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Amgen v. Sandoz: Reply Briefs Submitted to Supreme Court

As we previously reported, on February 16, 2016, Sandoz petitioned the United States Supreme Court for a writ of certiorari regarding the Federal Circuit’s interpretation of the BPCIA’s “notice of commercial marketing” provision—subsection (l)(8)(A)—as authorizing such notice only after FDA approval of an aBLA. In response, on March 21, Amgen…

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Busy Month Ahead for BPCIA Interpretation Questions

February will be a busy month for pending BPCIA cases, with activity on the horizon in Amgen v. Apotex, Amgen v. Hospira, and Janssen v. Celltrion: Amgen v. Apotex (Fed. Cir.) As we covered previously, Apotex appealed the district court’s order granting Amgen a preliminary injunction in Amgen v. Apotex. Apotex requested an expedited briefing…

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Roundup of Upcoming BPCIA Cases

As we have written about extensively, here, here, and here, the Federal Circuit recently interpreted two key provisions of the BPCIA in Amgen v. Sandoz. Three cases currently pending before District Courts raise related issues and each have the potential to reach the Federal Circuit. In this post, we provide…

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