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Main Issues
In a case where: (a) Company A, the patentee of the patent invention “N-to-bed 2-Siminlidine,” entered into a non-exclusive license agreement with Company B on the patent invention; (b) Company B, after obtaining import marketing approval on the pharmaceutical product to practice the patented invention; and (c) Company C, etc. filed an application for registration of extension against Company A pursuant to Article 134(1)3 of the former Patent Act; and (d) Company C, etc. filed an application for registration of extension pursuant to Article 134(1)3 of the former Patent Act; and (c) Company C, etc. filed an application for registration of extension against Company A; and (d) the Patent Tribunal’s “the period from the date following the clinical trial to the date following the date the date the declaration of imported pharmaceutical product was submitted” and “the period from the date the application for registration of completion of the raw material substance declaration and the date the request for examination of safety and effectiveness was submitted” due to a cause attributable to the patentee; and (d) the entire decision of revocation of the application should be revoked.
Summary of Judgment
A foreign company, the patentee of the patent invention “N-to-bed 2-Siminlidine,” entered into a non-exclusive license agreement with Eul corporation. After obtaining import marketing approval for a drug to practice a patented invention, Eul corporation filed an application for registration of extension of the term of a patent with regard to “the period excluding the preparation period for supplemental data during the period from the date of registration of the establishment of the patent right to the date of import marketing approval.” C corporation, etc. filed an application for registration of extension against Gap corporation pursuant to Article 134(1)3 of the former Patent Act (amended by Act No. 11117, Dec. 2, 2011; hereinafter the same shall apply) and “the period from the date following the date of clinical trial to the date of submission of the report of raw materials” (hereinafter “period 1”) and “the period from the date of issuance of the report of completion of a raw materials to the date of submission of the application for import approval and the request for examination of safety and effectiveness” (hereinafter “period 2”).
In the case of period 1, Eul company cannot be deemed to have neglected its duty of care to the extent generally required by social norms and thus, proximate causal relation between the time for submission of a report and the delay in permission even if it was submitted one day prior to the submission of a report, and foreign clinical trials are included in the "activity, safety test, etc. necessary for permission, etc." under Article 89 of the former Patent Act. Since foreign clinical trials conducted one year during the period are deemed to be necessary for obtaining marketing approval, the determination of this part of the trial decision is unlawful, and it is reasonable to determine that the period 1 is not the period required due to the reasons attributable to the patent company Gap, which is the patentee, and that the decision should be submitted for safety and effectiveness review and marketing approval, until the "act and clinical trial data" and the "act of manufacturing and marketing permission" are met, and it is reasonable to acknowledge proximate causal relation between the period required for the patent company Gap and the reasons attributable to the patent company Gap, which is the patentee, and thus, it is reasonable to seek revocation of the registration of the entire extension.
[Reference Provisions]
Articles 89 (see current Article 89(1) and 91(1)3 (see current Article 91(2) and (2) (see current Article 89(2)), 134(1)3 and (3) (see current Article 134(4)), 26(6) (see current Article 31(10) of the former Patent Act (wholly amended by Act No. 1117, Dec. 2, 201); 34(1) and (4) (see current Article 42(5) of the former Pharmaceutical Affairs Act (wholly amended by Act No. 8365, Apr. 11, 2007); 4(1) and (5) of the former Pharmaceutical Affairs Act (wholly amended by Act No. 11117, Dec. 2, 2011); 42(5) of the former Enforcement Rule of the Pharmaceutical Affairs Act (wholly amended by Ordinance of the Ministry of Health and Welfare No. 42(1)4(1) and (2) of the former Pharmaceutical Affairs).
Plaintiff
Noartis AG (Attorneys Kim Jong-seok et al., Counsel for the defendant-appellant)
Defendant
Ansan Pharmaceutical Co., Ltd. and one other (Law Firm Hawon, Attorneys Woo-type et al., Counsel for the plaintiff-appellant)
September 15, 2020
Text
1. The decision made by the Intellectual Property Tribunal on February 28, 2019 on the case No. 2256, February 2017, 2017, or 2257, shall be revoked.
2. Of the litigation costs, 30% is borne by the Plaintiff, and the remainder is borne by the Defendants, respectively.
The text of paragraph (1) is as follows.
Reasons
1. Basic facts
(a) A patented invention subject to registration for extension of the patent term (hereinafter “instant patented invention”);
(i) Name of the invention: N-Transfered 2-Sinominlidine
2) Date of international filing/priority claim/registration date/registration number: Date of registration/registration number: December 9, 1999/ 19.0/ August 11, 2005 (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) The date of application for registration of an extension (hereinafter “application for registration of an extension”)/application number: March 26, 2008 (application number omitted)
B) An applicant for registration of an extension: The plaintiff
(c) the extended period applied: February 23.
D)Decision to register an extension: July 14, 2008
(ii)the details of the extension registration;
A) Claims to be extended: Paragraphs 2, 4, 7 and 8;
B) The expiration date of the term prior to the registration of extension: December 9, 2019
(c) Extension: February 23, 200
(d) Contents of permission or registration: item 165 of item permission for import of drugs;
C. Import marketing approval of drugs (hereinafter “instant permission”).
1) Details of the instant permission
A) The Plaintiff, the right holder of the instant patent invention, entered into a non-exclusive license contract on the instant patent invention with the Korea Labor-Management Business Corporation (hereinafter “Korea Labor-Management Business Corporation,” “applicant,” and “permission authority”), and the Korea Labor-Management Business registered the non-exclusive license on February 26, 2008.
B) The Korea Labor Standards Commission applied for marketing approval of drugs (name 1 omitted (raw materials: hereinafter “the instant drug”) (hereinafter “the instant drug”), and obtained the instant license from the Commissioner of the Korea Food and Drug Administration on December 28, 2007, after conducting clinical trials on the instant drug, as seen below, as seen in the table: (a) the criteria and method of testing; (b) the safety and effectiveness of the instant drug; and (c) the Dogggggggggin’s drug information (Dru Fil, DMF).
On January 15, 2005, approval of a clinical trial plan was granted on January 15, 2005; on January 6, 2006, the establishment of the patent right is registered; on January 11, 2006, one (132 days) the examination of drug information (DMF) for drug items during the period of clinical trials; on May 19, 2006, the submission of a written request for review on October 28, 2006 (87 days) the submission of a written request for review on October 17, 2006 (52 days); and on January 26, 2007, the issuance of a written request for review of drug items; on January 26, 2007 (207. 87. 207. 8. 15. 206. 207. 8. 207. 15. 2007. 16. 2007. 27. 27. 15. 27. 20. 27. 27. 200. 25. 27. 27. 1. 20. 20. 8.
Note 4)
C) As to the patented invention of this case, from August 11, 2005, which was the date of patent establishment registration, from April 18, 2007, to December 28, 2007, the Korea Workers' Credit Union requested the Commissioner of the Korea Food and Drug Administration to supplement data on the request for examination of the flag/City from November 18, 2006 to January 8, 2007, which was the date before the date of submission of supplementary data, from November 30, 2007, from October 30, 2007, which was the date of submission of supplementary data from October 30, 2007, which was 2 days after the date of submission of supplementary data, from October 31, 2007 to October 31, 2007, which was the date of submission of supplementary data, the extension registration of this case was completed.
