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

A. Patent invention of this case

(i) Name: the method of manufacturing 9-Sim monin acid;

2) The international filing date/Priority Claim date/registration date/registration number: April 2, 2004/ April 11, 2003/ July 20, 2007 (registration number omitted)

3) A patentee: The plaintiff

4) Claims

The following chemical-type I’s 3-Meethyl-4-loakton acid containing a reaction reactioner with (Z)-Trinated salt of the following chemical-type II under the existence of a salter;

At this time, the method of manufacturing 9-(Z)-Emar acid, characterized by the characteristics of alkn chlorates of the chemical type I 3-Meethyl-4-Maxine alkyl chloride in the same reaction system, which are generated by decomposing from alkylchloro-3-Mechloro-4-Maxlorates, in the same reaction system:

Chemical Type I

A person shall be appointed.

Chemical Type II

A person shall be appointed.

In the above-mentioned formula:

M is Cyllium or kyllium;

X is halogen.

[Request 2, 11, 12] Deleted.

【Claim 3-10】 Attached Form

(b) Manufacturing and marketing marketing approval of drugs;

1) Date of permission: April 15, 2013

2) Details of permission: Import approval of medicines under Article 42 of the Pharmaceutical Affairs Act (hereinafter “instant item approval”).

(iii) active ingredients: 9-Sim Lestinocination (9-ccibination)

4) Item name: Alphreti older person (Altiretinoin)

5) Product name: Aluri Stockholm, capsule 10 milligrams (hereinafter referred to as “instant drug”).

6) Efficacy and effectiveness: A strong 4 weeks’ severe chronic loss of adults who do not respond to a strong national scard treatment.

C. Application for the extension of this case and decision of refusal

1) On July 15, 2013, the Plaintiff filed an application for registration of extension of the term of a patent right with Claim Nos. 1, 3, and 10 (hereinafter “patent subject to extension”) among the instant patent inventions as “claim subject to extension” on the ground that 458 days for the instant marketing approval were required (the filing number omitted; hereinafter “instant extension application”).

2) On November 12, 2013, the Korean Intellectual Property Office examiner notified the instant extension application on the ground that “The instant patent invention does not constitute a drug invention subject to an application for registration of extension, and the instant patent invention does not constitute an invention subject to an application for registration of extension, on the grounds that “as the instant patent application had already been permitted with respect to the said product and its principal ingredients (mainly 1) the same permission as the said product and its principal ingredients (mainly 1) prior to the instant patent application, the instant patent invention cannot be seen as a drug for which the first marketing approval was granted with new materials as its effective ingredients. Moreover, the period of application for extension exceeds the period during which the instant patent invention could not be implemented.”

Note 1)

3) Meanwhile, on April 14, 2014, the Plaintiff submitted an amendment to correct the application period for registration of extension on April 14, 2014 as 457 days, and submitted a written opinion to the effect that “The elderly in Altititi, an effective ingredient of the instant medicine, is a new substance, and the chemical structure of the active part indicating the efficacy is a new substance compared with the elderly in Altititi, which must be recognized as

4) On August 18, 2014, the Korean Intellectual Property Office examiner decided to reject the instant drug on the ground that “the instant drug does not fall under “new medicine” under Article 2 subparag. 8 of the Pharmaceutical Affairs Act, and is not subject to the application for registration of extension, and the grounds for rejection under the notification of submission of opinions have not been resolved.”

D. Details of the instant trial decision

1) On September 17, 2014, the Plaintiff filed a petition for an appeal against the foregoing decision of refusal with the Intellectual Property Trial and Appeal Board No. 2014 Won5801.

2) On September 23, 2016, the Intellectual Property Trial and Appeal Board dismissed the Plaintiff’s appeal on the following grounds.

