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https://ah.lib.nccu.edu.tw/handle/140.119/127998
題名: | “Plasma Concentration-Time Profile” as an Indefinite Claim Term: A Lesson from Forest Labs., Inc. v. Teva Pharm. USA, Inc. | 作者: | 陳秉訓 Chen, Ping-Hsun |
貢獻者: | 科管智財所 | 關鍵詞: | patent ; indefiniteness ; plasma concentration ; pharmacokinetics ; abbreviated new drug application | 日期: | Jun-2019 | 上傳時間: | 25-Dec-2019 | 摘要: | Forest Labs., Inc. v. Teva Pharm. USA, Inc., 716 F. App`x 987 (Fed. Cir. 2017), teaches that when “human pharmacokinetic study” is read into a claim, the specification should identify the experimental conditions for such human pharmacokinetic (PK) study in detail to prevent the claim from being held indefinite under 35 U.S.C. § 112. The description of such a human PK study should include a route of administration, dosage regimen, blood sampling technique, and characteristics of subjects, as required in the academic context. For those pending applications where the specification fails to provide a particular human PK study, a declaration made by the inventors may be submitted to clarify that. | 關聯: | Biotechnology Law Report, Vol.38, No.3, pp.154–164 | 資料類型: | article | DOI: | https://doi.org/10.1089/blr.2019.29116.phc |
Appears in Collections: | 期刊論文 |
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