| 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) | 2019-06 | |
| dc.date.accessioned | 25-Dec-2019 10:23:48 (UTC+8) | - |
| dc.date.available | 25-Dec-2019 10:23:48 (UTC+8) | - |
| dc.date.issued (上傳時間) | 25-Dec-2019 10:23:48 (UTC+8) | - |
| dc.identifier.uri (URI) | http://nccur.lib.nccu.edu.tw/handle/140.119/127998 | - |
| dc.description.abstract (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. | |
| dc.format.extent | 241972 bytes | - |
| dc.format.mimetype | application/pdf | - |
| dc.relation (關聯) | Biotechnology Law Report, Vol.38, No.3, pp.154–164 | |
| dc.subject (關鍵詞) | patent ; indefiniteness ; plasma concentration ; pharmacokinetics ; abbreviated new drug application | |
| dc.title (題名) | “Plasma Concentration-Time Profile” as an Indefinite Claim Term: A Lesson from Forest Labs., Inc. v. Teva Pharm. USA, Inc. | |
| dc.type (資料類型) | article | |
| dc.identifier.doi (DOI) | 10.1089/blr.2019.29116.phc | |
| dc.doi.uri (DOI) | https://doi.org/10.1089/blr.2019.29116.phc | |
