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

A. The patent of this case

(i) Name: Raw-aid products for the treatment of ornamental salt, and their manufacturing methods;

2) Date of application (priority date)/registration date/registration number: December 30, 2002 ( January 18, 2002)/ December 23, 2005 (registration number 1 omitted)

3) A patentee: The plaintiff (the plaintiff set up an exclusive license on May 2, 201, Korea FIM drugs Co., Ltd. and completed the registration thereof).

4) Claims

[ Claim 1] Fluorical products for the treatment and prevention of chronic infections, which contain fluoral, slur, pyrostal, surgical, surgical, surgical, surgical, surgical, red, surgical, and winding as active ingredients.

[Claims 5] In Paragraph 1, the pharmaceutical products, the quantity of which exceeds 0.01 to 95% of the total products.

[Claims 6] In paragraph 1, any pharmaceutical preparation, one of which is selected from among pharmaceutical preparations, administrative agents, refineds, pulc agents, liquid agents, and injection.

[Claims 2-4, 8, 11-14, 16-20] Deleted.

[Request 7, 9, 10, 15] Omitted

(b) Manufacturing and marketing marketing approval of drugs;

1) On March 13, 2012, the Korea FIMD Co., Ltd., the exclusive licensee of the instant patent (hereinafter “Korea FIM”) obtained permission for manufacture and sale (hereinafter “instant permission”) pursuant to Article 31 of the Pharmaceutical Affairs Act from the Minister of Food and Drug Safety on March 13, 2012, with respect to “Recidal” (No. 3 and No. 7).

2) To obtain the instant permission from the Minister of Food and Drug Safety with the approval of a clinical trial plan from the Minister of Food and Drug Safety, the Republic of Korea conducted a clinical trial from December 19, 2006 to March 23, 201, submitted data on safety and effectiveness, including toxic test data, from September 29, 201 to February 27, 201, and the period required for the Plaintiff’s reasons attributable to the Plaintiff during the said period is 807 days (Evidence A7).

C. Application for registration of extension of term and circumstances of the instant trial ruling

1) On June 12, 2012, the Plaintiff filed an application for registration of extension of the term of a patent with the Defendant to register the extension of the patent right claims Nos. 1, 5, and 6 of the instant patent claims (hereinafter “instant patent invention”) on the ground that the instant permission was granted (hereinafter “instant extension application”).

2) On November 12, 2012, the Korean Intellectual Property Office examiner notified the instant extension application on the ground that “this case’s drug is merely a combination of 12 publicly known raw drugs and cannot be recognized as the first permitted item, and it does not need to obtain permission under Article 89(1) of the Patent Act” (Evidence A No. 4).

3) On January 11, 2013, the Plaintiff submitted a written opinion to the effect that “The following: (a) according to the regulations on the examination of reporting on marketing approval of drugs, etc., the Plaintiff submitted a statement of opinion to the effect that, even if a drug is publicly notified, if such drug is not permitted as a complete medicine, it shall be deemed to be a new medicine; and (b) it shall submit data on safety, toxicity, pharmacological action, and clinical trial records; and (c) so, it constitutes a case where a license is required under Article 89(1) of the former Patent Act (Evidence 1)

4) However, on March 18, 2013, the examiner of the Korean Intellectual Property Office rendered a decision of refusal on the ground that “the instant pharmaceutical product is not a new drug under Article 2 subparag. 8 of the Pharmaceutical Affairs Act, but a ground for rejection under the notification of submission of opinions has not been resolved” (Evidence A No. 5).

5) On April 18, 2013, the Plaintiff filed a petition with the Intellectual Property Tribunal for an appeal against the foregoing decision of refusal (2013 Won2847). On January 22, 2015, the Intellectual Property Tribunal dismissed the Plaintiff’s appeal on the ground that “The Patent Tribunal dismissed the Plaintiff’s appeal on the grounds that the patented invention for which the patent term extension is recognized under Article 89 of the Patent Act and Article 7 of the Enforcement Decree of the Patent Act should obtain permission, etc. in accordance with the Pharmaceutical Affairs Act or the Agrochemicals Control Act to implement the patented invention, and that the patented invention requires a long period of time due to activity and safety tests to obtain permission, etc. for working the patented invention. The instant patent is granted permission under other Acts and subordinate statutes for executing the patented invention, but the effective ingredients of the patented invention subject to extension of the patent term are already verified, and thus it is not deemed that the patented invention takes a long period of time through activity and safety tests, etc.” (Evidence A).

