(a) Matters concerning the patent right concerning biphenyl (hereinafter referred to as the “original patent right of this case”) and the patent itself shall be referred to as the “original patent right of this case,” and the patent itself shall be referred to as the “original patent of this case”);

(a) Invention: biphenyl et al.;

(b) Application number: (1) (number 1 omitted); and

(2) Date of application: March 3, 198

(3) The publication date of application: April 21, 1998.

(4) Priority claim: March 4, 1987; P3706914.4; Switzerland (CH)

(2) The date of patent registration: December 23, 1997

③ A patentee: The Plaintiff (the first patentee and the first patentee and the second business and December 20, 1996 were merged and registered on February 26, 1998).

4) Claims: The claims are described in Appendix 1. The claims.

(b) Matters concerning the patent right related to the pharmaceutical products created for the crymprobol for chlobbane (hereinafter referred to as the “instant patent right”), and the patent itself shall be referred to as the “instant patent”);

(a) Invention name: A pharmaceutical product created for the clive administration of biphenylbrates;

(b) Application number: (1) (2) ;

(2) Date of application: April 30, 1996

(3) The publication date of application: April 21, 1997.

(4) Claim: March 4, 1987; P37069.4; and Germany (DE)

(5) The filing date of the original application: March 3, 198

(2) The date of patent registration: August 29, 1997

③ A patentee: The Plaintiff (the first patentee and the first patentee and the second business and December 20, 1996 were merged and registered on February 26, 1998).

4) Claims: The claims are described in Appendix 2. The claims.

On August 31, 200, Korea Nanotechnology Co., Ltd. obtained the import license (hereinafter “prior license of this case”) of the EXVulululululululululule (type 4 percent of the EXV) (hereinafter “the instant license”) from the Commissioner of the Korea Food and Drug Administration on January 5, 200, 3.0, 4.5, and 6.0§¯, and (2) on November 20, 2007 (hereinafter “the instant drug”); and (3) respectively, the import license of the drugs of this case was obtained from the Commissioner of the Korea Food and Drug Administration (hereinafter “the instant license”).

D. Operational status of the Defendant’s extension system of patent term

1) The application system for an extension of the patent term was first introduced as a new establishment under Article 53(2) and (3) of the former Patent Act (amended by Act No. 3891, Dec. 31, 1986; Act No. 3891, Jul. 1, 1987; hereinafter “the Patent Act of 1987”).

2) The purpose of the application system for the approval of extension of patent term is to restore patent rights by extending the term of patent rights for the period during which the invention could not be implemented within a five-year period, and where the patent is to be permitted or registered under other Acts and subordinate statutes in order to practice the patented invention. The Defendant’s “Research Council on Extension of patent term” issued in 2003 by the Defendant’s “Research Council on Patent Right Extension System” (No. 2) provides the following explanation:

It is essential to obtain permission or registration under other Acts such as the Pharmaceutical Affairs Act or the Agrochemicals Control Act in order to practice a listed pharmaceutical patent or pesticide patent contained in the main text. Since various tests required to obtain such permission or registration require a considerable long period of time, the implementation of the pharmaceutical and pesticide patented invention causes a very special problem different from other fields of technology. The aforementioned legal regulations on pharmaceutical and pesticide patented invention are absolutely necessary in terms of enhancing public health and sanitation and ensuring safety, and there is a limit to shorten the relevant period in terms of ensuring safety. Accordingly, even if a patent holder of a pharmaceutical and pesticide patent registers a patent effectively, it is not possible to practice the patented invention until obtaining permission or registration from the relevant agency. This problem is an important issue that goes against the basic principles of the patent system, and thus, the patent term extension system is an extension system that is introduced to solve this problem. If a patent holder is unable to obtain permission or registration under other Acts to practice the patented invention, the patent term extension system refers to the extension of the patent term necessary to obtain permission or registration for implementation of the patented invention.

3) However, the application system for the extension of the term of a patent has various problems, such as ① a case where a patentee is dissatisfied with the defendant's non-approval disposition on the application for extension of the term, ② a case where an application for the extension of the term can be filed before the expiration of the term of a patent, and ② a case where an application for the extension of the term can be filed after the lapse of a long period after obtaining the drug license.

4) In order to solve the above problems, the amended Patent Act (wholly amended by Act No. 4207, Jan. 13, 1990; hereinafter “the Patent Act of 1990”) changed the existing application system into the form of an application for registration of extension (Article 90). ② The application for registration of extension was allowed to be filed in the case of dissatisfaction against the decision of the Korean Intellectual Property Office (Article 167); ③ the application for adjudication of appeal was made in accordance with the demand of the related industry that wishes to make prompt decisions as to the extension of the patent term extension; ③ the amendment was made within three months from the date of obtaining the drug license.

5) Upon receipt of the first application for registration of extension on November 6, 1998, the Defendant opened the 73th Council for Operation of Industrial Property Rights to conclude that the application for registration of extension should be applied in accordance with the Patent Act in 1987, since the pertinent patent was filed in 1988 prior to the enforcement of the Patent Act in 1990, and determined the internal policy to apply the application for registration of extension to the patent filed before the enforcement of the Patent Act in 1990 after the enforcement of the Patent Act in 197.

6) The Defendant applied the above internal policy without exception, including: (a) the application system for the extension of the term extension and the application system for registration of extension; (b) the patent filed prior to the enforcement of the Patent Act in 1990 is entirely returned; and (c) the application for the extension is re-written; and (d) the application system differs depending on the time of the application; and (c) the internal examination guidelines and the examination manual, as well as the information collection for external distribution.

7) The application for an extension application was received on July 7, 2005 by applying the application period “within three years after the patent term expires.” On the other hand, the application for an extension registration was made from 1999 by applying the application period “within three months after permission”. As of the end of December 201, the total of 58 applications for an extension were received, and the total of 270 applications for an extension were received, and the total of 270 applications were received.

8) The Defendant, since December 22, 1995, has established and implemented a public notice of “the provision on the operation of the patent term extension system” for the specific operation of the application for registration of extension. When an application for approval for the first extension was received on July 7, 2005, the above public notice was also applied mutatis mutandis to the examination of extension approval, and even now, the above public notice is applied to the examination of extension approval.

9) On June 2006, the Defendant published and distributed the examination manual for the extension system of patent term (hereinafter “examination manual”) to clarify the matters set forth in the above notice, and has operated the extension application system and the extension registration system in accordance with the public notice and the examination manual so far.

E. The plaintiff's application for extension approval and the defendant's request for correction

1) On April 23, 2012, based on Article 53 of the Patent Act in 1987 and Article 9-3 of the Enforcement Decree of the Patent Act (amended by Presidential Decree No. 12199, Jul. 1, 1987; hereinafter “Enforcement Decree of the Patent Act in 1987”), the Plaintiff filed an application for approval for extension of the patent term of the patent right with the extension period of 1,278 days (hereinafter “instant application for extension”).

2) On October 18, 2012, the Defendant received the instant application for extension, on October 18, 2012, submitted to the Plaintiff a written request for correction to the effect that “the data proving the commencement and completion date of a clinical trial (data submitted to the Food and Drug Administration)” and “the method of calculating the extension period is “the period required for permission or registration to work patented invention (except for the period required due to reasons attributable to the applicant)” based on Article 9-2 of the former Enforcement Decree of the Patent Act, and the method of calculating the extension period is “the period required for permission or registration to work patented invention” (except for the period required due to reasons attributable to the applicant), which is substantially related to the application for registration of extension. The Defendant requested the Plaintiff to partially calculate the extension period based on “the period of clinical trial and the examination period of the documents required for permission for a clinical trial” under Article 205-13, which is the notification of the application for registration of extension. The Plaintiff

3) On February 8, 2013, the Defendant sent a written request for correction to the Plaintiff on February 8, 2013 to the effect that “A request for the extension of the term of a patent may be made only with respect to the first license in relation to a single patent pursuant to Article 3(3) of the Regulations on the Operation of the Extension System of the Term of Patent Right (Public Notice of the Korean Intellectual Property Office No. 2009-18, August 24, 2009). Since the instant medicine does not fall under the first license in relation to effective ingredients, the instant medicine does not fall under “where permission is necessary for the implementation of patented inventions” under Article 9-2(1)1 of the Enforcement Decree of the Patent Act of 1987.” Accordingly, the Plaintiff presented a written request for correction to the effect that “The grounds for refusal of approval are unreasonable.”