The drug contained in the main text contains Alti-Mythy's active ingredients, and obtained permission on April 15, 2013. Before the permission was granted for the above product, beer No-Mythy's license was granted. The elderly in Alti-Mythy's term is "9-Mythy's lethy's lethy's lethy" and Leti-Myth's lethy's lethy's lethy's lethy's lethy's lethy's lethy's lethy's lethy's lethythy's lethythy's lethy's lethythy's lethy's lethy's lethythy's lethy's leththy's lethy's lethy's leththy's leththy's lethth's lethth's eththth'

E. Relevant statutes

본문내 포함된 표 1) 구 특허법(2014. 6. 11. 법률 제12753호로 개정되기 전의 것, 이하 같다) ■ 제89조(허가 등에 따른 특허권의 존속기간의 연장) ① 특허발명을 실시하기 위하여 다른 법령의 규정에 의하여 허가를 받거나 등록 등을 하여야 하고, 그 허가 또는 등록 등(이하 ‘허가 등’이라 한다)을 위하여 필요한 활성·안전성 등의 시험으로 인하여 장기간이 소요되는 대통령령이 정하는 발명인 경우에는 제88조 제1항의 규정에 불구하고 그 실시할 수 없었던 기간에 대하여 5년의 기간 내에서 당해 특허권의 존속기간을 연장할 수 있다(이하 ‘이 사건 위임 조항’이라 한다). 2) 특허법 시행령(2013. 4. 3. 대통통령 제24491호로 개정된 것)(주2) ■ 제7조(허가 등에 따른 특허권의 존속기간의 연장등록출원 대상 발명) 법 제89조 제1항에서 “대통령령이 정하는 발명”이란 다음 각호의 어느 하나에 해당하는 발명을 말한다. 1. 특허발명을 실시하기 위하여「약사법」제31조 제2항, 제3항 또는 제42조 제1항에 따라 품목허가를 받아야 하는 의약품[신물질(약효를 나타내는 활성부분의 화학구조가 새로운 물질을 말한다. 이하 이 조에서 같다)을 유효성분으로 하여 제조한 의약품으로서 최초로 품목허가를 받은 의약품으로 한정한다]의 발명(이하 ‘이 사건 시행령 조항’이라 한다) 2. 특허발명을 실시하기 위하여「농약관리법」제8조 제1항, 제16조 제1항 및 제17조 제1항에 따라 등록하여야 하는 농약 또는 원제의 발명 3) 구 약사법(2013. 3. 23. 법률 제11690호로 개정된 것, 이하 같다) ■ 제2조(정의) 이 법에서 사용하는 용어의 뜻은 다음과 같다. 8. “신약”이란 화학구조나 본질 조성이 전혀 새로운 신물질 의약품 또는 신물질을 유효성분으로 함유한 복합제제 의약품으로서 식품의약품안전처장이 지정하는 의약품을 말한다.(주3) ■ 제31조(제조업 허가 등) ① 의약품 제조를 업으로 하려는 자는 대통령령으로 정하는 시설기준에 따라 필요한 시설을 갖추고 총리령으로 정하는 바에 따라 식품의약품안전처장의 허가를 받아야 한다. ⑪ 제1항부터 제4항까지 및 제9항에 따른 의약품 등의 제조업·위탁제조판매업 및 제조판매품목의 허가 또는 신고를 할 때 허가 또는 신고의 대상·기준·조건 및 관리 등에 관하여 필요한 사항은 총리령으로 정한다. ■ 제42조(의약품 등의 수입허가 등) ① 의약품 등을 수입하려는 자(이하 ‘수입자’라 한다)는 총리령으로 정하는 바에 따라 품목마다 식품의약품안전처장의 허가를 받거나 신고를 하여야 한다. 허가받은 사항 또는 신고한 사항을 변경하려는 경우에도 또한 같다. ④ 제1항에 따라 수입되는 의약품 등 또는 그 수입자에 관하여는 제31조 제7항·제10항·제11항을 준용한다. 이 경우 “제조” 또는 “생산”은 각각 “수입”으로, “제조업자” 또는 “품목허가를 받은 자”는 각각 “수입자”로 본다. ⑤ 제1항에 따른 의약품 등의 수입 품목 허가 또는 신고의 대상·기준·조건 및 관리 등에 필요한 사항은 총리령으로 정한다. 4) 의약품의 품목허가·신고·심사 규정(2013. 4. 3. 대통통령 제24491호로 개정된 것) ■ 제1조(목적) 이 고시는「약사법」제31조, 제35조, 제42조, 제76조에 따라 의약품의 제조판매품목허가 또는 신고, 의약품의 수입품목허가 또는 신고, 의약품의 안전성·유효성과 기준 및 시험방법의 심사에 있어 대상품목, 자료의 종류·작성 요령·요건·면제범위, 기준 및 관리 등에 관한 세부사항을 규정함을 목적으로 한다. ■ 제2조(정의) 이 규정에서 사용하는 용어의 정의는 다음 각호와 같다. 1.“유효성분”이란 내재된 약리작용에 의하여 그 의약품의 효능·효과를 직접 또는 간접적으로 발현한다고 기대되는 물질 또는 물질군(약리학적 활성성분 등이 밝혀지지 아니한 생약 등을 포함한다)으로서 주성분을 말한다. 7. “신약”이란「약사법」제2조 제8호에 따른 의약품으로서 국내에서 이미 허가된 의약품과는 화학구조 또는 본질 조성이 전혀 새로운 신물질 의약품 또는 신물질을 유효성분으로 함유한 복합제제 의약품으로서 [별표 1]의 의약품의 종류 및 제출자료의 범위 중 Ⅰ에 해당하는 의약품을 말한다. 다만「대한민국약전」(식품의약품안전처 고시) 또는 [별표 1의2]에 따라 식품의약품안전처장이 인정하는 공정서 및 의약품집에 수재된 품목은 제외한다. 8. “안전성·유효성심사 자료제출의약품(이하 ‘자료제출의약품’이라 한다)”이란 신약이 아닌 의약품이면서 이 규정에 의한 안전성·유효성 심사가 필요한 품목으로서 [별표 1]의 의약품의 종류 및 제출자료의 범위 중 Ⅱ에 해당하는 의약품(주4)을 말한다.

