Han Han Medicine Co., Ltd and three others (Patent & Patent Law Firm, et al., Counsel for the plaintiff-appellant)

2. As to the ground of appeal, the court below erred by misapprehending the legal principles on the grounds of appeal, as otherwise alleged in the ground of appeal.

February 13, 2017

1. All of the plaintiffs' claims are dismissed.

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

[2016Heo4498] The Korean Intellectual Property Trial and Appeal Board rendered a decision on May 23, 2016 on the case No. 2015Da2502 between Plaintiff 1 and Defendant shall be revoked.

[2016Heo4504] The Korean Intellectual Property Trial and Appeal Board rendered a decision on May 23, 2016 as to the case No. 2015Da2508 between Plaintiff 2 and the Defendant shall be revoked.

[2016Heo4511] The Korean Intellectual Property Trial and Appeal Board rendered a decision on May 23, 2016 on the case No. 2015DaDa2521 between Plaintiff 3 and Defendant before the taking-off of a lawsuit is revoked.

[2016Heo5620] The Korean Intellectual Property Trial and Appeal Board rendered a decision on May 23, 2016 regarding the case No. 2015Da2660 between Plaintiff 4 and the Defendant before the taking-off of the lawsuit is revoked.

1. Basic facts

(a) A patented invention subject to registration for extension of the patent term (hereinafter “instant patented invention”);

1. Name of invention: Precluorted or luminous agents using actradide brate as active ingredients;

2) The international filing date / the filing date / the application number / the registration number: November 4, 2003 / November 7, 2002 (registration number 1 omitted)/ June 23, 2010 / (patent registration number omitted)

B. Registration for the extension of a patent term (hereinafter “registration for the extension of a patent”);

1) The procedural background

A)/application number of the application for registration of an extension (hereinafter “instant application for registration of an extension”)/: March 28, 2014 (2 omitted)

B) An applicant for registration of extension: The defendant

(C) The extended period filed: 1) 382 days (the period of domestic clinical trials (from June 23, 2010, which is the date of registration of grant of a patent) after the date of registration of grant of a patent until August 10, 2010) + the period required for import marketing approval (the total of 334 days from January 31, 2013, the date of registration of grant of a patent until December 31, 2013, which is the date of application for import marketing approval)];

D) A decision to register the extension (hereinafter “decision to register the extension of this case”): January 20, 2015

(ii)the details of the extension registration;

A) Claims subject to extension: Paragraphs 1 to 10 (10) (hereinafter “the extension invention of this case”).

B) The expiration date of the term prior to the registration of extension: November 4, 2023

(C) Extension: 382 days;

(d) Contents of license or registration: No. 29 of import marketing approval of drugs.

C. Circumstances and details of the marketing approval of drugs (hereinafter “instant permission”).

1) Details of the instant permission

The Korea Youth Pharmaceutical Co., Ltd. (hereinafter referred to as the “Korea Youth Pharmaceutical Co., Ltd.”) filed an application for marketing approval of drug importation with respect to 50 milligrams (raw materials: Berabeg) of beta, the drug subject to the instant license, as follows. The details of the clinical trial and import approval are as follows. The instant license was simultaneously conducted for marketing approval and GMP evaluation of beta, 50 milligrams of beta, the complete drug, and for the Domna, the Domna, the substance of the drug, at the same time.

(2) On December 21, 2009, the date of the table publication contained in the main sentence: (a) the establishment of a patent/clinical trial (main 2), the examination of item approval (main 3)/Si examination (main 4) GMF examination (main 5) on December 21, 2009; (b) the commencement of clinical trials on August 10, 32010; and (c) the completion of clinical trials on January 31, 2013; (d) the submission of an application for the evaluation of GPM on March 20, 2013; (b) the submission of a report on the application for import approval on March 20, 13, 2013; and (c) the 3.4. Request for supplement data from DMF 1, 2013, May 29, 2013; and (d) the 3.0.3G Council (the Council) the submission of new and timely supplement data on July 24, 2013013

Note 2) Annive and genetic examination

Note 3) Time-to-time review

4) GPM assessment

Note 5) DMF Review

Note 6) Documents (as soon as possible) Review Council

Note 7) Council of Raw Materials (GMP)

2) Details, etc. of the instant permission

A) Date of the decision for item approval of import: December 31, 2013

(B) The date the import marketing approval arrives at the applicant (the date the import marketing approval certificate is issued): December 31, 2013.

(c) Contents of permission: item permission for import of medicines under Article 42 (1) of the Pharmaceutical Affairs Act;

(d) Products subject to permission: Betasiba 50 milligrams (Samigin)

(e)the use of a thing for which permission has been granted: treatment of cather, urine and/or bather symptoms that may arise from cathere patients;

(d) Trial decisions by the Intellectual Property Tribunal;

1) On April 10, 2015, Plaintiff 1 is the Intellectual Property Tribunal No. 2015Da25022, Plaintiff 2 is the Intellectual Property Tribunal No. 2015Da2508, Plaintiff 2 is the Intellectual Property Tribunal No. 2015Da2508, Plaintiff 8 before the lawsuit is initiated) 3 is the Intellectual Property Tribunal No. 2015Da2521, Plaintiff 9 before the lawsuit is initiated by the Intellectual Property Tribunal No. 2015Da260, respectively, against the Defendant, and the registration of the instant extension is invalidated pursuant to Article 134(1)3 of the Patent Act, since the extended period exceeds the period during which the patent invention could not be implemented. ② The registration of the instant extension was filed against an application for which the patentee or an exclusive licensee thereof or a non-exclusive licensee thereof has not been granted permission under the Pharmaceutical Affairs Act. Accordingly, each of the instant requests for a trial to invalidate the registration of the extension in accordance with Article 134(1)2 of the Patent Act.