F. Non-approval of the extension application of this case

On April 28, 2013, the Defendant approved the instant application for extension on the grounds of 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 (amended by the Korean Intellectual Property Office Notice No. 2009-18, Aug. 24, 2009; hereinafter “instant Notice”) (amended by the Korean Intellectual Property Office Notice No. 2012-15, Aug. 22, 2012; hereinafter “instant Disposition Notice”), stating, “the instant Disposition” (hereinafter “instant Disposition Disposition Grounds”; No. Serial No. Serial, etc., specified by the instant Disposition No. 1, etc.) that “the requirements under Article 9-2 of the Enforcement Decree of the Patent Act of 1987 were not satisfied” (hereinafter “instant Disposition”).

(4) The application period for the extension of the term of patent under Article 53(2) of the Patent Act shall not apply to cases where the above application for the extension of the term of patent under Article 53(2) of the Enforcement Decree of the Patent Act, 1987, 1. Article 53(2) of the Patent Act does not apply to cases where a person intends to work medicines whose active substance or safety is already confirmed as active ingredients, according to the Pharmaceutical Affairs Act. However, permission under the Pharmaceutical Affairs Act shall not be deemed to have been granted for each item, but such an extension of the term of patent (it shall not be deemed to require a long period of examination of stability) under Article 53(2) of the Patent Act, 1987. Since the term of patent application for the extension of the term of patent under Article 53(2) of the Patent Act, 197, 200, 300,000 won, which is an effective ingredient, has already been confirmed by the 19-year ex officio capsululul.

2. Whether the disposition is lawful;

A. The plaintiff's assertion

1) Claim in violation of the Administrative Procedures Act

The Patent Act of 1987 does not stipulate that the dispositions in this case shall be subject to the procedures equivalent to the administrative procedures such as prior notice or opportunity to present opinions with respect to the application for extension approval. Thus, the dispositions in this case shall be subject to the Administrative Procedures Act, and further procedures such as prior notice shall be conducted by each disposition reason. The defendant only notified the plaintiff only about the grounds in this case and provided the plaintiff with an opportunity to present opinions, but does not go through such procedures with respect to the remaining grounds for disposition. The disposition in this case is unlawful in violation of Articles 20 and 21 of the Administrative Procedures Act.

2) The allegation of illegality of the instant disposition grounds

A) As to the grounds for disposition (1) of this case: The deviation and abuse of discretionary power

The defendant's discretionary authority on approval for extension of the duration is not a rejection discretion that can refuse to grant extension approval even though the defendant's discretionary authority on approval for extension of the duration meets the requirements prescribed by law, but is only a discretion on choice of the duration. The plaintiff conducted a test requiring a long period to verify validity in the marketing approval process of the drug of this case and satisfies the requirements for extension of the duration prescribed by the Patent Act of 1987 and the Enforcement Decree of the Patent Act of 1987. Thus, the defendant has to grant extension approval, despite the fact that the validity of the respondent has already been verified due to X-cellulululululululul, so it is an error of law

B) As to the grounds for disposition. (2) The deviation and abuse of discretionary power

(1) The Patent Act and the Enforcement Decree of the Patent Act, 1987, did not yet introduce an application for registration of extension of the term of a patent right. Since the instant public notice was made to determine the details thereof after the introduction of the application for registration of extension, it cannot be applied to extension of the term of a patent right to which the Patent Act and the Enforcement Decree of the Patent Act, which are applied in 1987. In addition, the instant public notice is merely an internal administrative rule of the Korean Intellectual Property Office without statutory delegation. Accordingly, the Defendant’

(2) Since the date of establishment registration of the patent right of this case, 873 days were required for the Plaintiff to obtain the instant license, and the patent right of this case was able to execute the instant patent claim on November 20, 2007 when the duration of the patent right of this case remains long, and the Defendant’s refusal to grant extension approval on the ground that there were many applications for extension of the duration and applications for extension registration based on the subsequent permission, not the initial permission, was against the principle of equality. In full view of the above, the instant disposition is unlawful by deviating from and abusing discretion.

(3) Even if the instant notice applies to the extension of the patent term of the instant patent, the instant application for extension satisfies the requirements prescribed in Article 3 of the instant notice, comprehensively taking account of the following: (i) the instant patent and the instant original patent are different from the instant patent; (ii) the instant drug and the X-cellulululululululululululululululululululululululululululululule are different from the instant license and the instant prior permission are separate; (iii) the instant application for extension is the first applicant seeking the extension of the patent term of the instant patent; and (iv)

(3) Regarding the grounds for disposition in this case: Violation of the statutory interpretation or the principle of self-detention

(1) Article 9-2 (1) 1 of the Enforcement Decree of the Patent Act of 1987 does not stipulate an invention subject to approval for extension of the term extension, but Article 9-2 (1) 2 of the Enforcement Decree of the Patent Act provides for registration of imported items of pesticides or raw chemical substances. ② Article 7 (1) of the former Enforcement Decree of the Patent Act (amended by Presidential Decree No. 16852 of Jun. 23, 2000; hereinafter “Enforcement Decree of the Patent Act of 2000”) added "Article 34 (1) of the Pharmaceutical Affairs Act" to "Article 34 (1) of the Pharmaceutical Affairs Act" to include an invention subject to approval for extension of the term extension, which clearly states that the reason for the amendment does not discriminate against imported drugs, it is clear that Article 9-2 (1) 1 of the Enforcement Decree of the Patent Act of 1987 does not stipulate an item approval for the extension of the term extension of the term, and thus, it should also be interpreted that Article 2 (1) of the Paris Agreement.

(2) Article 7 subparagraph 1 of the Enforcement Decree of the Patent Act of 2000 included an invention of a medicine subject to import approval as an object of application for registration of extension. Thus, it should be interpreted that it is also included in the subject of application for registration of extension approval.

(3) Even if the imported pharmaceutical product invention does not include the imported pharmaceutical product invention under the statutory interpretation, the defendant opened the "Industrial Property Council on Application for Extension of Term" on March 15, 2006 and decided to recognize that the imported pharmaceutical product also constitutes the subject of approval for extension of term, and operated the application system for approval for extension of term according to the above decision. In accordance with the defendant's argument, Article 2 (2) of the Notice of this case that the application for extension of term is applied to the application for extension of term, also stipulates that the imported pharmaceutical product invention constitutes the subject of extension of term, and many cases of approval for extension of term based on the imported pharmaceutical product are introduced in the "patent extension extension of term and pesticide information collection" published by the defendant to assist in preventing unnecessary patent disputes in advance. In light of the above, the disposition of this case is unlawful against self-regulation, Article 4 (2) of the Administrative

(4) As to the ground for disposition, the statutory interpretation is unlawful, etc.

Although the Patent Act and the Enforcement Decree of the Patent Act in 1987 do not expressly stipulate the requirement that “the patent shall be the remaining patent at the time of the application for an extension,” the notice of this case shall be arbitrarily reduced or interpreted by adding the above requirement without delegation of the law. Thus, the disposition of this case applying such a notice is unlawful. Even if this is applied, Article 2(3) of the Notice of this case is not about the expiration of the patent term, but about the invalidation due to a trial decision, etc., and the patent right of this case at the time of the application for an extension is not invalidated due to a trial decision, etc., and it does not violate Article 2(3) of the Notice of this case. Accordingly, the application for an extension of the patent term under the Enforcement Decree of the Patent Act in 1987 and the Enforcement Decree of the Patent Act, and the approval thereof may be granted even after the expiration of the target patent term, the defendant erred by applying the

E) Regarding the ground for disposition 5 of this case: Violation of statutory interpretation

The expiration date of the patent term of this case is Saturday on April 21, 2012. However, the expiration date of the application period for the extension approval of the patent term of this case is extended on April 23, 2012 pursuant to Article 14 subparagraph 4 of the former Patent Act (amended by Act No. 7871, Mar. 3, 2006; hereinafter “the Patent Act, hereinafter “2006”). In addition, the defendant publicly announced that “the procedure subject to the patent application before 2006” pursuant to the Patent Act in 2006 should be regarded as a legal holiday. Accordingly, the extension application of this case is lawful, and it is unlawful that the defendant did not regard the day as a legal holiday only for the extension application of this case and did not take the disposition of this case.

B. Relevant provisions

Attached Table 3. Relevant Regulations shall be as stated.

C. Determination

1) The patent term of this case and the laws applicable to its extension

A) Whether Article 7 of the Addenda to the Patent Act of 1990 has expired

If there is no explicit measure to amend or delete the transitional provision of the Addenda to the previous Act at the time of the amendment of the Act, the transitional provision of the Addenda does not become null and void as a matter of course, even though there is no transitional provision in the amended Act (see Supreme Court Decision 2001Du1168 delivered on July 26, 2002).

