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Amgen Inc. v. Sandoz Inc.

  1. December 14, 2017

    3 Takeaways As Fed. Circ. Limits Biosimilar Lawsuits

    The Federal Circuit on Thursday averted potential chaos by not letting drugmakers use a wide variety of state laws to extract biosimilar manufacturing information from rivals, and its ruling will turn attention to what sort of information rivals must provide under federal law.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. July 13, 2016

    Life Sciences Cases To Watch In The 2nd Half Of 2016

    The second half of 2016 will produce industry-shaping court decisions regarding off-label marketing of medical devices, sales of biosimilars, drug exclusivity and anti-smoking regulations. Here are key cases to watch.

  7. March 22, 2016

    Amgen Hedges On Sandoz's High Court Biosimilar Petition

    Amgen on Tuesday said the U.S. Supreme Court should reject Sandoz's bid to revisit one part of a landmark Federal Circuit ruling on the obligations of biosimilar makers, but added that another part of the ruling should also be revisited if the justices do decide to weigh in.

  8. October 16, 2015

    4 Questions After Amgen-Sandoz Rehearing Bids Fizzle Out

    The Federal Circuit's refusal to rehear an epic fight between Amgen Inc. and Sandoz Inc. over the Affordable Care Act's biosimilars pathway raises the prospect of U.S. Supreme Court review and leaves critical disputes unresolved, attorneys say. Here, Law360 looks at questions that remain in the aftermath.

  9. October 16, 2015

    Fed. Circ. Won't Rehear Amgen-Sandoz Biosimilar Dispute

    The Federal Circuit on Friday refused to rehear a battle between Amgen Inc. and Sandoz Inc. over the Affordable Care Act's biosimilars pathway, leaving intact a landmark decision interpreting key provisions of the law.

  10. September 09, 2015

    Amgen, Sandoz Duel Over En Banc Bids In Biosimilars Fight

    Amgen Inc. and Sandoz Inc. separately asked the full Federal Circuit on Tuesday to reject the other's challenge to a fractured panel decision on key elements of the Affordable Care Act's approval pathway for biosimilars.

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