2) On May 23, 2016, the Intellectual Property Tribunal rendered a ruling to dismiss each of the instant appeals on the following grounds (hereinafter “instant ruling”).

① The period required for clinical trials after the date of registration of establishment of the patent right is 48 days from June 23, 2010, which is the date of establishment of the patent right, to August 10, 2010, and the period required for marketing approval of 50 milligrams, which is the drug subject to permission, shall be 34 days from January 31, 2013, which is the date of application for marketing approval, to December 31, 2013. In order to calculate the extension of the registration of the instant case, the period required for marketing approval shall be 34 days from the above 334 days to the date of registration of the instant patent right, which is 10 days before the date of registration of the instant patent right. The period required for marketing approval of the instant case is 10 days before the date of registration of the instant patent right and 2 days from the date of registration of the instant patent right, which is 10 days before the date of registration of the instant patent right. Thus, the Ministry of Food and Drug Safety’s request for marketing and Drug Safety Act’s supplement may not be made separately.

Note 10) The Ministry of Food and Drug Safety

[Ground of recognition] Facts without dispute, Gap evidence 1 through 4, Eul evidence 2-1 through 8, Eul evidence 5, 13, 14, 20, and 24, and the purport of the whole pleadings

2. The parties' assertion

A. Summary of the plaintiffs' assertion

1) Claim as to Article 134(1)3 of the Patent Act

If an applicant for permission of a drug submits data suitable for the provisions of the Act or a drug with no risk of serious problems, it is not required to supplement the data. Thus, if a request for supplement is made by the Ministry of Food and Drug Safety during the review period of the relevant permission data, it shall be deemed due to the cause attributable to the applicant for permission. Therefore, from the date of request for supplement to the date of submission of supplement data, it constitutes the period required due to the reason attributable to the applicant for permission. However, the method of calculating the extension period adopted by the trial decision of this case is a period not exceeding the period for review of data, which does not fall under the period for review of the data. However, even though the data was not prepared for some items through strategic submission by the patentee, in which case the examination by a certain department was conducted, and the remaining insufficient data were completed, and then the examination by another department was conducted after completing the examination. In light of the fact that the period required for submission of the defective data would result in an unfair result that the period of submission would not be excluded from the period required by the patentee.

Therefore, it is reasonable to calculate the extension of the patent term of this case by one of the following methods. However, unlike the above calculation method 1 through 4, the extension registration of this case extended beyond the registration period during which an invention could not be executed by calculating the extension through a wrong method. Ultimately, the registration of this case extended should be invalidated on the ground that “the extended registration period exceeds the period during which the patented invention could not be worked,” as provided by Article 134(1)3 of the Patent Act.

A) Method of calculation 1

The extension = The period of clinical trials (1) after the date of registration of the grant of a patent + the period during which a patent could not be worked for the purpose of examination of information and oil (2) - the period (3) required for reasons attributable to the patentee for an examination of information and oil = 132 days:

A person shall be appointed.

B) Method of calculation 2

Along with the period of clinical trials after the date of registration of establishment of a patent = (1) + [The period of examination of all documents (2) by the Ministry of Food and Drug (2) - the period required” for a cause attributable to a patentee (3+4)] = 172 days per week.

A person shall be appointed.

C) Method 3

The extension = The period of clinical trials after the date of registration of establishment of the patent + [the maximum period of review - the maximum period of review for the actual period of review - the period of submission of supplementary data for the procedures of examination] + 48 days + 48 days + (2), (3), (4) 237 days + 11 days = 296 days

(2) = 10,00 = 84 days = 10,000

(3) GTPP evaluation - Period for submitting supplementary data = 183 days

(4) = DMF examination - Supplementary data submission period = 237 days.

A person shall be appointed.

D) Method of calculation 4

Any extension = A clinical trial period (calculated method 1) period after the date the patent right is registered = 1 + [the period of reviewing all documents (the period specified in the calculation method 2) - the period of request for data supplementation (the period specified in the calculation method 2) in the DMF registration examination] = 48 days + 334 days + 70 days = 312 days.

2) Claim as to Article 134(1)2 of the Patent Act

The legislative intent of Article 134(1)2 of the Patent Act is to protect a third party’s interest by publicly announcing the existence of a non-exclusive license. Thus, the registration of a non-exclusive license should be terminated at the time of application for the instant license or at the time of the instant license. However, the Korean Switzerland medicine, which is a non-exclusive licensee of the instant patented invention, should only take place on January 24, 2014, when the non-exclusive license registration was not completed at the time of application for the instant patent, and the period of a non-exclusive license was retroactively retroactive to June 23, 2010, the date of registration of the establishment of the patent right. As such, the instant registration of the extension was registered with respect to an application for which the patentee or the person who has an exclusive license or a non-exclusive license on the patent has not been granted a license pursuant to the Pharmaceutical Affairs Act. Accordingly, the instant registration of the extension exists under Article 134(1)2 of the Patent Act,

B. Summary of the defendant's assertion

1) Claim as to Article 134(1)3 of the Patent Act

A) Regarding the calculation method 1 of the plaintiffs' assertions, the plaintiffs' assertion that ① clinical trials, ② internal and genetic tests, ③ visual examinations, ④ GMP evaluation, and ⑤ DMF evaluation procedures should be conducted in order to obtain marketing approval of drugs is not reasonable. Thus, the plaintiffs' assertion that only the period of clinical trials and the period of examination for internal and external tests is "the period during which it was impossible to conduct" is not reasonable.