2) Enforcement Decree of the Patent Act (amended by Presidential Decree No. 24491, Apr. 3, 2013)

Note 3) means

Note 4) Drugs

[Reasons for Recognition] Facts without dispute, Gap evidence Nos. 1 through 4, 6, Eul evidence Nos. 1, 2, and 13, the purport of the whole pleadings

2. The parties' assertion

A. Summary of the plaintiff's assertion

For the following reasons, the instant trial decision that maintained the rejection ruling rejecting the instant extension application as it is shall be revoked as it is unlawful.

1) The purport of the amendment of the Enforcement Decree of the instant case is to separately regulate an application for registration of extension by excluding the extension of the term of a patent based on a new, distinctive medicine medicine where active and safety are not verified by the existing permission, or the subject of extension of the term of a patent is not limited to an invention “new medicine” under the Pharmaceutical Affairs Act, not to determine according to the definition of “new medicine” under Article 2 subparag. 8 of the former Pharmaceutical Affairs Act, but to determine whether a medicine, which serves as the basis for application for registration of the term of a patent, contains “new substance” as an effective substance, by excluding the extension of the term of a patent based on “a subsequent permission that alters the use or type while including the active substance, or changes only the subject of treatment,” in the event that safety is already confirmed by the existing permission.

2) However, Alriti Seniors, the basis of which is the extension application of this case, are the active ingredients of the instant medicine, and the chemical structure is different compared to the existing active ingredients of the instant medicine, and there is a difference between the types of accommodation combined due to such structural differences, and clinical medicine effect is also different. Furthermore, the instant medicine, separate from the clinical trials of the previously permitted products, was granted 14 clinical tests, and obtained the instant item license under the condition that the instant medicine was equipped with safety and effectiveness data necessary for permission.

3) Therefore, it is clear that the elderly Altity constitutes a new substance (new substance) with the chemical structure of the active part indicating the efficacy, as stipulated in the instant provision of the Enforcement Decree.

B. Summary of the defendant's assertion

For the following reasons, the extension of the instant application must be refused.