After the enforcement of the Patent Act in 190, which was wholly amended, the provisions on patent term and extension thereof were amended several times. However, Article 7 of the Addenda to the Patent Act in 1990 (Transitional Measures on Patent Term) provides that "the term of a patent right and a patent right established before this Act enters into force shall be governed by the previous provisions," which provides that "the term of a patent right and patent right established before this Act enters into force shall be governed by the previous provisions," and there was no express measure to amend or delete it at the time of the amendment of the Patent Act, and therefore,

B) Whether the patent of this case is subject to Article 7 of the Addenda to the Patent Act of 1990

According to Article 52(2) of the former Patent Act (amended by Act No. 4757 of March 24, 1994), the patent right of this case is deemed to have been filed on March 3, 198, the original filing date of the patent application. This is prior to the enforcement of the Patent Act of 1990, and thus, the patent right of this case is subject to Article 7 of the Addenda of the Patent Act of 1990.

C) Whether Article 7 of the Addenda to the Patent Act of 1990 includes the extension of the term of existence

(1) The Patent Act of 1990 also applies this Act to matters arising prior to the enforcement of the Act (Article 2 of the Addenda). As seen earlier, the term of patent rights and patent rights established prior to the enforcement of the Act, “the term of patent rights” under the former provision, namely, Article 7 of the Addenda), but there was no explicit transitional provision regarding the extension of the term of patent rights.

(2) However, unlike new provisions (Articles 89 through 93, 95, and 134, etc.) relating to the extension of the term of a patent under Article 88 of the title "the term of a patent" as the amended patent law in 1990 without providing a new provision regarding the extension of the term, the patent law prior to the amendment in 197 also provides for the extension of the term under Articles 53 through 53, 2, and 3 of the title "the term of a patent" as the title "the term of a patent", and even if the patent law in 1990 does not have a separate transitional provision regarding the extension of the term, it can be interpreted by expanding the term to include not only the term "the term of a patent" but also the term "the extension of the term" as referred to in Article 7 of the Addenda. Accordingly, there is a difference between the applicable law and the procedure of appeal.

(3) As seen earlier, the main cause replacing the existing application system by the Patent Act in 1990 was to secure the effectiveness of remedy through simplification of the method of appeal and early confirmation of whether to register the extension. In light of the background of the amendment and the legal system before and after the amendment as follows, it is reasonable to view that the term of patent "Article 7 of Addenda to the Patent Act in 1990" includes the extension of the term.

① The procedure for extending the term of a patent under the Patent Act, 1987, is conducted by a patentee’s application and decision as to whether to grant approval pursuant to Article 53(3) of the Patent Act, 1987, Articles 9-2(2) through (4), and 9-3 of the Enforcement Decree of the Patent Act, and Article 9-3 of the Enforcement Decree of the Patent Act, and a patentee who is dissatisfied with the non-approval disposition is subject to administrative litigation. However, the procedure for extending the term of a patent under the Patent Act, 1990, is conducted by the circumstances between the patentee’s application for registration of extension and the examiner’s application for rejection in accordance with Articles 89 through 93 of the Patent Act, and a patentee who is dissatisfied with a ruling of rejection is subject to appeal under Article 167

(2) On the other hand, the Patent Act of 1990, in Chapter VII and appeal trials, newly prepared Article 134 "an invalidation trial on the registration of the extension of term of a patent right" in Article 134 and makes it possible for third parties to dispute the invalidation of the registration of the extension.

③ However, Article 4 of the Addenda to the Patent Act of 1990 provides, “The trial, appeal, review, and lawsuit concerning a patent established by a patent application prior to the enforcement of this Act shall be governed by the previous provisions,” and clarifying that the above provisions, ①, ②, are excluded from the application of new provisions, in a patent applied prior to the enforcement of the Patent Act of 190.”

④ If it is interpreted that an extension of the term of a patent is not included in “the term of a patent” under Article 7 of the Addenda, the application for registration of an extension is also applied to a patented invention filed prior to the enforcement of the Patent Act in 1990, and further, the procedure for objection against rejection ruling is subject to an appeal. This is inconsistent with the language and text of Article 4 of the Addenda.

⑤ The period of application for approval of extension under Article 53(3) of the Patent Act of 1987 and Article 9-3(1) of the Enforcement Decree of the same Act is “within three years of the expiration date of the patent of a patented invention” while the period of application for registration of extension under Article 90(2) of the Patent Act of 1990 differs as “within three months from the date permission, etc. is obtained under Article 89.” However, the period of application for registration of extension under Article 90(2) of the Patent Act of 1990 differs from the period of exercise of patent right. In addition, if the patent holder had already been established before the enforcement of the Patent Act of 1990 and three months have already passed from the date the permission, etc. for a patent has already been granted

D) Whether the application of Article 7 of the Addenda of the former Patent Act (amended by Act No. 5080, Dec. 29, 1995; Act No. 5080, Jul. 1, 1996; hereinafter “the Patent Act of 1996”) is excluded pursuant to Article 3(2) of the Addenda of the Patent Act (hereinafter “the Patent Act of 1996”).

Under Article 8(1) of the Patent Act of 1996, the term of a patent is amended to the effect that "the term of a patent shall be twenty years from the filing date of a patent application," and Article 3(1) of the Addenda of the Patent Act provides that "this Act shall not apply to a patent, the term of which has expired under the previous provision before this Act enters into force," and Article 3(2) of the Addenda of the Patent Act provides that "the term of a patent, the term of which is reduced due to the enforcement of this Act, among a patent pending at the time this Act enters into force, shall be governed by the previous provision." Article 3 of the Addenda of the Patent Act provides that "The remaining term of a patent at the time of the enforcement of the Patent Act of 1996, shall be determined by applying Article 88(1) of the Patent Act of 196, but the previous provision shall apply only to a patent, the term of which has been reduced due to the enforcement of the Patent Act of 199, notwithstanding Article 7 of Addenda of the Patent Act of the Patent Act.

However, according to Article 7 of the Addenda of the Patent Act of 1990, which is the previous provision of the Patent Act of 1996, and Article 53 (1) of the Patent Act of 1987, the term of the patent right of this case expires on April 21, 2012, which is 15 years from April 21, 1997, which is the date of publication of application, and on March 3, 2008, which is 20 years from March 3, 198, which is regarded as the date of patent application according to Article 88 (1) of the Patent Act of 1996, the term of the patent right of this case is reduced due to the enforcement of the Patent Act of 196.

Therefore, Article 7 of the Addenda to the Patent Act of 1990, which is the previous provision, shall apply to the term of the patent right of this case pursuant to Article 3 (2) of the Addenda to the Patent Act of 1996.

E) Sub-decisions

The duration and extension of the patent of this case are all subject to Article 7 of the Addenda to the Patent Act of 1990, and it is subject to the Patent Act of 1987.

2) Enforcement Decree applicable to the extension of the patent term of the instant case

A) Under Article 53(3) of the Patent Act of 1987, the Patent Act delegated specific matters to the Enforcement Decree of the Patent Act by stating that “the subject, requirements, and other necessary matters of a patented invention for which the term may be extended shall be prescribed by Presidential Decree.” The Enforcement Decree of the Patent Act of 1987 prescribed the subject, procedure, etc. of the application for extension in Articles 9-2 and 9-3.

B) The amended Enforcement Decree of the Patent Act (wholly amended by Presidential Decree No. 13078, Aug. 28, 1990; hereinafter “Enforcement Decree of the Patent Act of 1990”) with the amendment of the Patent Act in 190 only stipulates that an invention subject to extension registration shall be “an invention subject to extension registration” under Article 7, and does not stipulate the subject of and procedures for the application for extension registration.

C) The Enforcement Decree of the Patent Act of 1990 only provides that “this Decree shall enter into force on September 1, 1990,” and there is no transitional provision regarding the application of the previous provisions, such as Article 7 of the Addenda to the Patent Act of 1990, as the upper-tier corporation.

D) However, when interpreting that the Enforcement Decree of the Patent Act in 1987 was wholly invalidated on the ground that there is no transitional provision on the application of the previous provision, despite the transitional provision that applies Article 53 of the Patent Act in 1990, which is the previous provision, to “the term of a patent” under the Patent Act in 1990, Article 53 of the Enforcement Decree of the Patent Act has a legal gap as to the matters delegated by the Enforcement Decree. Therefore, as in the case of the Enforcement Decree of the Patent Act, deeming that the provisions of the Enforcement Decree of the Patent Act in 1987 are applied to “the term extension approval” in the case of the Enforcement Decree

E) Therefore, Articles 9-2 and 9-3 of the Enforcement Decree of the Patent Act of 1987 shall apply to the instant application for extension, except in extenuating circumstances.

