Patent Infringement, aBLA, Hatch-Waxman

[Virtual Conference] Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 14th - 30th, 1:00 pm EST

American Conference Institute (ACI) on 8/19/2025

ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more

N.D. Ill. Finds that a Foreign Parent Corp. May be Sued Under BPCIA Without the U.S. Subsidiary that Signed and Filed aBLA

Mintz - Intellectual Property Viewpoints on 9/21/2021

In what appears to be a case of first impression, on August 23, 2021 U.S. District Judge John Z. Lee of the United States District Court for the Northern District of Illinois denied a biosimilar applicant’s motion to dismiss...more

Federal Circuit Clarifies Probative Value of Patent Dance Statements

Jones Day on 11/29/2017

The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit. The Result: The court found that the commercial...more

Amgen v. Hospira: Court Considers Issues Regarding the Scope of Discovery and the RPS’s Ability to Assert Additional Patents in...

Goodwin on 5/13/2016

In a recent hearing held in Amgen v. Hospira, the parties offered arguments on some novel issues relating to litigation under the BPCIA, particularly: - ..Whether a reference product sponsor (“RPS”) can compel a...more

Riddle Me This: The Federal Circuit Provides a Measure of Clarity to the Enigmatic Biosimilar Approval Pathway

Fenwick & West LLP on 8/13/2015

In Amgen Inc. v. Sandoz Inc. (No. 2015-1499), a fractured panel of the Federal Circuit Court of Appeals recently decided two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009...more

Patent Infringement › aBLA › Hatch-Waxman

[Virtual Conference] Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 14th - 30th, 1:00 pm EST

N.D. Ill. Finds that a Foreign Parent Corp. May be Sued Under BPCIA Without the U.S. Subsidiary that Signed and Filed aBLA

Federal Circuit Clarifies Probative Value of Patent Dance Statements

Amgen v. Hospira: Court Considers Issues Regarding the Scope of Discovery and the RPS’s Ability to Assert Additional Patents in...

Riddle Me This: The Federal Circuit Provides a Measure of Clarity to the Enigmatic Biosimilar Approval Pathway

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