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Amgen Inc. et al v. Sandoz Inc. et al

  1. December 19, 2017

    Sandoz Gets Early Win In Amgen IP Dispute Over Neulasta

    A California federal judge gave Sandoz Inc. a quick win Tuesday in a patent infringement suit brought by Amgen Inc. over the biologic Neulasta, finding Sandoz's biosimilar doesn't infringe Amgen's formula.

  2. December 18, 2017

    Sandoz Says Neulasta Biosimilar Doesn't Infringe Amgen IP

    Sandoz Inc. urged a California federal judge Monday to find it hadn't infringed Amgen Inc.'s patent related to the biologic Neulasta, which treats chemotherapy side effects, because the recipe for Sandoz's biosimilar doesn't involve the step-by-step sequence described in the patent.

  3. December 14, 2017

    Biosimilar Act Trumps State Laws, Fed. Circ. Rules

    The federal biosimilars act prevents drugmakers from using state laws to punish rivals for withholding information about copycat products, the Federal Circuit ruled Thursday.

  4. September 12, 2017

    DOJ Backs Biosimilar Makers In Info-Sharing Fight

    The U.S. Department of Justice on Monday sided with biosimilar makers in the aftermath of a major U.S. Supreme Court ruling involving Amgen and Sandoz, telling the Federal Circuit that state laws can’t be used to extract information from biosimilar companies.

  5. August 29, 2017

    Amgen, Sandoz Battle Over High Court's Biosimilar Ruling

    In the aftermath of the U.S. Supreme Court's landmark biosimilars ruling, Amgen Inc. and Sandoz Inc. clashed late Monday over whether biosimilar makers can be punished for not divulging their approval applications to innovator rivals.

  6. June 29, 2017

    Sandoz Wants Big Biosimilar Case Sent To District Court

    Sandoz Inc. on Thursday asked the Federal Circuit to send its biosimilars brawl with Amgen Inc. back to the district court level, arguing that an issue raised by the U.S. Supreme Court is best handled there first.

  7. April 15, 2015

    Amgen Can't Halt Sandoz's Biosimilar Launch Ahead Of Appeal

    A California federal judge on Wednesday denied a bid by Amgen Inc. to prevent Sandoz Inc. from launching the first copycat biologic drug approved under the Affordable Care Act while the parties wait for an appeals court decision, ruling that Amgen failed to demonstrate irreparable harm.

  8. March 20, 2015

    3 Things To Watch After Sandoz's Biosimilars Win

    Sandoz Inc.'s triumph over Amgen Inc. in the first big court fight over key provisions of the Biologics Price Competition and Innovation Act carries major implications for a coming wave of biosimilars and related litigation, attorneys say. Here are three things to watch in the aftermath.

  9. March 19, 2015

    Sandoz Beats Amgen Bid To Delay Biosimilar Competition

    A California federal judge on Thursday handed Sandoz Inc. a major victory over Amgen Inc. in a high-stakes fight over the Affordable Care Act's approval pathway for biosimilars, clearing the way for sales of the first copycat biologic approved under the law.

  10. March 13, 2015

    Sandoz ACA Violation Unlikely In Amgen Suit, Judge Says

    A California federal judge said Friday he's unlikely to rule that Sandoz Inc. flouted the Affordable Care Act by failing to notify Amgen Inc. of its biosimilar version of a blockbuster drug for cancer patients, putting Amgen's bid for an injunction in doubt.

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