[1] In a case where the procedure of permission, etc. is delayed due to a cause attributable to a person who obtained permission, registration, etc. pursuant to the Pharmaceutical Affairs Act, etc. to implement an invention of drugs, etc., whether the period for which causes are recognized

[2] Whether the “reasons attributable to a patentee” under Article 89(2) of the former Patent Act includes the grounds related to the exclusive licensee and non-exclusive licensee who filed an application for permission, etc. necessary to obtain the registration of extension of a patent term when determining the “reasons attributable to a patentee”

[3] In a case where a trial for invalidation of registration of term extension is requested pursuant to Article 134(1)3 of the former Patent Act on the ground that the extended period exceeds the period during which permission, etc. was delayed due to a cause attributable to a person who obtained permission, registration, etc. pursuant to the Pharmaceutical Affairs Act, etc. to implement an invention of a drug, etc., and the extended period exceeds the period during which the patented invention cannot be executed, the person who is liable to assert and prove the cause (=a person who files a

[4] Even if the examination of supplemental requirements for the application for permission for manufacture, sale, and import of drugs by the Ministry of Food and Drug Safety failed to proceed with the examination of supplemental data by the request of any of the Review departments of the Ministry of Food and Drug Safety, in cases where the procedures of examination, etc. for permission for manufacture, sale, and import of the relevant drugs have been continued in the past, whether the procedure of permission, etc. may be deemed to be delayed due to a cause attributable to the person who obtained permission or registration

[1] In order to implement an invention of a medicine, etc., permission, etc. shall be obtained in accordance with the Pharmaceutical Affairs Act, etc. in order to promote public health and sanitation and to ensure safety and effectiveness of the invention. A patentee may not perform the patented invention in the process of obtaining such permission, etc. Therefore, in order to relieve such disadvantages and protect and encourage the invention of a medicine, etc., Article 89(1) of the former Patent Act (amended by Act No. 12753, Jun. 11, 2014; hereinafter the same) provides for a system for extending the term of a patent right for an invention prescribed by the Presidential Decree, which takes a long time due to an examination of activation, safety, etc. necessary for executing the patented invention (hereinafter “permission, etc.”) by providing that “The term of a patent right may be extended by up to five years for the period during which it could not be implemented, notwithstanding the provisions of Article 88(1).”

However, Article 89(2) of the former Patent Act provides, “In the application of paragraph (1), the period required for a cause attributable to a patentee shall not be included in “unable period” under paragraph (1). Thus, where a procedure for permission, etc. is delayed due to a cause attributable to a person who obtained the permission, etc., the period for which such cause is recognized shall not be included in the scope of extension of the patent term.

[2] The scope of persons eligible to file an application for permission, registration, etc. necessary to obtain registration for extension of the term of a patent (hereinafter “permission, etc.”) includes exclusive or non-exclusive licensee, other than a patentee. Thus, the determination of “reasons attributable to a patentee” under Article 89(2) of the former Patent Act (amended by Act No. 12753, Jun. 11, 2014) includes the grounds related to the exclusive or non-exclusive licensee who filed the application for the said permission, etc.

[3] In order to practice an invention of a medicine, etc., a person who requests a trial to invalidate the registration of extension of the term of a patent under Article 134(1)3 of the former Patent Act shall be liable to assert and prove the cause thereof, on the ground that the extended period exceeds the period during which permission, etc. is delayed by registration of extension due to a cause attributable to a person who has obtained permission, registration, etc. pursuant to the Pharmaceutical Affairs Act, etc., and the extension period exceeds the period during which the patented invention cannot be executed under Article 89(1)3 of the former Patent Act.

[4] The permission for manufacturing, selling, and importing items of drugs by the Ministry of Food and Drug Safety is conducted with respect to the application for permission by the relevant examination department for each of the matters stipulated in Article 4(1) of the Regulations on Safety of Drugs, etc., and specific examination procedures, including the request for supplementation, are also conducted in accordance with the internal circumstances of the relevant examination department. However, the examination by the relevant examination department is limited to the division of duties within the Ministry of Food and Drug Safety, and all of the examination procedures should be completed. Ultimately, the procedure for the examination by the examination department is an intermediate process leading to the final permission, and can be evaluated as a whole as

In light of these circumstances, even if a request for supplement was made by a review division within the Ministry of Food and Drug Safety and the review of the requirements for supplement was not carried out until materials are submitted as a result, the period can also be deemed the period required for permission, unless there are other special circumstances. Thus, it cannot be readily concluded that the procedure for permission, registration, etc. is delayed due to reasons attributable to a person who obtained permission, registration, etc. in accordance with the Pharmaceutical Affairs Act, etc. to implement the invention of drugs, etc.

[1] Article 89 of the former Patent Act (Amended by Act No. 12753, Jun. 11, 2014) / [2] Article 89(2) of the former Patent Act (Amended by Act No. 12753, Jun. 11, 2014) / [3] Articles 89 and 134(1)3 of the former Patent Act (Amended by Act No. 12753, Jun. 11, 2014) / [4] Article 89 of the former Patent Act (Amended by Act No. 12753, Jun. 11, 2014); Article 4(1) of the Rules on Safety of Drugs, etc.