2) Details, etc. of the instant permission
A) The date the import marketing approval certificate is issued: December 28, 2007
(b) Contents of permission: item permission for import of medicines under Article 42 (1) of the Pharmaceutical Affairs Act;
(c) Products subject to a license: (Name 1 omitted)(B)(B)(B)(B)(B)(B)(B)(
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(d) the relevant provisions;
1) The former Patent Act (amended by Act No. 11117, Dec. 2, 2011; hereinafter the same)
(2) Notwithstanding Article 88 (1), where an applicant for registration of an extension of the term of a patent has failed to obtain permission, etc. under Article 89, the term of the patent may be extended by up to five years, to the period during which the application cannot be made, if the application falls under any of the following subparagraphs. (1) An examiner shall make a decision to refuse the registration of an extension of the term of the patent; 2. Where it is not deemed necessary to obtain the permission, etc. under Article 89; 3. Where the working of the patent right or an exclusive or non-exclusive license holder has failed to obtain the permission, etc. under Article 89; 4. Where the period of application for extension exceeds the period of the patented invention; 4. Where the applicant for registration of an extension is not the patentee, etc.; 4. Where the applicant for registration of an extension has made the application for registration of an extension of the term of the patent, the term of the patent right may not be included in the period of application for registration of an extension under Article 9 (3).
2) Relevant notices
Article 2 (Transitional Measures) of the Addenda to Article 205-13 (Enforcement Date of June 17, 2005) of the Regulations on the Operation of the Extension System of the Term of Patent Right, which was in force at the time of the application for registration of the extension of the instant application for registration of extension (hereinafter referred to as the “Public Notice of the Korean Intellectual Property Office”), states, “The previous provisions shall apply to the application for registration of drug, pesticide, or pesticide product, or drug, pesticide, or pesticide product, or pesticide product, for which the application for registration of item license was already obtained or registered prior to the enforcement date of this Public Notice.” The “application for item license” under Article 2 of the Addenda includes “application for approval of the clinical trial plan” as a prior procedure for item license. Since the date of approval of the clinical trial plan for the instant permission is prior to June 17, 2005, which was the enforcement date of the above Public Notice, dispute between the parties to the instant application for registration of the extension of a patent right is not applied (see Supreme Court Decision 2007Do16816.
The period during which it is impossible to practice a patented invention under the provisions of Article 89 of the Patent Act, which is included in the main sentence [referring to the period during which it is possible to obtain an extension of the period permitted by the Commissioner of the Korea Food and Drug Administration pursuant to the provisions of Article 26 (6) of the Pharmaceutical Affairs Act or the provisions of Article 29 (1) of the same Act. The period from the date when a clinical trial plan is approved by the Commissioner of the Korea Food and Drug Administration pursuant to the provisions of Article 29 (6) of the Enforcement Decree of the same Act or the date when the establishment of a patent right is registered, whichever is later, shall not be the period from the date when a permit was obtained by the Commissioner of the Korea Food and Drug Administration pursuant to the provisions of Article 200-7 (Enforcement Date of December 20, 200; hereinafter referred to as the "Public Notice of the Korean Intellectual Property Office of 200] of the Korea Food and Drug Administration for the purpose of conducting a clinical trial under the provisions of Article 16 (3) of the same Act:
E. Details of the instant trial decision
1) Defendant 1 filed a petition for an invalidation trial on the registration of the instant extension against the Plaintiff, the patentee of the instant patent invention, as the Intellectual Property Trial and Appeal Board No. 2017Da2256, and Defendant 2 filed a petition for an invalidation trial on the registration of the instant extension against the Plaintiff, the patentee of the instant patent invention as the Intellectual Property Trial and Appeal Board No. 2017Da2257, respectively, by asserting that “The period of February 23, 200, whichever the term of the instant patent invention, should not be included in the extension, shall be invalidated pursuant to Article 134(1)3 of the former Patent Act.”
2) On February 28, 2019, the Korean Intellectual Property Trial and Appeal Board held that “(i) the period from January 7, 2006 after the end of the clinical trial to May 18, 2006, which falls under 132 days from May 18, 2006 (hereinafter “period 1”) and ② the period from June 15, 2007, which falls under the period from June 15, 2007 to August 8, 2007, which is the day immediately before the date of filing an application for import approval and a written request for examination of safe and milk (hereinafter “period 2”) falls under the period used due to a cause attributable to a patentee, and thus, the period of 1,23 days during which the term of the patented invention of this case is extended, which falls under the period of 1,187 days from February 23, 2006, cannot be exempted from being nullified.”
A) The period 1 falls within the period required by a patentee’s liability for the following reasons:
(1) Necessary data for reporting of drug substances or for requesting an examination of a weather or demonstration are irrelevant to data on the efficacy and safety of drugs obtained in the clinical test. Therefore, there is no reasonable reason to delay reporting of drug substances or request for examination of drug substances for the purpose of analyzing and arranging data on the clinical test.
(2) Although the clinical research report submitted one time period, the national entertainment report, the sub-national entertainment analysis report, (name 1 omitted), the bridge data of the Korea Food and Drug Administration, and the presentation data of the Korean Food and Drug Administration are those to be submitted for the purpose of internal and genetic examination as data on the clinical test, it is not those necessary for the report of drug or the examination of the flag or flag of a drug.
③ It is reasonable to deem that the Plaintiff, a patentee, had already been secured before the clinical trial in Korea. Moreover, it is difficult to ascertain whether the patentee delayed the notification of a drug for any reason until the period of 1 (132 days) expires after the clinical trial is completed, and further, there is no circumstance to deem that the period of 1 is the preparation period required for reporting a drug, which is one of the procedures for marketing approval of drugs.
B) A period of up to two years is the period required for the reasons attributable to the patentee for the following reasons:
(1) As the examination division on the license of drugs within the Korea Food and Drug Administration takes charge of the duties of each department in charge, and the examination of data submitted are independently conducted, it is reasonable to view that the request for examination of safe and milk may be made when the procedures for examination of drugs are in progress. However, in light of the fact that the request for examination of safe and milk was made only on August 9, 2007, 200 days after the issuance of the certificate of completion of the report on the drug for raw materials and 55 days, the above period 2 falls under the period of liability delayed due to the commercial consideration of the patentee and the personal reasons, such as failure to perform duties
② Since a clinical trial conducted in Korea for the marketing approval of this case was conducted to an extent that safety and effectiveness can be verified for Korean people through simple statistical processing, it is reasonable to view that there is a cause attributable to the patentee for the delayed period of about one year and seven months from January 6, 2006 to August 9, 2007 after the completion of the clinical trial.
(3) If an applicant for a permit voluntarily withdraws his/her application for a permit, it is reasonable to view that the patentee voluntarily withdraws his/her application for a permit.
[Reasons for Recognition] Facts without dispute, Gap's entries in Gap's 1 through 5, 7, 8, 12, 14, 16, 23, 26 through 28, 40, and 41, and the purport of the whole pleadings
2. Summary of the parties' arguments;
A. The plaintiff
1) The period of 1, 2 determined in the instant trial decision as the period of liability, and 2 were the period for which the extension was recognized as an administrative repeated by the Korean Intellectual Property Office in accordance with the “Notice of the Korean Intellectual Property Office in 2000,” which was an administrative rule, as the internal administrative rule of the Korean Intellectual Property Office. In addition, even in the case of Supreme Court Decision 2016No83 Decided January 26, 2018, the instant trial decision included the corresponding period as the “standing interest” in accordance with the previous notification, but the instant trial decision exceeded and abused discretion and infringed the Plaintiff’s expectation
2) As the period 1 cannot be deemed to be the period required due to a cause attributable to the Plaintiff, the patentee, for the following reasons, the instant trial decision otherwise determined is unlawful.
① In light of the fact that the clinical trial of this case was completed by the completion of the domestic clinical trial (name 1 omitted) which is only one of the 51 clinical trials reviewed for permission (name 1 omitted), the instant trial decision erred by misapprehending that the clinical trial of this case was completed during the period 1, 2384, while the clinical trial of this case was conducted by foreign countries, and that the period 1 of the period between the commencement of the permission procedure was determined to be responsible for the period. Foreign clinical trials of this case 2384 are necessary for the instant permission, and there is no legal basis to exclude the period from the extension of the duration.