(d) Relevant statutes;

1) Article 89 of the former Patent Act (amended by Act No. 11117, Dec. 2, 2011; effective March 15, 2012; hereinafter “former Patent Act”) (Extension of Term of Patent Right by Permission, etc.)

(1) Notwithstanding the provisions of Article 88 (1), where permission, registration, etc. under other Acts and subordinate statutes is required to work a patented invention, and it takes a long time due to activity, safety tests, etc. necessary for such permission, registration, etc. (hereinafter referred to as "permission, etc."), the term of the relevant patent right may be extended by up to five years for the period during which the patented invention could not have been worked.

2) Article 7 (Inventions subject to Application for Registration of Extension of Term of Patent Right pursuant to Permission, etc.) and Article 89(1) of the former Enforcement Decree of the Patent Act (amended by Presidential Decree No. 23341, Dec. 2, 2011; effective March 15, 2012; hereinafter “former Enforcement Decree of the Patent Act”) means any of the following inventions:

1. Invention of medicines subject to the item license under Article 31 (2) and (3) or 42 (1) of the Pharmaceutical Affairs Act for the purpose of embodying the patented invention;

2. Invention of agricultural chemicals or raw materials that shall be registered pursuant to Articles 8 (1), 16 (1) and 17 (1) of the Agrochemicals Control Act to work a patented invention.

3) The remaining relevant statutes, notifications, etc. are as shown in the attached Form.

[Reasons for Recognition] Uncontentious Facts, Gap evidence 1 to 7, Eul evidence 1, the purport of the whole pleadings

2. The parties' assertion

A. Summary of the grounds for revoking the Plaintiff’s trial decision

1) Even where the former Patent Act, the Enforcement Decree of the former Patent Act, and criteria for examination under Article 89 of the former Patent Act, there is no basis to exclude inventions based on the permission for the submission of materials and medicines corresponding to the instant medicine from “an invention requiring a long period of time due to activity, safety, etc. required for permission, etc.” as prescribed by Article 89 of the former Patent Act. Since a long period of time is required due to activity, safety, etc. required to obtain permission for the instant medicine

2) Before the enforcement of the amended Enforcement Decree of the Patent Act (amended by Presidential Decree No. 24491, Apr. 3, 2013; hereinafter “amended Enforcement Decree of the Patent Act”), the Korean Intellectual Property Office recognized the registration of the extension of the term of the relevant patent invention with respect to the “combined drug for ingredients other than a new substance” in the form similar to the instant pharmaceutical product (hereinafter “combined product”). Therefore, there was a reasonable expectation that the extension of the term of the relevant patent invention may be granted based on the initial license for the complex product, and this is subject to protection, so the registration of the instant extended application ought to be recognized under the principle of self-regulation of administration.

B. Defendant’s assertion

1) In light of the developments leading up to the introduction of the patent term extension system with a material patent, equity with other industries, differences in the period required to develop new drugs (new substances) and submitted medicines, and differences in the scope of submission necessary to examine safety and effectiveness of materials, etc., patent term extension shall be exceptionally recognized only for new drugs (new substances). An invention related to publicly known ingredients composite shall not constitute “an invention required for a long period of time due to tests of activation, safety, etc. necessary for permission, etc.” under Article 89 of the former Patent Act.

2) The instant pharmaceutical product was already exempt from considerable part of the submission of active and safety test data on the ground that the pharmaceutical product had already been licensed for the same ingredient in Korea. Thus, it does not constitute “an invention required for a long period of time due to activity, safety test, etc. necessary for permission, etc.” under Article 89 of the former Patent Act.

3. Determination

A. Whether the provision of Article 89(1) of the former Patent Act can be interpreted by limiting it to the new substance (new substance)

1) In full view of the statements in Gap evidence 8 to 11, Gap evidence 13 to 21, Gap evidence 25 to 32, Gap evidence 35 to 39, Eul evidence 14 and 15, the following facts are acknowledged.

