As a physician caring for patients in New Orleans, I see the consequences of America’s prescription drug affordability crisis every day. Many of my patients need essential medications like insulin, blood thinners, and inhalers to manage chronic conditions that impact their day-to-day lives. But far too often, these medicines are unaffordable, even for patients with solid health insurance.
One major reason prescription medicines are so expensive is a little-known Big Pharma tactic called serial patent litigation. That’s when pharma companies repeatedly sue generic drug manufacturers in order to delay or stop affordable generic medicines from entering the market. It’s an abuse of our patent and court systems, and it keeps drug prices high, often for years, causing substantial health and financial harm to patients and families.
Here’s an example. I frequently prescribe a chronic heart failure medication called Entresto, which typically costs more than $700 a month even with a GoodRx coupon. When a generic manufacturer sought approval for a lower-cost version of Entresto in 2019, Novartis sued over several patents. Then, three years into the initial litigation, the company obtained a new patent and filed a second lawsuit. When the generic competitor finally launched, it was clear why Novartis had sued to delay competition: Today, on Cost Plus Drugs, a month’s supply of the generic version of Entresto costs about $13, without insurance.
It’s hard for me to stomach that, for years, patients couldn’t afford medication that would have improved their heart function and reduced mortality. How did we get here?
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In the mid-1980s, Congress passed balanced drug-patent legislation that smoothed the path for affordable generic drugs to enter the market, while incentivizing pharmaceutical companies to continue investing in new-drug development. Critically, the law created a fair, streamlined patent dispute process.
But in the early 2000s, drug companies spotted a loophole in the law: If they could get more patents on drugs, they could file more lawsuits against generic manufacturers, allowing them to delay generic-drug market entry.
Today, some medicines are protected by more than one hundred patents. Brand drug companies can prolong disputes by obtaining new patents or withholding patents from an initial lawsuit, giving them additional grounds to sue if they lose. In fact, they don’t even need to win for the tactic to work: Each new lawsuit imposes significant costs and risks on generic competitors, delaying and deterring market entry and keeping costs high.
Some serial litigation goes on for years, punishing patients whose medicines remain unaffordable. The manufacturer of Cabometyx, a treatment for certain advanced cancers, first sued the generic manufacturer in 2019. It lost on the patent at the heart of that suit, clearing the way for an August 2026 generic launch. But while the original case was pending, the manufacturer filed two more lawsuits involving related patents. This ongoing litigation has delayed the generic’s launch until at least 2030, at a cost borne by patients, insurers, employers, and taxpayers.
Louisianans shouldn’t have to choose between paying their rent or accessing life-saving medications. It’s time for Congress to step in and stop abusive serial patent litigation. By requiring drug companies to bring all their patent claims up front and mandating clear rules of the patent-litigation road, they could save Louisiana patients millions of dollars, and add years to their lives.
Reuben Mathew is an internal medicine-pediatrics resident in New Orleans. He is also a former Gene A. Copello Health Advocacy Fellow with Doctors for America and a graduate of the Bloomberg School of Public Health at Johns Hopkins University.