(2) No clinical trials and the examination of item licenses do not have a correlation between DMF and DMF, and no relevant statute imposes a duty of care to submit a DMF report prior to the completion of a domestic clinical trial or to apply for item licenses prior to the completion of the DMF reporting procedure on the permitting authority.
③ Since “DMF procedures” and “DMF procedures” are independent procedures, permission shall not be prompt even if they are to submit a DMF report at least one time prior to the intended period. In addition, for the instant marketing approval, it is possible after September 25, 2007, which is the date of European marketing approval, to submit a DMF report. Thus, even if the DMF report was submitted at least one time prior to the filing date of the DMF report and the delay of permission, there is no proximate causal relation between the timing for submission of DMF report and the delay of permission.
(4) The permitting authority has prepared a report on the 2355 domestic clinical trial, a national assumption report on Asian patients, and a research report on Korean patients (Evidence A, A, 10, 11) to the Korea Food and Drug Administration for one-year period, and submitted it to the Commissioner of the Korea Food and Drug Administration, which shall include the period required for the instant permission in accordance with the provisions of the former Patent Act.
3) As the period 2 cannot be deemed to be the period required due to a cause attributable to the Plaintiff, the patentee, for the following reasons, the instant trial decision otherwise determined is unlawful.
① Although the application for the item license of this case was withdrawn during the 2-year period, the period from June 15, 2007 to July 31, 2007 (hereinafter “period 2-1”) was 47 days, which was the date of withdrawal of the request for examination of the second safe and milk (hereinafter “period 2-1”), the period required for permission was the period required for permission by the Korea Food and Drug Administration. Furthermore, even if the procedure was withdrawn, the contents already examined were omitted or finished in the event of re-application without having been examined by the Korea Food and Drug Administration. Thus, it cannot be viewed as a cause attributable to the fact of withdrawal.
② In order to obtain the product license of this case, the Korea Food and Drug Administration shall submit a certificate of manufacture and sales to the Korea Food and Drug Administration in accordance with the relevant provisions, and since data submitted at the time of the application for the product license of this case are Europe, it is possible to submit a certificate of manufacture and sales in Europe after September 25, 2007. Thus, it is “any circumstance beyond the scope of responsibility” of the permitting authority as a document that could not be submitted at the time of the application for the product license of this case. Thus, during the two-year period, there was no period from August 1, 2007 to August 8, 2007, which is from August 1, 2007, which is the date following the date of withdrawal of the second request for the product license of this case, and thus, it is difficult to find a proximate causal relation with the delay of the product license of this case.
③ Since the instant trial decision regarding the term 2 years is irrelevant to each other, it erred by setting a period for delay of permission by substituting virtual scenarios that the application for marketing approval (design examination) could have been filed during the DMF procedures.
B. The Defendants
1) The purpose of Article 89 of the former Patent Act is to protect “the period during which the patented invention could not be executed, ① the period directly required for obtaining permission or filing for registration, etc., and ② the period required for the long time due to the test of activation, safety, etc. necessary for such permission or registration.” Therefore, the period 1 and 2 is the period used due to the Plaintiff’s failure to file an application for permission or registration for working the patented invention due to the Plaintiff’s “commercial consideration” or “business know-how, etc.” and is the period used due to the Plaintiff’s cause attributable to the Plaintiff. In addition, the reason why the applicant for permission is delayed is due to the lack of “the pharmaceutical and clinical trial data verified by the permitting country” and “the certificate of manufacture and sale”, which are necessary materials for permission, and if there is no data to undergo such a review, it is nothing more than the reason for the applicant for the examination.
2) The period 1 is the period required for the following reasons to be attributable to the Plaintiff, the patentee.
(1) In order to analyze and arrange data on clinical trials, there is no reasonable ground to delay reporting of drug substances or request for examination at a time, and it is reasonable to deem that materials on drugs have already been secured before the clinical trial was conducted in Korea by the permitting authority, and there is no circumstance that the period of time 1 is the preparation period to the extent required for reporting of drug substances.
② A new assertion that “the fact that a foreign clinical trial was conducted even after the completion of the domestic clinical trial, on July 14, 2006,” etc. had not been submitted or claimed by the permitting authority at the time of registration for extension of the term of the patent right is not permissible as an unlawful assertion.
③ There were two tests of 2301 and 2384-2 of 2301 and 2384. Only the 2301 test did not have any legal impediment to the enforcement of the patent of this case under the domestic procedure. Even if a subsequent 2384 test was submitted, it cannot be said that this test was essential.
3) The period 2 is the period required for the following reasons to be attributable to the Plaintiff, the patentee.
(1) It is reasonable to view that there is no direct connection with data to be submitted for an examination of safe and genetic resources as a result of a report on drug substances, or a result of an examination of drug substances, and that a request for an examination of safe and genetic resources may be made
② After the completion of the clinical trial, the permitting authority voluntarily voluntarily voluntarily voluntarily withdraws the application for permission on July 31, 2007 after the completion of the clinical trial. Such voluntary withdrawal period is reasonable to deem that the permitting authority voluntarily voluntarily voluntarily voluntarily voluntarily withdraws the application for permission due to a cause attributable to the said authority.
(3) The delay period related to the submission of a certificate of manufacture or sales is only based on commercial consideration of the competent permitting authority, and thus cannot be subject to registration of the extension. The competent permitting authority is entitled to obtain permission for manufacture other than that for import after conducting a clinical trial in the Republic of Korea, and in such cases, he/she could obtain permission for manufacture promptly.
(4) A failure to submit data required by statutes and public announcements to obtain marketing approval constitutes a cause attributable to the permitting authority. Moreover, the period for preparing the said data cannot be deemed to include the period for extending the duration. Furthermore, considering the foreign permission procedures in relation to the registration for extension of patent term, legal stability would be significantly harmed, given the foreign permission procedures.
⑤ In applying for registration of the instant extension, the permitting authority recognized that the period from November 18, 2006 to January 8, 2007, which was voluntarily interrupted by the Commissioner of the Korea Food and Drug Administration, was the period required due to the grounds attributable to the patentee. The Plaintiff’s assertion that “the period required to obtain marketing approval from Europe does not fall under the period of liability.” The assertion that “the period required to obtain marketing approval from Europe does not fall under the period of liability is unfair, contrary to the principle of gold-competence.” Moreover, such assertion is impermissible as it is based on a new ground that the permitting authority had never claimed at all
4) If an internal examination is completed between November 1, 2007 and November 26, 2007 and the importing marketing approval department is notified, the period from the notification date to November 26, 2007 shall be null and void since any examination by the relevant department is not conducted.
3. Whether the trial decision of this case is unlawful
A. Key issue
1) During the examination process of the application for registration of the instant extension, 54 days (one day before October 30, 2007, which included the total of 54 days (two days) from August 11, 2005 to December 28, 2007, which was the date of registration of the patent right for the instant patent invention (name 1 omitted), including the period from August 11, 2005, which was the date of registration of the establishment of the instant patent invention, until November 18, 2006, which was the date of request for supplementary data for the extension of the period from November 18, 2006 to January 8, 2007, which was the date of submission of supplementary data (52 days) and the period from October 30, 2007, which was the date of request for supplementary data for the extension of the period from October 30, 207 to October 27, 2007, excluding the period from August 111 to 27, 20197.
