Tagged as: Amgen

Federal Circuit Denies Hospira’s Petition to Rehear Safe Harbor Ruling in Epoetin Biosimilar Dispute

The Federal Circuit has declined to reconsider its December 2019 affirmance of the district court ruling in the Amgen v. Hospira (epoetin alfa) dispute.  As we have previously reported, that ruling upheld a jury verdict finding (among other things) that Hospira’s manufacture of certain drug substance batches was not protected…

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District Court of Delaware Construes “Following Fermentation” in Genentech v. Amgen Trastuzumab and Bevacizumab Cases

We have previously reported on the BPCIA Genentech v. Amgen cases relating to trastuzumab and bevacizumab. This week, Judge Connolly construed the term “following fermentation” as it relates to U.S. Patent No. 8,574,869 (“the Kao patent”) to mean “after the earlier of harvesting or purification has begun.” By way of…

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BREAKING NEWS: Federal Circuit Rejects Genentech’s Bid to Block Sales of Amgen’s Trastuzumab Biosimilar

Following the oral argument three days ago, the U.S. Court of Appeals for the Federal Circuit today affirmed the lower court’s denial of Genentech’s motion for a preliminary injunction to enjoin sales of Amgen’s KANJINTI (trastuzumab-anns) biosimilar product. As we previously reported, Amgen launched KANJINTI in the United States in…

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Amgen Responds to Hospira’s Motion For Rehearing En Banc of the Safe Harbor Ruling in the Epoetin Biosimilar Dispute

We previously reported that Hospira filed a petition for rehearing en banc of the Federal Circuit’s affirmance of a $70 million damages award to Amgen in the parties’ BPCIA litigation regarding Hospira’s RETACRIT (epoetin alfa-epbx), a biosimilar of EPOGEN. Last week, Amgen filed its response. As background, in December 2019,…

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Litigation Update: Genentech’s Motion to Dismiss Amgen’s Counterclaims Denied in Avastin Biosimilar Litigation

On February 11, 2020, in the Biogen v. Amgen BPCIA litigation regarding MVASI (bevacizumab-awwb), Amgen’s biosimilar of AVASTIN, Judge Colm Connolly of the Delaware District Court denied most of Genentech’s motion to dismiss Amgen’s affirmative defenses and counterclaims.  Amgen had pled counterclaims seeking declaratory judgments that the asserted patents are…

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Amgen Sues Pfizer Over Proposed Neulasta Biosimilar

On February 11, 2020, Amgen sued Pfizer and its affiliate Hospira for patent infringement based on their proposed biosimilar of NEULASTA (pegfilgrastim).  Pegfilgrastim is indicated for decreasing the incidence of infection in patients receiving myelosuppressive chemotherapy.  In the complaint, Amgen alleges that Hospira’s aBLA infringes U.S. Patent No. 8,273,707 (“the…

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Another Biosimilar Litigation Settlement: Amgen v. Tanvex (Filgrastim)

Following last month’s dismissal of the Amgen v. Kashiv filgrastim biosimilar litigation, yesterday Amgen and Tanvex filed a joint stipulation of dismissal in their BPCIA litigation concerning Tanvex’s filgrastim biosimilar candidate. The stipulation states that the parties agree “to the dismissal, without prejudice, of all remaining claims and counterclaims in…

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BREAKING NEWS: Federal Circuit Affirms Amgen’s $70 Million Damages Award Against Pfizer Unit

This morning, a three-judge panel of the U.S. Court of Appeals for the Federal Circuit issued a 24-page opinion affirming the district court’s judgment in favor of Amgen in its four-year long BPCIA patent ligation against Hospira, a subsidiary of Pfizer, regarding a biosimilar of Amgen’s EPOGEN (epoetin alfa). On…

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