투여용법ㆍ용량을 포함하는 의약용도발명의 권리범위

신혜은 한국지식재산학회 2015 産業財産權 Vol.- No.48

This article is related to scope of protection of pharmaceutical use invention including dosage regimen According to Korean Patent Examination Guideline, medical activities such as methods for treatment of the human body by surgery, therapy or diagnosis is being regarded as industrially inapplicable inventions, therefore, cannot be patented even though they satisfy the requirements of novelty, inventive step and so on. Meanwhile, Korean supreme court usually held that new dosage regimen, correspond to a medical activity, is not a constitutional element of pharmaceutical use invention. As a result, in Korea, there was no need to discuss as to scope of protection of dosage regimen. However, recently there was a Supreme Court en banc decision ruling that in cases where the administration and dosage are added on top of the target disease or efficacy of a medicine as an invention of a product, such administration and dosage should be viewed not so much as a medical practice itself, as an expression of those features through which a medicine may fully realize its efficacy, thereby constituting an element of invention that attaches an entirely new significance to the medicine as a product. A new patent may be granted to a medicine meeting the patentability requirements, including novelty and nonobviousness, by virtue of the addition of administration and dosage. Under these circumstances, it is urgent to establish the scope of protection of pharmaceutical use invention including dosage regimen and this article suggested the reasonable protection range.

그림책의 치료적 활용, 그림책 다시 읽기

신혜은 한국독서치료학회 2011 한국독서치료학회 학술대회지 Vol.- No.9

본 발표는 그림책의 미디어적 특성과 인간 몸마음 사이에 작동하는 순환론적 상호작용의 특성을 살펴보고, 이를 토대로 그림책의 치료적 활용에 있어서 새로운 치료적 접근을 제시하는 데 그 목적이 있다. 본 발표에서 제시하는 ‘그림책 다시 읽기, 첫 그림책 치료’는 인간의 몸마음의 근본적인 작동 원리를 따르는 체화된 마음 접근과 몸으로의 철학을 전제로 하며, 그림책도 동일한 전제하에서 만들어지고 또 지각되고 작동하는 미디어라는 관점에서 출발한다.

