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
September 21, 2021 marked the fourth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fourth year...more
Generic manufacturers seeking to put an end to Hatch-Waxman Act patent litigation over a branded company’s Orange Book-listed patents can seek to do so by converting from Paragraph IV (“PIV”) patent certifications to...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 August 8, 2019, the Court of Queen’s Bench of Alberta dismissed Allergan’s application for judicial review of a decision by the Alberta Minister of Health (the Minister) to designate Allergan’s glaucoma treatment product...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
In the first Federal Circuit case involving the Biologics Price Competition and Innovation Act (“BPCIA” or “Biosimilars Act”), the Court of Appeals for the Federal Circuit affirmed Judge Maxine E. Chesney’s (N.D. Cal.)...more