The Supreme Court's decision in Sandoz v. Amgen introduces uncertainty into provisions that many viewed as necessary and enforceable, but its impact may ultimately be modest.
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References
Sandoz, Inc. v. Amgen, Inc., 582 US (June 12, 2017), No. 15–1039, slip op.
42 USC § 262(k)(7)(A).
42 USC § 262(k)(7)(B).
42 USC § 262(k)(2).
42 USC § 262(l)(2)(A).
42 USC § 262(l)(3)(A).
42 USC § 262(l)(3)(B).
42 USC § 262(l)(3)(C).
42 USC § 262(l)(4)(A).
42 USC § 262(l)(5)(A).
42 USC § 262(l)(5)(B).
42 USC § 262(l)(6).
42 USC §§ 262(l)(8)(B), (l)(9)(A).
42 USC § 262(l)(8)(A).
Sandoz, slip op. at 8.
Id.
Id.
Amgen, Inc. v. Sandoz, Inc., No. 14-cv-04741-RS, 2015 US Dist. LEXIS 34537 (N.D. Cal. Mar. 19, 2015).
Amgen, Inc. v. Sandoz, Inc., 794 F.3d 1347, 1351 n.1, 1357 (Fed. Cir. 2015).
Id. at 1359.
Sandoz, slip op. at 13 n.2, 14–15.
Id. at 10, 13.
Id. at 15.
Id. at 10–13.
Id. at 12.
Id. at 12–13.
42 USC § 262(l)(8)(A).
Amgen, 794 F.3d at 1360.
Id. at 1358.
Id. at 1359–60.
Sandoz, slip op. at 16.
Amgen, 794 F.3d at 1358.
Sandoz, slip op. at 18.
See Complaint at 6, AbbVie, Inc. v. Amgen, Inc., No, 16-cv-666 (D. Del. Aug. 4, 2016), ECF No. 1.
Amgen Inc. v. Hospira Inc., No. 16–2179, slip op. at 2 (Fed. Cir. Aug. 12, 2016).
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Royzman, I., Monroe-Yavneh, N. The Supreme Court's interpretation of the biosimilars statute and the value of certainty. Nat Biotechnol 35, 916–919 (2017). https://doi.org/10.1038/nbt.3977
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DOI: https://doi.org/10.1038/nbt.3977