일본의 허가특허연계제도 및 우리에게 주는 시사점

신혜은,복정정 한국지식재산학회 2021 産業財産權 Vol.- No.66

허가특허연계제도는 미국의 ‘Hatch-Waxman법’에서 유래한 제도이다. 호주, 캐나다, 싱가포르 등 국가들은 미국과의 자유무역협정 체결을 위 해 동 제도를 도입하였다. 허가특허연계제도를 “후발의약품의 제조판 매 승인시 신약에 관한 특허를 고려하는 법령 내지 행정운용상의 제도 설계”로 정의하는 경우 일본은 이미 허가특허연계제도를 시행하고 있 다고 할 수 있다. 그러나 일본은 ‘Hatch-Waxman법’에서 유래하는 전형적 인 형태의 허가특허연계제도를 도입하고 있지는 않다. 그런데 최근 포 괄적ᆞ점진적 환태평양경제동반자협정(이하, ‘CPTPP’)이 발효되고, 역 내포괄적경제동반자협정(이하, ‘RCEP’)이 타결됨에 따라 일본의 제도 에도 변화가 일어날 것으로 예상된다. 본 논문에서는 법과 제도가 우리와 매우 유사하지만 아직은 본격적 인 허가특허연계제도를 도입하고 있지 않은 일본의 제도를 검토해봄으 로써 우리에게 주는 시사점을 도출하고자 하였다. 일본은 제네릭 의약품 허가시 해당 의약품의 특허침해 여부를 어떻 게 고려하여야 하는지 직접 규율하는 법령은 없다. 그러나 평성6년 및 평성21년 6월 5일 후생노동성 통지에 근거하여 소위 일본형 허가특허연 계제도를 운용하고 있다. 일본형 허가특허연계제도는 제도의 명확성 측면, 전문성 측면 및 투명성 측면에서 제고의 여지가 있다. 그럼에도 불구하고 현재 상황에서 일본이 미국식 허가특허연계제도를 당장 도입 할 가능성이 큰 것으로 보이지는 않는다. 다만 ‘CPTPP’ 발효와 ‘RCEP’ 타결과 같은 최근의 움직임, 2021년 6월 시행되는 중국 제4차 개정 전리 법이 허가특허연계제도를 본격적으로 도입하고 있는 점 등을 고려해 볼 때, 일본 또한 조만간 허가특허연계제도를 도입할 가능성이 없지 않은바 일본의 움직임을 주목할 필요가 있다. The drug approval-patent linkage system is derived from the “Hatch-Waxman Act” of the United States. Countries such as Australia, Canada, and Singapore have introduced this system to sign free trade agreements with the United States. When the drug approval-patent linkage system is defined as “a legal ordinance that considers patents related to new drugs when approval for manufacturing and sales of generic drugs, or a system designed for administrative operation”, Japan has already implemented the system. However, Japan has not introduced a typical drug approval-patent linkage system derived from the “Hatch-Waxman Act”. As the Comprehensive and Progressive Agreement for Trans-Pacific Partnership(hereinafter referred to as ‘CPTPP’) is in effect and the Regional Comprehensive Economic Partnership(hereinafter referred to as ‘RCEP’) is concluded, changes in the Japanese system are expected. This thesis aims to review Japanese systems whose laws and systems are very similar to Korean but which have not yet introduced a typical drug approval-patent linkage system, and to draw implications for us. Japan does not have a law that directly regulates how to consider the patent infringement of a generic drug when it is approved. However, based on the notification of the Ministry of Health and Welfare on June 5, 2009 and 1994, the so-called Japanese drug approval-patent linkage system is in operation. The Japanese patent linkage system has room for improvement in terms of system clarity, expertise, and transparency. Nevertheless, in the current situation, it does not appear that there is a high possibility that Japan will introduce the US-style patent linkage system immediately. However, considering the recent movements such as the entry into force of the 'CPTPP' and the conclusion of the 'RCEP', and the fact that the 4th revised patent law in China, which takes effect in June 2021, has been fully introducing the drug approval-patent linkage system, Japan is also likely to introduce a drug approval-patent linkage system sooner or later. It is worth paying attention to Japan's movement.

일본의 디지털 방송 프로그램 보호를 위한 제도 - ‘카피원스’

신혜은 한국스포츠엔터테인먼트법학회 2008 스포츠와 법 Vol.11 No.3

This thesis is related on ‘copy once’ system in Japan. The terminology 'copy once' is derived from 'copy one generation' and means only one copy is available for digital broadcasting program. This system is introduced based upon the characteristics of digital copies which are easier to be made and have higher quality compared with analog ones. ‘Copy once’ is very unique system only exist in Japan. Japanese government has been operating very powerful intellectual property protecting policies since 2000 and that is why Japan has that kind of unique system in part. However, even in Japan there are lots of criticisms against 'copy once' based on fair use and access right. Recently Japanese government is trying to switch 'copy once' to 'dubbing ten' so as to balance fair use and incentive for the creators. 디지털 방송은 아날로그 방송에 비해 화질이나 음질이 뛰어나고 다양한 방송양식과 부가서비스를 즐길 수 있는 등 많은 장점이 있으나 방송의 디지털화에 따라 여러 가지 문제점도 나타나기 시작했는데 그 중에서도 가장 중요한 것은 디지털화에 따른 저작물복제의 용이화이다. 본 논문에서는 우리나라 보다 방송의 디지털화가 몇 년 앞선 일본의 사례를 일본 특유의 제도인 ‘카피원스’를 중심으로 살펴보았다. 일본의 디지털 방송관련 정책들은 그 동안 많은 시행착오가 있었지만 저작권자나 방송사업자와 같은 권리자, 저작물의 이용자(시청자), 가전업체 등의 참여를 구하고 그 과정을 공개하여 투명화를 꾀하면서 3 당사자의 이익을 비교・형량하여 무게중심을 잡아나가는 방향으로 나아가려 한다는 것을 알 수 있었다. 이와 같은 일본의 사례는 디지털 방송프로그램 보호를 위한 우리의 제도 구축에 참고가 될 수 있을 것이다.