3) Whether the Administrative Procedures Act is in violation

Article 21(1) of the Administrative Procedures Act provides that in cases where an administrative agency imposes an obligation on the parties or imposes a restriction on their rights and interests, it shall notify the parties concerned of the title of the disposition, name or title and address of the parties concerned, the facts leading to the disposition, the grounds for the disposition, the contents of the disposition, and the legal grounds therefor, the submission of their opinions, the processing methods when the submission of opinions is not made, the name and address of the agency which submitted opinions, and the deadline for submission of opinions, etc. In such cases, barring special circumstances, even if the disposition is not made upon the parties concerned, the rejection disposition against the application does not directly restrict the rights and interests of the parties, and thus, it does not constitute "a disposition that restricts the rights and interests of the parties concerned" as it does not constitute "a disposition that restricts the rights and interests of the parties concerned" (see Supreme Court Decision 2003Du67

In addition, Article 2(3) and Article 3(3) of the Notice of this case, which applies mutatis mutandis to the application system for the extension of patent term as stated in the Patent Act and the Enforcement Decree of the Patent Act in 1987, provides for a rule on the exercise of discretionary power granted by the defendant in relation to the extension of patent term. Thus, it is difficult to deem that the Disposition of this case was in violation of Article 20 of the Administrative Procedures Act solely on the ground that the defendant did not separately establish and publicly announce the disposition standards applicable to the application for the extension of patent term.

Therefore, this part of the plaintiff's assertion is without merit.

4) Whether the instant disposition grounds are lawful

A) Whether the patent of this case is subject to the application for extension (3)

(1) In Article 9-2 (1) 1 of the Enforcement Decree of the Patent Act in 1987, the part of "Article 26 (1)" in Article 9-2 (1) of the Enforcement Decree of the Patent Act is subject to the application for extension on the ground that it is unconstitutional

(A) Relevant constitutional and legal provisions

Article 75 of the Constitution provides, “The President may issue a Presidential Decree with regard to the matters specifically determined and delegated by Act.” Such delegation order is based on the Constitution and delegated by Act, and is subordinate to the delegated Act, and the time of entry into force, content, loss of effect, etc. of delegation order is premised on the mother’s law. Therefore, it cannot be prescribed that it violates the parent’s law.

Article 22(2) of the Constitution provides that the right of an inventor shall be guaranteed by the law, and as a part of which, Article 53(2) of the Patent Act of 1987 provides, “The Commissioner of the Korean Intellectual Property Office shall obtain permission or make registration pursuant to other Acts and subordinate statutes to work a patented invention, notwithstanding the provisions of paragraph (1) (the part for which the term of a patent is 15 years), and may extend the term of the patent within a period not exceeding five years where it requires a long-term test of activation, safety, etc. necessary for such permission or registration.” Article 22(3) provides, “The subject, requirements, and other necessary matters for a patented invention for which the term may be extended pursuant to paragraph (2) shall be prescribed by Presidential Decree.” Article 53(2) of the Patent Act of 1987 provides, “The subject

Meanwhile, 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 under Article 53(2) of the Act (hereinafter “patent term”) shall be limited to an invention for which the invention under domestic practice or the preparation for implementation has been completed at the time of the application for extension of the patent term, and which falls under any of the following subparagraphs.” Article 9-2(1)1 of the Enforcement Decree of the Patent Act provides that “an invention of a medicine subject to the item approval under Article 26(1) of the Pharmaceutical Affairs Act for the purpose of executing a patented invention” and subparagraph 2 of the same Article provides that “an invention of a pesticide or an agricultural chemical substance subject to registration under Articles 8(1) and 9(1) of the Agrochemicals Control Act for the purpose of executing a patented invention.”

Article 26(1) of the former Pharmaceutical Affairs Act (amended by Act No. 4268 of Dec. 27, 1990; hereinafter “former Pharmaceutical Affairs Act”) at the time of enforcement of the Patent Act and the Enforcement Decree of the Patent Act in 1987 provides for the item license for manufacture and the item license for import under Article 34(3) of the former Pharmaceutical Affairs Act, respectively. The former Pharmaceutical Affairs Act does not provide for the item license for drugs in addition to the above two provisions.

(B) Issues, etc. of this part

Article 9-2(1)1 of the Enforcement Decree of the Patent Act in 1987 provides for an application for extension of the patent term for “the case where a person shall obtain an item license for a patented invention under the former Pharmaceutical Affairs Act” and “the case where a person needs to obtain an item license for a patented invention under the former Pharmaceutical Affairs Act” under Article 53(2) and (3) of the Patent Act in 1987. However, the scope of the application is limited to “the case where a person needs to obtain an item license for a patented invention under the former Pharmaceutical Affairs Act.”

The plaintiff argues that Article 9-2 (1) 1 of the Enforcement Decree of the Patent Act of 1987 does not expressly state the invention subject to an application for extension of a pharmaceutical product subject to an import item approval, "it is not clear legislation because it discriminates against the inventor of a pharmaceutical product subject to an import item approval, and the inventor of a pesticide subject to an import item registration, and therefore, regardless of the language and text, it shall be interpreted that not only the invention subject to an import item approval but also the invention subject to an import item approval is included in the subject of an application for extension." However, it goes beyond the possible interpretation of the language and text, so it cannot be accepted (However, the plaintiff's above assertion can be deemed that the exclusion of an invention subject to an import item approval under Article 9-2 (1) 1 of the Enforcement Decree of the Patent Act of 1987 from the subject of an application for extension of a pharmaceutical product from the subject of an import item approval under the Constitution.)

However, Article 107(2) of the Constitution of the Republic of Korea provides, “Where an order, rule or disposition violates the Constitution or a law and becomes the premise of a judgment, the Supreme Court has the authority to finally examine it.” Thus, the lower court also has the authority to examine the unconstitutionality or illegality of the order, and thus, the court of the lawsuit in charge of the judgment should examine ex officio whether the enforcement decree, which serves as the premise of the judgment, is unconstitutional or unlawful. Of Article 9-2(1)1 of the Enforcement Decree of the Patent Act of 1987, the part of “Article 26(1)” (hereinafter “the part subject to examination of this case”) which limits only the subject of an application for extension of the patent term to a drug invention subject to an item approval of the patent term under Article 9-2(1)1 of the Enforcement Decree of the Patent Act, is the premise of the judgment of the instant case, and thus, the court ex officio examines this part of

(C) The instant portion subject to examination is unconstitutional and invalid as it violates Article 11(1) of the Constitution.

○ Restrictions, etc. on protection areas and constitutional rights under Article 11(1) of the Constitution

Article 11(1) of the Constitution provides, “All citizens shall be equal before the law, and no person shall be discriminated against in all areas of political, economic, social, or cultural life on the basis of gender, religion, or social status.” The principle of equality based on which the principle of equality is based is prohibited, in essence, from arbitrarily treating the same thing. It means that not only when the law is applied, but also when the legislation is made, unreasonable discrimination shall not be treated (see Supreme Court en banc Decision 2007Du8287, Nov. 20, 2008, etc.).

However, the subject portion of the examination of this case is limited to the subject matter of an application for extension of a pharmaceutical product invention subject to an import item approval, and it is treated differently from the subject matter of a pharmaceutical product invention subject to an import item approval. In addition, the former Agrochemicals Control Act (wholly amended by Act No. 3322, Dec. 31, 1980; hereinafter “former Agrochemicals Control Act”) at the time of enforcement of the Patent Act and the Enforcement Decree of the Patent Act (wholly amended by Act No. 3322, Dec. 31, 1980; hereinafter “former Agrochemicals Control Act”) stipulates not only the manufacture item registration but also the import item registration, and Article 9-2(1)2 of the Enforcement Decree of the Patent Act of 1987 provides that an agrochemical invention subject to an import item approval shall also be subject to an application for extension of the patent period. On the other hand, the subject portion of examination of this case is excluded from the subject matter of the examination of this case’s invention subject to an import item approval.

In determining whether such discriminatory treatment is consistent with the Constitution, it is unreasonable to approach the aforementioned discriminatory treatment from the perspective of discrimination between the citizen and the foreigner. The citizen (including domestic corporations) is entitled to practice a patented invention by obtaining permission for manufacture in the Republic of Korea and may practice the patented invention by obtaining permission for import (including cases where the working of the patented invention is conducted not only by a patentee but also by obtaining permission for exclusive or non-exclusive license from a patentee). Therefore, whether the subject of the examination of this case is unconstitutional or not is, in essence, ① regardless of nationality, ① a person who executes the patented invention by obtaining permission for manufacture in the Republic of Korea and an importer of the patented invention by obtaining permission for import; ② a discrimination between the manufacturer of the patented invention and the importer of the patented invention in the case where the working method of the patented invention is imported; ② a person who executes the patented invention and the importer of the patented invention in the Republic of Korea, i.e., the person who obtains permission for manufacture in the Republic of Korea and the importer of the patented invention, and the right as a patentee (hereinafter referred to as a foreigner) can be protected by Article 23(1)1) through the Constitution.