B) Regarding the method of calculating the Plaintiffs’ assertion 2 and 4, where a separate examination of the application, etc. for permission was conducted by another department for the period of supplementation required by any department of the Ministry of Food and Drug Safety, the period of supplementation cannot be deemed to be the period delayed due to any cause attributable to a patentee’s responsibility. Therefore, the period of supplementation cannot be deemed to be the period delayed due to a cause attributable to a patentee’s liability. Therefore, without examining whether the request for supplementation was a cause attributable to a patentee’s liability, the period of supplementation cannot be excluded from the “period during which it was impossible to implement the instant extension invention.” Newly, even if the determination of the causal relationship with the delay of permission was different, it cannot be presumed that there was a cause attributable to a patentee solely on the ground that the request for supplementation was made. Even if each review division submitted all the necessary materials, even if the request for authorization was required for further examination or even if it was actually submitted, it cannot be deemed that there was a cause attributable to a patentee’s responsibility.

C) Regarding the calculation method 3 of the plaintiffs' assertion, even if the permission period has expired because each review division did not make a temporary request for supplementation in accordance with the internal structure and procedure of the Ministry of Food and Drug Safety where an independent review is conducted, it cannot be said to be due to the reasons attributable to the patentee. Thus, the prior plaintiffs' assertion on a different premise is not reasonable.

D) Even if the period for submitting the data as alleged by the Plaintiffs were to be recognized as the period required for all the period required for the correction of the data, and further, even if the other review department of the Ministry of Food and Drug Safety of the Korea Food and Drug Safety excludes the further period from the date of completion of the clinical test of the instant drug from August 10, 2010 to January 31, 2013, the date of application for the clinical test of the instant drug, various preparatory works were conducted for the request for permission, such as progress of the test, preparation of bridge materials, preparation of eye materials, information, and preliminary re-examination, and at least one year was required to do so, this should be included in “the period during which it was impossible to implement the invention,” under Article 89 of the Patent Act. Since the said period is far more than the period claimed by the Plaintiffs that the extension should be excluded from the instant extension, it cannot be deemed that the extension of the instant drug should have been duly extended, and therefore, it cannot be deemed that there exists grounds for invalidation under Article 134(1)3 of the Patent Act.

2) Claim as to Article 134(1)2 of the Patent Act

Article 134(1)2 of the Patent Act does not limit the time of registration of a non-exclusive license, but provides for the subject of registration of the extension. The need for registration of a non-exclusive license is merely to oppose against the transferee and the exclusive licensee of the non-exclusive license. Therefore, even if the Republic of Korea Youth Products, which applied for registration of a non-exclusive license after the permission of this case, was registered as a non-exclusive licensee of the patented invention of this case, the ground for invalidation under Article 134(1)2 of the Patent Act does not constitute grounds for invalidation

3. Determination

A. Determination as to the assertion on Article 134(1)3 of the Patent Act

1) Relevant legal principles

A) Article 89(1) of the Patent Act provides, “In cases of an invention prescribed by Presidential Decree, which requires permission, registration, etc. pursuant to other Acts and subordinate statutes to practice a patented invention, and which requires a long period of time due to an examination of validity, safety, etc. necessary for such permission, registration, etc. (hereinafter “permission, etc.”), notwithstanding Article 88(1), the term of the patent right may be extended only once by up to five years for the period during which the invention could not be worked,” and Article 88(2) of the Patent Act provides, “in applying paragraph (1), the period required by the person who has obtained the permission, etc. for any reason for which the patent is responsible shall not be included in “unworking period” under paragraph (1). Meanwhile, Article 91 of the Patent Act provides, “Where the period of application for extension does not exceed the period recognized pursuant to Article 89” under subparagraph 3 of the Patent Act.

As above, the extension of the term of a patent created by the Patent Act is a system that extends the term of a patent for an invention that requires permission, etc. prescribed by the statutes to practice a patented invention within the term of a patent and that requires considerable period of time to undergo necessary tests or permissions within the scope of five years. In the case of an invention of a drug, pesticide, etc., permission, registration, etc. (hereinafter “permission, etc.”) by the regulatory authority pursuant to the Pharmaceutical Affairs Act or the Agrochemicals Control Act, etc. aiming at securing safety and effectiveness of the invention, and requires a long period of time to undergo necessary tests, examinations, etc. for such purpose. In such a case, even if the patent continues to exist, a patentee would suffer disadvantages in executing a patented invention without executing the patented invention and receiving benefits from the monopoly of the right to the patent during the said period so that the patentee would not be able to practice the patented invention for an extended period of up to 3 years after the expiration of the term of a patent right, and thus, would lose equity in comparison with the patent right in other industrial areas. Accordingly, Article 89(1) of the Patent Act can be implemented for the expiration of the term of the term.

