On June 16, 2021, the District Court for the District of Delaware issued a claim construction order construing a key term in the ongoing patent dispute between Amgen and Hospira over Hospira’s proposed biosimilar of Amgen’s...more
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
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...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
We previously reported that Hospira filed a petition for rehearing en banc of the Federal Circuit’s affirmance of a $70 million damages award to Amgen in the parties’ BPCIA litigation regarding Hospira’s RETACRIT (epoetin...more
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...more
On February 11, 2020 Amgen sued Pfizer and its affiliate Hospira for patent infringement based on their proposed biosimilar of NEULASTA (pegfilgrastim). Pegfilgrastim is indicated for decreasing the incidence of infection in...more
In December, in Amgen v. Hospira, 944 F.3d 1327 (Fed. Cir. 2019), a panel of the Federal Circuit issued the first decision applying the statutory Safe Harbor of 35 U.S.C. § 271(e)(1) to BPCIA patent litigation. ...more
Last month, a three-judge panel of the Federal Circuit affirmed a Delaware district court’s judgment of infringement against Hospira and $70 million damages award to Amgen in the parties’ BPCIA litigation regarding Hospira’s...more
Below we provide an update on some recent developments from this and recent weeks in biosimilar-related cases on appeal before the Federal Circuit. Genentech v. Hospira & U.S., Fed. Cir. Case No. 18-1933 – protein...more
It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more
On December 16, 2019, the Federal Circuit affirmed a Delaware jury verdict finding that Hospira infringed Amgen’s method of manufacturing patent on erythropoietin (EPO) and that Amgen was entitled to $70 million in damages...more
As we close out another calendar year, we look back at the top legal developments of 2019 that could influence the market for biologics and biosimilars. These five major court decisions will likely impact the legal strategy...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
The European Commission has released a report summarizing the European Commission and the national competition authorities’ work to enforce European Union antitrust and merger rules in the pharmaceutical space. The report...more
Here are our picks of some legal developments to keep an eye out for in the new year: 1. Etanercept biosimilar trial decision – This past September, in the Immunex v. Sandoz BPCIA patent litigation concerning Sandoz’s...more
Early last month, we reported that in the Amgen v. Hospira BPCIA litigation concerning Hospira’s Retacrit™ (epoetin alfa) biosimilar, Hospira had filed an appeal to the Federal Circuit from the Delaware district court’s final...more
The 2011 America Invents Act (AIA) provided a variety of new ways to administratively challenge patents, including the now widely used inter partes review (“IPR”) procedure. In two recent appeals of IPR decisions, Genentech...more
As we have previously reported, a jury in September 2017 issued a $70,000,000 verdict against Hospira based on its drug substance manufacturing activity in 2013-2015 in connection with its biosimilar of Amgen’s Epogen®...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
For just the tenth time since the implementation of the BPCIA, the FDA has approved a biosimilar product. Today, the FDA announced that it has approved Pfizer-subsidiary Hospira’s Retacrit™ (epoetin alfa-epbx) for the...more
Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017...more
Marketing approval for US biosimilars has taken off in 2017. FDA has approved five biosimilar products this year, increasing the number of approved biosimilars from four to nine. In addition to new biosimilars of AbbVie’s...more
As we recently reported, a federal jury awarded Amgen $70 million in damages last week after finding that Hospira’s manufacture of 14 batches of drug substance between 2013 and 2015 was not protected under the safe harbor...more
In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents...more