Archives for 

BPCIA and Related U.S. Statutes

Federal Circuit Oral Arguments in NYC today: A Review

Amgen v. Apotex (pegfilgrastim)  •  Biologics Litigation  •  BPCIA and Related U.S. Statutes  •  Janssen v. Celltrion (infliximab)  •  Patent Dance  •  U.S. Biosimilar Litigation News
As we noted earlier today, this week the Federal Circuit is holding oral argument at various venues in New York City. Two of today’s oral arguments were in biosimilar cases that we have been closely […]

View More

Amgen v. Sandoz Appeal: Parties Submit Supplemental Briefing; Court Grants US Extension to File Amicus Brief

Amgen v. Sandoz (filgrastim)  •  Biologics Litigation  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  U.S. Biosimilar Litigation News
As we previously reported, following the Supreme Court’s June 12, 2017 decision in Sandoz v. Amgen,  the Federal Circuit on July 26, 2017, issued an order recalling its October 23, […]

View More

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 […]

View More

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 […]

View More

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 […]

View More

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).  […]

View More