① The extension of the patent term system was introduced by the amendment of the Patent Act on December 31, 1986 (Article 53(2) at the time of the introduction). Since the aforementioned system requires permission or registration under the Pharmaceutical Affairs Act, the Agrochemicals Control Act, etc. in order to practice a patented invention in the field of medicine, agricultural chemicals, etc., a problem of equity with other industries without such restriction arises, in the event of a patent for an invention of pharmaceutical products, agricultural chemicals, etc., the patent term of the patent right can be extended by up to five years for the period during which the patent was registered but it was impossible to practice the patented invention due to lack of permission, etc. under the relevant statutes.

② Article 89(1) of the former Patent Act and Article 7 of the former Enforcement Decree of the Patent Act stipulate the requirements for registration for extension of the term of a patent as “where permission is required to implement a patented invention in accordance with the Pharmaceutical Affairs Act, etc., and a long-term period is required due to an activity, safety test, etc. required for such permission, etc., and does not distinguish whether permission for new drugs is granted or whether permission for materials is granted or not. In addition, even new drugs may not require a long-term test required for permission, if domestic clinical trials are fully or partially exempted, and even in the case of a drug for which materials are submitted, the test for activation, safety, etc. is required to obtain permission according to the pharmaceutical products, and a considerable amount of materials is required to be submitted (see subparagraph 2, e.g., the provisions on marketing approval, reporting, etc. for

③ In the Korean Intellectual Property Office’s “Rules on the Operation of the System for Extension of the Term of Patent Right” (amended on August 24, 2009, the Korean Intellectual Property Office Notice No. 2009-18, hereinafter “instant Notice”), new drugs subject to extension of the term and submitted medicines are not distinguished (Article 3(3) of the Notice provides that the Defendant is aware that the extension registration is granted only to the first license as effective ingredients themselves. However, Article 3(3) of the Notice provides that “where multiple licenses or registrations exist with respect to one patent, only the first license or registration is granted.” As such, if multiple patents exist with respect to one effective ingredient, the registration of extension cannot be interpreted to the effect that only the first license is granted, and if the first license is granted in order to (a) the effective ingredients subject to extension registration application, the Defendant’s assertion that Article 3(3) of the Notice No. 3 provides that if one effective ingredient is available, the first license can only be seen as being applicable to A’s application for registration of extension.”

④ Examining the case of the Korean Intellectual Property Office’s examination on patent application for extension of patent term extension, both new drugs and submitted medicines were registered from 1999 to 2007. From 2008 to 201, an application for registration of extension of patent term extension had been combined with respect to submitted medicines. Since 2012, all of the registration of submitted medicines was rejected (No. 1) 39. Furthermore, with respect to cases where an application for registration of extension or extension of patent term extension has been filed from 2004 to 2011 based on the permission for the complex ingredients, most of the patent term extension or extension was recognized or approved (Evidence No. 8 through 11, A13 to 21, A25 to 32).

⑤ Meanwhile, Article 7 of the Enforcement Decree of the Patent Act, which was amended on April 3, 2013 (amended by the same day), limited the subject matter under Article 89(1) of the former Patent Act to “an invention of a drug (limited to a drug that has been manufactured with a new substance (referring to a substance whose chemical structure of the active part having medicinal effects is new) as an effective substance and for which a permit for items has been granted first pursuant to Article 31(2) and (3) or 42(1) of the Pharmaceutical Affairs Act to practice a patented invention,” and the said amended provision is applicable to an invention for which an application for registration of extension of the term of a patent is filed after its enforcement (Article 2 of the Addenda of the Enforcement Decree of the Patent Act), and does not apply to the instant application for extension.

2) In light of the legislative purport of the Act on the Extension of Term of Patent Right, contents of the provision, process of amendment of the Act, details of the notification, examination practice, etc., it cannot be deemed that the subject of extension of term extension can be uniformly ruled out regardless of whether a long-term test for activation, safety, etc. is required for submission of data, etc., by interpreting “an invention prescribed by Presidential Decree requiring a long-term period of time due to an activity, safety, etc. necessary for permission” under Article 89(1) of the former Patent Act as an invention of a new drug. Therefore, it is unlawful to reject the registration of term extension without examining whether a drug that is not a new drug (new substance) is required for submission of non-new drugs.