B) Meanwhile, Article 34(1) of the former Pharmaceutical Affairs Act (amended by Act No. 10788, Jun. 7, 201) provides that a person who intends to conduct clinical trials of drugs, etc. shall prepare a clinical trial plan and obtain approval from the Commissioner of the Korea Food and Drug Administration. Articles 31 and 32 of the former Enforcement Rule of the Pharmaceutical Affairs Act (amended by Ordinance of the Ministry of Health and Welfare No. 52, May 6, 201; hereinafter the same shall apply) provide for the details of clinical trial plans, standards for the implementation of clinical trials. Article 9 subparag. 6 of the former Rules on the Safety of Drugs, Etc. (amended by Ordinance of the Prime Minister No. 1081, May 9, 2014) provides that an applicant who has no capacity to practice the patented invention for a period of time until the date of permission or sales, etc. for which the patentee has no capacity to submit to the applicant for approval of drugs, etc., shall not extend the duration of the patented invention for specific reasons such as general and abstract acts.

2) Determination of the plaintiffs' assertion on the grounds of illegality of the trial decision of this case

A) In light of the background of the instant permission, etc., the period during which it was impossible to implement the instant extended invention shall be calculated based on the period from June 23, 2010, which was the date of registration of the establishment of the patent right, to August 10, 2010, and the period from January 31, 2013, which is the date of submission of the instant application for permission, to December 31, 2013, which is the date of submission of the instant application for permission, from January 31, 2013, which is the date of submission of the instant application for permission, to December 31, 2013, which is the date of receipt of the instant decision to grant permission. Accordingly,

B) First, we examine the Plaintiffs’ assertion regarding “calculated method 1”.

The plaintiffs' assertion 1 is based on the premise that "the period during which it was impossible to conduct" under Article 89 of the Patent Act refers to the period of clinical trials which takes a long time to assess the safety and effectiveness of drugs as stated in the text of Article 89 of the Patent Act and the period required to review the administration of submitted clinical trial data, such as ① the period required for clinical trials after the date of registration of establishment of the patent right, ② the period excluding the period required for clinical trials after the date of registration of establishment of the patent right and the period required for the reasons attributable to the patentee, etc.

In order to obtain marketing approval for import of drugs, pursuant to Articles 31(2), 34(1), and 42(1) of the former Pharmaceutical Affairs Act and Articles 4(1) and 9 of the former Rules on the Safety of Drugs, Etc. (amended by Act No. 13114, Jan. 28, 2015; hereinafter the same) (i) clinical trials, (ii) internal and genetic testing, (iii) internal and Si tests, (iv) GM evaluation, and (v) DMF examination procedures shall be conducted only through the period prescribed by Presidential Decree. Thus, the period required for internal and genetic testing, time limit, GMP evaluation, and DMF evaluation in the instant permission process may be considered to be based on the calculation of the period during which the patented invention could not be implemented. Meanwhile, Article 89(1) of the Patent Act provides that “the period of clinical trials cannot be limited to the period prescribed by Presidential Decree for which the patented invention could not be implemented only due to an example of validity and safety, etc.”

Therefore, the above assertion that it is unlawful to calculate the period of time during which the instant extension invention could not be implemented, including the period of clinical trial, the period of review, the period of evaluation, and the period of examination for DMF, as well as the period of time for clinical trial, that is, the instant trial decision is illegal on a different premise.

C) Next, we examine the Plaintiffs’ assertion regarding “calculated method 2”.

The calculation method 2 of the Plaintiffs’ assertion is a summary of the following premise: (a) the period that is excluded from the irrecoverable period of patent invention is limited to “requirements” regardless of whether it is delayed due to a cause attributable to the patentee; and (b) the period that is excluded from the irrecoverable period of patent invention should be excluded from the period during which patent invention could not be implemented, regardless of whether other departments have been examined during the period of supplementation at the request of the Review Department.

As seen earlier, the period during which a patent holder could not implement the instant extension invention should be excluded from the period during which a proximate causal relation is recognized between the grounds for patent holders’ responsibility and the delay in permission, etc. However, the examination division on permission for drugs in the Ministry of Food and Drug Safety takes charge of each department, and each examination on the submitted data is carried out independently by each department in charge within the Ministry of Food and Drug Safety, barring special circumstances, even if the examination of the department is suspended due to the request for supplementation by a certain department, the other department continues to proceed with the examination. Even if the supplementation is required due to the request for supplementation by a certain department, if the other department is under way, it cannot be deemed that the permission has been delayed due to the causes for which another department is under way, such as patent holders, etc., and thus, it is reasonable to deem that the overlapping period cannot be excluded from the period during which the extension of the instant invention cannot be implemented.

Therefore, in calculating the period during which the extension invention of this case could not be implemented, the trial decision of this case which held that the period that overlaps with the period of review conducted by another review department in accordance with a request for supplementation by a certain review department does not constitute the period delayed due to a cause attributable to the patentee does not constitute the period delayed.

D) Next, we examine the Plaintiffs’ assertion regarding “calculated method 3”.

The method of calculating the plaintiffs' assertion 3 is on the premise that the calculation of the period required due to the causes attributable to the patentee depending on the overlap of the period for correction varies depending on the premise that it is unreasonable to determine the calculation of the period required due to the causes attributable to the patentee, and it is a summary that it is necessary to determine the period for which the patented invention can not be implemented by excluding the correction period required due to the correction of the examination department from the maximum examination period without considering the overlap

In determining "the period required for a patentee due to a reason attributable to a patentee" under Article 89 (2) of the Patent Act, the determination of "the period required for a patentee" should be made by neglecting the duty of care to the extent generally required by social norms under the circumstances such as the review, permission procedure, structure, etc. of the Ministry of Food and Drug Safety. However, the above calculation method 3 is merely a method of calculating the period delayed due to a reason attributable to a patentee, instead of an abnormal examination and permission process in the process of internal review and permission process of the Ministry of Food and Drug Safety. In other words, each examination division in the Ministry of Food and Drug Safety may conduct an independent examination of the application documents for permission and make a request for supplementation individually by each department. Thus, even if the patentee, etc. is not at the same time due to a reason different from each other, if the patentee, etc. is not at the same time responsible for delivery of supplementary materials, it is not reasonable to deem that the period is beyond the internal scope of the patent owner's responsibility.