Therefore, the right to apply for extension of the patent term pursuant to Article 53(2) and (3) of the Patent Act of 1987 without discrimination as a person who executes a patented invention by obtaining import marketing approval falls under the protection area under Article 11(1) of the Constitution. The examination area of this case is limited to only the invention subject to marketing approval, thereby guaranteeing the right to apply for extension under Article 11(1) of the Constitution.

○ Whether restrictions on rights guaranteed by Article 11(1) of the Constitution are justified, etc.

① In general, the requirements for the review of the principle of prohibition against a person, which is the criteria for determining whether to infringe upon the rights guaranteed by Article 11(1) of the Constitution, are the existence of discrimination in relation to whether the person is treated differently in essence, and whether it can be deemed arbitrary if there is such discrimination. On the other hand, with respect to the above requirements, the determination of whether two comparative groups are essentially the same in essence is in line with the relevant provisions of the Constitution and the relevant provisions of the law, and the existence of arbitraryness of discrimination in relation to the requirements for the above (see, e.g., Constitutional Court Order 2001HunBa64, Jan. 30, 2003). In addition, in order to determine discrimination based on reasonable grounds in relation to the discrimination against the constitutional rights, the purpose of discrimination should be a justifiable purpose consistent with the Constitution, and the criteria for discrimination should be a substantial relation for the realization of the purpose, and the degree of discrimination should also be appropriate (see, e.g., Constitutional Court Order 93HunBa75, Aug. 29, 196).

② In accordance with the foregoing review criteria, first of all, the manufacturing marketing approval inventions and import marketing approval inventions which are treated differently under Article 9-2(1) of the Patent Act, 1987, and the patent invention and pesticide invention are essentially the same.

Article 22(2) of the Constitution of the Republic of Korea explicitly provides for the special protection of scientific technicians, etc. by providing that “The rights of authors, inventors, scientists, and artists shall be protected by law.” This is the purpose of promoting free and creative research and development of science and technology, and by protecting the research and production in the theories and actual aspects, thereby enhancing the achievement of culture. Accordingly, the Copyright Act, Invention Protection Act, Patent Act, Science and Technology Promotion Act, National Technical Qualifications Act, etc. (see Constitutional Court Order 92Hun-Ma87, Nov. 25, 1993).

The purpose of the Patent Act is to promote the development of technology by protecting and encouraging inventions and promoting the use thereof, thereby contributing to industrial development (Article 1). In other words, the inventor shall grant exclusive rights, a right to practice inventions for a certain period of time, and protect the invention by providing an inventor with an opportunity to use the invention to the general public through publication and implementation of the invention, thereby promoting the advancement and development of technology and ultimately promoting the national industrial development. To achieve this objective, the Patent Act grants exclusive rights to practice the patented invention for business purposes to the patentee whose patent is registered (Article 94) and grants exclusive rights to practice the patented invention (Article 99), and protects and encourages new inventions by protecting patent rights with property value, such as granting patent assignment (Article 64), while disclosing and encouraging the publication of the invention by having the patentee or exclusive licensee (Article 100), and non-exclusive licensee (Article 102), thereby promoting the use of the invention by providing them with an opportunity to use the invention for a certain period of time, and ultimately contributing to industrial development under Article 107(20) of the Patent Act.

Meanwhile, Article 53 (1) of the Patent Act of 1987 provides that "the term of a patent shall be 15 years from the date of publication of the application, 15 years from the date of establishment registration, and 15 years from the date of establishment registration, and where there is no publication of the application, the Commissioner of the Korean Intellectual Property Office shall obtain permission or registration under other Acts and subordinate statutes to practice the patented invention notwithstanding the provisions of paragraph (1) and may extend the term of the patent within a period of five years where it requires a long-term test of activation, safety, etc. necessary for such permission or registration." The purport of the above extension of the term of the patent is as seen above, the above extension of the term of the patent shall be subject to permission or registration from the regulatory authority in order to promote the health and safety of the people. As such, as a considerable long-term period of time is required for testing, examination, etc. to this end, the patentee may not enjoy the benefits from the monopoly of the right, and thus, it shall be extended to the extent necessary for such permission or registration within a certain period.

In full view of the meaning and purpose of the above constitutional provisions and the provision on the extension of patent term extension, a pharmaceutical product and an agrochemical subject to permission or registration under the Pharmaceutical Affairs Act or the Agrochemicals Control Act shall be deemed to be essentially the same in that they are not working of the patented invention during the period required for the test of activation, safety, etc. required for such permission or registration. In addition, the import pharmaceutical products are essentially different solely on the ground that the domestic pharmaceutical products and their production place are different, or that the import pharmaceutical products are in essence different from the imported agricultural chemicals, or that the need for the restoration of a patent is less than the need for the restoration of a patent. Thus, Article 9-3(1)1 of the Patent Act of 1987 excluded the invention of a pharmaceutical product subject to the import marketing approval subject to the extension of patent term, which is, the patentee or the licensee of the patented invention, and the importer

③ Next, we examine whether there are reasonable grounds for such discrimination.

The defendant asserts to the effect that the patent law in 1987 excluded a product invention subject to an extension of the patent term from the scope of an imported product license was to protect and foster the domestic pharmaceutical industry in relation to the pharmaceutical industry by introducing the material patent system in response to the request of the United States at that time while minimizing damage to domestic industry and fostering the manufacturing foundation of the domestic pharmaceutical industry, namely, domestic pharmaceutical enterprises using the patent technology of foreign pharmaceutical enterprises (the product manufactured by the same ingredients after the patent term expires, which has the same efficacy and effect as the product manufactured by the same ingredients, but due to price competition, has a very low price compared to the patent medicines) in order to protect and foster the domestic pharmaceutical industry.

A foreigner’s patent right can be implemented not only by the patentee but also by the domestic pharmaceutical company that has obtained an exclusive license or non-exclusive license from the foreigner, and the different treatment of an invention subject to an imported product license and an invention subject to an imported product license is not discrimination between the national patentee and the foreigner’s patentee, but also discrimination between the manufacturer and the importer. Furthermore, according to the evidence evidence No. A. 7, the patent right of which the patent period has been extended by August 2012 or the patent period has been extended by an application for extension approval or registration of the patent is 89% of the foreigner’s patent right. The majority of the cases of extension of the patent right is the case where the domestic pharmaceutical company obtained an exclusive license or non-exclusive license from the foreigner to practice the patented invention. Ultimately, the part excluded from the imported product license of Article 9-2(1)1 of the Patent Act of 1 of 1987, which is the exclusive license of the foreigner’s patent licensee, is no longer the exclusive license of the manufacturer or non-exclusive licensee, and the foreigner’s exclusive license has been granted the exclusive license to the foreigner’s domestic pharmaceutical product.

In light of these circumstances, the term of the Patent Act’s legislative purpose is to promote the use of a patented invention by not only the patented invention but also a third party such as an ordinary and exclusive licensee, thereby ultimately contributing to industrial development. The purpose of the subordinate patent extension system is to restore the rights of a patentee or licensee who could not practice a patented invention for a certain period of time due to the regulation to promote public health and sanitation and ensure safety. The extension pursuant to Article 53(2) of the Patent Act of 1987 is recognized as equal to the period necessary for permission and registration within the extent not exceeding five years, and most patent rights extended by the patent term are foreigner’s patent rights, but it does not constitute grounds to justify discrimination against drug importers.

In addition, the following circumstances, which are recognized by Eul or 3 evidence, are as follows: (a) where pesticides using patented invention technology are high added value; (b) where one active ingredient that can be used as pesticides is commercialized, a new substance organic compound should be compounded up to 2-40,000; (c) where the biological activity of a chemical is verified; (d) the average development period of 8-12 years and 50 billion won or more should be invested in investigating manufacturing methods, development of medicine, market feasibility, economic feasibility, etc.; and (e) on the other hand, the productization rate is "high-risk high-risk high-risk high-risk high-risk medicine; (e) where there is no difference with the pharmaceutical product; (e) where one active ingredient that can be used as pesticides is commercialized; (e) where one pesticide product is commercialized, and most of the domestic pharmaceutical products are imported from the domestic pharmaceutical product manufacturer and the pharmaceutical products importer do not use the pharmaceutical products or to protect the pharmaceutical products from the domestic pharmaceutical product manufacturer’s development of pharmaceutical products in the context of 1987 years Patent Act.