2) Of February 23, 2006, the issue is whether ① the period corresponding to 132 days from January 7, 2006 after the completion of the clinical trial until May 18, 2006, which falls under the 132-day period from May 18, 2006, which is the day before the date of submission of a drug declaration certificate; ② the period from June 15, 2007, which falls under the 55-day period from June 15, 2007 to August 8, 2007, which is the day before the date of submission of an application for marketing approval and a request for examination of safe and milk supply of the instant patented invention, falls under the period required for the reasons attributable to the permitting authority, etc., i.e., the period
본문내 포함된 표 일자 내용 2005. 1. 25. 국내 임상시험(CLAF237A2355) 개시(갑 제8호증) 2005. 6. 29. 외국 임상시험(CLAF237A2384) 개시(갑 제9호증) 2005. 8. 11. 특허권(특허 제509311호) 설정등록(갑 제1, 2호증) 2006. 1. 6. 국내 임상시험(CLAF237A2355) 종료(갑 제8호증) 기간 1(132일: 2006. 1. 7.~2006. 5. 18.) Drug Product Approval DMF 심사 기ㆍ시 심사 안ㆍ유 심사 허가 2006. 5. 19. DMF 신고(갑 제12호증) 2006. 6. 2. 1차 심사의뢰(갑 제13호증) 2006. 6. 28. 심사의뢰(갑 제14호증) 2006. 7. 14. 외국 임상시험(CLAF237A2384) 종료(갑 제9호증) 2006. 10. 30. 보완요청(갑 제12호증) 2006. 11. 17. 보완요청(갑 제14호증) 2007. 1. 9. 보완자료 제출(갑 제14호증) 2007. 1. 26. 보완자료 제출(갑 제12호증) 심사결과 승인(갑 제16호증) 2007. 2. 2. 보완요청(갑 제17호증) 2007. 3. 30. 1차 안ㆍ유 취하(갑 제19호증) 2007. 5. 4. 2차 안ㆍ유 및 1차 품목허가 신청(갑 제20호증) 2007. 5. 29. 보완요청(갑 제21호증) 2007. 5. 31. 보완자료 CD 제출(갑 제22호증) 2007. 6. 14. 신고필증(갑 제23호증) 기간 2(55일: 2007. 6. 15.~2007. 8. 8.) 2007. 7. 30. 보완독촉(갑 제24호증) 2007. 7. 31. 2차 안ㆍ유 및 1차 품목허가 신청 취하(갑 제25호증) 2007. 8. 9. 3차 안ㆍ유 및 2차 품목허가 신청(갑 제26호증) 2007. 8. 16. 보완요청(갑 제27호증) 2007. 10. 29. 보완요청(갑 28호증) 2007. 11. 1. 보완자료 제출(갑 제28호증) 2007. 11. 26. 보완자료 제출(갑 제27호증) 2007. 12. 28. 허가증(갑 제41호증)
B. Note 5) Relevant legal principles
1) In order to implement an invention of a medicine, etc., a patentee shall obtain permission, etc. in accordance with the Pharmaceutical Affairs Act, etc. to promote the public health and sanitation and ensure the safety and effectiveness of the invention. As such, a patentee may not work the patented invention in the process of obtaining such permission, etc. Therefore, Article 89(1) of the former Patent Act (amended by Act No. 12753, Jun. 11, 2014; hereinafter the same shall apply) shall obtain permission, registration, etc. in accordance with other Acts and subordinate statutes to practice the patented invention, and if the procedure for patent registration is an invention prescribed by Presidential Decree that requires a long period of time due to an examination of activation, safety, etc. (hereinafter referred to as “permission, etc.”) and that such procedure for patent registration may not be extended within five years for the period during which the patentee could not work, notwithstanding the provisions of Article 88(1)5 of the former Pharmaceutical Affairs Act, including the extended period of time for which the patentee is entitled to an exclusive licensee under Article 88(1) of the former Pharmaceutical Affairs Act.
2) Article 89(2) of the former Patent Act excludes the period required for a cause attributable to the patentee, etc. from the period during which the patentee, etc. could not practice the patented invention. Here, the term “period required for a cause attributable to the patentee, etc.” means the period during which the permission, etc. of the Pharmaceutical Affairs Act, etc. was actually delayed due to a cause attributable to the patentee, etc., that is, the period during which proximate causal relation is acknowledged between the cause attributable to the patentee, etc. and the delay of permission, etc. under the Pharmaceutical Affairs Act, etc. (see, e.g., Patent Court Decision 2016Heo498
C. As to the period 1
The period 1 is 132 days from January 7, 2006 to May 18, 2006, which is the day before the date of the submission of the DMF report, after the completion of domestic clinical trials, and the following [mark] is the red display.
A person shall be appointed.
1) Grounds attributable to
A) Whether the duty of care to submit the DMF report at least one time prior to the end of the domestic clinical trial
(1) According to delegation under Article 34(1) of the former Pharmaceutical Affairs Act (wholly amended by Act No. 8365 of Apr. 11, 2007; hereinafter the same), Article 23(1)1(h) of the former Enforcement Rule of the Pharmaceutical Affairs Act (wholly amended by Ordinance of the Ministry of Health and Welfare No. 434 of Jan. 15, 2008; hereinafter the same shall apply) only provides for submission of an application (attached Form 12) under [Attachment 12] to the "application for marketing approval" (referring to the "application for marketing approval" and the "application for raw material declaration" and there is no provision that the permitting authority should submit the MF report prior to the date of the domestic clinical trial.
(1) A person who intends to import drugs, etc. (hereinafter referred to as "importer") shall obtain permission or report from the Commissioner of the Korea Food and Drug Administration for each item, as prescribed by Ordinance of the Ministry of Health and Welfare. The same shall also apply where he/she intends to modify permitted or reported matters, as prescribed by Ordinance of the Ministry of Health and Welfare. (b) A person who intends to obtain permission for items of drugs, etc. pursuant to Article 23 (Application, etc. for Permission for Items Manufactured or Imported under Article 26 (1) or 34 (1) of the Act (including an application in attached Form 12) shall submit an application (including an electronic document) pursuant to attached Form 12 to the Commissioner of the Korea Food and Drug Administration along with the documents (including an electronic document) according to the following classifications:
(2) In the pharmaceutical industry, there are many cases where a person applies for marketing approval at or around the same time after the clinical trial is completed (the Patent Court Decision 2016Heo498, 4504 Decided March 16, 2017). The “pharmaceuticals” under the Patent Court Decision 2016Heo3549, 3563 Decided February 1, 2018 (the Patent Court Decision 2016Heo4535 Decided August 10, 2018; the “pharmaceuticals” under the Patent Court Decision 2016Hun-Ba4535 Decided August 10, 2018; the “pharmaceuticals” under the Patent Court Decision 2017Hun-Ba157 Decided January 19, 2017; the “Pharmaceuticals” under the Patent Court Decision 2016Hun-Ga364, Jun. 16, 2017; the Patent Court Decision 2016Hun-Ga36, supra.
B) Whether a proximate causal relationship exists between the DMF report and the timing for granting permission
In the procedure of permission of this case, it is difficult to find a proximate causal relationship between the time limit for submission of the DMF report and the delay of permission because the DMF examination procedure and the procedures for safety and effectiveness of the DMF examination conducted by submitting data on physical and chemical properties, process control, etc. of the drug itself, and the procedures for the DMF examination conducted by examining the safety and effectiveness of the drug subject to permission, are mutually independent procedures. Therefore, even if the DMF examination procedure is advanced one earlier than the time limit, it cannot be deemed that the DMF report is prompt. Therefore, even if the DMF report was submitted at least one time prior to the time limit, it is difficult to find a proximate causal relationship between the time limit for submission of the DMF report and the delay
2) Whether the period of foreign clinical trials implemented for one year constitutes the period during which the patented invention could not be worked
As examined below, in cases where a foreign clinical trial has been conducted between the starting date of the domestic clinical trial and the date when the permission, etc. was late from the date when the applicant reaches the relevant date, it is reasonable to view that the foreign clinical trial period falls under the period during which the foreign clinical trial could not be conducted if it is necessary for the foreign clinical trial to obtain domestic marketing approval.