韓國人에 적합한 Nutritional Assessment의 基準値의 設定에 關한 硏究(Ⅱ)

申惠恩,安成淑,申鉉澤,金洛斗 한국병원약사회 1986 병원약사회지 Vol.3 No.2

Nutritional support for the hospitalized patients with malnutrition is essential for not only the favorable clinical outcomes of medical treatment, but also the maintenance of patients' lives themselves. Effective nutritional support is possible only when the accurate nutritional assessment for adequate nutrient formulation is available. Nutritional assessment should include both the anthropometric measurements and laboratory tests. So far, the standard anthropometric values of Korean poqulation for nutritional assessment are not investigated. This study is primmarily aimed to establish more reliable standard values based on the general population than the velues which were investigated n the small group of population in 1985. Comparing with the data of 1985, the standard deviations for each sampling group and the mean values of males with the ages of 45-54 and females of 35-54, are larger than those of 1985 witch were calculated via the extrapolation technique from the mean values of the group with large sampling numbers. The standard anthropometric values calculated based on the randomly collected data during this study period are presented and may be clinically applicable for the more accurate nutritional assessment than before.

중환자실 환자의 입원기간에 따른 사지 둘레 변화 및 관련요인

신혜은,강지연,Shin, Hye Eun,Kang, Jiyeon 한국중환자간호학회 2016 중환자간호학회지 Vol.9 No.2

Purpose: This study was conducted to identify changes in limb circumferences among patients admitted to the intensive care unit (ICU) and related factors. Methods: We conducted a prospective observational study with 27 patients from 3 ICUs at a university hospital located in B city of Korea, from September 1 to October 30, 2015. The circumferences of the left and right upper arms, thighs, and lower legs were measured on the first, third, fifth, and seventh days of ICU admission. Information on the related factors was collected from the medical records. The data were analyzed using a linear mixed model method. Results: The limbs circumferences significantly reduced from day 3, and the changes continued till day 7. These changes were related to the gender of the subjects, restraints application, use of steroids, and continuous renal replacement therapy. Conclusions: Based on the above results, it can be concluded that ICU-acquired weakness begins before the third day of admission. Thus, early mobilization protocols for ICU patients need to be developed and implemented in order to improve long-term outcomes.

중국 특허법 개정과 허가특허연계제도의 도입이 제약산업에 미치는 영향

신혜은,복정정 한국지식재산학회 2021 産業財産權 Vol.- No.69

지금까지 중국의 의약품 허가특허연계제도(이하, ‘허가특허연계제도’) 도입 여부에 대해 견해가 엇갈렸다. 허가특허연계제도의 의미를 넓게 해석하여 의약품 품목허가시 특허권의 존재를 고려하는 것으로 보는 경우 중국은 이미 동제도를 도입하였다고 볼 수 있지만, 특허목록 집 작성 및 공개, 특허권자 등에 대한 통지제도, 판매금지를 위한 조치와 같이 의약품 등록절차에서 특허권을 연결시키는 진정한 의미에서의 허가특허연계제도는 존재하지 않았기 때문이다. 그런데 최근 중국은 제4차 특허법 개정을 통해 의약 특허 존속기간 연장에 관한 조항을 신설하였고, 의약품 특허분쟁의 조기해결을 위한 장치를 마련하였다. 결국 진정한 의미의 허가특허연계제도는 중국 특허법 제4차 개정을 통해 시작된 것이라고 볼 수 있다. 중국의 허가특허연계제도의 본격 도입은 우리 기업에 미칠 영향도 적지 않을 것인바, 본 논문에서는 중국 특허법 개정과 허가특허연계제 도의 도입이 제약산업에 미치는 영향을 분석하고 우리에게 주는 시사 점을 도출하고자 하였다. Has China introduced a patent-approval linkage system? Opinions differ on this. If the patent-approval linkage system is defined as checking the existence of a patent right when a drug product is approved, it can be said that China has already introduced this system. However, there is no real patent-approval linkage system that connects patent rights in the drug registration process, such as preparation and publication of patent list, notification system to patent holders and measures to ban sales. However, recently, through the amendment of the 4th Patent Law, China has newly established a provision on the extension of the duration of patent rights, and has prepared a mechanism for early resolution of drug patent disputes. In the end, it can be said that the true meaning of the patent-approval linkage system was started through the 4th amendment of the Chinese Patent Law. The full-scale introduction of China's patent-approval linkage system will have a significant impact on Korean companies. In this paper, we tried to analyze the impact of the revision of the Chinese Patent Law and the introduction of the patent-approval linkage system on the pharmaceutical industry and draw implications for us.

