Drug prices remain a top concern for many Americans, with one in four people reporting difficulty affording their prescriptions. Politicians are taking note, with President Biden recently commenting, “We pay more for prescription drugs than any — any nation on Earth.”

In response, the White House’s new budget includes several policies that aim at the high cost of drugs. The proposed reforms include the authority for Medicare to negotiate prices and requirements for drugmakers to pay rebates to Medicare for treatments that increase in price faster than the inflation rate. 

While these reforms focus on prices, they fail to address the real source of high costs and the pharmaceutical industry’s power: America’s outdated drug patent system. 

Drugmakers have been quietly gaming the nation’s patent system for decades to lock in inflated prices through manipulative patenting practices.

Patent law says that if you invent and successfully patent a product, no one else can make or sell it for 20 years. Fair enough. But drugmakers have learned to work the system in their favor by creating “thickets” of patents that stifle competition and extend their monopoly power past the 20-year mark. This multitude of patents creates a dense jungle of legal protection — in some cases, hundreds of patents for a single drug — based on slightly tweaked formulas, dosages, indications or other dubious claims of uniqueness. Prices remain artificially high as the patent thickets keep low-cost competing versions of top-selling medicines off the market for years.

Over-patenting allows drugmakers to sue would-be competitors for patent infringement and extract payments from settlements. And with patent monopolies on seven out of 10 of America’s blockbuster drugs expected to expire this decade, the industry increasingly relies on patent thickets to safeguard their profits. This systemic, under-the-table patent abuse is gouging patients — of all ages — who need affordable medications. It’s also a critical reason prescription drug spending in the United States is poised to reach nearly a trillion dollars in the next 10 years.

On average, there are 140 patents filed and 74 patents granted on each of America’s 10 top-selling drugs. And most of these patent applications were filed after FDA approval, often for frivolous or minor product modifications. A new  Drug Patent Book gives Congress and the public an eye-opening window into the industry’s unrelenting patent abuse. The data underscore the weakness of a system that has become a vehicle for unprecedented profits rather than an engine for discoveries that are truly unprecedented.

Take the case of America’s top-selling anti-inflammatory drug, Humira, made by AbbVie. The drug’s first biosimilar competitor entered the market earlier this year, but not before AbbVie made an extra $114 billion after the expiration of its primary patent in 2016. In other words, the drug company’s thicket of patents allowed it to hold onto its monopoly for seven years beyond its main patent. Despite litigation efforts, all the competitor companies settled.

Even an antitrust action failed: a federal appeals court judge threw out a lawsuit that accused AbbVie of building patent thickets to protect the drug from would-be competitors. He ruled that the company had not violated antitrust laws and posed the confounding question, “What’s wrong with AbbVie having 132 patents on a single drug?” But the courts are not the only avenue to address drugmakers’ drug patent chicanery. Three essential reforms are needed to revert the patent system to its original intent — one that rewards actual invention while prioritizing patients over excessive profits.

First, Congress must work with the Food and Drug Administration and the U.S. Patent and Trademark Office to raise the bar for what gets patented. There is growing bipartisan support for such reform. A group of senators recently wrote to the USPTO urging a crackdown on drugmakers’ patent excesses. 

Second, there must be a stronger balance of public and private interests in the patent system, which can be accomplished by electing more members of the broader public to the USPTO advisory committee.

And finally, the process for challenging undeserving patents must be less costly and complicated to ensure the U.S. patent system better serves the public.

The outlandish cost of prescription drugs is not a Republican or Democratic issue. When the patent system fails, we all suffer. The Biden administration and Congress must summon the will to come together across party lines to end drug patent abuse and clear the way for all Americans to access affordable life-saving medicines.