Hanm Co., Ltd. and three others (Bae, Kim & Lee LLC et al., Counsel for the plaintiff-appellant)

1. As to the ground of appeal pointing this out, the court below erred by misapprehending the legal principles on the grounds of appeal, thereby affecting the conclusion of the judgment.

Patent Court Decision 2016Heo4498, 4504, 4511, 5620 decided March 16, 2017

All appeals are dismissed. The costs of appeal are assessed against the plaintiffs.

The grounds of appeal are examined (to the extent of supplement in case of supplemental appellate briefs not timely filed).

1. As to the grounds of appeal Nos. 1 to 4, and 6

A. In order to implement an invention of a medicine, etc., permission, etc. is required in accordance with the Pharmaceutical Affairs Act, etc. in order to promote public health and sanitation and to ensure safety and effectiveness thereof. A patentee is at a disadvantage in failing to implement the patented invention in the process of obtaining such permission, etc. Therefore, in order to remedy such disadvantage and protect and encourage the invention of a medicine, etc., Article 89(1) of the former Patent Act (amended by Act No. 12753, Jun. 11, 2014; hereinafter the same) provides for a system for extending the term of patent rights by providing that “an invention prescribed by Presidential Decree, which takes a long period of time due to an activity, safety test, etc. necessary for executing the patented invention (hereinafter “permission, etc.”), notwithstanding the provisions of Article 8(1) of the former Patent Act, for the period during which it could not be worked, may not extend the term of patent rights by up to five years.”

However, Article 89(2) of the former Patent Act provides, “In applying Article 89(2) of the former Patent Act, the period required for a cause attributable to a patentee shall not be included in “non-working period” under paragraph (1). Thus, in cases where a procedure for permission, etc. is delayed due to a cause attributable to a patentee, the period for which the cause attributable to the patentee is recognized shall not be included in the scope of extension of the patent term. Meanwhile, the scope of a person eligible to apply for permission, etc. necessary to obtain registration of extension of the patent term includes an exclusive licensee and non-exclusive licensee, other than the patentee. Therefore, even in determining “reasons attributable to a patentee,” it is reasonable to interpret that the said provision

In addition, a person who requests a trial to invalidate the registration of extension of term under Article 134(1)3 of the former Patent Act on the ground that the extended period exceeds the period during which permission, etc. is delayed due to a cause attributable to the person who has obtained permission, etc., and the extended period exceeds the period which could not work the patented invention under Article 89(1) of the former Patent Act, shall be liable to assert and prove such cause.

B. The lower court acknowledged the following facts based on the evidence duly admitted.

(1) On June 23, 2010, the Defendant registered the instant patent invention (patent registration number omitted) under the name of “herebical light treatment chemicals using an Athiopid guide as active ingredients,” and concluded a non-exclusive license agreement on the instant patent invention with the Korea Youth Chemicals Co., Ltd. (hereinafter “Korea Youth Chemicals”), and registered the said non-exclusive license on January 24, 2014.

(2) On January 31, 2013, the Republic of Korea filed an application for marketing approval of the instant patent invention with the Minister of Food and Drug Safety on the 50mg (raw materials: U.S. S. S. S. S. S. S. S. S. S. S. S. S. S. S. S. S. S. S. S.C. on the following grounds: (a) the Minister of Food and Drug Safety applied for marketing approval of drugs; (b) the examination of safety and effectiveness; and (c) the standard and method of testing; and (d) the application for evaluation of the criteria for manufacturing and quality control of drugs (hereinafter “GMP”).

(3) On March 20, 2013, the Minister of Food and Drug Safety: (a) requested supplementary data on the examination of safety and effectiveness, criteria and method of examination, and DMF examination; and (b) on July 25, 2013, the Minister of Food and Drug Safety submitted supplementary data on the examination of safety and effectiveness, standards and method of examination, and DMF examination on May 29, 2013; and (c) on December 12, 2013, the Minister of Food and Drug Safety submitted supplementary data on the evaluation of GMF. The Minister of Food and Drug Safety, after the examination of supplementary data, approved the importation of drugs on December 31, 2013.

(4) On March 28, 2014, the Defendant filed an application for registration of an extension with the Commissioner of the Korean Intellectual Property Office with respect to the claims under paragraphs (1) through (10) of the instant patent invention, 48 days from June 23, 2010, from June 23, 2010, until August 10, 2010, the date the patent registration was completed, plus 334 days from January 31, 2013, the date the application for permission for import was filed to the applicant, plus 334 days from December 31, 2013, the date the decision for permission for import became final, and accordingly the registration of extension (hereinafter “instant registration”).

