The Briefing – Late Night, Early Dismissal: The Santos-Kimmel Copyright Case
(Podcast) The Briefing – Late Night, Early Dismissal: The Santos-Kimmel Copyright Case
Fifth Circuit Affirms District Court’s Striking of Class Allegations
Eighth Circuit Reverses Dismissal of Putative Class Claims
Nota Bene Episode 98: The U.S. Supreme Court’s Mark on U.S. Antitrust Law for 2020 with Thomas Dillickrath and Bevin Newman
Class Action Suit Against Instagram for New Terms of Service Dismissed
On April 12, 2024, the Federal Circuit dismissed CAFC Appeal No. 24-1402 and Cross-Appeal No. 24-1405 for lack of jurisdiction following its February 22, 2024 order directing Regeneron and Mylan / Biocon to show cause why the...more
On November 22, 2019, the parties in the Amgen v. Kashiv BPCIA litigation, concerning Kashiv’s proposed biosimilar of NEUPOGEN (filgrastim), submitted a stipulation of dismissal indicating that they have “agree[d] to the...more
On November 1, 2018, Genentech and its co-plaintiffs dismissed the lawsuits they brought against Celltrion and Teva under the BPCIA in the District of New Jersey, in which the plaintiffs alleged that Celltrion’s filing of an...more
On May 17, 2017, Janssen sued Samsung Bioepis in the District of New Jersey for patent infringement under the BPCIA based on Samsung Bioepis’s filing of its aBLA for Renflexis® (infliximab-abda), a biosimilar of Remicade®...more
As we reported on Friday, Genentech has informed the District of Delaware that it will not file an amended complaint in its declaratory judgment action against Amgen regarding Amgen’s application to market a biosimilar of...more
Recently, the U.S. District Court of Delaware dismissed a complaint filed by Genentech under the Biologics Price Competition and Innovation Act (“BPCIA”). The complaint was filed in response to Amgen seeking FDA approval to...more
Judge Sleet of the U.S. District Court for the District of Delaware has dismissed Genentech’s complaint against Amgen for allegedly failing to comply with the the Biologics Price Competition and Innovation Act (BPCIA), but...more
Today, Judge Gregory Sleet of the U.S. District Court of Delaware orally dismissed Genentech’s lawsuit against Amgen alleging violations of the BPCIA. Judge Sleet did not issue a written opinion, but his order states that...more
On July 22, 2016, the District Court for the District of New Jersey granted Sandoz’s motion to dismiss Amgen’s declaratory judgment action related to Sandoz’s biosimilar of Amgen’s Neulasta (pegfilgrastim). As...more
Sandoz Inc. announced on October 2, 2015 that FDA accepted its regulatory application for a proposed biosimilar of Amgen Inc.’s biologic arthritis drug Enbrel for review. The acceptance comes years after Sandoz attempted to...more
The courts must “say what the law is,” even when that law, as Judge Lourie described the BPCIA, is “a riddle wrapped in a mystery inside an enigma.” Today, in Amgen Inc. v. Sandoz Inc., No. 2015-1499 (Fed. Cir. July 23,...more
Both Sides Come Away with Wins in Amgen v. Sandoz - Yesterday, in Amgen, Inc. v. Sandoz, Inc., the Federal Circuit construed multiple provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). ...more
On March 19, 2015, Judge Seeborg of the United States District Court for the Northern District of California denied Amgen Inc.’s motion for a preliminary injunction in the Amgen v. Sandoz case, thereby removing one more...more