문화인지구조는 어떻게 구성되는가? : 체화이론과 발달적체계접근을 기초로

신혜은 한국문화교육학회 2013 문화예술교육연구 Vol.8 No.3

본 논문은 문화와 인지의 오래된 이분법을 넘어, 인간 인지와 문화를 둘러싼 다양한 현상 이해를 위한 새로운 틀로서 ‘문화인지’ 개념을 제안함을 그 목적으로 하고 있다. 이를 위하여 우선 새로운 융합개념인 ‘문화인지’ 개념을 기존의 인지와 문화의 이분법과 대비시킴으로서 ‘문화인지’ 개념 출현의 필요성을 제기하였다. 그리고 문화인지 개념 출현의 이론적 토대로서 ‘체화이론’ 개념과 ‘발달적 체계접근’을 도입하여 기존의 인지와 문화 각각의 개념으로는 설명되지 않았던 문화인지 현상의 구조와 기능의 독특성에 대해 면밀한 분석을 시도해 보았다. 또 유기체내에 존재하지 않던 전혀 새로운 구조와 기능의 출현을 의미하는 ‘문화인지’ 구조가 어떠한 다양한 조건과 맥락 내에서 형성되고 구조화 되는지를 다양한 예들의 제시를 통해 문화인지 구조 개념의 가설적 타당성을 검증해 보고자 하였다. 마지막으로 표상 양식에 따른 다양한 인지와 문화인지의 예를 가설적으로 설정함으로써 새로운 구성개념인 문화인지 개념의 출현과 구성이 지니는 다양한 함의를 발달과 교육, 그리고 예술과 치유의 측면에서 조망해 보았다. This paper aims to suggest the concept of cultuĝnition as a new frame to overcome an old dichotomy between gene and environment and to explain various phenomena around human cognition and culture. For this purpose, there were firstly described the need of a new emergent construct cultuĝnition which is not a combination but a consilience. Two theoretical bases which are embodiment theory and developmental systems approach were implemented for constructing the concept of cultuĝnition. The embodiment theory is the fourth generation in cognitive science and profoundly accepted in various academic fields. Embodiment paradigm has demonstrated that cognition is grounded in bodily interactions with the environment and that abstract concepts are tied to the body's sensory and motor systems. Developmental systems approach is also been considered as a promising model to explain emergent new structure and function in human ontogeny as well as phylogeny. Based on this embodiment and developmental systems approach, the process of formation cultuĝnitive structure were investigated. There were discussed some implications from developmental, educational, therapeutical aspects with various samples of cultuĝnitive phenomena. This cultuĝnitive account is useful in understanding and organizing accumulating discoveries of cultural variations in human mind and the body.

