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FTC Files Amicus Brief in CareFirst v. Amgen: What You Need to Know

The Federal Trade Commission has intervened in the ongoing antitrust litigation CareFirst v. According to the FTC's filing in the U.S. Court of Appeals for the Fourth Circuit, acquiring patent applications can carry significant exclusionary power and should…

FTC Files Amicus Brief in CareFirst v. Amgen: What You Need to Know

The Federal Trade Commission has intervened in the ongoing antitrust litigation CareFirst v. According to the FTC’s filing in the U.S. Court of Appeals for the Fourth Circuit, acquiring patent applications can carry significant exclusionary power and should not receive automatic immunity under the Noerr-Pennington doctrine.

The Central Dispute Over Enbrel Patent Acquisitions

Amgen acquired the Enbrel intellectual property through its 2002 purchase of Immunex. When Amgen’s core patents approached expiration in 2012, threatening to clear the path for lower-cost biosimilars, the company sought to bolster its market exclusivity.

Court records show that in 2004, Amgen purchased Roche’s remaining rights in a family of pending patent applications known as the Brockhaus Patents. This purchase made Amgen the exclusive licensee, allowing the company to prosecute and amend those pending applications to secure extended patent protection for Enbrel through 2029. Plaintiffs in the case, including CareFirst, allege that this strategy delayed biosimilar competition and forced purchasers to pay hundreds of millions of dollars per year in overcharges. The plaintiffs sued Amgen under Section 2 of the Sherman Act, asserting that the acquisition of the pending patent applications constituted anticompetitive monopolization.

Amgen’s Defense and the Noerr-Pennington Doctrine

Amgen moved to dismiss the Sherman Act claims, arguing that its acquisition of patent applications cannot qualify as anticompetitive conduct under Section 2. According to court filings, Amgen contends that its actions are shielded by the Noerr-Pennington doctrine because the company subsequently prosecuted the applications before the U.S. Patent and Trademark Office and enforced the resulting patents in federal court.

FTC Files Amicus Brief in CareFirst v. Amgen: What You Need to Know
Photo: crowell.com

While the U.S. District Court for the Eastern District of Virginia denied Amgen’s motion to dismiss—ruling that petitioning the government is immune from antitrust liability, but purchasing the underlying patent rights is not—Amgen appealed that decision to the Fourth Circuit. The core legal question on appeal centers on whether buying the rights to pending patent applications enjoys the same antitrust immunity as petitioning government agencies.

The FTC’s Core Arguments on Antitrust Scrutiny

In its amicus brief submitted to the Fourth Circuit, the FTC asserts that private commercial transactions acquiring patent applications are subject to antitrust laws just like the purchase of issued patents. The Commission outlines three main principles for life sciences and health care industry participants to follow:

From Instagram — related to files amicus brief carefirst, FTC CareFirst Amgen
  • Pending applications carry exclusionary power: Control over a pending patent application lets a company shape the scope of the eventual patent in ways that fixed claims on already-issued patents do not, effectively helping a monopolist block competitors before a patent is even granted.
  • Noerr-Pennington does not protect commercial deals: The FTC draws a firm boundary between private asset purchases and government petitioning, arguing that buying private rights to position oneself for later government engagement is not shielded from antitrust liability.
  • Patient access and drug pricing are at stake: The Commission emphasizes that commercial maneuvers delaying biosimilar market entry directly impact healthcare costs and patient access to affordable therapeutics.

The Fourth Circuit’s upcoming decision on the appeal will determine whether private acquisitions of pending patent applications remain exposed to antitrust claims under the Sherman Act.

About the author: Dr Natalie Singh - Health Editor

Board‑certified internal‑medicine physician and MPH. Natalie authored peer‑reviewed studies on infectious disease and served as medical editor. “Dr. Natalie Singh delivers evidence‑based health news, medical breakthroughs, and expert wellness guidance.”