1) Since the extension of the term of existence system is a system derived from the United States, the pharmaceutical product subject to application for registration of extension shall be deemed to be a drug that obtained marketing approval as “new drug” like the U.S. Patent Act.

2) The reason why the instant provision was amended is to clarify the legal basis for limiting the invention subject to application for registration of extension of term extension as above, and to exclude the patented invention relating to “pharmaceuticals” which is partially exempt from submission of data for safety and effectiveness review due to the confirmation of activation and safety by existing permission from the scope of extension of term extension.

3) The instant medicine is “data submission medicine” and was exempted from the submission of some permission data due to the existence of the existing permission for medicines for the elderly, and also shows the common nature and efficacy that all the elderly in Alti and Leti are combined into the RARs (5) a week, and the common nature and efficacy of the instant medicine are expressed, and three different characters of the instant medicine (9-Sim Nos. 10, 2000, 6) are two different characters of the instant medicine, namely, three different characters of the instant medicine, namely, three different characters of the instant medicine (9-Sim Nos. 10, 200, 2000, 2000, 2000, 2000, 3000,000

3. Whether the trial decision of this case is unlawful

A. Interpretation of the Enforcement Decree of this case

1) Method of interpretation

As a matter of principle, since the law is a universal norm with the same binding force against many and unspecified persons, it is necessary to clarify the standard meaning of the law in its interpretation so as to ensure objective validity, and to maintain consistency with all the people as much as possible so as to avoid undermining legal stability. Meanwhile, since positive law is established in consideration of a universal and typical matter, it is also required to interpret that the law can be the most reasonable solution appropriate for specific matters in applying the law in various cases that occur in society reality. In short, the goal of statutory interpretation must be to find concrete validity within the extent that does not undermine legal stability. Furthermore, in principle, the interpretation must be faithfully interpreted within the ordinary meaning of the text used in the law, as far as possible, in light of the legislative intent and purpose of the law, the history of its enactment and amendment, harmony with the entire legal order, and relationship with other Acts and subordinate statutes, thereby complying with the above request for statutory interpretation (see, e.g., Supreme Court en banc Decision 2013Da343181, Jul. 17, 2013).

2) Specific interpretation

A) The history of the amendment

(1) As the Patent Act was amended by Act No. 3891 on December 31, 1986, the extension of the term was first introduced, and the patent law was amended by Act No. 4207 on January 13, 1990, and the location of the provision was changed to Article 89 at the same time, and there was a change in the location of the provision on several occasions, such as deletion of the lower limit of less than two years in the patent law. However, as a substitute until the former Patent Act, the requirement for extension of the term was prescribed to mean the extension of the term of an invention “an invention as prescribed by the Presidential Decree requiring a long period of time due to tests of activity, safety, etc. under other Acts and subordinate statutes” for the purpose of permission, registration, etc. (hereinafter “permission, etc.”).

(2) Meanwhile, after the enforcement of the Patent Act, the term extension extension application system was introduced, the term “an invention determined by the President” under the delegation of the Patent Act, and the term “an invention of a drug subject to marketing approval under the Pharmaceutical Affairs Act to practice a patented invention.” However, only the term “Article of the Enforcement Decree of the instant case” prescribed the meaning of the said drug as “a drug manufactured with a new substance (referring to a substance whose chemical structure in the active part having medicinal effects is new) as an effective substance, and for which the first marketing approval has been granted.”

In the process of amendment of the provision of the Enforcement Decree of this case, the Enforcement Decree of the Patent Act, which includes the contents of defining “new substance” for the purpose extremely similar to the definition provision of “new substance” under the former Pharmaceutical Affairs Act, was pre-announceed (Article 7-1, 2, 8-1, 2, and 8-2 of the evidence No. 7), but the actual amendment was conducted differently from the contents of the legislative notice (the Defendant did not submit any data on the grounds that the amendment was made differently from the legislative notice, even though he requested the Ministry of Government Legislation to examine the above amendment).

