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BPCIA and Related U.S. Statutes

Amgen v. Sandoz: Federal Circuit Vacates Opinion and Mandate, Reinstates Appeal, Orders Further Briefing on Remanded Issues

Amgen v. Sandoz (filgrastim)  •  Approved Biosimilar Products  •  Biologics Litigation  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  U.S. Biosimilar Litigation News  •  U.S. Federal Circuit Decisions  •  U.S. Supreme Court Decisions
As we previously reported, following the Supreme Court’s decision in Sandoz v. Amgen, Sandoz requested a remand to the District Court to answer the two questions that the […]

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Supreme Court Oral Argument in Sandoz v. Amgen

Amgen v. Sandoz (filgrastim)  •  Approved Biosimilar Products  •  Biologics Litigation  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  Patent Dance  •  U.S. Biosimilar Litigation News  •  U.S. Federal Circuit Decisions
The Supreme Court held a 70-minute oral argument in Sandoz v. Amgen this morning. Before beginning the argument, the Chief Justice announced that the Court would give each side five extra minutes–a highly unusual step reflecting […]

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Summary of Sandoz’s Response and Reply Brief in Sandoz v. Amgen

Amgen v. Sandoz (filgrastim)  •  Biologics Litigation  •  BPCIA and Related U.S. Statutes  •  Patent Dance  •  U.S. Biosimilar Litigation News
On March 31, Sandoz filed its consolidated response and reply brief in Sandoz v. Amgen. We have previously covered Amgen’s consolidated opening and responsive brief and Sandoz’s opening brief.  Amgen’s final reply brief […]

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Amgen v. Hospira: FEDERAL CIRCUIT ORAL ARGUMENT HELD

Amgen v. Hospira (epoetin alfa)  •  BPCIA and Related U.S. Statutes  •  Patent Dance  •  U.S. Biosimilar Litigation News
On April 3, 2017, the Federal Circuit heard oral argument concerning the discovery dispute between Amgen and Hospira in their litigation concerning Hospira’s proposed biosimilar of Amgen’s product Epogen®/ Procrit® (epoetin alfa) (audio available here).  […]

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CELLTRION FILES RESPONSE BRIEF IN INFLIXIMAB APPEAL

Biosimilar News  •  BPCIA and Related U.S. Statutes  •  Janssen v. Celltrion (infliximab)  •  Patent Dance  •  U.S. Biosimilar Litigation News  •  U.S. District Court Decisions
As we previously reported, in Janssen v. Celltrion, Janssen appealed the district court’s partial final judgment that Janssen’s ‘471 patent, relating to monoclonal antibodies including infliximab, is invalid. As we also previously reported, Janssen filed its opening appeal […]

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Summary of Amgen’s Opening and Responsive Brief in Sandoz v. Amgen

Amgen v. Sandoz (filgrastim)  •  Approved Biosimilar Products  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  Patent Dance  •  U.S. Biosimilar Litigation News  •  U.S. Federal Circuit Decisions
On Friday, March 10, Amgen filed its consolidated opening and responsive brief to the Supreme Court in Sandoz v. Amgen.  As we covered in a previous post, Sandoz filed its opening brief in the case […]

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