A) Whether the foreign clinical trial is excluded from the “activity, safety, etc. test necessary for permission, etc.” under Article 89 of the former Patent Act
(1) Article 89 of the former Patent Act stipulates that “the activity and safety test required for permission, etc.” is “the activity and safety test” and Article 26(6) of the former Pharmaceutical Affairs Act applicable mutatis mutandis under Article 34(4) provides that “the report on the test of safety and effectiveness” shall be submitted to obtain permission, but the same does not limit the performance of clinical trials in Korea.
(2) Any person who intends to obtain permission from the Commissioner of the Korea Food and Drug Administration or to report items in accordance with Ordinance of the Ministry of Health and Welfare shall obtain permission from the Commissioner of the Korea Food and Drug Administration or report items, as prescribed by Ordinance of the Ministry of Health and Welfare.
(2) Article 27(1) of the Enforcement Rule of the former Pharmaceutical Affairs Act, which was delegated by the former Pharmaceutical Affairs Act, stipulates “data on the results of clinical trials” as one of the test results of safety and effectiveness, and delegates detailed regulations to the Commissioner of the Korea Food and Drug Administration.
Article 27 (Examination of Safety and Effectiveness) (1) (1), 26 (1), (6) and (8) or 34 (1), (4) and (5) of the Table contained in the main sentence of this Article shall undergo an examination of safety and effectiveness of the relevant item after submitting the following data (including electronic documents). In this case, matters necessary for the management of a non-clinical trial conducted to prepare detailed regulations on the items subject to examination, guidelines for preparation of data, requirements for exemption and examination, scope of exemption and criteria for examination, etc., and the data on toxicity and pharmacological action, etc. shall be governed by the Commissioner of the Korea Food and Drug Administration:
(3) Article 6(1)6-A-2 of the Regulations on the Examination of Safety and effectiveness of Drugs, Etc. (Enforcement of the Food and Drug Safety Agency Notice No. 2007-30, May 25, 2007; hereinafter “Public Notice of the Korea Food and Drug Safety Agency”) delegated by the former Enforcement Rule of the Pharmaceutical Affairs Act (Article 6(1)6-2 of the same Act) is recognized as legitimate permission materials even if the test materials conducted in a “foreign country” were submitted or approved by the government of the permitting country (permission or registration agency) or “a notarized materials.”
The requirements for the data under Article 6 (Requirements for Submissions) (1) through (9) of the Table included in the text of this Act are as follows: (a) Data on the results of clinical trials; (b) In the case of foreign data, data on the results of clinical trials; (a) in the case of foreign data, the data which has been submitted and assessed at the time of the application for permission, and which has been submitted or approved by the Government of the country of permission (the licensing or registration authority) or which has been notarized (a).
(4) Therefore, it is reasonable to deem that the “activities, safety, etc. necessary for permission, etc.” under Article 89 of the former Patent Act includes foreign clinical trials, and it is difficult to find reasonable grounds to discriminate against domestic clinical trials and foreign clinical trials.
B) Whether a foreign clinical trial is necessary to obtain the instant permission
In light of the following circumstances acknowledged by comprehensively taking account of the overall purport of the pleadings as to the statements in Gap evidence Nos. 9, 26, 33, 41, 42, and 45, it is reasonable to deem that the foreign clinical trial of 2384 is a blatergly operated solution, but it was examined as to the "safety and effectiveness of blatergly operated solution" in the instant permission, and thus, it is reasonable to deem that it is necessary to obtain the instant item license.
(1) On August 9, 2007, the result of the 2384 foreign clinical trial shows the result of a test to find out “the abnormal reaction between Dagggle (Modver) Investment Group and Madver Investment Group” (No. 26) at the time of the application for the second item license of this case, and the result of the 2384 foreign clinical trial is as follows (No. 9 No. 4).
A person shall be appointed.
The phrase “it is proved that the type 2 urine patients are safe by showing whether they have abnormal reaction profilings similar to those of the three directions and dosages at least once a day, twice a day, 50mg, or once a day, and whether such profilings are similar to those of the medicine” in the table contained in the main text, “24 hours after treatment of 14 hours, 50mg, or 100mg per day,”
(2) The report on the results of the Korean Food and Drug Administration prepared by the Korea Food and Drug Administration stating the data on foreign clinical trials 2384 and state 6) (Evidence A 33) and the content of the results of the clinical trial on the Dolinized Dolin’s Dolin’s Dolin’s Dolin’s Dolin’s Dolin’s Dolin’s Dolin’s Dolin’ in the 2384 foreign clinical trials (Evidence A 41)
【Written Examination Results (Evidence A No. 33)】
A person shall be appointed.
[Import Product License Certificate (Evidence A No. 41)]
A person shall be appointed.
(b)
A person shall be appointed.
(b)
A person shall be appointed.
(3) The certificate of product approval of this case contains the following: “2,264 persons shall be deemed to have received blickly gly gly gly gly gly gly gly gly gly gly gly gly gly gly gly gly gly gly gly gly gly gly gly gly gly gly gly gys (
A person shall be appointed.
(4) Although the foreign clinical trial of 2384 is about the sole dose of Dogly-gly-established solution, the item of "The Gu Guidelines for the Clinical Trials of Blood Products (Evidence A No. 45) issued by the Korean Institute of Food and Drug Safety Evaluation" states that "the comparison of Magly-in and test medicine in the clinical trial of a single law shall be essential to assess the effects and safety aspects of the blood transfusion of a new blood transfusion, regardless of whether it is a separate law or a pathology."
(5) In addition, there is a close relationship between the two in that both the “paroglycin” and the “scarbin” and the “scarbin” are related to the “sucin treatment of urine,” which are the same effective ingredients.
3) Review of the Defendants’ assertion
A) The Defendants asserted that the Plaintiff’s assertion of the validity of the extension registration of the patent term of this case is unlawful, and thus, it is not permissible since it is unlawful to newly assert the following: “The Plaintiff did not submit or assert at the time of the application for registration of the extension of the patent right of this case, the fact that the foreign clinical trial was conducted by July 14, 206
As seen earlier, the Korea Labor Standards Commission, a non-exclusive licensee, filed an application for extension of the term of February 23, 2007, excluding two days from August 11, 2005, the date of the establishment of the patent right of this case, to December 28, 2007, for the period from August 18, 2006, the date of request for the supplementation of data on the request for examination of the term and time limit from November 18, 2006 to January 8, 2007, the date of request for the supplementation of data on the request for examination of safe and time limit, and from October 30, 207, the date of submission of supplementary data, until October 31, 2007, which is two days before the date of the establishment of the patent right of this case, and filed an application for extension of the term of February 23, 2007. Accordingly, the extended period was not erroneous in the plaintiff's assertion that the Defendants could not implement the patented invention of this case for more than 3181 time period.
Therefore, this part of the Defendants’ assertion is difficult to accept.
B) The Defendants also asserted that the test of Dogggggggggggggggggly's sole test of 2301 and 2384-2, and that the test of 2301 alone did not have any legal impediment to the implementation of the patent of this case under the domestic procedure, and that even if the test was submitted after the next 2384, this test cannot be deemed essential.
However, as seen earlier, foreign clinical trial data was submitted from the item approval of this case as examination data, and it was examined as data on the "safety and validity" of Doggggggggin in the item approval of this case, such as where both the results of foreign clinical trials are written in the internal and genetic test report of this case and the import approval certificate of this case. Therefore, it is reasonable to view it as necessary data for obtaining the item approval of this case.