B) Legislative intent and purpose

(1) In the process of the amendment of the Patent Act (amended by Act No. 3891, Dec. 31, 1986), explanatory materials, examination reports, etc., which were introduced for the first time by the extension system, include the following:

Since more research and development costs and long-term regulations on products, such as safety and pollution prevention, are strengthened as the period required for the commercialization of the invention is gradually long, and the period required for the commercialization of the invention is relatively short for the inventor who has received the patent to sell the patent product in the market and receive compensation for the effort to make the invention, the patent period of 12 years now shall be extended to 15 years according to international general practices within the extent that does not seriously undermine the interests of the consumers of the patent product, and the patent restitution system is newly introduced to strengthen the protection of the inventor by adopting the patent restitution system.

(2) Considering the legislative intent and purpose of the aforementioned Act, the extension of the term under the former Patent Act is a system that extends the term of a patent to an invention that requires permission, etc. under the statutes to practice a patented invention within the term of a patent, and that requires a long period of time due to necessary tests, etc., for a period not exceeding five years. In the case of an invention of medicine, agricultural chemicals, etc., permission, registration, etc. shall be obtained from the regulatory authority in accordance with the Pharmaceutical Affairs Act or the Agrochemicals Control Act, etc. aimed at securing safety and effectiveness to practice the invention. For this purpose, a long period of time is required to undergo necessary tests, examinations, etc., and a patent holder suffers disadvantages without executing the patented invention during the said period. This goes against equity compared with patent rights in other industries. Accordingly, Article 89 of the former Patent Act provides that the term of a patent may be extended to the extent of five years for which permission, etc. could not be granted to promote technological development by resolving such unreasonable outcomes and protecting and encouraging the invention of medicines, etc.

C) The purpose of delegation

(1) As the standard to determine a patented invention subject to application for registration of extension of the term of existence belongs to highly professional and technical matters and needs to revise its contents in order to actively and flexibly cope with technological development or age situations, the instant delegation provision is delegated to subordinate statutes instead of directly stipulating the specific and detailed contents of the said standard in the law. However, the instant delegation provision limited the scope of the patented invention subject to registration of extension to “an invention requiring a long period of time due to an activity, safety test, etc. necessary for permission, etc.”

(2) In light of the legislative purport, purpose, content, and form of the instant delegation clause, in interpreting the scope of delegation clause, whether a long-term period of time is required due to activity, safety test, etc. for permission, etc. cannot be said to be an absolute standard. In other words, even if a “new drug” invention requires more long-term period of time in clinical trials, examination, etc. compared with other pharmaceutical inventions and requires continuous development for permission, etc. even after filing an application, considering the legislative purport, purpose, content, and form of the instant delegation clause, the scope of delegation clause cannot be interpreted to be limited to an “new drug” invention based on such circumstances.

(3) In cases of products whose term extension system was extended, approved or registered as “new drug” after the introduction of the extension system, a considerable number of years of extension period is less than one year (Evidence Nos. 25 through 28, No. 29-1 through 3). Considering the fact that an examination of the instant medicine was conducted for 484 days at the place of food and drug at the place of food and drug as to the instant medicine, it is difficult to readily conclude that the term “period required due to testing activity, safety, etc.” is limited to a new drug. Such circumstances also are grounds for limiting the scope of authorization of the instant delegation provision to a new drug invention.

D) Ordinary meaning of the language and text

(1) Article 2(1) of the Enforcement Decree of the instant case provides that “an invention related to a drug for which a first marketing approval is granted, which is a product manufactured with a new substance whose chemical structure in the active part indicating efficacy is a new substance as an effective ingredient, as one of the inventions subject to extension of duration.”

However, such a provision on the definition of “new substance” is obvious that it does not coincide with the definition of new medicine under Article 2 of the former Pharmaceutical Affairs Act (hereinafter “new medicine” refers to a new material medicine, the creation of a chemical structure or essence of which is entirely new, or a composite medicine, the substance of which contains new materials as effective ingredients, as designated by the Minister of Food and Drug Safety).

