智財散步
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2019國際藥品專利連結研討會
2019-11-13 @ 9:00 上午 - 4:30 下午
【議程/Agenda】
| 時間 /Time | 題目/Topic | 主講人/Speaker |
| 8:40-9:10 |
報到 Registration |
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| 9:10-9:25
(15 mins) |
開幕
Opening Remarks
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【致詞人 Speaker】
呂正華，經濟部工業局局長 Jang-Hwa Leu, Director-General, Industrial Development Bureau, Ministry of Economic Affairs
陳惠芳，衛生福利部食品藥物管理署副署長 Hwei-Fang Cheng, Deputy Director-General, Taiwan Food and Drug Administration |
| 9:25-9:35 |
團體照Group photo |
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第一節 Session 1 |
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| 9:35-10:45
(70 mins) |
主題1：
藥品申請上市前之專利登錄項目，登錄範圍的爭議及解決。 Patent listing disputes of new drug application and resolution
Topics: (70 mins) – Orange-Book patent listing issues, practice and related litigation
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【主持人Moderator】
吳全峰，中央研究院法律學研究所副研究員 Chuan-Feng Wu, Associate Research Professor, Institutum Iurisprudentiae, Academia Sinica
【主講人Speaker】(70 mins) Barbara Rudolph，飛翰法律事務所合夥律師 Barbara Rudolph, Partner, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Amanda K. Murphy，飛翰法律事務所合夥律師 Amanda K. Murphy, Partner, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP |
| 10:45-11:00 |
休息 Break (15 mins) |
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| 11:00-12:00
(60 mins) |
Topics: (40mins)
-Taiwan’s experiences in submitting patent information for a new drug application
Session 1 Q&A (20 mins) |
【主講人Speaker】(40mins)
張哲倫，理律法律事務所合夥律師 Roger Chang, Partner, Lee and Li Attorneys-at-Law
劉君怡，理律法律事務所資深專利師 Joyce Liou, Senior Patent Attorney, Lee and Li Attorneys-at-Law
主題1現場問答Q&A (20 mins) |
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12:00-13:10 |
午飯/交流 Lunch/Opinion Exchange (70 mins) |
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第二節 Session 2 |
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| 13:10-14:35
(85mins) |
主題2：
生物製劑發展趨勢及生物相似藥專利挑戰 Biopharmaceutical trends and biosimilar’s patent challenges
Topics: ( 50 mins) – The current status and trends of biologics in South Korea – Strategies for biosimilar patent litigation
Topics: (20 mins) – The current status and trends of biologics in Taiwan
Session 2 Q&A (15 mins) |
【主持人Moderator】
黃文鴻，陽明大學衛生福利研究所兼任教授 Weng-Foung Huang, Adjunct Professor, Institute of Health and Welfare Policy, National Yang-Ming University
【主講人Speaker】(50mins) Yoon, Kyung Ae，律村法律事務所專利代理人 Yoon, Kyung Ae, Patent Attorney, Yulchon Attorneys-at-Law
Lee, Samuel SungMok，律村法律事務所資深外國法律顧問 Lee, Samuel SungMok, Senior Foreign Counsel, Yulchon Attorneys-at-Law
戴建丞，經濟部技術處科長 (20 mins) Chien-Cheng Tai, Section Chief, Department of Industrial Technology, Ministry of Economic Affairs
主題2現場問答Q&A (15 mins) |
| 14:35-14:50 |
休息 Break (15 mins) |
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第三節 Session 3 |
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| 14:50-16:15
(85 mins) |
主題3：
學名藥以P4 (paragraph Ⅳ)申請上市考量及專利挑戰 Session 3: Legal issues and patent challenges of generic drugs applied for ANDA with a paragraph IV certification
Topics: (70mins) -Legal issues to be considered before filing an ANDA with a paragraph IV certification -Defense strategies available for generic drug companies after ANDA litigation is initiated
Session 3 Q&A (15 mins) |
【主持人Moderator】
李素華，國立臺灣大學法律學院副教授 Su-Hua Lee, Associate Professor , College of Law, National Taiwan University
【主講人Speaker】(70 mins) Nicholas Mitrokostas，高贏律師事務所合夥律師 Nicholas Mitrokostas, Partner, Goodwin Procter LLP
Huiya Wu，高贏律師事務所合夥律師 Huiya Wu, Partner, Goodwin Procter LLP
Emily Rapalino，高贏律師事務所合夥律師 Emily Rapalino, Partner, Goodwin Procter LLP
主題3現場問答Q&A (15 mins) |
| 16:15-16:25
(10 mins) |
總結/閉幕 Closing Remarks |
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