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Amgen Voluntarily Dismisses Federal Appeal Against Colorado Drug Board

Pharmaceutical giant Amgen Inc. and its subsidiaries have voluntarily dismissed their Federal Circuit appeal challenging Colorado's Prescription Drug Affordability Review Board. The dismissal without prejudice allows Amgen to potentially refile the case in the future.

AI-generated Summary
4 min readcourtlistener
Seal of the Federal Circuit Court of Appeals

Case Information

Case No.:
25-1641

Key Takeaways

  • Amgen and subsidiaries voluntarily dismissed their Federal Circuit appeal against Colorado's drug affordability board
  • Dismissal without prejudice allows Amgen to potentially refile the challenge in the future
  • Case involved challenge to multiple Colorado officials overseeing prescription drug affordability review

The Federal Circuit Court of Appeals has dismissed an appeal by pharmaceutical company Amgen Inc. and its subsidiaries against Colorado's Prescription Drug Affordability Review Board after the parties jointly stipulated to voluntarily dismiss the case without prejudice.

The court issued a nonprecedential order on Feb. 2, 2026, in *Amgen Inc. v. Colorado Prescription Drug Affordability Review Board* (Fed. Cir. 2026), formally ending the appeal that began in the U.S. District Court for the District of Colorado under Judge Nina Y. Wang.

Amgen Inc., along with Immunex Corporation and Amgen Manufacturing Limited, had challenged multiple Colorado state officials in their official capacities. The defendants included Gail Mizner, chair of the Colorado Prescription Drug Affordability Review Board, and four other board members: Sami Diab, Amarylis Gutierrez, Catherine Harshbarger, and James Justin Vandenberg. The lawsuit also named Michael Conway, commissioner of the Colorado Division of Insurance, and Philip Weiser, Colorado's attorney general.

The voluntary dismissal came through a joint stipulation filed by both parties under Federal Rule of Appellate Procedure 42(b). Under the terms of the dismissal, each side will bear its own costs. The Federal Circuit noted in its order that it "generally does not specify whether a dismissal of an appeal is with or without prejudice," but the parties' joint stipulation explicitly requested dismissal without prejudice.

The distinction between dismissal with and without prejudice is legally significant. A dismissal without prejudice means Amgen retains the right to refile its challenge against Colorado's drug affordability review process in the future, should circumstances change or new legal arguments arise. This preserves the pharmaceutical company's legal options while ending the current litigation.

Colorado's Prescription Drug Affordability Review Board represents part of a broader state-level effort to address rising prescription drug costs. The board has authority to review prescription drug pricing and can make recommendations or take action regarding drugs deemed unaffordable for Colorado residents. Such state-level drug pricing initiatives have faced legal challenges from pharmaceutical companies across the country.

The case originated in federal district court, where Amgen likely challenged the board's authority or actions under various legal theories that could include constitutional commerce clause violations, federal preemption, or due process concerns. However, the specific legal claims and underlying facts that prompted Amgen's challenge are not detailed in the appellate court's dismissal order.

The Federal Circuit's jurisdiction over the case suggests the dispute may have involved intellectual property issues, as this specialized appeals court primarily handles patent and other intellectual property matters, along with certain government contract disputes and other specialized federal law areas.

Amgen, one of the world's largest biotechnology companies, manufactures numerous prescription medications that could potentially fall under review by state drug affordability boards. The company's decision to voluntarily dismiss the appeal suggests either a strategic litigation decision or potentially a negotiated resolution that addresses the parties' concerns outside of court.

The timing of the dismissal is notable, coming relatively early in the appellate process. The case was assigned number 2025-1641, indicating it was filed in 2025, making this a relatively swift resolution at the Federal Circuit level.

For Colorado's drug affordability review process, the dismissal removes immediate legal uncertainty about the board's operations. However, the without-prejudice nature of the dismissal means the state's authority could face future legal challenges if Amgen or other pharmaceutical companies decide to pursue litigation under different circumstances.

The case reflects ongoing tensions between state efforts to control prescription drug costs and pharmaceutical industry resistance to pricing regulations. Multiple states have established or are considering drug affordability review boards as healthcare costs continue to burden residents and state budgets.

The court issued its order as a mandate on the same date as the decision, Feb. 2, 2026, making the dismissal immediately effective. The mandate formally concludes the Federal Circuit proceedings and returns any jurisdiction over related matters to the district court level.

While this particular legal challenge has ended, the broader policy debate over state authority to regulate prescription drug pricing continues across multiple jurisdictions. The voluntary dismissal suggests both sides found value in ending this specific litigation, but it does not resolve the underlying legal and policy questions about state drug affordability review boards.

Topics

drug affordabilityregulatory compliancepharmaceutical litigationstate regulationappellate procedure

Original Source: courtlistener

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