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2020.09.27

クリースビータ®の再審査期間終了

2029年9月19日 All day

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Fubuki

「医薬系 "特許的" 判例」ブログ

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ジーラスタ®の再審査期間終了

Fubuki

I am an in-house patent attorney for a pharmaceutical company in Japan. My practice includes advising the company on all issues relating to intellectual property law and the protection/enforcement of its intellectual property, developing IP portfolio strategies for new products, managing the world-wide registration of the company’s patents/trademarks and supervising outside legal counsel on patent/trademark litigation issues.

E-mail: fubuki@tokkyoteki.com

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日本のパテントリンケージの現状の課題とその解決に向けた提案
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15 All day: アリムタ®に関する用法用量特許第5102928号及び第5469706号の存続期間満了日 2021年6月15日 All day https://www.tokkyoteki.com/2019/12/20191128-v-3010115-10116.html アリムタ®のビタミン療法特許、ジェネリックメーカーのチャレンジによく耐えました。製品価値に貢献して今年の6月15日にその寿命を全うしそうです。 https://twitter.com/tokkyoteki/status/1357665269552795650?s=20 Google カレンダー続きを読む

25 All day: The Biological Product Patent Transparency (BPPT) amendments to 42 U.S.C. 262(k) of the Biologics Price Competition and Innovation Act (BPCIA) will take effect. 2021年6月25日 All day The Biological Product Patent Transparency (BPPT) amendments to 42 U.S.C. 262(k) of the Biologics Price Competition and Innovation Act (BPCIA) will take effect. https://purplebooksearch.fda.gov/faqs#5 Q5: What Purple Book listing requirements were added by the Biological Product Patent Transparency section of the Consolidated Appropriations Act of 2021 enacted December 27, 2020? A5:The Biological Product Patent Transparency (BPPT) section of the legislation requires that, by 180 days after enactment (June 25, 2021), FDA publish and make available to the public in a searchable, electronic format a list of biological products, by nonproprietary name, for which a biologics license under section 351(a) or 351(k) of the Public Health Service Act (PHS Act) is in effect; the date of licensure of the marketing application and the application number; and the licensure status and, if available, marketing status. The BPPT section also requires that FDA revise the list every 30 days to include any additional products licensed under section 351(a) or 351(k) of the PHS Act. In addition, for each biological product on the list, the BPPT section requires that the Purple Book list each reference product exclusivity period and each first interchangeable exclusivity period for which FDA has determined such biological product to be eligible and for which such period has not concluded. The BPPT section also requires publication in the Purple Book of patent lists provided by reference product sponsors (i.e., biologics license application (BLA) holders) to FDA for certain licensed biological products. Specifically, a reference product sponsor is required to provide to FDA the list of patents and corresponding expiry dates (referred to here as the “initial list”), not later than 30 days after the reference product sponsor has provided the initial list to a 351(k) applicant under section 351(l)(3)(A) or (l)(7) of the PHS Act. The reference product sponsor is also required to provide to FDA any subsequent or supplemental lists, and their corresponding expiry dates, within 30 days of the provision of such lists to a 351(k) applicant under section 351(l)(3)(A) or (l)(7) of the PHS Act. FDA will begin publishing patent lists in the Purple Book not later than 180 days after the date of enactment (June 25, 2021), or when FDA has received any such lists from reference product sponsors, whichever is later. FDA subsequently will revise the list on a monthly basis to include any additional initial lists and any updates from subsequent or supplemental lists. 関連記事: https://www.tokkyoteki.com/2021/01/fda-orangebook-purplebook.html Google カレンダー続きを読む

29 All day: 「逆流性食道炎の再発抑制剤」に関する特許6283440の無効審決取消請求事件（知財高裁令和2年(行ケ)10094）の判決言渡日 2021年6月29日 All day 知的財産高等裁判所東京高等地方簡易裁判所合同庁舎17階千代田区霞が関1丁目1-4, 東京都マップ「逆流性食道炎の再発抑制剤」に関する特許6283440の無効審決取消請求事件（知財高裁令和2年(行ケ)10094）の判決言渡日特許6283440号特許権者：EAファーマ存続期間満了日：2037.04.04 無効審判（無効2019-800035）請求人：沢井製薬 https://www.j-platpat.inpit.go.jp/c1800/PU/JP-6283440/412EAE699A3FC48FF7A0A51C8C462ED10B13E69F9089E32ECA10BD913B74128F/15/ja 【請求項１】ベンズイミダゾール系プロトンポンプ阻害剤を有効成分とし、維持療法を行う前の治療により治癒したプロトンポンプ阻害剤抵抗性逆流性食道炎患者に対する維持療法のために、プロトンポンプ阻害剤抵抗性ではない逆流性食道炎患者に対する治療期の常用量のベンズイミダゾール系プロトンポンプ阻害剤を１日２回、４週間以上投与され、前記プロトンポンプ阻害剤抵抗性ではない逆流性食道炎患者に対する治療期の常用量が１０ｍｇであり、前記ベンズイミダゾール系プロトンポンプ阻害剤が、ラベプラゾール、ラベプラゾールのプロドラッグ、又はそれらの薬学上許容される塩若しくは溶媒和物であることを特徴とする、逆流性食道炎の再発抑制剤。 Google カレンダー続きを読む

30 All day: ネキシウム®の再審査期間終了 2021年6月30日 All day 詳細 Google カレンダー続きを読む

IYAKUKEI-"TOKKYOTEKI"-HANREI BLOG is the personal website of the Author. Material on this website is not legal advice and does not establish an attorney-client relationship. All information on this website should be double-checked for its accuracy and current applicability.