Meanwhile, the Plaintiffs asserts to the effect that it is unreasonable to recognize the period for supplementation as the extension of the period for supplementation on the grounds that the examination of other examination items is being carried out even if the applicant has submitted a strategic application before the materials necessary for the examination are fully prepared. However, under the former Pharmaceutical Affairs Act related statutes at the time of the application for permission, etc. of this case, the request for examination, examination and examination of safe and milk may be filed simultaneously with the application for permission for import of drugs or the request for prior examination independently before the application for permission for import of drugs was made (see Article 24(1)1 and 2 of the former Enforcement Rule of the Pharmaceutical Affairs Act, etc.). In particular, in light of the following: (a) the applicant may submit a notice of the result of examination at the time of the application for permission for import of drugs (see, e.g., Article 24(1)1 and 2 of the former Enforcement Rule of the Pharmaceutical Affairs Act) by undergoing a prior examination so that the applicant can be processed more promptly in the pharmaceutical license phase only if all materials were fully prepared; and (b) it is difficult to find that the aforementioned procedure for delay and delay.

Therefore, under the actual circumstances such as the procedure and structure of the Korea Food and Drug Safety Act, the trial decision of this case, which calculated the period delayed due to the patentee's causes attributable to the patentee, shall not be deemed to have any error as alleged above by the plaintiffs.

E) Next, we examine the Plaintiffs’ assertion regarding “calculated method 4”.

The calculation method of the plaintiffs' assertion 4 is that when the raw materials of the complete drug applied for approval of manufacture, sale, or import of the drug are subject to registration of DMF, it must be registered as DMF before the completion date of the manufacture, sale, or import approval of the relevant drug. The complete drug license can not be completed unless DMF is registered without relation to the completion of the examination, time examination, or GMP evaluation. Thus, during DMF registration period, the period for supplementation of DMF registration falls under "the period used for a cause attributable to a patentee, etc." regardless of whether the application period for approval of complete drug items is supplemented by the Ministry of Food and Drug Safety. As a result, in the examination of DMF as to the registration of the drug at the time of the instant permission, the period from March 20, 2013 when a request for data supplementation was made to the date of submission of supplementary materials should be excluded from the period required by a patentee, and thus, the invention in this case may not be extended from the period required by the patentee.

As seen earlier, the instant license is divided into: (a) the marketing approval and the GMP evaluation for 50 milligrams 50 milligrams, which is a complete medicine; and (b) the DMF evaluation for the Mesium, which is an ingredient for the import approval of drugs; (c) not only the DMF examination procedures for raw materials but also the Mesium examination; and (d) the GMF evaluation should be passed in order to obtain marketing approval of drugs; and (e) the Mesium examination is divided into the examination of documents on the quality of raw materials (c) and the examination of documents on the manufacturing facilities of raw materials that are conducted from the pharmaceutical standards and the quality of drugs, and the fact-finding examination of the materials that are conducted from the pharmaceutical quality. Even if the Mesium’s request for supplementation was made and the submission of supplementary materials was suspended, it is difficult to see that there was a reasonable causal relation between the Plaintiff’s request for authorization and the Mesium examination or the examination division for import approval for another reason, such as delay in submitting supplementary materials for the period of time from 201 March 29, 201.

F) As to this, the Plaintiffs responded to July 3, 2013 as of the time of the instant permission, the results of the examination of the flag or Si from the time of the instant permission were sent to July 3, 2013, and the results of the examination and the results of the examination of the safety and oil related to the item approval were all respondeded on July 4, 2013, and this part of the examination was completed thereafter, and thereafter, on July 25, 2013, the Plaintiffs asserted that the period of suspension of the examination falls under the period used for any cause, such as a patentee, etc., inasmuch as the request for the supplementation of data from the GPM Review Department and the request for the supplementation of data from the DMF review overlap, which led to the submission of the relevant supplementary data from around that time to December 12, 2013, even if the Ministry of Food and Drug issued an order to submit the supplementary data by October 7, 2013 at the time of the instant permission, it is clear that the patentee is responsible for at least the period.

According to the statements in Eul evidence 2-7 and 8, the Ministry of Food and Drug Safety issued an order to submit GMP supplementary data to the Korea Youth Products on July 25, 2013 by October 7, 2013, and the Korea Youth Products submitted GMP supplementary data to the Ministry of Food and Drug around December 12, 2013.

However, evidence No. 6 contains some of the statements that were presented as supplementary data related to GDPR from July 25, 2013 among the DNAF examinations, and on December 12, 2013. However, in light of the records No. 13 and the results of inquiry into the Korea Food and Drug Safety Evaluation Institute of Food and Drug Safety at this court (the response of February 1, 2017), the Ministry of Food and Drug Safety at the time of the instant permission was submitted, and it is difficult to accept the request for supplement data from 30 milligrams 50 milligrams at the time of the instant request for supplement data from 200 milligrams 50 milligrams at the time of the instant request for supplement data from the 20th examination department (the Council for Review on Raw Materials No. 137, May 29, 2013). Accordingly, it is difficult to accept the request for supplement data from 20.3G 3G 201 to 3G 2013.3G 2013.

