| Project/Area Number |
16K13331
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| Research Category |
Grant-in-Aid for Challenging Exploratory Research
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| Allocation Type | Multi-year Fund |
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| Research Field |
New fields of law
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| Research Institution | The University of Tokyo |
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Principal Investigator |
MASUDA Sachiko 東京大学, 先端科学技術研究センター, 准教授 (70508150)
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| Project Period (FY) |
2016-04-01 – 2018-03-31
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| Project Status |
Completed (Fiscal Year 2017)
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| Budget Amount *help |
¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2017: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Fiscal Year 2016: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
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| Keywords | バイオ医薬品 / 特許紛争 / クレーム解釈 / バイオ後続品 / バイオシミラー / 抗体医薬 / 特許権 / 差止請求権 / 新薬開発 / 知的財産法 |
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| Outline of Final Research Achievements |
In this study, the appropriate systems of intellectual property protection for biopharmaceuticals were examined based on the current situation of rapidly expanding biopharmaceutical market in both new drugs and follow-on products, which is different from traditional systems of small molecular medicine. Through conducting comparative study of regulations as well as patent infringement cases among Japan, the United States, and Europe, we identified diferrences and possible future issues in Japan to avoid delays in the sale and diffusion of biopharmaceutigals in Japan.
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