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題名 Drafting a Pharmaceutical Composition Claim Covering Later-Developed Combination Drugs Without Losing the Disclosure Requirement Challenge: In re Entresto, 125 F.4th 1090 (Fed. Cir. 2025)
作者 陳秉訓
Chen, Ping-Hsun
貢獻者 科管智財所
關鍵詞 patent; enablement; written description; heart failure; Entresto®
日期 2026-08
上傳時間 19-Aug-2026 13:37:02 (UTC+8)
摘要 Novartis Pharmaceuticals Corp. has listed U.S. Patent No. 8,101,659 (“659 Patent”) in the Orange Book for Entresto® used to treat heart failure with reduced ejection fraction. The Federal Circuit in its recent decision, In re Entresto, 125 F.4th 1090 (Fed. Cir. 2025), found the 659 Patent valid under the requirements of enablement and written description. Entresto may indicate that the disclosure requirement does not bar a drug company from asserting patent infringement of a later-developed combination drug not disclosed or implied in its patent. With proper use of “administered in combination” as a claim term, a pharmaceutical composition claim can represent a kit product composed of physically separate active ingredients and cover a combination drug containing the same active ingredients.
關聯 Biotechnology Law Report, Vol.45, No.4, pp.254-262
資料類型 article
DOI https://doi.org/10.1177/0730031X261468422
dc.contributor 科管智財所
dc.creator (作者) 陳秉訓
dc.creator (作者) Chen, Ping-Hsun
dc.date (日期) 2026-08
dc.date.accessioned 19-Aug-2026 13:37:02 (UTC+8)-
dc.date.available 19-Aug-2026 13:37:02 (UTC+8)-
dc.date.issued (上傳時間) 19-Aug-2026 13:37:02 (UTC+8)-
dc.identifier.uri (URI) https://ah.lib.nccu.edu.tw/item?item_id=184547-
dc.description.abstract (摘要) Novartis Pharmaceuticals Corp. has listed U.S. Patent No. 8,101,659 (“659 Patent”) in the Orange Book for Entresto® used to treat heart failure with reduced ejection fraction. The Federal Circuit in its recent decision, In re Entresto, 125 F.4th 1090 (Fed. Cir. 2025), found the 659 Patent valid under the requirements of enablement and written description. Entresto may indicate that the disclosure requirement does not bar a drug company from asserting patent infringement of a later-developed combination drug not disclosed or implied in its patent. With proper use of “administered in combination” as a claim term, a pharmaceutical composition claim can represent a kit product composed of physically separate active ingredients and cover a combination drug containing the same active ingredients.
dc.format.extent 105 bytes-
dc.format.mimetype text/html-
dc.relation (關聯) Biotechnology Law Report, Vol.45, No.4, pp.254-262
dc.subject (關鍵詞) patent; enablement; written description; heart failure; Entresto®
dc.title (題名) Drafting a Pharmaceutical Composition Claim Covering Later-Developed Combination Drugs Without Losing the Disclosure Requirement Challenge: In re Entresto, 125 F.4th 1090 (Fed. Cir. 2025)
dc.type (資料類型) article
dc.identifier.doi (DOI) 10.1177/0730031X261468422
dc.doi.uri (DOI) https://doi.org/10.1177/0730031X261468422