비침습눈물막파괴시간이 각막곡률계측의 재현성에 미치는 영향

신혜은,정소연,정지원 대한안과학회 2023 대한안과학회지 Vol.64 No.2

Purpose: To evaluate the effects of the non-invasive keratograph break-up time on the repeatability of keratometric measurements derived using the Keratograph 5M in patients with dry eye syndrome. Methods: Thirty-six patients with dry eye and 30 controls were enrolled. We measured keratometric values twice in all subjects and explored whether the two measurements differed by more than 0.5 diopter (D) (the absolute value). We also evaluated the relationship between the absolute difference and the non-invasive keratograph break-up time (NIKBUT). Results: The intraclass correlation coefficients for astigmatism, flat keratometry (K), steep K, and mean K were all higher than 0.95 in patients, thus lower than in controls. The proportion of eyes with absolute differences over 0.5 D between the two keratometric values differed significantly between the dry eye and control groups in terms of the flat K and Kmax values (p = 0.033, 0.037). The average NIKBUT was negatively correlated with the absolute differences in Kmax and astigmatism (p = 0.030, R2 = 0.134 and p = 0.017, R2 = 0.160). Conclusions: In patients with dry eye syndrome, keratometric measurements are reliably repeatable, but slightly less so than in normal controls. The proportions of eyes exhibiting absolute keratometric differences over 0.5 D (two measurements) differed in the dry eye and control groups. The lower the non-invasive keratograph break-up time, the poorer the repeatability of keratometric measurements in the dry eye group. Therefore, care is required when obtaining keratometric values for such patients. 목적: 건성안 환자에서 KeratographⓇ5M (K5M)을 사용하여 평가한 비침습눈물막파괴시간(non-invasive keratograph break-up time, NIKBUT)이 K5M으로 측정한 각막곡률계측의 재현성에 미치는 영향을 평가하고자 한다. 방법: 건성안 환자 36명과 대조군 30명에서 두 번씩 측정한 각막곡률 값의 재현성을 평가하였고, 두 군사이에 두 번씩 측정한 각막곡률 값의 차이의 절대값이 0.5 diopter (D)를 넘는 비율에 차이가 있는지 분석하였으며, 건성안 환자에서 NIKBUT와 각막곡률 값 차이의 절대값 사이의 상관성을 평가하였다. 결과: 건성안 환자에서 K5M으로 측정한 최대각막곡률을 제외한 각막곡률 값 및 난시값의 급내상관계수는 0.95 이상이었으나 대조군에비해서는 낮은 수치를 보였고 편평한 각막곡률과 최대각막곡률 값의 차이의 절대값이 0.5 D를 넘는 비율에 건성안 유무에 따른 유의한 차이가 있었다(p=0.033, 0.037). NIKBUT-average와 각막곡률 값 차이의 절대값에 대하여 선형회귀분석 시행 시 최대각막곡률과각막난시에서 유의한 음의 상관관계를 보였다(p=0.030, R2=0.134 and p=0.017, R2=0.160). 결론: 건성안 환자에서 K5M으로 측정한 각막곡률계측의 재현성은 높았으나 정상 대조군에 비해서는 다소 떨어지며, 각막곡률계측의유의한 차이를 보이는 비율이 건성안 유무에 따라 차이가 있었다. 또한 건성안에서 비침습눈물막파괴시간이 낮을수록 각막곡률 값의측정의 재현성은 낮아질 수 있어서 심한 건성안군에서는 각막곡률측정에 주의할 필요가 있겠다.

허가 등에 따른 존속기간이 연장된 특허권의 효력범위 - 치료효과나 용도의 실질적 동일을 중심으로 -

신혜은 충북대학교 법학연구소 2020 과학기술과 법 Vol.11 No.2

According to the Korean Patent Act Article 97, the scope of protection of a patented invention shall be determined by the descriptions of the claims. During the duration of the patent right, the patentee will enjoy the exclusive right over the entire scope of the claims. However, Article 95 of the Korean Patent Act states that the effects of a patent, the term of which has been extended under Article 90, that is an applications for Registration of Extended Patent Terms by Permission, shall extend only to practicing the patented invention on the things on which permission, etc. for registration of the extension is based (things used for specified purposes, if the purposes of such things are specified in the permission, etc.). Despite the fact that a considerable period of time has passed since the registration system for the extension of the duration of patent rights was introduced in Korea, it was unclear to what extent the scope of the extended patent rights could be recognized. However, in the first Supreme Court ruling on the scope of the validity of the patent right with an extended duration (Supreme Court Decree of Jan. 17, 2019, 2017Da245798; hereinafter referred to as 'Solifenacin ruling'), reasonable criterion was presented and it is expected that the confusion can be cleared up to some extent. In this paper, focusing on the criteria suggested by the Solifenacin ruling, I investigated in which direction it would be desirable to interpret the scope of validity of patent rights with extended duration. As a result, I came to the following conclusion. First, considering the purpose of the Pharmaceutical Affairs Law and the Patent Law, and the text of the relevant law, it is desirable to determine the effects of a patent, the term of which has been extended in accordance with the purpose of the patent law. Second, to determine the effects of a patent, the term of which has been extended, it is important to explore what the essence of 'the patented invention' is. In conclusion, even if there is a difference in salt, etc., it should be regarded as belonging to the scope of validity of the extended patent right if it can be easily selected by a person with ordinary skill in the art. In addition, if the patentee who developed the new substance obtains the drug product license and then obtains the registration for an extension of the duration of the patent right based on this, the scope of the validity of the extended patent right will be extends to the range that can be regarded as substantially the same as the therapeutic effect of the diseases, for example, such as high blood pressure and diabetes, etc..