Meanwhile, Article 2 subparag. 7 of the former Pharmaceutical Affairs Act defines new drugs for the purposes similar to those of the former Pharmaceutical Affairs Act (Article 2 subparag. 7); and Article 2 subparag. 1 of the same Act defines the meaning of “effective ingredients” as “material group or material group (including raw drugs, etc., in which the efficacy and effect of which are expected, directly or indirectly, by internal pharmacological action, are not revealed).” (Article 2 subparag. 1).

(2) It seems that there is no generally established concept about the meaning of "virative part indicating efficacy" in the pharmaceutical field.

(3) Meanwhile, the issue arises as to whether a pharmaceutical invention can be qualified for extension of the term of existence. The pharmaceutical invention is “here-use invention” (see, e.g., Supreme Court Decision 2012Hu3664, May 16, 2014); “alternative invention” (see, e.g., Supreme Court Decision 2012Hu3664, May 16, 2014); “absent invention” (see, e.g., Supreme Court Decision 2002Hu1935, Oct. 24, 2003); “abste-type invention” (see, e.g., Supreme Court en banc Decision 2010Hu2865, Jul. 14, 201); “abste-type invention” (see, e.g., Supreme Court Decision 2009Hu4322, Oct. 13, 2011; 2015Hu2515, etc.).

Invention of medicinal use is an essential professional idea that a specific substance (i.e., active component; hereinafter referred to as “vient component”) has a treatment effect against a specific disease. The active component and its pharmaceutical use are inventions (see, e.g., Supreme Court Decision 2012Hu3664, May 16, 2014). Alternative invention claiming a compound, which is a subordinate concept of active component, has the treatment effect on a specific disease. Furthermore, the treatment effect of an invention has a common effect on a specific disease if it is revealed that it has treatment effect on a specific disease. In addition, the treatment effect of a specific medicine invention has the treatment effect on a specific disease.

(4) Taking into account the foregoing examples of use and the meaning of active elements in the invention of a medicine, it seems natural to interpret the chemical structure of the part that represents the treatment effect of a specific disease as a new substance by using an inherent pharmacological action in the composition of a medicine rather than by deeming it as a new drug under the former Pharmaceutical Affairs Act, as alleged by the Defendant.

E) General: Interpretation of the Enforcement Decree of the instant case

Considering the legislative intent and purpose of the former Patent Act, the purport of delegation, and the history of amendment, centering on the literal meaning of the delegation provision of this case and the enforcement decree of this case, it is reasonable to deem that a drug under the enforcement decree of this case is a drug that has treatment effect different from that of the existing permitted drug, and at the same time, manufactures “new substance with the chemical structure of the part that represents the above treatment effect compared with the existing permitted drug” as an effective substance, and thus, is a drug that has obtained marketing approval for the first time (However, in the legislative theory, it is desirable to clarify the scope of delegation by clearly stating the contents of the invention required for a long period of time as stipulated in the enforcement Decree, or by amending the law by specifically explaining the criteria for determining the

B. Whether the instant medicine constitutes a provision of the Enforcement Decree of the instant case

1) The active ingredients of the instant medicine, 9-Simnocuic cid, are in a relationship between the elderly people who are the active ingredients of the medicine already approved, the elderly people of letititititis (Evidence No. 14), the elderly of letitititis (Evidence No. 14) and the nature body of the gememesis (Titrus, gemere omomer, gemere 10) of the instant medicine.

Note 10)

The active ingredients of the instant medicine may be assessed to vary between the active ingredients of the medicine for which marketing approval is granted and the three-dimensional structure of the medicine.

On the other hand, hythrative body has different three-dimensional structure and has a significant difference in physical and chemical properties such as ionization or biological activity.

A person shall be appointed.

2) Furthermore, unlike the combination of Leti No. 9-Sim Leti No. 9-Sim Industries (hereinafter referred to as Eti No. 9-Sim r. 11) by Letis ratians only into RAR among the accommodations, the combination of RAR as well as RAR not only a week but also a week 12) LXR. In addition, Letisan has a chronic hiver treatment effect without Letis latians (Evidence No. 5, No. 14, No. 16, and No. 17). The difference between these treatment effects seems to arise from the difference before the operation.

