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New BPCIA Litigation: Amgen v. Hospira

Amgen has initiated new litigation over the patent provisions of the BPCIA, this time against Hospira in the U.S. District Court for the District of Delaware, regarding Hospira’s biosimilar application for FDA licensure of a biosimilar version of Amgen’s Epogen (epoetin alfa) product, which was approved by FDA in 1989…

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Janssen v. Celltrion Supplemental Briefing in Light of Amgen v. Sandoz: Opposition Brief from Celltrion and Hospira

As we reported in a previous post, the parties in Janssen v. Celltrion–a BPCIA-related case pending in the District of Massachusetts—are currently litigating whether Celltrion’s pre-FDA-licensure notice of commercial marketing was legally effective under the BPCIA. The parties have filed cross-motions for partial summary judgment on this issue, and these motions were pending when the Federal Circuit issued…

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Amicus Briefs Filed in Amgen v. Sandoz

Hospira, Inc., Celltrion Healthcare Co., Ltd., and Celltrion Inc. (jointly) and the Biosimilars Council filed amicus briefs today in support of Sandoz’s petition for rehearing en banc in Amgen v. Sandoz.  The briefs are now publicly available and are attached here and here. UPDATE: Mylan Inc. has also filed an amicus…

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BREAKING NEWS--Sandoz launches biosimilar product Zarxio in the U.S.

Following the end of the injunction imposed by the Federal Circuit’s July 21st opinion in Amgen v. Sandoz, Sandoz today launched its biosimilar product Zarxio–the first product to be approved under the BPCIA’s abbreviated approval pathway for biosimilars.  Zarxio is a biosimilar product referencing Amgen’s Neupogen (filgrastim) product, and will be sold at…

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PTAB Seeks to Nip Abusive IPRs in the Bud

The PTAB is asking for briefing on whether IPRs filed by the Coalition for Affordable Drugs against Shire PLC should be dismissed for abuse of the IPR process. The petitions (Nos. IPR2015-00990 and IPR2015-01093) concern U.S. Patent No. 7,056,886, directed to GLP-2 peptides and analogs thereof, which may be used…

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BREAKING NEWS--Federal Circuit Denies Amgen's Emergency Motion for a Temporary Injunction in Amgen v. Sandoz

The Federal Circuit has denied Amgen’s Emergency motion for a temporary injunction pending en banc consideration and review in Amgen v. Sandoz.  Per the Federal Circuit’s July 21st decision, Sandoz was enjoined from marketing its biosimilar filgrastim product, Zarxio, until 180 days from the date it received FDA approval for its product.  That original injunction…

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BREAKING NEWS – Amgen v. Sandoz:  Sandoz’s Response to Amgen’s Emergency Motion for an Injunction Pending En Banc Consideration and Review

Sandoz has filed its opposition to Amgen’s motion seeking an “emergency”  injunction from the Federal Circuit to extend the injunction blocking Sandoz from launching its Zarxio biosimilar past September 2, the date the injunction is currently set to expire.  In its opposition, Sandoz blasts Amgen’s motion as “perfunctory” and not meeting…

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