行情總在絕望中誕生

 Buying when others have despaired, and selling when they are full of hope, takes fortitude！行情總在絕望中誕生，在半信半疑中成長，在憧憬中成熟，在希望中毀滅！

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不當登錄橘皮書

不知不覺橘皮書也走過40個年頭

今年FDA也針對橘皮書40周年開了線上研討會

有興趣可以參考https://www.fda.gov/drugs/news-events-human-drugs/regulatory-education-industry-celebrating-40-years-depth-examination-fda-orange-book-10272020

今天40周年要來談談橘皮書登錄問題

按FDA規定，新藥取證後45天內須填寫3542form去登錄專利

登錄的專利種類分三種

1. Substance  2.Product  3.Method of use

由於登錄的時間會影響到後面的獨賣期

還有30 month stay的問題

各家藥廠對於這些動作都是無所不用其極

可以看到今天這案例，是Sanofi的產品Lantus，一款胰島素注射用筆

爭議點在8,556,864 (“the '864 patent”) - claims aspects of a drive mechanism of the Lantus^® SoloSTAR^® insulin glargine injector pen

將注射筆機制專利登錄在橘皮書內之藥的使用方式

引發的後續效應包含，將醫材專利登錄在橘皮書是否適當以及是否有反托拉斯的情況

後續效應值得繼續觀察

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EUDAMED歐盟醫材資料庫 Actor Registration

Actor Registration 上線囉~

https://ec.europa.eu/health/md_eudamed/actors_registration_en

可以稍微窺略一下未來醫材資料庫的樣貌

雖然比預期的早

明年五月就要完全上線

看到新時程應該是2022/5月上線

鳩竟能不能趕得了上線期限

且讓我們繼續看下去

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