○ If so, the part subject to the review of this case is unconstitutional and invalid by arbitrarily reducing the subject of the extension approval of the patent term, thereby infringing the right to equality as provided by Article 11 of the Constitution.

(D) The instant portion subject to examination is illegal and invalid in violation of Article 53(2) and (3) of the Patent Act, 1987.

Article 53(2) and (3) of the Patent Act, 1987, when permission or registration under other Acts and subordinate statutes is required in order to work a patented invention, and it requires a long-term period of examination of activation, safety, etc. necessary for such permission or registration, the relevant patent period may be extended for a period not exceeding five years, and the subject, requirements, and other necessary matters of the patented invention shall be prescribed by Presidential Decree.

According to the language and text of the above provision, while the legislators delegated the subject matter of a patented invention which can be extended under Article 53(3) of the Patent Act in 1987, the legislators may determine and delegate specific scope so that it can be included in the subject matter of an application for extension in the case of “where it requires a long-term examination of activation, safety, etc. for obtaining permission for the implementation of a patented invention” under Article 53(2) of the Patent Act. In order to implement a patented invention, in the case of a pharmaceutical invention for which an import license is required under the former Pharmaceutical Affairs Act, it requires a long-term period of time for testing of activation, safety, etc. for obtaining such permission. Thus, the Enforcement Decree of the Patent Act in 1987, which is subject to delegation order, is consistent with the mother Act (Article 53(2) and (3) of the Patent Act in 1987). Nevertheless, the part of the instant subject matter of examination except this case,

(2) Even in the interpretation of Article 7 subparagraph 1 of the Enforcement Decree of the Patent Act of 2000, the patent of this case can be subject to the application for extension.

(A) As long as the interpretation of administrative laws does not deviate from the ordinary meaning of the language and text, the teleological interpretation that takes into account the legislative intent and purpose, etc. does not exclude (see Supreme Court Decision 2006Du11590, Sept. 20, 2007, etc.). In interpreting the meaning of the subject of extension of a patent right, it is reasonable to respect the legislative purpose and purpose as far as possible so that it accords with it.

(B) Article 7 Subparag. 1 of the Enforcement Decree of the Patent Act in 2000, which provides for the application for registration of an extension, was amended, and the invention of a drug subject to import license (Article 34(1) of the Pharmaceutical Affairs Act) was added to the subject.

(C) In full view of the following circumstances, based on the legal principles of the above (A), the amended Enforcement Decree of the Patent Act in 2000 also regulates the subject matter of the application for an extension. Article 7 subparag. 1 of the Patent Act provides that “an invention as prescribed by the Presidential Decree under Article 89 of the Act” shall be extended to the concept “the subject matter of a patented invention for which the term may be extended under Article 53(2) of the Patent Act in 1987,” and it is reasonable to interpret the amended Enforcement Decree of the Patent Act by extending the scope of “the subject matter of a patented invention for which the term may be extended under Article 53(2) of the Patent Act in 1987.”

① Article 27(1) of the Intellectual Property Agreement, which entered into force on January 1, 200, provides that “The patent shall be granted without any discrimination depending on the import or domestic production of the invention site, technology field, or product, and the patent shall enjoy the patent right.” Article 7 subparag. 1 of the Enforcement Decree of the Patent Act, in 2000, included the invention in the invention subject to application for registration of grant of import marketing approval, is for implementation of the above provisions of the Intellectual Property Agreement, and was intended to clarify that it does not discriminate against the imported drug (the defendant asserts that Article 27(1) of the above Agreement is merely a non-discrimination clause on compulsory licensing (the kind of limitation on the exclusive right of a patent that allows compulsory use of the patent without the consent of the owner of the intellectual property right). However, the above provision provides that a patent right shall be enjoyed without any discrimination depending on the import or domestic production, so it shall not be exercised by recognizing “import” as a patent license, but shall also be viewed as prohibiting domestic production of the product and its substantive scope.

② The Enforcement Decree of the Patent Act of 2000 does not have any separate transitional provision prohibiting retroactive application to Article 7 subparag. 1 of the amended Act. Thus, even in cases of a patent 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, if an application for registration of extension was filed after July 1, 200, the enforcement date of the above Enforcement Decree is included in

③ At the time of the amendment, there existed only the case of an application for registration of extension since the first application for registration of extension was filed in 199, and there was no one case of an extension approval until 2005 even after the amendment. In light of the current status of practice at the time of the amendment and the purport of the amendment of the Enforcement Decree, it is difficult to view that the legislator’s legislative intent, which amended Article 7 subparag. 1 of the Enforcement Decree of the Patent Act in 2000, expanded the scope of the application for registration of extension, but did not expand only the scope of the application

④ On March 15, 2006, the Defendant opened an “Industrial Property Rights Operation Council for Application for Extension of the term” and decided not only to include the invention in the application system for registration of extension but also to include the invention in the subject of extension, and then approved an application for extension of the term of marketing approval according to the above decision. This extended interpretation of the meaning of the language and text in accordance with the purport of the amendment of the Enforcement Decree of 2000.

⑤ From 2005 to August 2012, 2012, the Defendant approved the application for extension of a patent right with respect to 45 pharmaceutical products, and 28 of which was approved for extension based on import marketing approval.

6. In 2008, the Defendant issued and distributed an information collection at a two-year period following the publication of the term extension of patent rights and pesticide information collection in order to "in order to improve the R&D efficiency of domestic pharmaceutical manufacturers, etc. and prevent unnecessary patent disputes in advance with respect to improved new medicine or collapses," and each information collection contains all the information on the cases for which permission for extension has been granted based on an import item as described in the above paragraph 5.

(3) Sub-determination

The part subject to examination of this case is unconstitutional and invalid by infringing the right to equality of the inventor of imported drugs in violation of Article 11 of the Constitution. Since it is illegal and invalid in violation of Article 53(2) and (3) of the Patent Act in 1987 (see, e.g., whether a child violates the Paris Convention or the Intellectual Property Agreement or the principle of self-regulation of administration). Article 9-2(1)1 of the former Enforcement Decree of the Patent Act only has the effect of “an invention of a drug subject to permission of items under the Pharmaceutical Affairs Act to implement a patented invention,” and therefore, the patent of this case, which is an invention subject to permission of items imported, constitutes the subject of an application for the extension of patent term extension.

In addition, due to the amendment of the Enforcement Decree of the Patent Act in 2000, "an invention subject to marketing approval of imported drugs for working" is included in the subject of application for extension of patent term. Thus, the patent of this case is subject to the application for extension approval.

Ultimately, the grounds for the instant disposition are premised on the fact that the instant patent is not subject to the application for an extension of the patent term, and thus, it does not constitute a legitimate ground for disposition as to the instant disposition.

B) Whether the application period has been complied with (iv)

(i)The patent remaining effective at the time of the application for an extension is not a requirement for the application for an extension;

Article 9-3(1) of the Enforcement Decree of the Patent Act in 1987 provides that "a patentee who intends to apply for the approval of extension of a patent because the patented invention falls under any subparagraph of Article 9-2(1) shall submit to the Commissioner of the Korean Intellectual Property Office an application for approval of extension of a patent which states the following matters within three years from the expiration date of the patent term of the patented invention." However, this provision stipulates that the period for submission of an application is set as follows, and it cannot be said that the term of patent is effective at the time of the application for extension, and there is no provision that the said requirements are prescribed under the Patent Act and the Enforcement Decree of the Patent Act

In addition, the main text of Article 90(4) of the Patent Act of 1990 provides that "when an application for registration of extension of the term of a patent is filed, the term shall be deemed to have been extended." While there is no provision in the Patent Act of 1987, if an application for registration of extension by a patentee was filed at the time of expiration of the patent term, even if the patent term remains, if the application for registration of extension by the patentee was filed at the time of expiration of the patent term, the patent right can not be avoided if the patent term is extended retroactively from the expiration date of the patent term, and the validity is extended retroactively from the expiration date of the patent term at the time of approval of extension by the defendant. Thus, unless the Patent Act of 1987 and the Enforcement Decree of the Patent Act of the Patent Act of 1987 provide that "the remaining term shall be a patent right at the time of approval of extension, the patent right shall be deemed to have been valid."

Therefore, "the patent which remains effective at the time of application for extension" cannot be considered as a requirement for approval for extension of the term.

(2) Furthermore, since the expiry date of the patent term of the instant patent on April 23, 2012, the instant application for extension made on the same day complies with the submission period of the application.

