Source: https://tiipm.nccu.edu.tw/zh_tw/alumni/Alumni/%E5%BE%9EAmgen-v-Sandoz%E6%A1%88%E7%9C%8B%E7%BE%8E%E5%9C%8B%E5%B0%88%E5%88%A9%E8%88%9E%E8%B9%88%EF%BC%88Patent-Dance%EF%BC%89-68955493
Timestamp: 2019-04-22 06:46:20+00:00

Document:
42 U.S.C. §262(l)(2).(2009) (“Not later than 20 days after the Secretary notifies the subsection (k) applicant that the application has been accepted for review, the subsection (k) applicant—(A) shall provide to the reference product sponsor a copy of the application submitted”).
 42 U.S.C. §262(l)(8)(A).(2009) (“The subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).”).
 Amgen Inc. v. Sandoz Inc., 794 F.3d 1347,*7 (Fed. Cir. 2015) (“opted not to provide Amgen with Sandoz’s biosimilar application within 20 days of the FDA’s notification of acceptance”).
 Amgen Inc. v. Sandoz Inc., 2015 WL1264756 ( N.D.Cal. Mar. 19, 2015).
 Supra note 3, at *4 (“unravel the riddle, solve the mystery, and comprehend the enigma.”).
 Supra note 3, at *12-*13.
 Supra note 3, at *14.
 Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, *6 (Fed. Cir. 2015) (Judge NEWMAN, dissenting-in-part.).
 Id. (“Absent adequate factual support in a complaint for manufacturing method claims, declaratory jurisdiction may be unsupported.”).
 Supra note 3, at *17.
 Supra note 3, at *18.
 Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, *7 (Fed. Cir. 2015) (Judge CHEN, dissenting-in-part.).

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