B. Whether the extension application of this case satisfies the requirements of Article 89(1) of the former Patent Act

1) Where permission under other statutes is required to work a patented invention;

A) The instant drug constitutes a drug that requires the examination of safety and effectiveness as a new product and the biological substance of specifications prescribed in Article 2 subparag. 6 of the Regulations on Product Licenses and Reports of Herb Products. In the event that the instant drug is manufactured and sold, the manufacture and marketing approval shall be obtained from the Minister of Food and Drug Safety (Article 31(2) of the Pharmaceutical Affairs Act), and data on test results, etc. of safety and effectiveness shall be submitted to obtain permission (Article 31(10) of the Pharmaceutical Affairs Act).

B) In order to practice the instant patent invention, the Plaintiff submitted test data on toxicity of the instant drug, the results of clinical trials on the second and third occasions, etc. to the Minister of Food and Drug Safety. As a result, the Plaintiff obtained marketing approval of the instant drug on March 13, 2012.

C) Therefore, the instant patent invention subject to the instant extension application constitutes “cases where permission, etc. should be obtained pursuant to Article 31(2) and (3) of the Pharmaceutical Affairs Act for implementation” as prescribed by Article 89(1) of the former Patent Act and Article 7 of the Enforcement Decree of the former Patent Act.

(ii)an invention requiring a long-term period of time due to activity, safety, etc. tests necessary for licensing.

A) The Plaintiff was registered on December 23, 2005 with respect to the instant patented invention, but obtained marketing approval for the instant patented invention only on March 13, 2012, and conducted clinical trials from December 19, 2006 to February 27, 2012 to obtain permission, and submitted data on validity and safety, including toxic data and clinical trial data. The period required by the Plaintiff for any cause attributable to the Plaintiff during the said period is 807 days.

B) As to whether the period required for active and safety tests was “the long-term period,” the instant public notice, etc. does not separately provide for the period, and on March 2012, Rule 7102 of the Patent and Utility Model Examination Guidelines issued by the Defendant, the notice, etc. stated as reference matters, stating that “If an invention is provided for in any subparagraph of Article 7 of the Enforcement Decree of the Patent Act, the permission, etc. requires a long-term period of time.” In addition, the Defendant recognized the extension registration for a patented invention relating to a drug, the patent registration period from the patent registration date to the marketing approval date is short or similar compared to the instant case as shown below.

The patent registration number date of the table included in the main text shall not be extended to Moti ton (No. 9) (registration No. 2 omitted) on February 27, 2007 on September 25, 2008, 16 May 16, 2011 (No. 13 No. 13 omitted) (registration No. 3 omitted) on October 20, 2009 on December 5, 2001 (No. 16 No. 16 of April 12, 2004) (Registration No. 949, Sept. 26, 1989) No. 979, Sep. 3, 197 (Registration No. 94, Nov. 26, 2004) on April 16, 2004

C) In full view of these circumstances, the instant patent invention constitutes a case where a long-term period of active and safety tests necessary to obtain a license for implementation of the patent invention (the Defendant did not separately assert that the period required for the instant pharmaceutical license is not “long-term”.

C. Sub-committee

Therefore, the Defendant’s refusal to file the instant patent application on the ground that the instant drug constitutes a drug subject to submission of data, despite the need for long-term testing for activation, safety, etc. necessary to obtain permission under the Pharmaceutical Affairs Act, is unlawful.

4. Conclusion

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

[Attachment] Relevant Statutes and Notice: omitted

Judges Jeong Jong-young (Presiding Judge)

1) Of the number of refusals of registration for extension of the materials provided for in the evidence No. 39, some were rejected on the ground that the same effective substance is based on the follow-up permission, such as a type permission (Evidence No. 35, 36, and 37 of the A), other parts were rejected on the ground that the patented invention and the permitted medicine are not identical (Evidence No. 38 of the A), and some decision of refusal are pending (Evidence No. 39 of the A).