Article 161 of the Civil Act (amended by Act No. 8720 of Dec. 21, 2007, including the case where the last day of the term is a Saturday or a holiday) providing that “the term of a patent shall expire on the following day” shall apply to the calculation of the term of a patent, as there is no provision of the Patent Act separately on the case where a holiday, etc. is the last day of the term of a patent, and ultimately, Article 161 of the Civil Act (amended by Act No. 8720 of Dec. 21, 2007, including the case where the last day of the term is a Saturday)” (this is also an explanation given by “No. 4 of the Protocol of the Patent Act (No.

The fact that the publication date of the patent application of this case was April 21, 1997 is as seen earlier, and the fact that April 21, 2012, which was 15 years thereafter, was Saturday is remarkable in this court. As such, the substantive duration of the patent of this case expires on April 23, 2012, and thus, the Plaintiff’s application for extension of the patent of this case is lawful within three years after the expiration date of the patent of this case.

(3) Even if the expiry date of the patent term of the instant case was April 21, 2012, the instant application for extension was filed in compliance with the period for submission of the application.

(A) Article 53(1) of the Patent Act of 1987 provides, “The term of a patent shall be 15 years from the date a patent application is published, if an application is published, or 15 years from the date a patent application is registered, if no application is made.” Article 9-3(1) of the Enforcement Decree of the Patent Act provides, “A patentee who intends to apply for approval for extension of a patent shall submit an application for approval for extension of the patent to the Commissioner of the Korean Intellectual Property Office within 3 years from the expiration date of the patent term.” This provision sets the period for submitting an application for approval for extension of a patent from “three years before the expiration date of the term

(B) Meanwhile, Article 14 Subparag. 4 of the Patent Act of 2006 provides that "if the last day of the period for patent-related procedures falls on an official holiday (including the Workers' Day under the Designation of Workers' Day Act and Saturdays), the said period shall expire on the following day." According to the proviso to Article 6 of the Addenda of the Patent Act of 2006 and the proviso to Article 1 of the former Patent Act (amended by Act No. 11117, Dec. 2, 201) of the Addenda of the Patent Act of 2006, the said provision shall also apply to the calculation of the period for patent of this case. Article 14 Subparag. 4 of the Patent Act of 2006 intends to prevent disadvantages arising from the expiration of the period for patent-related procedures falling under an official holiday. Thus, in the period for submitting an application for extension of the period for patent-related procedures, the "day" as referred to in the above provision shall be deemed to have expired, and on April 21, 2012.

As to this, the Intervenor joining the Defendant (hereinafter referred to as the “ Intervenor”) asserts that the period for submitting the written application should reverse, and thus, the “period for submitting the written application should begin,” and the “three years before the expiration of the term” will end, and accordingly, the Defendant asserts that the application for the extension of this case is not subject to Article 14(4) of the Patent Act in 2006.

In order to find a "three years prior to the expiration of the term", first of all, a "date prior to the expiration of the term" should be counted on the basis of the "date prior to the expiration of the term". However, this cannot be said to be the "day prior to the beginning of the period for submission" under Article 14 subparagraph 4 of the Patent Act, 2006, on the ground that the period for submission was only a method to find the beginning date of the period for submission, and such method was taken. Therefore, the Intervenor's above assertion is without merit (in determining the period for act, before the due date prior to the due date or after the due date in determining the period for act), if the Intervenor uses the expression "after the due date prior to the due date" or "after the due date, after the due date", it is inevitable to specify the "day prior to the due date." However, the last day of the period prior to the due date of 97 days prior to the due date of the ruling of the Supreme Court, 90 days prior to the due date of 97 days prior to the due date.

(4) Sub-determination

Therefore, at the time of the application for the extension of the patent of this case, the patent of this case is still valid, and even if otherwise, according to Article 14 subparagraph 4 of the Patent Act of 2006, the application for the extension of this case shall be deemed to have been filed within three years after the patent term expires. Thus, the ground for disposition 4 of this case and

C) Whether the discretionary authority is deviates or abused (in this case ①, and ② Whether the grounds for disposition are legitimate)

(1) Criteria for examination of legality

(A) When the administrative act is classified into the so-called binding act, binding act, discretionary act, or discretionary act or discretionary discretionary act with respect to the existence and scope of the discretion, the division shall be determined by considering all the structure, form, and text of the law based on which the act in question was the basis of the act in question, the main purpose and characteristics of the administrative area to which the act in question belongs, and the individual nature and type of the act in question. The judicial review of the two separate types shall be based on the facts established by the court through the interpretation and application of the laws and regulations in the case of the former, and shall be based on the method of determining the legitimacy of the judgment in the case of the latter. However, in the latter case, the court shall only examine whether the act in question is a deviation or abuse of discretion based on the discretion of the administrative agency in consideration of the possibility of determining the public interest based on the discretion of the original, and the examination of whether the act in question deviates or abuse of discretion shall be subject to the determination of mistake, the principle of proportionality and equality, the purpose of the act in question, or its motive (see, etc.).

(B) In light of the legal system, form and language of the Patent Act in 1987, and the nature as a beneficial administrative act of extending the term of patent rights, etc., in determining whether “where permission or registration requires a long-term test of activation, safety, etc. necessary for permission or registration” (hereinafter “1 requirement”) and “where permission, etc. is required by other Acts and subordinate statutes to implement patented inventions” (hereinafter “two requirements”), the discretion of the defendant is granted to the defendant.

(C) In addition, Article 3(3) of the instant notice is a rule on the exercise of discretion granted to the Defendant in relation to the extension of the term of patent rights, and the specification of the standard for determining whether to meet the requirements for statutory extension is within the discretion of an administrative agency. As such, the administrative agency’s intent should be respected as possible, unless it is deemed that the standard objectively is unreasonable or unreasonable, and that it abused discretion.

(2) Cases where a long-term test is required for the instant permission, such as safety, etc. (i) Whether the instant disposition grounds are lawful

In full view of the following circumstances, Gap evidence 9, Gap evidence 10, Gap evidence 11, Eul evidence 22, Eul evidence 23, Gap evidence 24, Gap evidence 25, Gap evidence 35, Gap evidence 36, Gap evidence 37, Gap evidence 50, Eul evidence 50, Eul evidence 54, Eul evidence 10, Eul evidence 11, Eul evidence 14, and Eul evidence 14, the patent of this case seems to have taken a long-term period of time for the safety test, such as activation and safety test for obtaining the permission. Nevertheless, the defendant presumed that the activation and safety of the drug of this case was confirmed solely on the grounds that prior permission was granted to the same active ingredients, and the defendant did not examine how much the safety test of this case was actually implemented by the plaintiff, and it did not review the abuse of discretionary authority in light of the purpose of the patent right.

① On or after April 21, 1998, the publication date of the original patent application of this case, the Plaintiff obtained the prior permission of August 31, 200, following the examination and examination as to active elements of the original patent invention of this case.

② At the same time, the Plaintiff underwent the process of verifying the activation of the active elements of the original patent application of this case (the verification of the active elements of the above active elements is the premise for licensing the patent of this case), and the first medicine using the above active elements, namely, X-to-cellulululululululululululul, from the time when the development of the above active elements is completed, developed the active elements of the same, but the development of pharmaceutical products and specifications suitable for the light injection of the active elements of the patent of this case with different administration routes, in order to implement the patent of this case.

③ The Plaintiff, at the first stage of the development of light-brising products and type, conducted a comparative experiment on the toxicity, attachment, bio-use, resistant substance, internal medicine, resistant substance, stability, and worn-out nature, and conducted a variety of climatic climatic climatic climatic climatic climatic climatic cliffs using different four experimental climatic cliffs from October 197 to February 2, 200.

④ During the development process, the Plaintiff discovered that the above active elements are imminently unstable due to decomposition under the presence of oxygens, and, in order to solve these problems, the Plaintiff made an invention of TPP “TDS containing antibiotics (a delivery system, Trr transport-predelivery)” and filed an international application for the said patent on January 8, 199, and also filed a domestic application on June 12, 200.

⑤ 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 the instant permit, and obtained approval on January 14, 2004, and conducted a clinical trial against 60 patients from April 30, 2004 to May 10, 2006 for the purpose of assessing the effectiveness, safety, and durability of the instant medicine once a day. The Plaintiff was notified by the Commissioner of the Korea Food and Drug Administration of the results of each review on September 14, 2007, after undergoing the procedures for submitting materials for safety and effectiveness review and supplementary materials, standards, method of application, submission of supplementary materials, etc.

(6) On the other hand, the Plaintiff, not only domestically but also worldwide, conducted the drug license procedure for the instant patent. On October 2002, the Plaintiff obtained approval of the clinical trial plan for the instant patent from the U.S. Food and Drug Administration (FDA) and the European Pharmaceutical Organization, and conducted the third clinical trial in 20 countries from November 2003 to July 2006.