Meanwhile, the proviso of Article 55(3) of the Regulations on the Examination of Report of Drug Approval (amended by the Ministry of Food and Drug Safety Notice No. 2013-238, Nov. 25, 2013; hereinafter the same) provides that “where a civil petitioner requested the extension of the period for supplementation on the ground that he/she cannot supplement it within the period for which supplementation is requested, the period for supplementation shall be determined taking into consideration the request.” According to the result of the inquiry into the Korea Food and Drug Safety Evaluation Institute of Food and Drug Safety with the Ministry of Food and Drug Safety at the time of the instant permission (the reply of November 29, 2016), the drug quality and the pharmaceutical quality of the Korea Youth Evaluation Institute at the time of the instant permission is recognized as having been extended the period for supplementation in accordance with the order to submit the above GMP data by January 10, 2014, it is difficult to view that the submission of the materials was within the period for submission, not the initial data for 1 month prior to the 120th of December 13, 2012013.

In full view of the above all the circumstances, it is reasonable to view that the examination of other review departments, including DMF registration review departments, have continued to have been conducted after July 4, 2013 when the permission of this case was sent with the result of the internal and genetic examination related to the item permission of imported goods at the time of permission of this case.

However, according to subparagraph 2-7 and 8, the Ministry of Food and Drug Safety’s 2-M review department’s 2-M review department’s 2-M review and revision of the 1-M review department’s 2-M review and revision of the 1-M review and 3-M review department’s 2-M review and revision of the 1-M review and 3-M review department’s 2-M review and revision of the 1-M review and notification of the 3-M review and revision of the 1-M review department’s 2-M review and revision of the 1-M review and notification of the 3-M review and revision of the 1-M review department’s 2-M review and revision of the 1-M review and notification of the 1-M review and revision of the 3-M review department’s 2-M review and revision of the 1-M review and notification of the 3-M review and revision of the 1-M review department’s 2-M review and notification of each of the 3-M review.

Therefore, the period from July 25, 2013 to December 12, 2013, which is the date of request for the supplementation of the data from the GMP evaluation department, cannot be deemed as the delayed period of permission due to the reasons attributable to the patentee, etc.

3) Whether the extension of the instant case was lawful

A) As seen earlier, unlike the instant trial decision, the “date of conference” of each of the examination departments in the Ministry of Food and Drug Safety was confirmed. However, the “date of conference” refers to the date on which a result of examination was examined by each department of the Pharmaceutical Affairs and Drug Examination Department and the date on which a result of examination was sent to the Pharmaceutical Examination Division. Around that time, the examination by each department of the Pharmaceutical Examination Department was completed. As such, the extension of the period is determined on the basis of the foregoing.

B) In this case, the starting date of the clinical trial ( December 21, 2009) constitutes “the date the patentee, etc. started the test of validity, stability, etc. necessary to obtain permission, etc. under the Pharmaceutical Affairs Act,” but the patent registration date ( June 23, 2010) is later than this, so the period during which it is impossible to conduct the extended invention of this case is 48 days from June 23, 2010 to August 10, 2010, which is the period required for the clinical trial after the registration date of establishment of the patent right, and from January 31, 2013 to December 31, 2013, which is the date when the application of this case was submitted, the period should be calculated based on “the period required for the patent right holder’s liability for the reasons excluded from each of the above periods.” Thus, the review is conducted as to “the period required for the extension invention of this case.”

First of all, the period of review conducted by each department within the Ministry of Food and Drug Safety is from March 20, 2013 to May 29, 2013, which is the date on which the request for data supplementation concerning DMF was made (hereinafter “period 1”) and from July 25, 2013 to December 12, 2013, which is the date on which the request for data supplementation was made, from March 20, 2013 (hereinafter “period 2”).

However, since the examination of the GMP evaluation department was continued during the "period 1", the period for supplementation cannot be deemed as a delayed period due to the patentee's liability, and there is no proximate causal relationship between the causes attributable to the patentee, etc. and the delay in permission, etc.

In addition, since the Council's credit for the DMF registration review was made on December 4, 2013, it is deemed that the DMF registration review division was conducted from July 25, 2013 to December 3, 2013 among the "period 2", and therefore, the aforementioned period cannot be deemed the delayed period due to a patentee's responsible cause, and thus, there is no proximate causal relation between the patentee's cause and delay in permission, etc.: Provided, That it may be deemed that the GMF assessment division's review was suspended during the period from December 4, 2013 to December 12, 2013. However, as seen earlier, it is reasonable to deem that there was an examination of marketing approval and registration of DMF with the pharmaceutical examination division during the above period, and therefore, it is not recognized that proximate causal relation between the aforementioned period and the period of permission, etc. is not acknowledged.

C) Therefore, the extension invention of this case should not be excluded from the period during which it was impossible to execute the patent invention of this case. Thus, it is lawful to calculate 382 days including 48 days, which were the period required for clinical trials after the date of registration of the establishment of the patent right, and 334 days, which were the period required for marketing approval of import of the beta Satong, 50 milligrams, which is the drug subject to the permission of this case, as the period during which the extension invention of this case was not conducted.

