Search Results for: "amgen v apotex"

Breaking News: Supreme Court Denies Cert. in Apotex v. Amgen

Today, the Supreme Court denied certiorari in Apotex v. Amgen, a closely-watched case involving the interpretation of key provisions of the BPCIA.  Our most recent blog coverage can be found here. Even though the Court has declined to hear Apotex v. Amgen, the Supreme Court has before it another vehicle for addressing the hotly-contested…

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FDA Accepts Coherus’s aBLA for Neulasta® Biosimilar

In August, we reported that Coherus Biosciences, Inc. submitted an aBLA for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate.  Last week, Coherus announced that FDA has accepted its aBLA. Under the BPCIA, Coherus has 20 days from FDA acceptance to trigger the patent dance by providing the reference product sponsor (Amgen) with a…

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Amgen v. Apotex, Petition for Certiorari

We have been closely following the Amgen v. Apotex case.  On September 9, 2016, Apotex petitioned the Supreme Court for certiorari to review the Federal Circuit’s decision.  In its petition, Apotex presents two questions for the Supreme Court: Whether the Federal Circuit erred in holding that biosimilar applicants that make…

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Breaking News: Apotex Does not Infringe Amgen’s Filgrastim and Pegfilgrastim Patent; Apotex is Permanently Enjoined From Launch Until It Provides 180 Days’ Notice

The District Court for the Southern District of Florida today ruled that Apotex’s proposed filgrastim and pegfilgrastim products will not infringe the asserted claims of Amgen’s ’138 patent (U.S. Patent. No. 8,952,138).  The court, having found in favor of Apotex on the infringement issue, did not reach Apotex’s counterclaim that the…

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