7) Around September 2006, the Plaintiff filed an application with the U.S. FDA for approval of the instant medicine, and obtained approval on July 6, 2007, along with the approval data, filed an application for the instant permission with the Commissioner of the Korea Food and Drug Administration on October 30, 2007.

8) As the examination data for the instant permission, the Plaintiff submitted the long-term preservation test and speed test data, shortly toxic test data, the national toxic test data, the test data, the effective test data, the test data, the clinical trial data, the absorption, distribution, ambassador, and gymology data, the clinical trial performance data, the results of clinical trials in foreign countries, etc., the comparison and review with domestic similar products, the data on the characteristics of the relevant drug, invith degree/invivoet test data, and the U.S. FDA submission certificate, etc.

9) At the time of the application for the extension of this case, the Plaintiff submitted data proving the commencement and completion date of the clinical trial under the above paragraph to the Defendant, and the Defendant requested the submission of the amendment by recognizing only the remainder of 873 days as “the period required for permission or registration to practice patented inventions” after excluding part of the 1,278 days originally applied for extension on the ground that “the period required due to the Plaintiff’s responsible cause”

(10) Since the release from the European Union in 2007 in 2007, the drug of this case was replaced by the existing oral dementia treatment chemicals and formed a large market of USD 1.2 billion annually. However, due to high technical barriers to TPP, which is a core technology necessary for the implementation of the patented invention, high technology for the implementation of the patented invention, it was difficult to enter the market of the same-type competitive product. As a example, Japan’s Epicary Director developed a pattern that scams the same active substance as 'Iribrate' of the dementia treatment chemicals for the self-scamb, and applied for a clinical trial to FDA in 2010 after submitting an application for the commencement of the clinical trial to the U.S. in 207 and conducting a test for the safety verification, it was difficult for the U.S.FDA to respond to all issues within the designated period, and then the Korea Food and Drug Administration decided to withdraw the development of the new-type infection treatment technology.

(3) Permission under other Acts and subordinate statutes is required for working the patented invention of this case (2) Whether the grounds for disposition are lawful

In full view of the following circumstances, the above facts and Gap evidence 2, Gap evidence 8, Gap evidence 11, Eul evidence 17, Eul evidence 23, Eul evidence 23, and Eul evidence 3, the disposition of this case is not only against the notice of this case, which is a discretionary rule applied by the defendant to the extension application system, but also against the notice of this case, which is a discretionary rule applied by the defendant, and it is reasonable to view that the disposition of this case goes beyond the limit of discretion granted to the defendant in order to determine whether "the case where permission, etc. is required by other Acts and subordinate statutes to implement patented invention" is a "case where permission, etc. is required by other Acts and subordinate statutes to implement patented invention

① Article 3(3) of the instant notice cited by the Defendant as the ground for the instant disposition provides that an extension is recognized only for the first permission if there are multiple permits, etc. in relation to a single patent. In such a case, it is possible to practice the patented invention by obtaining the first permission, and thus, it is not recognized as necessary for working the patented invention.

② However, Article 3(3) of the Notice of this case does not apply to the patent of this case, because the patent of this case was not a patent of this case, but a patent of this case for purposes of embodying the patented invention of this case. In other words, although the active elements of the patented invention of this case are the same as the active elements of the patent of this case 2 invention of this case, the active elements of the patented invention of this case are the same as those of the patent of this case, but have the effect of maintaining the active elements over a long period compared to the scam or scamscamscamscamscamscamscams, and the ordinary technicians can not easily make the patented invention of this case by facilitating the scamscams and scamscamscamscamscamscamscamscamscamscamscamscamscamscamscamscamscamscamscamscamscamscamscamscams.

③ On September 30, 1995, the Plaintiff rendered a ruling of rejection on the ground that the Plaintiff’s claim for examination of an application for patent was defective as a single patent by combining the original patent of this case with the original patent of this case, and that the invention of a compound and the invention of a pharmaceutically created product is different in the technical field, and thus, it goes against the “Invention 11 Patent Act” under the Patent Act. Accordingly, the Plaintiff filed a decision of patent as to the patent of this case by dividing it.

④ The scope of an invention subject to extension is determined by the enforcement decree delegated by the Patent Act, and Article 53(2) of the Patent Act of 1987 only recognizes the discretion to determine “where permission, etc. is required to implement a patented invention” and “where it takes a long period of time in the examination” to the Defendant. However, as alleged by the Defendant, the mere fact that multiple patented inventions, as alleged by the Defendant, have “the same active substance” as its active substance, recognizes only multiple patents as the requirement for an extension approval, is nothing more than that of a medicine invention that uses a new substance as an effective substance, i.e., an invention of a medicine that uses a new substance as an effective substance, and thus, it deviates from the Defendant’s discretionary power. The instant notice only prescribes the frequency of extension of a single patent (Article 3), and does not specifically limit the subject matter to the patent of a material invention (Article 2(1)).

⑤ Article 7 of the amended Enforcement Decree of the Patent Act (amended by Presidential Decree No. 24491, Apr. 3, 2013; hereinafter “Enforcement Decree of the amended Patent Act”) reduced the scope of extension compared to the previous one by stating that “a medicine for which an application for registration of extension is filed with a new substance (referring to a substance, the chemical structure of which in the active part having medicinal effects is new; hereinafter the same shall apply in this Article) as effective ingredients, is a medicine for which an application for registration of extension is filed with a new substance as an effective substance.”

(6) The above amendment is based on the Defendant’s amendment of the Patent Act around February 2012, 2012. The Defendant’s improvement plan only stipulates that the subject matter of application for registration of extension of a patent is an invention subject to permission under the Pharmaceutical Affairs Act, but does not determine “requirements for determining registration of substantial extension,” and the amendment of the Enforcement Decree reflecting the contents thereof was made.

(2) Inventions in each subparagraph of paragraph (1) shall be permitted or registered for the first time with respect to new materials whose chemical structure or nature is entirely new, as a result of the initial extension of patent term, only for new materials, and the use or restriction of publicly notified materials is consistent with the patent term extension system of the United States, the European Union, which does not recognize the extension of patent term of the new materials.

7) However, Article 7 of the Enforcement Decree of the amended Patent Act does not apply to the application for extension approval, and even if it is applied to the application for extension approval due to a teleological extension interpretation, it is applied to the application for extension registration after April 3, 2013, which is the enforcement date pursuant to Article 2 of the Addenda to the above Enforcement Decree. Thus, it does not apply to the patent in this case.

8) Ultimately, this case’s ground for disposition goes against the purport that Article 7 of the Enforcement Decree of the amended Patent Act, which reduces the scope of extension to the level of legislation cases of the United States and the European Union, applies retroactively to the application for extension of this case, and Article 2 of the Addenda of the amended Patent Act does not apply retroactively the amended provisions of Article 7.

D) Additional statement of the reasons for the disposition

As part of an unreasonable extension strategy beyond the scope permitted by the Patent Act, the Defendant asserts that the application for extension of the patent term of this case was legitimate since the Plaintiff intentionally delayed and delayed the procedure for the permission of this case in order to prevent the Plaintiff from working the patented invention of this case by extending the patent term of this case to the maximum extent, and thus, the rejection of the application for extension of this case is lawful. However, this cannot be added as a ground for disposition depending on the grounds that are the basis for the disposition of this case at the time of the disposition of this case and the basic factual relations are different, and it is difficult to view that the Plaintiff had the intention to delay the procedure for the permission of this case (see, e.g., Paragraph (c)(2) (see, e., Decision 38 pages).

E) Sub-decision

Therefore, even though the plaintiff applied for the extension of the patent of this case which constitutes the subject of the extension approval within a legitimate deadline, the disposition of this case is erroneous in applying the law erroneous and deviating from and abusing the scope of discretion given to the defendant.

3. Conclusion

Therefore, the plaintiff's claim of this case shall be accepted on the grounds of its reasoning, and the judgment of the court of first instance is unfair on the grounds of its conclusion, and it is so decided as per Disposition by cancelling it and accepting the plaintiff's claim of this case.

[Attachment Omission]

Judges Kim Jong-soo (Presiding Judge)

심급 사건

-서울행정법원 2013.9.26.선고 2013구합53356

서울고등법원 2014.5.16.선고 2013누48417

-대법원 2018.10.4.선고 2014두37702

원심판결

-서울행정법원 2013. 9. 26. 선고 2013구합53356 판결

본문참조판례

-대법원 1978. 10. 10. 선고 78도2208 판결

-대법원 1996. 7. 9. 선고 96누5469 판결

-대법원 2001. 2. 9. 선고 98두17593 판결