4) Sub-committee

Therefore, the trial decision of this case, which held that the registration of this case cannot be deemed to have a ground for invalidation under Article 134 (1) 3 of the Patent Act, cannot be deemed to have been unlawful as alleged by the plaintiffs, and since the extension of the registration of this case does not exceed the period during which the invention of this case could not be implemented, there is no ground for invalidation under Article 134 (1) 3 of the Patent Act in the registration of this case without further determination as to the remaining arguments of the defendant.

B. Determination as to the assertion on Article 134(1)2 of the Patent Act

1) Relevant legal principles

Article 134(1) of the Patent Act provides that "an interested party or examiner may file a petition for trial to invalidate the registration of extension of a patent under Article 92 where the registration of extension of the patent right falls under any of the following subparagraphs." Article 134(2) provides that "Where the registration of extension has been granted to a patentee or an exclusive licensee of the patent right or a non-exclusive licensee of the patent right without obtaining permission, etc. under Article 89." Meanwhile, Article 90(1) of the Patent Act provides that "the grounds for extension prescribed by Ordinance of the Ministry of Trade, Industry and Energy (which can be accompanied by materials proving such grounds)" in subparagraph 6 of Article 134 provides that "the applicant for registration of extension may amend the matters under paragraph (1) 3 through 6 (excluding the patent number of the patent right subject to extension among the matters entered in the written application for registration of extension before the Commissioner of the Korean Intellectual Property Office issues a certified copy of the registration of extension, and Article 53(1) or 6 of the Enforcement Rule of the Patent Act provides that "the patentee or non-exclusive licensee is registered under Article 13(1)."

As seen earlier, the Patent Act covers the extension of a patented invention only during the period during which a patentee, etc. could not work the patented invention although he/she had the intent and ability to do so. Thus, if an application for permission, etc. under the Pharmaceutical Affairs Act, etc. after the date of registration of the patent is filed after the date of registration of the patent, an application for permission, etc. shall be made by a patentee or an exclusive or non-exclusive licensee who is legally capable of working the patented invention on behalf of the patentee or an exclusive or non-exclusive licensee. However, unlike the exclusive license, a non-exclusive license, unlike the exclusive license, arises merely from the express or implied agreement with the licensee and does not need to be in a special form. The registration of a non-exclusive license is merely a requisite for setting up against a third party (see Articles 102(1) and 118(3) of the Patent Act). Thus, in order for a non-exclusive licensee to fall under the non-exclusive license, a non-exclusive licensee must complete the registration of a non-exclusive license and submit a certified copy of the application to obtain registration of the extension.

Therefore, Article 134(1)2 of the Patent Act provides for the grounds for invalidation of a provisional registration under Article 134(1)2 of the Patent Act and the provision that “where a registered non-exclusive licensee has registered an extension of a patent right with respect to an application for which no permission, etc. has been obtained under Article 89, the scope of a person, other than a patentee or exclusive licensee, shall be included in the non-exclusive licensee. However, in light of the essential contents in the application for registration of extension of a patent right and evidentiary materials, if the registration of a non-exclusive license has been registered with omission, it shall be interpreted that the registration should be invalidated because the non-exclusive licensee, who applied for the permission, etc., should complete the registration of a non-exclusive license from the time of application.

2) Determination

(5) Comprehensively taking account of the overall purport of the arguments stated in Gap evidence 2, 3, and Eul evidence 2-1, 4, and 19, 25 through 32, the defendant filed a report on the completion of clinical trials with the Korea Food and Drug Administration from December 21, 2009 to August 10, 2010.

According to the above facts, the Republic of Korea Youth medicine was in the position of non-exclusive licensee who is legally able to practice the patented invention of this case at the time of the application for marketing approval of the drug of this case, and it shall be deemed that the above non-exclusive license registration and the submission of evidentiary materials related thereto was completed before the patent examiner's certified copy of the decision on the extension registration of this case was delivered by the Korean Intellectual Property Office. Thus, the registration of the extension of this case cannot be deemed as the grounds for invalidation under Article 134

3) Sub-decisions

Therefore, the trial decision of this case, which held that the registration of this case cannot be deemed as having a ground for invalidation under Article 134 (1) 2 of the Patent Act, cannot be seen as having been erroneous as alleged by the plaintiffs.

4. Conclusion

Therefore, the plaintiffs' claims seeking the revocation of the trial decision of this case are without merit, and all of them are dismissed. It is so decided as per Disposition.

Judges Lee Dae-Gyeong (Presiding Judge)

1) Article 6(1)6 main text of the former Regulations on the Operation of the Extension System of the Term of Patent Right (amended by the Notice of the Korean Intellectual Property Office No. 2015-19, Aug. 21, 2015) (amended by the Notice of the Korean Intellectual Property Office No. 2015-19, Apr. 6, 2015) provides that “the period for filing an application for extension shall be the same as “○○○” when the period calculated

Note 2) The examination of safety and effectiveness is to examine safety and effectiveness, such as toxicity, pharmacological action, etc., as a result of the clinical test on a drug subject to a license.

3) Examination of the standards and testing methods for pharmaceutical products shall be conducted to examine whether the criteria for the manufacture and quality control of pharmaceutical products [e.g., sex, net level, content, quantitative method, special test (fire extinguishing force, micro-organism test), etc.] and specific testing methods for confirmation thereof are determined; hereinafter referred to as “time examination”).

4) The standards for manufacturing and quality control of pharmaceutical products and quality control refer to the standards to be observed throughout the production process from the purchase of raw materials, including the structure and equipment of the factory, to the manufacturing, packing, and shipment, in order to manufacture excellent pharmaceutical products, the quality of which is guaranteed. The evaluation of the standards for manufacturing and quality control of pharmaceutical products is to evaluate whether such standards are satisfied; hereinafter referred to as “GM evaluation”).

