Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On November 4, the United States Supreme Court granted a petition for writ of certiorari to review the Federal Circuit’s decision in Amgen Inc., v. Sanofi. Certiorari was limited to the question of whether the enablement...more
At the end of last month, three amicus curiae briefs were filed following the petition for a writ of certiorari in the Amgen, Inc. v. Sanofi, Inc. case. We previously discussed the petition for a writ of certiorari in detail...more
As we have previously discussed, on February 11, 2021, the Federal Circuit decided Amgen Inc. et al. v. Sanofi, Aventisub LLC, et al. The Federal Circuit affirmed the district court’s grant of JMOL that Amgen’s Repatha®...more
As we reported earlier this year, Amgen filed a petition for rehearing en banc to the Federal Circuit, arguing that the panel in Amgen v. Sanofi improperly created a new and heightened test for enablement of genus claims with...more
The Supreme Court denied certiorari last week in Amgen Inc. v. Sanofi, in a case that asked the Court to review the Federal Circuit's jurisprudence related to the written description requirement of 35 U.S.C. § 112(a)....more
Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017...more
On June 12, the Supreme Court decided Sandoz Inc. v. Amgen Inc., the first case under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) to reach the high court. The BPCIA establishes a regulatory pathway for...more
On Friday, the Supreme Court granted both petitions for writs of certiorari and consolidated the Sandoz v. Amgen (No. 15-1039) and Amgen v. Sandoz (No. 15-1195) appeals. Sandoz had petitioned the Court on February 16, 2016...more
The Supreme Court has granted Sandoz’s petition for certiorari, and Amgen’s cross-petition for certiorari in Amgen v. Sandoz. The Order is excerpted below and can be found here...more
On November 8, 2016, Amgen submitted a brief in opposition to Apotex’s petition for certiorari challenging the Federal Circuit’s application of its holding in Amgen v. Sandoz that subsection (l)(8)(A) of the BPCIA allows an...more
Among the first generation of biosimilar litigation under the Biologics Price Competition and Innovation Act (BPCIA) is a dispute between Amgen and Apotex over Apotex’s proposed biosimilar versions of Amgen’s Neupogen...more
On September 9, 2016, Apotex Inc. filed a petition for writ of certiorari in the U.S. Supreme Court seeking review of the Federal Circuit’s decision in Amgen Inc. v. Apotex Inc., Case No. 2016-1308. This case involves...more
We have been closely following the Amgen v. Apotex case. On September 9, 2016, Apotex petitioned the Supreme Court for certiorari to review the Federal Circuit’s decision. In its petition, Apotex presents two questions for...more
In Amgen v. Apotex, the Federal Circuit rejected Apotex’s arguments that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the “patent dance” process of the Biologics...more
On June 20, 2016, instead of deciding whether to grant certiorari in the biosimilar patent dance dispute between Amgen and Sandoz, the Supreme Court invited the Solicitor General “to file a brief in this case expressing the...more
As we posted on June 20, the Supreme Court has invited the Solicitor General to file briefs regarding the Sandoz v. Amgen and Amgen v. Sandoz petitions for certiorari. Below we provide further analysis and commentary on the...more
On June 20, 2016, the Supreme Court invited the Solicitor General to file briefs regarding the Sandoz v. Amgen and Amgen v. Sandoz petitions for certiorari...more
As we previously reported, on February 16, 2016, Sandoz petitioned the United States Supreme Court for a writ of certiorari regarding the Federal Circuit’s interpretation of the BPCIA’s “notice of commercial marketing”...more
As we covered in a previous post, following the Federal Circuit’s decision in Amgen v. Sandoz, Sandoz filed a petition for a writ of certiorari asking the Supreme Court to review the Federal Circuit’s interpretation of the...more
Although Amgen originally did not petition the Supreme Court for certiorari to review the first Federal Circuit decision interpreting the BPCIA framework for resolving biosimilar patent disputes, Amgen now has filed a...more
On February 16, 2016, Sandoz, Inc. filed a petition for writ of certiorari to the Supreme Court, asking the Court to overturn the Federal Circuit decision that interpreted the “patent dance” provisions of the Biologics Price...more
Amgen has decided not to seek Supreme Court review of the Federal Circuit’s Amgen v. Sandoz decision, as the January 14, 2016 deadline to file has now passed without Amgen petitioning for certiorari. Amgen v. Sandoz is...more
The Federal Circuit today denied the petitions for rehearing by the panel and rehearing by the en banc Court filed by both parties in Amgen v. Sandoz. Amgen had petitioned for rehearing on the panel's decision that the...more