Therefore, this part of the Defendants’ assertion is difficult to accept.
(iv) Results of review
In full view of the above contents, since the period 1 cannot be deemed as the period required due to a cause attributable to the Plaintiff, the patentee, and thus, the trial decision of this case otherwise determined is unlawful.
D. As to the period 2
1) Period 2
On June 2, 2006, the permitting authority requested a preliminary examination on March 30, 2007, but withdrawn it on March 30, 2007; again, on May 4, 2007, the first marketing approval was applied along with a preliminary marketing approval; again, on July 31, 2007, withdrawn it on July 31, 2007; and on August 3, 2007, upon the application of the second marketing approval, the importing drug was approved only on December 28, 2007.
However, the period 2 during the above period is the period from June 15, 2007 to August 8, 2007, which is the day immediately preceding the date of the issuance of the certificate of completion of DMF report, and the period from June 15, 2007 to August 8, 2007, which is the day before the date of the application for the second item approval, and the period from June 15, 2007 to July 31, 2007, which is the red indication as follows: (a) the period 2-i) and the period from August 1, 2007 to August 8, 207.
A person shall be appointed.
2) Whether there exists a cause attributable to
A) The submission of data necessary for the instant permission
According to the relevant laws and regulations, the requirements for submission of data for marketing approval of imported drugs include a certificate of manufacture of the producing country, a certificate of marketing approval of the permitting country, etc. (Article 23(1) of the former Enforcement Rule of the Pharmaceutical Affairs Act), and the examination of the knowledge and oil for marketing approval of imported drugs are required to confirm or verify that “the pharmaceutical test data” and “clinical trial results data” submitted to the Korea Food and Drug Administration are submitted or approved by the government of the permitting country (Article 6(1)5 and 6 of the Notification of the Korea Food and Drug Safety Agency). The detailed contents are as follows.
(i) Certificate of manufacture and sales;
Article 23(1)1(e) of the former Enforcement Rule of the Pharmaceutical Affairs Act (amended by Act No. 34(1) of the former Pharmaceutical Affairs Act) provides that in order to obtain a license for imported drugs such as the instant drugs, the government or public institution of the producing country must submit a certificate of manufacture proving that the relevant items are manufactured in conformity with the laws and regulations of the producing country and a certificate of sale proving that the relevant items are sold in compliance with the laws and regulations of the permitting or registering country (hereinafter “certificate of manufacture and sale”).
(1) Any person who intends to import drugs, etc. (hereinafter referred to as "importer") shall obtain permission or report from the Commissioner of the Korea Food and Drug Administration for each item, as prescribed by Ordinance of the Ministry of Health and Welfare. The same shall also apply to any modification to permitted or reported matters. [The same shall apply to any person who intends to obtain permission for items of drugs, etc. pursuant to Article 23 (Application, etc. for Permission for Manufacturing or Import Items) (1) or 34 (1) of the former Enforcement Rule of the Pharmaceutical Affairs Act (attached Form 12), along with an application (including an application in electronic form) under Article 26 (1) or 26 (1) of the Act (attached Form 12), shall submit to the Commissioner of the Korea Food and Drug Administration, along with the documents (including an electronic document) according to the following classifications. 1.
(2) summary and clinical trial data confirmed and certified by the permitting country;
As seen below, Article 34(1) of the former Pharmaceutical Affairs Act and Article 27(1)5 and 6 of the notification of the Korea Food and Drug Administration notified by the Commissioner of the Korea Food and Drug Administration to which matters concerning marketing approval of imported drugs have been delegated in succession pursuant to Article 34(1) of the former Pharmaceutical Affairs Act and Article 6(1)5 and 6 of the notification of the Korea Food and Drug Administration to which the instant license has been granted shall provide that the “morry test data” and “clinical trial data” submitted to the Korea Food and Drug Administration must be submitted or approved by the government of the permitting country (the licensing or registration agency) or the “notarial test data” (hereinafter “the pharmaceutical and clinical trial data confirmed and
(1) Any person who intends to obtain permission for items or obtain permission for items or make a report on items or obtain permission for items or obtain permission for items or obtain permission for items or make a report on items or obtain permission therefor from the Commissioner of the Korea Food and Drug Administration, as prescribed by Ordinance of the Ministry of Health and Welfare. The same shall also apply to cases where he/she intends to modify matters permitted or reported. [1) Article 27 (Examination of Safety and Effectiveness) (1) Article 23 (1), 26 (1), (6) and (8) or 34 (1), (4) and (5) of the Act, which fall under any of the following subparagraphs (including electronic documents) shall be subject to examination or obtain approval for items or obtain permission for items or obtain permission for items or obtain permission for items or to make a report on items or obtain permission for items or obtain approval for the following matters at the time of the examination.
(1) Note 5 (1) through (9) 7)
(b)Non-submission of data on requests to supplement data by the Korea Food and Drug Administration and withdrawal of applications;
According to the statements in Gap evidence Nos. 21, 22, 23, and 24, the following facts may be acknowledged:
(1) The Korea Food and Drug Administration, on May 4, 2007, sent on May 29, 2007, the official text requesting the supplementation of safety and effectiveness as follows (Evidence A) to the Korea Food and Drug Administration (No. 21) with respect to the examination of internal and external milk and the first application for the marketing approval of Korea Labor Standards, and on which two days have not passed since the date of the said request for supplementation (No. 22) (No. 8) (No. 22) with respect to the submission of a CD on May 31, 2007, in which the Korea Labor Standards Commission stored all of the data previously submitted, stored them in the CD, and submitted the CD on May 31, 2007.
In accordance with the Regulations on the Safety and Effectiveness Review of Drugs, etc. (Notice No. 2007-20, April 5, 2007), the following data shall be submitted to the head of the relevant Si/Gun/Gu. 1. Data on the toxic Test suitable for Article 6(1)4; 3. Data on pharmacological action suitable for Article 6(1)5; 3. The end of the data on clinical trial records suitable for Article 6(1)6.
(2) The Korea Food and Drug Administration did not properly supplement the request made by the Korea Food and Drug Administration to supplement the Korea Food and Drug Administration. On July 30, 2007, the Korea Food and Drug Administration sent a letter of urge for the following safety and effectiveness supplement materials (Evidence A24), and the Korea Labor Standards Commission withdrawn the request for the first marketing approval on July 31, 2007, which is the following day.
In accordance with the Regulations on the Examination of Safety and Effects of Drugs, etc. (Notice No. 2007-20, April 5, 2007, Notification No. 2007, No. 2007, No. 2007, No. 2007, No. 1) Data on pharmacological action suitable under Article 6(1)5(a)(ii) and on clinical trial records in conformity with Article 6(1)6(a)(ii). 3) Paper data are prepared mainly on comparison, etc. between the armed forces in the Korea Recruitment Organization, and it is difficult to determine differences among the people, so it is difficult to submit the whole data to be submitted pursuant to Article 6(1)5(a).
C) The reason attributable to the permitting authority and proximate causal relation
(1) In light of the following circumstances revealed by the above facts, it is reasonable to view that a reasonable causal relationship exists between the time limit 2 and the time limit 2 until the time when “the pharmaceutical and clinical trial data confirmed and officially verified by the permitting authority” and “the permission for manufacture and sale” are satisfied, and that the time limit 2 is the time limit ever delayed due to the reasons attributable to the patentee, and that there is a proximate causal relationship between the causes and the delay of permission, etc.
(A) As to CDs submitted as supplementary materials upon receipt of a request to supplement the second internal and genetic test, the Plaintiff stated that “the Plaintiff stored all the previously submitted materials in the CD and submitted them on May 31, 2007.” According to the Plaintiff’s statement, the Korea Nanotechnology again submitted materials at the time of the second internal and genetic test and the first application for marketing approval. As such, there seems to have been no supplement to the Korea Food and Drug Administration’s request for supplement.
