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    题名: “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
    贡献者: 科管智財所
    关键词: patent;indefiniteness;plasma concentration;pharmacokinetics;abbreviated new drug application
    日期: 2019-06
    上传时间: 2019-12-25 10:23:48 (UTC+8)
    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
    数据类型: article
    DOI 連結: https://doi.org/10.1089/blr.2019.29116.phc
    DOI: 10.1089/blr.2019.29116.phc
    显示于类别:[科技管理與智慧財產研究所] 期刊論文

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