3) Therefore, even though 9-Sim Hatysan and Leti Seniors have common character combining the RAR, and where the medicine of this case is administered to the human body, it is reasonable to deem the medicine of this case as the first product license, since the chemical structure of the part having the above treatment effect is manufactured with new material as an active ingredient, compared with the existing permitted medicine, in light of the general nature of the Hati Seniors and the differences in the effect of each active ingredient, as seen earlier, in light of the general nature of the trathic body and the differences in the effect of each active ingredient, it is reasonable to deem the medicine of this case as the first product license.

C. General: Whether the trial decision of this case is unlawful

Therefore, the patented invention subject to extension of this case constitutes an invention prescribed by the Enforcement Decree of this case, which requires a long period of time to undergo the activity, safety, etc. test necessary to obtain permission under the former Pharmaceutical Affairs Act to implement the patented invention, but the defendant's refusal to file an application for extension of this case on the ground that the drug of this case does not constitute a new drug is illegal.

4. Conclusion

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

[Attachment]

Judges Kim Jong-soo (Presiding Judge)

1) The le-franchise No. 1, the active ingredients of the Leti Seniors of the instant medicine, is in the relationship between the 9-Sim Leti Industries (product name: Alti Seniors of the instant medicine) and the vegetable nature (product name: see the detailed content set forth below 3. b.).

2) Article 2 of the Addenda (the amended provisions of Article 7 shall apply to the instant extension application filed after April 3, 2013, the enforcement date of which was the date of enforcement of the foregoing Enforcement Decree, pursuant to Article 2 of the Addenda (the amended provisions of this Decree shall apply to the invention subject to an application for registration of extension of the term of a patent pursuant to permission, etc. granted after the enforcement of

Note 3) hereinafter referred to as “new drugs”).

Note 4) [Attachment 1] provides for the following matters: “a drug containing a new salt as an active ingredient”; “a drug containing a new efficient substance as an active ingredient”; “a new fluent substance”; “a new fluent substance”; “an increase or decrease of a new creation or content of an effective ingredient”; “a new fluent route medicine”; “a new fluent dosage medicine”; and “a new fluent dosage”.

5) Retinoid A Recer (RR, Letinod A) refers to a host.

Note 6) See Section 3.2(b) below.

(2) Notwithstanding the provisions of paragraph (1), the Commissioner of the Korean Intellectual Property Office shall obtain permission or make registration pursuant to other Acts and subordinate statutes to practice a patented invention, and may extend the term of the relevant patent by up to five years, if it requires a long period of examination of vitality, safety, etc. necessary for such permission or registration. etc.

(1) An invention for which a patent term (hereinafter referred to as the “patent term”) may be extended under Article 53 (2) of the Enforcement Decree of the Patent Act (amended by the Presidential Decree No. 12199, Jul. 1, 1987) shall be limited to the invention for which a patent term extension is completed at the time of the application for extension of the patent term and which falls under any of the following subparagraphs:

9) The term “material” means material used for the purpose of diagnosing, treating, alleviating, treating, or preventing human or animal diseases (Article 96(2) of the former Patent Act and Article 2 of the former Pharmaceutical Affairs Act).

Note 10) Subdivision is identical to that of molecular, but different in nature from each other’s arrangement is different from that of molecular body. While molecular body is identical to molecular body, the spatial arrangement between the original or original body is identical to that of the other “structured body” or between the original body and the original body, but the spatial arrangement of the original or original body is different from each other’s “three-dimensional body.” Meanwhile, the form of molecular body is equal to the form of molecular body, but the form of molecular body is identical, but the form of molecular body is different from each other’s image, and thus it cannot overlap with each other’s three-dimensional structure. The form of molecular body is different from the form of the original body or the body of the original body or the body of the original body or the body of the original body or the body of the original body or the body of the original body or the body of the original body or the body of the original body or the body of the latter.

Note 11) A receptor means a structure that exists in a cell body or a cell constitution and causes a particular reaction to a cell with recognition of a material or a physical organ outside the cell. The body is protegres, but is special combination at a particular part where recognition of a particular substance is given.

Note 12) Retino X Recer (RX, e.g. X)