C. The lower court determined as follows based on the aforementioned factual basis.

(1) According to the above import marketing approval, the period during which the instant patent invention could not be executed shall be calculated based on 48 days from June 23, 2010, which was the date the establishment of the patent right is registered, to August 10, 2010, and 334 days from January 31, 2013, which was the date the application for import marketing approval was submitted and from December 31, 2013, which was the date the application for import marketing approval was submitted to the applicant.

(2) The period of review interrupted by each review division within the Ministry of Food and Drug Safety is from March 20, 2013 to May 29, 2013 (hereinafter “period 1”) which is the date on which a request for complementary data is made for the standards and method of testing, and from July 25, 2013 to December 12, 2013, which is the date of request for complementary data from July 25, 2013 to the date of submission of supplementary data (hereinafter “period 2”).

However, since the examination of the GMF evaluation division was continued during the above "period 1", it cannot be deemed that the period for correction is the period delayed due to the patentee's responsible reasons since there is no proximate causal relation between the causes attributable to non-exclusive licensee and the delay of permission. Furthermore, since the Council was on December 4, 2013 with respect to the DMF examination, it shall be deemed that the DMF examination division was being conducted from July 25, 2013 to December 3, 2013 during the "period 2," and therefore, the above period cannot be deemed as the period delayed due to the patentee's responsible reasons. However, since there is no proximate causal relation between the causes attributable to non-exclusive licensee and the delay of permission, it shall not be deemed that there was a delayed causal relation between the above "period 2" and the period from December 4, 2013 to December 12, 2013.

(3) Therefore, there is no ground for invalidation under Article 134(1)3 of the former Patent Act with respect to the registration of the instant extension.

D. In light of the above legal principles and the relevant laws and records, the following is determined.

(1) The permission for manufacturing, selling, and importing items of drugs by the Ministry of Food and Drug Safety is conducted with respect to the application for permission by the relevant examination department for each of the matters stipulated in Article 4(1) of the Regulations on Safety of Drugs, Etc., and the specific examination procedures, including the request for supplementation, are also conducted in accordance with the internal circumstances of the relevant examination department. However, the examination by the relevant examination department is limited to the division of duties within the Ministry of Food and Drug Safety, and all of the examination procedures should be completed. Ultimately, the procedure for the examination by the examination department is an intermediate process leading to the final permission, and can be evaluated as a whole

In light of these circumstances, even if a request for supplement was made by a review division within the Ministry of Food and Drug Safety and the review of the request for supplement was not carried out until the report was submitted as a result, the period can also be deemed the period required for permission, unless there are other special circumstances. Thus, it cannot be readily concluded that the procedure for permission, etc. is delayed due to reasons attributable to a person who obtained permission, etc. on the ground that it is a period due to reasons attributable to the person who obtained permission, etc.

(2) According to the reasoning of the lower judgment, there is no period during which the examination by the Ministry of Food and Drug Safety was not conducted at all among the periods during which the instant patented invention was not implemented, and there is no other evidence to acknowledge the period to be excluded from the “reasons of a person who obtained permission, etc.”. Therefore, the instant registered extension cannot be deemed as grounds for invalidation under Article 134(1

(3) Therefore, the lower court’s conclusion that the instant registration of extension did not have such grounds for invalidation is acceptable. In so doing, contrary to the allegations in the grounds of appeal, there were no errors by misapprehending the legal principles as to the causes attributable to, and the duty of care to, the patentee, the causes attributable to, and the period required for permission, etc., and the proximate causal relation between the causes

2. As to the fifth ground for appeal

A. The lower court determined as follows on the grounds stated in its reasoning.

(1) As a ground for invalidation of provisional registration under Article 134(1)2 of the former Patent Act, “the case where a registered non-exclusive licensee has registered the extension of a patent right with respect to an application for which no permission, etc. has been obtained” means that the scope of a non-exclusive licensee is included in the scope of a person eligible to apply for permission, etc. necessary to obtain registration of extension of patent term. However, in light of the essential matters in the application for registration of extension of patent right and evidentiary materials, if the registration of a non-exclusive licensee has been registered with omission, it is reasonable to interpret that the registration should be invalidated because the non-exclusive licensee fails to meet the lawful registration requirements. On the contrary, the purport that the non-exclusive licensee who applied for the permission, etc. should complete

(2) At the time of the application for marketing approval of the instant patent invention, the Republic of Korea esthers medicine was in the position of a non-exclusive licensee who is legally able to practice the instant patent invention at the time of the application for marketing approval of import, and the patent registration of the instant patent invention and the submission of evidentiary materials therefor was made before the certified copy of the decision of patent examiner

B. Examining the reasoning of the lower judgment in light of the relevant statutes and the records, including the duly admitted evidence, the lower court’s determination is acceptable, and contrary to what is alleged in the grounds of appeal, there were no errors by misapprehending the legal doctrine on the interpretation of Article 134(1)2 of the former Patent Act.

3. Conclusion

Therefore, all appeals are dismissed, and the costs of appeal are assessed against the losing party. It is so decided as per Disposition by the assent of all participating Justices on the bench.

Justices Park Sang-ok (Presiding Justice)