Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
The Supreme Court heard oral arguments in Amgen v. Sanofi yesterday in an extended session with arguments from the parties and the U.S. government. The Justices showed a great deal of interest, albeit with some difficulty,...more
The Supreme Court's decision to grant certiorari in Amgen v. Sanofi is the first time in almost a hundred years that the Court has deigned to consider sufficiency of disclosure decisions, in this case enablement under 35...more
On November 4, 2022, the Supreme Court granted certiorari in Amgen v. Sanofi, No. 21-757, to review “[w]hether enablement is governed by the statutory requirement that the specification teach those skilled in the art to make...more
On November 4, 2022, the Supreme Court granted certiorari in Amgen v. Sanofi, No. 21-757, agreeing to review, “whether enablement is governed by the statutory requirement that the specification teach those skilled in the art...more
In 2021, the Federal Circuit determined that Amgen’s biotech antibody patents lack enablement, i.e., the specification did not teach one of ordinary skill in the art how to make and use the invention without undue...more
Last week, the Supreme Court granted Amgen’s petition for certiorari to reconsider the enablement requirement for genus claims. The Supreme Court will review whether the Federal Circuit panel in Amgen v. Sanofi improperly...more
Uniloc USA, Inc. v. Motorola Mobility LLC, Appeal Nos 2021-1555, -1795 (Fed. Cir. Nov. 4, 2022) - Our Case of the Week is ostensibly a case about whether a patent owner has standing to sue when that patent holder has...more
The Supreme Court has granted Amgen’s Petition for a Writ of Certiorari, agreeing to address what it means to provide an enabling disclosure. In particular, Amgen asked the Court to address...more
High Court Will Tackle Proper Enablement Standard - Constituting something of a surprise, the Supreme Court on Friday, November 3rd granted Amgen's petition for certiorari on the second of the Questions Presented in its...more
The U.S. Supreme Court agreed today to review “whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to ‘make and use’ the claimed invention, 35 U.S.C. § 112,...more
On June 12, 2017, in Sandoz Inc. v. Amgen Inc., the United States Supreme Court unanimously held that a drug manufacturer may give a required 180-day notice of its intent to market a biosimilar drug before receiving FDA...more
On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting various provisions of the Biologics...more
On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more
On Friday, January 13, the Supreme Court granted certiorari in Amgen v. Sandoz (Nos. 15-1039 & 15-1195). The Supreme Court originally deferred its decision on the parties’ certiorari petitions in order to consider the...more
The U.S. Supreme Court has agreed to review some of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). The Court granted certiorari in the dispute between Amgen and Sandoz,...more
Responding to the Supreme Court’s request for its views, the Solicitor General recently recommended granting certiorari and reversing some of the Federal Circuit’s key holdings in Amgen v. Sandoz (Nos. 15-1039 & 15-1195)....more
On Monday, December 12, 2016, the Supreme Court denied certiorari in Apotex v. Amgen, No. 16-332. Apotex had petitioned the Court to clarify provisions of the Biologics Price Competition and Innovation Act (BPCIA) set forth...more
On November 21, 2016, Apotex submitted a reply brief in support of its petition for certiorari. A procedural note: the case was also distributed on November 21 for consideration at the Supreme Court’s private conference...more
On November 8, 2016, Amgen asked the Supreme Court to deny Apotex’s September 9, 2016 petition for review in Apotex v. Amgen, No. 16-332. Apotex had asked the High Court to clarify 42 U.S.C. § 262(l)(8)(A) of the Biologics...more
On Monday, June 20, 2016, the Supreme Court deferred a decision on the certiorari petitions filed by both parties from the Federal Circuit’s decision in Amgen v. Sandoz, 794 F.3d 1347 (2015), and instead called for the views...more
In a recent per curiam order granting the plan fiduciaries’ petition for certiorari and reversing the Ninth Circuit, the United States Supreme Court made clear that it expects lower courts to faithfully apply the pleading...more