The U.S. District Court for the District of Delaware has denied Amgen’s motion to consolidate a recently filed action against Pfizer and its affiliate Hospira relating to Hospira’s filgrastim biosimilar with an ongoing litigation between the parties involving the same product, which is set for trial in May 2021. As…
As we previously reported, Amgen sued Pfizer and its affiliate Hospira in July 2018 based on Hospira’s submission of an aBLA for a biosimilar of NEULASTA (filgrastim). That same month, Pfizer obtained FDA-approval and, in October 2018, it launched its biosimilar in the United States as NIVESTYM (filgrastim-aafi). Since that…
More than a dozen BPCIA patent litigations are currently pending in various U.S. district courts. Below are some highlights of activity in some of those cases from this month. Genentech v. Amgen (D. Del.): bevacizumab On August 2, 2018, Judge Sleet issued a memorandum in response to the parties’ ongoing…
Today, Amgen filed a complaint for patent infringement under the BPCIA against Hospira and its parent Pfizer concerning their proposed biosimilar of Neupogen® (filgrastim). According to the complaint, the parties engaged in the patent dance, during which the parties negotiated and ultimately agreed that, of the seven patents that Amgen…
Pending U.S. District Court BPCIA Litigations Resolved U.S. District Court BPCIA Litigations Last updated: April 16, 2024