(B) The Korea Food and Drug Administration, on May 29, 2007, stated in the official text of the request for supplementation of safety and effectiveness, which was sent to the Korea Food and Drug Administration on May 29, 2007, that “the materials on clinical trial records appropriate for Article 6(1)5, are included in the notification of the Korea Food and Drug Administration.” However, “the materials on clinical trial records appropriate for Article 6(1)6” as stated in the notification of the Korea Food and Drug Administration, but no supplementary materials have been submitted. Accordingly, the Korea Food and Drug Administration, on July 30, 2007, specified the matters requested for supplementation in detail in relation to the above internal and genetic tests, and stated that “the materials on clinical trial records appropriate for Article 6(1)6(a) and (2)” were to be supplemented, and the Korea Food and Drug Administration additionally requested supplementation of the materials on clinical trial records, and then withdrawn the above application for supplementation.
(C) The “marry and clinical trial data confirmed and certified by the permitting country” and “certificate of manufacture and sales”, which are necessary materials for the instant permission, are materials that can be submitted after obtaining permission from a foreign country. Since the European Product License for the instant medicine was granted on December 28, 2007, it was unclear whether the submission was possible on May 4, 2007, which was the time when the second and first applications for permission were filed, and the said application was withdrawn on July 31, 2007, the European Product License was not granted.
(D) The domestic clinical trial necessary for the instant permit was already completed on January 6, 2006, and the foreign clinical trial was completed on July 14, 2006 (it was completed at the latest on August 2, 2006, even if considering the additional foreign clinical trial of the Plaintiff’s assertion, at the latest on August 2, 2006), and (b) through (5) of the request for the submission of the pertinent data within the period for supplementation.
(E) If so, the Korea Labor Standards Commission applied for the second safe examination and the first item approval as well as the first item approval as unclear whether it is possible to submit the data which the permitting authority should submit for the examination and marketing approval of this case, such as the drug and clinical trial data confirmed and published by the permitting authority, and the first item approval as to the above, and the request made by the Korea Food and Drug Administration to supplement it is impossible to submit it, the application is deemed to have been withdrawn. In the end, the period 2 is the period of delay until the time when “the pharmaceutical and clinical trial data confirmed and published by the permitting authority” and “the permission for manufacture and sale,” and the period of delay is the period required due to the reasons attributable to the patentee and there is a proximate causal relation between the causes attributable to the granting authority and the delay of the permission.
(2) In this regard, the Plaintiff asserts that the period required to secure “a summary and clinical trial data confirmed and certified by the permitting country” and “a certificate of manufacture and sale” shall be included in the period during which the invention could not be executed due to the extension of the duration.
In light of the relevant laws and regulations, the term “a summary and clinical trial data verified and certified by a permitting country” and “a certificate of manufacture and marketing” stipulate that an applicant for permission has the obligation to submit such data for the examination and marketing approval. If the submission of such data is unclear and it is impossible to submit it within the prescribed period, and the application is withdrawn, it shall not be included in the period during which the invention could not be executed within the period required by the cause attributable to the permitting authority. Furthermore, these data may be submitted after the acquisition of the European marketing approval, and it shall not be deemed that they are included in the period during which the invention could not be executed until the date of delay until the submission of the above data.
Therefore, the Plaintiff’s above assertion is difficult to accept.
3) Whether the period 2-1 falls under the period during which the Korea Food and Drug Administration was examined, and the patented invention could not be worked.
For the following reasons, it is reasonable to view that the period of 2-1 does not include the period during which the patented invention could not be worked.
A) The period 2-(i) is from June 15, 2007 to July 31, 2007, after the date of issuance of the certificate of completion of report of DMF, and from June 15, 2007, the period from June 15, 2007, until July 31, 2007, when the application for the first marketing approval was withdrawn. Such withdrawal is deemed to have expired due to the withdrawal of the above application. On August 3, 2007, the examination procedure was completed upon the application for the second marketing approval, and the marketing approval was conducted on December 28, 2007. Therefore, it is difficult to deem that the period 2-1 was examined by the Commissioner of the Korea Food and Drug Administration.
In this regard, the plaintiff asserts that the continuity of the procedures before and after the Korea Food and Drug Administration had maintained the prior review and continuity of the procedures "re-application after withdrawal and return" before the implementation of the civil petition history system, and that the period from the withdrawal of the first application for marketing approval until the second application for marketing approval is recognized.
However, there is no objective evidence to acknowledge that there was a practical practice that maintained the continuity and transfer review of the re-application procedure after withdrawal and reflection by the Korea Food and Drug Administration at the time of the permission in this case. Rather, according to each of the evidence Nos. 68 and 69, after the permission in this case was granted, the "Civil Petition System for Permission and Examination" was introduced and operated in order to recognize the result of the previous review at the time of re-application and maintain consistency only for the defective matters after being withdrawn and reflected due to the lack of some items, and thereafter, the provision on the "Rules for Permission, Report and Examination of Drugs, etc." was newly established on June 30, 2009 in Article 5-2 of the "Rules on the Regulation for Permission, Report and Examination of Civil Petition System for Civil Petition System". In implementing the above civil petition history system, it is recognized that the civil petition history card should be prepared for each of the above examination items, and it should be stated whether the results of the examination are appropriate or not, and it should be further examined by adding the necessary parts of the examination.
Therefore, the permission of this case is 10 weeks prior to the introduction and operation of the license and examination civil petition system, and there are no other circumstances to deem that the relocation and continuity are maintained. Thus, this part of the Plaintiff’s assertion is difficult to accept (On the other hand, the Plaintiff excluded the period extended from November 18, 2006 to January 8, 2007 with respect to the application for registration of the extension of this case, excluding the period extended from the extension of the period from January 18, 2006 to January 8, 2007. Since the first period was withdrawn, according to the Plaintiff’s assertion, the continuity of the second and third internal examination is recognized and it is not necessary to exclude it from the extension of the period).
B) Even if the continuity of the period is recognized, as alleged by the Plaintiff, from the date of withdrawal of the first application for marketing approval until the date of the second application for marketing approval, the period 2, as seen earlier, cannot be deemed to have been delayed until “the pharmaceutical and clinical trial data confirmed and authenticated by the permitting country” and “the manufacture and marketing approval permit” were prepared, and it cannot be deemed that the Korea Food and Drug Administration had made a substantial examination on the safety and oil of this case and the marketing approval of this case, and thus, it is difficult to accept the Plaintiff’s above assertion.
4) Review of the Plaintiff’s assertion
A) The Plaintiff asserts that, without any exception, eight cases of examination cases applied to the notification of the Korean Intellectual Property Office in 2000, all of the “the entire period from the approval date of a clinical trial plan or the registration date of a patent to the permission date of a medicine” were extended to the entire period from the date of approval of a clinical trial plan or the registration date of a patent, and thus, this constitutes deviation from and abuse of discretion and non-compliance with the discretionary rules, and the expected interest by the notification of the Korean Intellectual Property Office in 200 should be protected.
