Search Results for: "amgen v apotex"

Amgen v. Apotex: District Court Decides that the ’138 Patent is Not Invalid on Some Grounds; Enablement is Still an Open Issue

As we previously reported, on July 5, the Federal Circuit affirmed the district court’s grant of a preliminary injunction enjoining Apotex from launching its biosimilar version of Amgen’s Neulasta (pegfilgrastim) until it receives FDA licensure, gives Amgen a post-licensure notice of commercial marketing, and then waits for 180 days to…

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Hospira to Court: Amgen v. Apotex does not address the specific question raised by Hospira’s Motion to Dismiss in Amgen v. Hospira - UPDATED: Amgen's Response

  Tuesday’s Federal Circuit opinion in Amgen v. Apotex  is already being picked up and analyzed in other BPCIA litigation: in Amgen v. Hospira, Hospira has submitted the Federal Circuit’s opinion to the District Court for the District of Delaware (J. Andrews) in connection with its pending motion to dismiss…

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Amgen v. Apotex: Analysis of the Fed. Cir. Opinion

  As we posted yesterday, the Federal Circuit has issued its decision in Amgen v. Apotex, affirming the district court’s (S.D. Fla, J. Cohn) order preliminarily enjoining Apotex from launching its biosimilar version of Amgen’s Neulasta (pegfilgrastim) until it has received FDA licensure, given Amgen a post-licensure notice of commercial marketing, and…

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Breaking News: CAFC Affirms in Amgen v. Apotex

The Federal Circuit issued its decision in Amgen v. Apotex (re: Apotex’s Neulasta biosimilar) this morning.  The Court affirmed the district court, holding that the commercial-marketing provision in 42 U.S.C. § 262(l)(8)(A) is mandatory and enforceable by injunction, even where the biosimilar applicant has triggered the patent dance by providing its…

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Celltrion Opposes Janssen's Request for Expedited Trial

We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab).  Last week, we also reported that in Janssen v. Celltrion, Janssen filed a letter to the court stating that the “Defendants notified us that they intend to begin commercial sales of their biosimilar in no later than 180 days…

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Amgen v. Apotex: Federal Circuit Oral Argument Held

Attorneys for Amgen and Apotex appeared before the Federal Circuit yesterday to argue about whether the notice of commercial marketing provision, 42 U.S.C. § 262(l)(8)(A), is optional when a biosimilar applicant has provided its application and information to the reference product sponsor (RPS) under paragraph (l)(2)(A). The notice of commercial marketing triggers a…

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Biocon and Mylan Team Up for Biosimilar Regulatory Filings

Biocon, a prominent Indian biopharma company, entered into a partnership with Mylan in 2009 for joint research and development of biosimilars. That partnership now appears to be yielding results.  The companies expect to submit regulatory filings in both the U.S. and EU 2016: trastuzumab, pegfilgrastim, adalimumab, and insulin glargine. As Big…

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