News & Analysis as of

Pharmaceutical Patents Petition for Writ of Certiorari Food and Drug Administration (FDA)

Jones Day

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

Jones Day on

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

Foley Hoag LLP

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

Foley Hoag LLP on

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

Herbert Smith Freehills Kramer

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

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

Goodwin

Mylan Files Amicus Brief in Support of Certiorari in Amgen v. Apotex

Goodwin on

Mylan filed an amicus brief in support of Apotex’s petition for certiorari in Amgen v. Apotex. Mylan’s arguments focus on the Federal Circuit’s interpretation of the BCPIA as requiring 180 days of pre-marketing notice after...more

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

BakerHostetler

Sandoz Requests Supreme Court Review of the Federal Circuit’s Interpretation of Biosimilar Law

BakerHostetler on

On February 16, 2016, Sandoz Inc. filed a petition for a writ of certiorari with the U.S. Supreme Court, asking the Court to review the Federal Circuit’s interpretation of the Biologics Price Competition and Innovation Act...more

Fish & Richardson

Biosimilar Law May Head to the Supreme Court

Fish & Richardson on

Sandoz is seeking U.S. Supreme Court review of the Federal Circuit’s first ruling related to biosimilars, interpreting the Biologics Price Competition and Innovation Act (“BPCIA”)....more

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