USMCA 및 CPTPP 등 최근 FTA에서 의약품 관련 지식재산 조항에 관한 소고

이주하 ( Lee¸ Ju-ha ),이헌희 ( Lee¸ Heon-hui ) 한양대학교 법학연구소 2021 법학논총 Vol.38 No.1

미국은 최근 몇 년간 국제통상을 통한 지식재산 보호 및 강화를 의도하고 있다. TPP를 주도하는 시기와 USMCA의 협상을 주도하는 시기뿐만 아니라, 심지어 미중무역분쟁에 있어서도 미국은 상대국가를 압박하는 수단으로 지식재산을 선택했었다. 이러한 미국의 입장은 국제무대에서 지속될 것으로 예상되기에 이를 대비할 필요가 있어 보인다. 미국의 국제사회에서의 통상문제를 접근함에 있어 특히 의약품과 관련된 조항들은 다시한번 살펴볼 필요가 있다. 의약품과 관련된 지식재산 조항은 규범의 측면뿐만 아니라 의약품산업에도 직접적인 영향을 미치기 때문이다. 예를들어 의약품 존속기간이 늘어나거나 의약품 자료보호 기간이 늘어나게 되면 신약과 제네릭 의약품 회사간 이해관계가 충돌하게 될것이며, 이는 단순히 기업의 문제가 아닌 국가적 차원의 산업에 영향을 미칠 수 있기 때문이다. 이러한 측면에서 최근 미국이 CPTPP 및 USMCA 협상에서 의약품에 관한 지식재산 조항을 도입함에 있어 상당히 높은 수준을 유지하고 있음을 주지할 필요가 있다. 우리나라는 이미 미국과의 관계에서 한미 FTA를 통해 높은 수준의 국내법을 마련하고 있다. 의약품자료보호, 존속기간 연장, 허가특허연계 등 다양한 이슈에서 미국이 의도한 보호수준을 마련하고 있다. 다만, 한미 FTA 당시 포함되지 않았던 바이오 의약품 자료보호와 관련해서 두 협정에서 활발히 논의되고, 협정문에 반영되었지만 결국 관련 조항이 삭제되거나 유예되었다. 하지만 다자체계에서 다수 국가의 반대에 의해 반대, 미의회의 입장 등을 반영한 것이기 때문에 향후 한미 재협상을 하는 경우 미국이 최종적으로 어느 수준으로 보호될지는 미지수이지만, 최소한 미국은 이를 협상카드로는 사용할 것으로 예상해 볼 수 있어 이에 대한 대비가 필요해 보인다. 이를 위해 우리나라의 신약 및 제네릭 의약품 산업, 바이오의약품 산업 등 다양한 이슈들의 변화에 따른 우리나라의 의약품 산업의 영향을 분석한 후 구체적인 협상방안을 마련할 필요가 있어 보인다. The United States has intended to protect and strengthen intellectual property through international commerce in recent years. The US has chosen intellectual property as a means of pressing its counterparts, not only during the time of the TPP and the USMCA negotiations, but even in the trade disputes between the US and China. This position of the United States is expected to continue on the international stage, so it seems necessary to prepare for it. In approaching how the United States is dealing with trade issues related to pharmaceuticals in the international community, it is necessary to revisit the provisions of intellectual property especially related to pharmaceuticals. This is because such related provisions have a direct impact not only on the aspects of the norm, but also on the pharmaceutical industry. For example, if the duration of the patent term or the data protection period of medicines is extended, there will be a conflict of interests between new medicines and generic medicines companies, as it may affect the industry at the national level, not just a company issue. In this regard, it is worth to note that the US has maintained a fairly high level in introducing the IP provisions on pharmaceuticals in the recent CPTPP and USMCA negotiations. Korea has already established high-level domestic laws through the KORUS (Korea-US) FTA. The US is settling the level of protection intended by the United States in various issues such as pharmaceutical data protection, duration of patent term extension, and patent linkage. However, with regard to the protection of biopharmaceutical data, which was not included in the KORUS FTA, in the above two agreements, it was initially reflected in the above two agreements through active discussions, but eventually the relevant provisions were deleted or suspended. Since it reflects opposition from many countries in the multilateral system and the position of the US Congress, it is expected that the US may use it as a negotiation card in the future and it is necessary to prepare for renegotiation. To this end, it seems necessary to prepare specific negotiation plans after analyzing the impact of Korea's pharmaceutical industry according to changes in various issues such as Korea's new and generic pharmaceutical industry and biopharmaceutica industry.

