Colorado Tried to Slash Enbrel's Price by 70%. A Judge Said No.

First, patent preemption. This was the big one. Amgen argued that federal patent law gives drugmakers a deliberate bargain: you disclose your invention to the public, and in return you get a limited window of exclusive rights, including pricing power. Colorado's price cap, Amgen said, "strips away the rights and economic incentives that Congress sought to create." In other words, you can't let someone own a patent and then tell them what they're allowed to charge for it.

Second, the Dormant Commerce Clause. Colorado's cap didn't just apply at the pharmacy counter. It reached into upstream transactions involving wholesalers, PBMs, and health plans, some of which negotiate contracts in other states entirely. Amgen argued this amounted to Colorado regulating commerce beyond its own borders, which is a constitutional no-go.

Third, due process. Amgen claimed the PDAB operated with "vast unguided discretion" and lacked clear standards for determining when a drug is "unaffordable" or how to set the cap. Without meaningful guardrails, the company argued, the board could impose arbitrary, confiscatory prices.

The Judge Picks a Side (for Now)

Judge Domenico didn't mince words. Citing binding precedent from the Federal Circuit (involving a similar D.C. price-control attempt), he concluded that "caps on the price of patented drugs like Enbrel are preempted by federal law."

His reasoning was straightforward: Congress designed the patent system to give innovators a period of exclusive pricing power. Colorado's attempt to override that balance, however well-intentioned, collides with federal law. "Colorado's attempt to rebalance Congress's patent system is preempted by federal law," he wrote.

On the question of harm, Domenico acknowledged what everyone in pharma already knows: the drug supply chain is, in his words, "convoluted, confusing, and often counterintuitive." Colorado had argued that the financial pain might be absorbed by middlemen (distributors, insurers, PBMs) rather than Amgen itself. The judge wasn't buying it. He applied what he called "basic economic logic": if you slash the ceiling on what can be paid for a drug, the manufacturer inevitably takes home less money. And that damage to future contracts and negotiations, he found, couldn't simply be undone with a check later.

Notably, Domenico went out of his way to separate the policy question from the legal one. He acknowledged that high drug prices make medications "difficult, if not impossible, for many citizens to afford." He even noted Amgen's counterpoint that blockbuster profits fund the many failed experiments behind every successful drug. But policy sympathy, he said, doesn't change the legal calculus. He suggested Colorado could pursue affordability through subsidies or negotiated price reductions instead of directly capping patented drug prices.

Why This Matters Way Beyond Colorado

Colorado wasn't the only state watching this play out. At least four states (Colorado, Maryland, Minnesota, and Washington) have authorized affordability boards to set upper payment limits on certain drugs. About 12 states had created PDABs by early 2025, and several were considering expanding their powers.

This ruling throws cold water on all of them.

The logic of the injunction is simple and broadly applicable: if your state board tries to cap the price of a drug that's still under patent, you're likely running headfirst into federal preemption. That's not a Colorado-specific problem; it's a structural one. Any state with a PDAB that targets branded, patent-protected biologics now faces the same legal vulnerability.

For the pharmaceutical industry, the decision is a significant legal win. It validates the argument that patent rights carry real pricing power, and that states can't simply legislate that power away. Amgen's stock reportedly got a boost from the news, and other branded biologic makers are surely taking notes.

For patients, the picture is more complicated. Enbrel still costs more than $46,000 a year in Colorado, and no biosimilar competition is expected in the U.S. until 2029 at the earliest. Medicare did negotiate a lower price (around $2,355 for a 30-day supply, down from a $7,106 list price), but that applies to Medicare beneficiaries, not the broader market.

What Comes Next

The preliminary injunction is exactly that: preliminary. The full case still needs to play out, and an appeal is virtually guaranteed regardless of who wins at trial. The broader constitutional questions (due process, Commerce Clause) haven't been fully resolved yet.

But the signal from this ruling is loud and clear. States that want to tackle drug prices can't just draw a line in the sand and tell patent holders to deal with it. The courts are saying: if you want affordability, you need to find a path that doesn't run through the patent system.

Colorado tried to be first. It might end up being the last to try this particular approach.

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