Note 5) Raw material information means the information on a drug, namely, the facility details of the relevant raw material factory for a drug, indistincts, residual organic solvents, process management, packaging materials, stability testing materials, etc. A raw material information review is an assessment of the foregoing matters; hereinafter referred to as “DMF review”).

Note 6) The “DMF review” is divided into ① document review on the quality of raw materials carried out in accordance with pharmaceutical standards and ② document review and fact-finding survey on the quality of drugs and on the manufacturing facilities of raw materials carried out in accordance with pharmaceutical standards. The “DMF review” means the conference on ①.

Note 7) “The Council on Raw Materials (GMP)” refers to each Note 6) 2.

Note 8) At the time of the request for the above trial, the name of the company was “YIS (corporation registration number 1 omitted),” but on May 3, 2016, the company changed its trade name to “YIS Global,” and the company division was newly established through corporate division under the Commercial Act, and the said new company succeeded to all the rights and obligations relating to the pharmaceutical sector including the instant lawsuit.

9) At the time of the above request for a trial, the name of the company was “Japan Pharmaceutical Co., Ltd. (corporation registration number 3 omitted),” but on August 1, 2016, the trade name was changed to “ Il Dongdong Holdings Stock Co., Ltd.” and the company was newly established through corporate division under the Commercial Act as the newly incorporated company under the Commercial Act, and the “ Il Dongdong Pharmaceutical Co., Ltd. (corporate registration number 4 omitted)” and “ Il Dongdong Pharmaceutical Co., Ltd. (corporate registration number 4 omitted)” succeeded to all the rights and duties of the pharmaceutical sector, including the instant lawsuit.

10) As examined below, the organization at the time of reporting the completion of clinical trials related to the permission of this case was “Korea Food and Drug Safety Agency,” but the Korea Food and Drug Administration was abolished on March 23, 2013 following structural reform, and the Ministry of Food and Drug Safety was established. The Ministry of Food and Drug Safety established on March 23, 2013.

Note 11) The calculation method 1 through 3 is the plaintiff 1 through 3's assertion, and the calculation method 4 is the plaintiff 4's assertion, but it is judged by the plaintiffs' assertion. The specific arguments of each calculation method are to be followed by the final arranged contents, and the calculation method 1 and 2 are to be followed by the pleading data of the plaintiff 1 through 3's attorney on December 19, 2016 (it was stated as a preparatory document at the second pleading date). The calculation method 3 is to be followed by the pleading data of the plaintiff 1 through 3's attorney on February 13, 2017 (it was stated as a preparatory document from the fourth pleading date), and the calculation method 4 is to be arranged by the contents of the preparatory document of the plaintiff 4's attorney on February 10, 2017.

Note 12) The purport is that the period of examination for all items shall be included in the period during which it is impossible to practice the patented invention, but the whole of the period of examination for other departments shall be excluded from the “requirements” period due to the reasons attributable to the patentee, regardless of whether the examination for other departments has been conducted during the period

Note 13) The purport is that it is sufficient to complete each examination and obtain product licenses if the date of the actual review is the maximum of the review period.

14) According to the evidence No. 2-4, the date of approval for the clinical trial plan of the instant drug is October 13, 2009; the date of commencement of the clinical trial is December 21, 2009; and the date of completion of the clinical trial is August 10, 2010. As such, in relation to the approval for the clinical trial plan of the instant drug, Article 34 of the former Pharmaceutical Affairs Act (amended by Act No. 10788, Jun. 7, 201); Articles 31 and 32 of the former Enforcement Rule of the Pharmaceutical Affairs Act (amended by Ordinance of the Ministry of Health and Welfare, May 6, 201) shall apply.

15) Article 24 of the former Enforcement Rule of the Pharmaceutical Affairs related to marketing approval of drugs was wholly amended by Ordinance of the Ministry of Health and Welfare on March 23, 2013. Article 24 of the former Enforcement Rule of the Pharmaceutical Affairs (amended by Ordinance of the Ministry of Health and Welfare No. 188) was completely deleted. The "Rules on Safety of Drugs, etc.", which is the Ordinance of the Prime Minister on the same day, was enacted and implemented, and the provisions of Article 4

16) The filing date of an application for marketing approval of the instant drug is January 31, 2013. Since the date of the decision on marketing approval of the instant drug is December 31, 2013, Article 42 of the former Pharmaceutical Affairs Act (amended by Act No. 13114, Jan. 28, 2015) is applicable with respect to marketing approval of the instant drug.

Note 17) As seen below b. 2, in this case, the Republic of Korea has applied for marketing approval of drugs as of January 31, 2013 after first applied for marketing approval of drugs subject to the instant license as non-exclusive licensee of the instant patent invention, as of the date of the application for marketing approval of drugs as of January 31, 2013. Accordingly, the examination process was conducted concurrently (after each of the above pre-examination was withdrawn).

The Food and Drug Safety Agency was abolished on March 23, 2013 pursuant to Article 2 of the Addenda to the Organization of the Ministry of Food and Drug Administration and its affiliated agencies, which was enacted by Presidential Decree No. 24458 on March 23, 2013, and “Korea Food and Drug Safety Agency” was established by the Ministry of Food and Drug Safety. Accordingly, the name of the organization at the time of reporting the completion of the clinical trial was