Private Equity's Inversion Excursion: Pepper Hamilton Talks Tax With the Deal
At the end of last month, Judge Connolly denied defendants Hospira and Pfizer’s motion to dismiss following a telephone conference with the parties. We previously reported back in February 2020 that Amgen sued Pfizer and its...more
Last week, Amgen filed a new complaint against Pfizer and Hospira under the BPCIA for infringement related to Hospira’s filgrastim biosimilar. The action is related to newly granted U.S. Patent No. 10,577,392, which is...more
The 10th anniversary of the U.S. biosimilar pathway the Biologics Price Competition and Innovation Act of 2009 (BPCIA) is quickly approaching and marks an expansion of the U.S. biosimilar market. The BPCIA, signed into law...more
This morning, a three-judge panel of the U.S. Court of Appeals for the Federal Circuit issued a 24-page opinion affirming the district court’s judgment in favor of Amgen in its four-year long BPCIA patent ligation against...more
On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen. The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more
Here are some recent developments in U.S. legal proceedings relating to biosimilars: On December 10, 2018, in the Southern District of Florida, Apotex filed a motion to dismiss the patent infringement complaint that Amgen...more
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....more
Today, Amgen filed a complaint in the District of Delaware against Hospira and its parent Pfizer alleging infringement of U.S. Patent No. 9,643,997 based on Hospira’s filing of an aBLA seeking FDA-approval to engage in the...more
Pfizer’s proposed biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® (epoetin alfa) is poised to be the first erythropoietin (EPO) biosimilar in the U.S. FDA staff recommended approval of Pfizer’s product as a...more
Six years after the biosimilar pathway was enacted into law, FDA has approved three biosimilars for marketing in the US. Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen, was the first biosimilar to be approved. Zarxio, a...more