According to the evidence evidence No. 37, among the cases of conducting a domestic clinical trial, there were eight cases applied to the Korean Intellectual Property Office in 2000 among the cases of conducting a clinical trial, and all of the above eight cases is recognized as having been extended "the whole period from the date approval of a clinical trial plan or the date of registration of a patent to the date of permission for drugs from the latest date of the registration of a patent". However, since the above eight cases did not dispute whether a patentee's cause was attributable to the patentee within the entire period, it is difficult to deem that the notice of the Korean Intellectual Property Office in 200 was recognized as having extended the duration of the entire period without considering the causes attributable to the patentee. In addition, it is difficult to view the above eight cases alone as administrative practice to recognize the whole period from the latest date of approval of a clinical trial plan or the date of registration of a patent to the date of
Therefore, it is difficult to accept the Plaintiff’s assertion on this part, on the grounds that excluding the period for which the patentee’s causes attributable to the patentee during the entire period from the date of approval of the clinical trial plan or the registration date of patent rights to the date of permission of medicine constitutes deviation or abuse of discretion, or is contrary to the expected interest by the notification of the Korean Intellectual Property Office
B) The Plaintiff asserts to the effect that, for a two-year period, 2384 foreign clinical trials and 2303E1, 2304E1, 2305E1, 2309E1, and 2309E1, the Plaintiff prepared a report on these materials, it constitutes a period during which the invention could not be implemented. Moreover, since materials for foreign clinical trials were delivered around May 2007, the Plaintiff could not be examined two days prior to the said period.
In addition, it is difficult to view that the additional clinical demonstration data of 2303E1, 2304E1, 2305E1, 2309E1, except for 2384 foreign clinical trials, are included in the period during which the patented invention could not be executed as a matter of course.
Even if such a period is considered, it is difficult to view that the period 2 is the period necessary to prepare for the 2384 foreign clinical trial since July 14, 2006, which is the end of the 2304 foreign clinical trial, or since July 28, 2006, which is the end of the 2304E1 foreign clinical trial, and the end of the 2304 EE1, which is the last day of the 2304 foreign clinical trial, to have sufficiently arranged and prepared the materials for the 11-month period from July 15, 2007, respectively. In addition, since the 2384 foreign clinical trial materials can be easily obtained from the plaintiff's side, it is difficult to view that there is an inevitable circumstance in which the 2384 foreign clinical trial materials are delivered late.
Therefore, this part of the Plaintiff’s assertion is difficult to accept.
C) In addition, the Plaintiff does not provide for the return of an application for marketing approval without attaching a certificate of manufacture and sales to the former Pharmaceutical Affairs Act, the Enforcement Decree, and the Enforcement Rule of the same Act. ② The “Korea Pharmaceutical License System” (Evidence No. 63) provides that “where it is impracticable to submit a certificate of manufacture and sales at the time of the application, it may submit it within the relevant examination period.” ③ Article 4(4) of the “Rules on the Examination of Product License, Report, and Examination of Drugs, etc.” enacted in 2008 provides that “where it is impracticable to submit it at the time of application, it may submit the relevant civil petition within the processing period.” ④ The research paper (Evidence No. 64) introduces Korea as a country where it can submit a certificate of manufacture and sales after the application for marketing approval. Thus, the submission of a certificate of manufacture and sales falls under the requirements of “permission” rather than the requirements for “application”.
According to the statements of evidence Nos. 63, 64, and 70, it is acknowledged that submission of the certificate of manufacture and sales at the time of the application for the permission of this case was permitted in practice within the examination period.
However, Article 23(1) of the former Enforcement Rule of the Pharmaceutical Affairs Act provides that any person who intends to obtain marketing approval of drugs, etc. shall submit an application for marketing approval, accompanied by a certificate of manufacture and sales, to the Commissioner of the Korea Food and Drug Administration, and that the application for marketing approval may be returned if he/she fails to submit it within the period for supplementation after receiving a request from the Commissioner of the Korea Food and Drug Administration to submit a certificate of manufacture and sales. Moreover, even if the permitting authority does not submit a certificate of manufacture and sales, it is difficult to deem that the immediately return of the application for marketing approval should take into account the convenience of the permitting authority in order not to delay the import of drugs, and for this reason, it should be calculated from the extension of the duration until the date of securing the certificate of manufacture and sales. In addition, the certificate of manufacture and sales is a data that can be submitted only through the submission of a foreign marketing approval, and it is not reasonable to delay the procedure until the submission of the application by the date of the application.
Therefore, this part of the Plaintiff’s assertion is difficult to accept, since it is difficult to view the period until the issuance of the above manufacture and sale certificate to be included in the period during which the patented invention was not implemented.
5) Results of review
In full view of the above contents, the period 2 is the period required due to the reasons attributable to the plaintiff, who is the patentee. Therefore, this part of the decision is legitimate.
E. Determination as to the Defendants’ assertion
The Defendants asserts that if an internal and genetic examination has been completed between November 1, 2007 and November 26, 2007 and it was re-established to the importing item approval department, the period from November 26, 2007 to November 26, 2007 is a period for which no examination has been conducted by the relevant department.
In light of the facts alleged by the Defendants, even if there was a request from November 1, 2007 to November 26, 2007 for the Council concerning the examination of safe and remaining conditions, the validity of the results of the examination and the examination of documents regarding the final item approval shall be deemed to have been carried out from that time. Furthermore, considering that the completion period of the period during which the working of a patented invention could not be carried out by the Pharmaceutical Affairs Act, etc. reaches the applicant and the disposition of permission, etc. under the Pharmaceutical Affairs Act, etc. is the date on which the disposition becomes effective, it is reasonable to deem that the above period of the Defendants’ assertion falls under
Therefore, this part of the Defendants’ assertion is difficult to accept.
4. Conclusion
Therefore, there is no reason to seek revocation of the instant trial decision regarding the period 2. However, as long as the part seeking revocation of the instant trial decision is based on the grounds for the claim for revocation of the period 1, it would affect the whole period of the registered extension, and thus, it is reasonable to have the Intellectual Property Trial and Appeal Board rendered a trial decision invalidating registration of extension only for the extended period exceeding the period during which the instant patent invention could not be implemented pursuant to Article 134(3) of the former Patent Act. Ultimately, the instant trial decision should be
Therefore, the plaintiff's claim seeking the revocation of the trial decision of this case is justified, and this is accepted, but since the plaintiff actually lost part of it, it is decided as per Disposition by applying Articles 98 and 101 of the Civil Procedure Act to the burden of litigation costs.
Judges Kim Jong-jin (Presiding Judge)
1) Examination of the standards and testing methods for pharmaceutical products is to examine whether the standards for the manufacture and quality control of pharmaceutical products [for example, sex, net level, content, quantitative method, special test (fire extinguishing force, micro-organism test)] and specific testing methods for confirmation are determined; hereinafter referred to as “regular examination”).
Note 2) Safety and effectiveness tests are to examine safety and effectiveness, such as toxicity, pharmacological action, etc., as a result of clinical trials on drugs subject to a license; hereinafter referred to as “alternative and genetic testing”).
Note 3) Raw material information on drugs means information on drugs, namely, the facility details of the relevant raw material factory for the relevant drug; in other words, net organic solvents; process management; packaging materials; stability test materials; and the examination of material drug information is an assessment of the aforementioned matters; hereinafter referred to as “DMF examination”).
4) The delivery date of the import marketing approval means the date on which the import marketing approval (No. 41 certificate) reaches the applicant.
(5) Article 89(1) and (2) of the former Patent Act (amended by Act No. 12753, Jun. 11, 2014) stated in the relevant legal doctrine are the same purport as Article 89, Article 91(1)3, and Article 91(2) of the former Patent Act applied in this case.
Note 6) The part pertaining to the instant permission is the color marking (the coloring and red marking part is added to the part pertaining to other permitted matters).
Note 7) sets forth the scope of data to be submitted for drugs, etc.
Note 8) See the Plaintiff’s preparatory brief dated August 20, 2020 20
9) Around March 2006, an application for marketing approval was filed in the United States with respect to the instant pharmaceutical product, but the United States failed to obtain marketing approval in the United States.
10) The Plaintiff also recognized the fact that the instant item license was made prior to the enforcement of the civil petition history system, and thus, the civil petition history card was not prepared.