Drug Patents Triple Over Decades as Pharma Extends Monopoly Pricing

Prescription drug costs remain a major burden for American patients, and a significant driver is how the pharmaceutical industry deploys the patent system. New research published in JAMA documents a sharp rise in this practice over the past three decades.

The Patent Explosion#

Patent applications on small-molecule medications have grown dramatically since 1990. The average number of patents granted per drug has jumped from roughly 2 per drug in 1990 to nearly 7 per drug approved in 2019—a more than threefold increase. This expansion directly translates into prolonged monopoly control: the typical patent protection period for a drug extended from about two years in 1990 to over six years in 2019.

How the System Gets Gamed#

The bulk of this growth stems from what researchers call "nonprimary" patents—protections that have little to do with a drug's actual active ingredient. Instead, they cover incremental changes: minor adjustments to inactive formulation ingredients, new dosing instructions, or proprietary delivery mechanisms like specialty auto-injectors.

When layered together across a single medication, these patents form what's known as a "patent thicket." This legal barrier prevents generic manufacturers from entering the market, even though the drug itself poses no clinical advantage over earlier versions. The result is that brand-name drugs command monopoly-level prices far longer than their core innovation would justify.

The Real Cost#

According to the study, led by patent and drug law expert S. Sean Tu at the University of Alabama, this strategy means patients and health systems bear unnecessary costs through prolonged pricing without receiving additional medical benefits. As Tu and his colleagues note, patent protection is what enables manufacturers to maintain inflated prices without competitive pressure from generics.

The research examined FDA-approved small-molecule drugs from 1990 through 2019, with a five-year follow-up window. Current patent activity extends even further—up to nine years post-approval—suggesting that today's patent thickets are substantially larger than what the study captured.