Repeated intranasal inoculation of endotoxin-contaminated organic feed dust induces persistent lung inflammation in mice

Juha Song,Yirang Na,Daun Jung,Hailian Quan,Hyewon Chung,Jeong Won Kwon,Hae-Kwan Cheong,Byung Chul Chun,Jae-Hak Park,Seung Hyeok Seok 한국실험동물학회 2017 한국실험동물학회 학술발표대회 논문집 Vol.2017 No.8

Pregnancy, childbirth, and puerperium outcomes in female firefighters in Korea

Juha Park,Yeon-Soon Ahn,Min-Gi Kim 대한직업환경의학회 2020 대한직업환경의학회지 Vol.32 No.-

Background: Female firefighters are exposed to hazardous environmental (chemical and physical) and working (shift work, psychological, and ergonomic factors) conditions that have reported or are suspected of adverse effects on reproductive health. However, no previous studies have reported on pregnancy, childbirth, and puerperium outcomes (PCPOs) in female firefighters. Methods: The present study compared hospital admissions for PCPOs, based on 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) codes, among Korean female firefighters with those of the general Korean population. Standardized admission ratios (SARs) and their 95% confidence intervals (CIs) were calculated. Results: The study population included 1,766 female firefighters. Total follow-up duration was 9,659 person-years. Compared to the general female population, the female firefighters" SARs were higher in all admissions for PCPOs (SAR, 1.92; 95% CI: 1.79–2.05); pregnancy and abortive outcomes (SAR, 1.56; 95% CI: 1.12–2.12); other maternal disorders predominantly related to pregnancy (SAR, 2.65; 95% CI: 1.99–3.46); maternal care related to the fetus, amniotic cavity, and possible delivery problems (SAR, 2.13; 95% CI: 1.74–2.57); labor and delivery complications (SAR, 1.55; 95% CI: 1.15–2.06); delivery (SAR, 1.94; 95% CI: 1.80–2.08); and complications predominantly related to puerperium (SAR, 4.68; 95% CI: 2.02–9.23). Conclusion: The results of this study showed high SARs in all and specific subcategories of PCPOs in female firefighters.

Targeting Macrophages in Age-related Macular Degeneration

Juha Song,Sung Wook Park,Yirang Na,Dayoung Kim,Jeong Hun Kim,Seung Hyeok Seok,Jae-Hak Park 한국실험동물학회 2016 한국실험동물학회 학술발표대회 논문집 Vol.2016 No.08

UMTS-an Evolution Path to 3rd Generation Global Mobile Communications

Juha Rapeli 대한전자공학회 1996 대한전자공학회 워크샵 Vol.1996 No.-

Money Supply Rules and Exchange Rate Dynamics

Juha Tervala 한국국제경제학회 2012 International Economic Journal Vol.26 No.4

This paper examines the implications of monetary policy rules for exchange rate dynamics. I extend a standard New Open Economy Macroeconomics model with the introduction of a simple money supply rule, whereby central banks change their monetary policy if output diverges from potential output or if inflation diverges from the target inflation. A key result is that, in the case of permanent technology and monetary shocks, the nominal exchange rate does not follow a random walk; instead, the exchange rate undershoots its long-run value. An undershooting of the exchange rate derives from the active monetary policy that both countries conduct.

On the fluidity of bones in Mongolic and beyond

( Juha JANHUNEN ),( Uluhan ÖZALAN ) 한국알타이학회 2021 알타이학보 Vol.- No.31

This paper examines the fact that the words for ‘bone’ in Mongolic and Tungusic belong to a formal class containing a marker that normally refers to uncountable homogeneous substances, especially liquids. While there may be several factors underlying this curious situation, some possible light is shed on the issue by Turkic data, which suggest a semantic confusion between ‘bone’ and ‘bone marrow.’ Another phenomenon that deserves attention in this context is the use of the concept of ‘bone’ to indicate genetic lineages or ‘tribes’ in the nomadic society.

The Importance of `Common Understanding` in the Management of Major Accidents

Juha Kaskinen(유하 카스키넨),Kimmo Laakso(킴모 라악소) 과학기술정책연구원 2014 Future Horizon Vol.- No.21

Khitan: Understanding the Language Behind the Scripts

Juha A. Janhunen 훈민정음학회 2012 Scripta Vol.0 No.4

Khitan was the dynastic language of the Liao empire in Manchuria and Northern China (907-1115). Although today extinct, samples of Khitan are preserved in two native scripts, known as the Khitan Large Script and the Khitan Small Script. Both scripts may be classified as “Sinitic” or “Sinoform” in the typological sense, though only the Large Script has a direct connection with the Chinese script. Recent progress in the decipherment of, in particular, the Khitan Small Script allows the lexicon and grammar of the Khitan language to be assessed in much more detail than before. Khitan may be defined as a Para-Mongolic language, meaning that it represents a branch related to, but collateral with, the extant and historically known Mongolic languages. The present paper examines the genetic position of the Khitan language with regard to Mongolic with the help of the methods of comparative linguistics, as applied to the deciphered Khitan language material.

Policy Implications from Selected Countries for Promoting EMR Certification in Korea

( Juha Baek ) 한국보건사회연구원 2023 Research in Brief Vol.2023 No.1