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題名 A Crisis on Patenting of “Ready-to-Use” Oral Liquid Formulations: Azurity Pharms., Inc. v. Alkem Lab’ys Ltd
作者 陳秉訓
Chen, Ping-Hsun
貢獻者 科管智財所
日期 2024-06
上傳時間 10-九月-2024 13:07:57 (UTC+8)
摘要 In Azurity Pharms., Inc. v. Alkem Lab’ys Ltd., 655 F. Supp. 3d 270 (D. Del. 2023), U.S. Patent Nos. 10,786,482 and 10,918,621 covering Epaned® liquid were invalidated on the ground of obviousness. The claimed invention was an oral liquid formulation of enalapril consisting of enalapril, a buffer, sweetener, a preservative, and water. The district court there found that before the claimed invention, a person of ordinary skill in the art would have combined those ingredients recited in the disputed claims. The appellate court then upheld the district court’s obviousness determination because there was substantial evidence supporting the factual findings. This article is intended to analyze the district court to figure out what constitutes substantial evidence of obviousness. Azurity Pharms., Inc. may block the patenting of “ready-to-use” oral liquid formulations that consist of known excipients. Four aspects can be drawn: (1) it may be obvious to combine ingredient limitations and stability limitations; (2) a buffer limitation with a range of pH values would have been obvious; (3) common excipient limitations would have been obvious; (4) a buffer limitation with a concentration value or range would have been obvious because adjusting the concentration of a chosen buffer to meet the target pH is routine.
關聯 Biotechnology Law Report, Vol.43, No.3, pp.142-150
資料類型 article
DOI https://doi.org/10.1089/blr.2024.29102.aa
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) 2024-06
dc.date.accessioned 10-九月-2024 13:07:57 (UTC+8)-
dc.date.available 10-九月-2024 13:07:57 (UTC+8)-
dc.date.issued (上傳時間) 10-九月-2024 13:07:57 (UTC+8)-
dc.identifier.uri (URI) https://nccur.lib.nccu.edu.tw/handle/140.119/153659-
dc.description.abstract (摘要) In Azurity Pharms., Inc. v. Alkem Lab’ys Ltd., 655 F. Supp. 3d 270 (D. Del. 2023), U.S. Patent Nos. 10,786,482 and 10,918,621 covering Epaned® liquid were invalidated on the ground of obviousness. The claimed invention was an oral liquid formulation of enalapril consisting of enalapril, a buffer, sweetener, a preservative, and water. The district court there found that before the claimed invention, a person of ordinary skill in the art would have combined those ingredients recited in the disputed claims. The appellate court then upheld the district court’s obviousness determination because there was substantial evidence supporting the factual findings. This article is intended to analyze the district court to figure out what constitutes substantial evidence of obviousness. Azurity Pharms., Inc. may block the patenting of “ready-to-use” oral liquid formulations that consist of known excipients. Four aspects can be drawn: (1) it may be obvious to combine ingredient limitations and stability limitations; (2) a buffer limitation with a range of pH values would have been obvious; (3) common excipient limitations would have been obvious; (4) a buffer limitation with a concentration value or range would have been obvious because adjusting the concentration of a chosen buffer to meet the target pH is routine.
dc.format.extent 105 bytes-
dc.format.mimetype text/html-
dc.relation (關聯) Biotechnology Law Report, Vol.43, No.3, pp.142-150
dc.title (題名) A Crisis on Patenting of “Ready-to-Use” Oral Liquid Formulations: Azurity Pharms., Inc. v. Alkem Lab’ys Ltd
dc.type (資料類型) article
dc.identifier.doi (DOI) 10.1089/blr.2024.29102.aa
dc.doi.uri (DOI) https://doi.org/10.1089/blr.2024.29102.aa