Patent Litigation, Petition for Writ of Certiorari, Food and Drug Administration (FDA)

U.S. Supreme Court Invites Solicitor General to Submit Briefing on "Skinny Labels"

Jones Day on 7/1/2025

On June 23, 2025, the Supreme Court invited the Solicitor General to submit a brief expressing the views of the United States—dramatically increasing the likelihood that the Court will eventually grant review—in Hikma...more

Previewing Generic’s Skinny Label: Supreme Court to Rule on Teva’s Certiorari Petition

Foley Hoag LLP on 5/12/2023

The Supreme Court is expected to consider Teva’s pending petition for certiorari in the highly anticipated GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. on May 11, 2023, a case that could carry enormous implications for the...more

Year in Review: Top Five Legal Developments of 2017

Goodwin on 12/29/2017

Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017...more

Supreme Court Issues Highly Anticipated Decision Interpreting the Biologics Price Competition and Innovation Act

Herbert Smith Freehills Kramer on 6/16/2017

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

Supreme Court asks SG for views on Sandoz, Amgen petitions: Analysis and Next Steps

Goodwin on 6/21/2016

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

Amgen Hedges Its Bets With Cross-Petition For Certiorari Of Biosimilar Decision

Foley & Lardner LLP on 4/12/2016

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