When Congress passed the Hatch-Waxman Act in 1984, it was a model of smart policymaking. The law struck a careful balance, maintaining patent protections to reward pharmaceutical innovators for undertaking the risks of drug development, while ensuring that once patents expired, lower-cost generics could quickly reach the market. The framework it established worked for decades, fueling innovation and saving American patients billions.
But that framework has been hijacked by Big Pharma’s newest innovation: serial patent litigation. A new white paper from the Association for Accessible Medicines and the Biosimilars Council details how.
Brand-name companies flood the patent system with dozens of minor patents on the same drug — covering formulations, methods of use, and even manufacturing impurities. When a generic company files to launch a drug, brand-name companies sue, alleging patent infringement but strategically hold back certain patents during the first lawsuit. Then, after losing the initial case, they file a second lawsuit based on patents they held back, or on new patents they’ve filed during the first lawsuit forcing generic competitors into another costly legal battle. Sometimes, brand companies will do this over and over forcing generic companies into a cycle of endless, costly lawsuits.
The results are predictable: patients are stuck with sky-high medicine prices as cheaper options are blocked for years. Seniors and families suffer, and competition is crushed, as generic companies face more lawsuits and staggering legal costs.
Instead of promoting innovation, these tactics turn the patent system into a tool of monopoly and greed. This isn’t free-market capitalism; it’s abuse of our patent and court systems that puts corporate profits over patients.
Republicans should be the ones to fix this. We are the party that believes in free markets and competition. We are the party that stands with patients and families, not with corporate lobbyists. And we are the party that can restore Hatch-Waxman’s original intent: to reward true medical breakthroughs while ensuring everyone has access to the affordable drugs they need. Leaders like Senator Mike Lee, who has long fought corporate cronyism, and Senator Chuck Grassley, a champion for transparency and lower drug prices, are precisely the kind of lawmakers who should take this fight head-on. In the House, conservatives on the Judiciary and Energy & Commerce Committees should push reforms to close the loopholes Big Pharma is abusing.
The necessary reforms are straightforward. Congress should narrow the grounds for serial litigation so that brand-name companies get one fair chance to defend their monopoly on a drug — not endless bites at the same apple. If Big Pharma loses the first lawsuit and chooses to sue again, then the penalties in subsequent lawsuits should be limited, to ensure the additional lawsuits on later-issued patents are significantly less intimidating and less likely to delay generic drugs’ market entry. These reforms would protect genuine innovation while ending manipulation: drug companies would still receive legitimate patent protections for genuine breakthroughs, but abusive tactics that prevent generics from entering the market would likely be stopped.
Republicans have a real opportunity to lead on this issue with common-sense reforms that lower drug prices without expanding government. We don’t need more bureaucracy or price controls. We just need to restore competition and fairness. Every day of delay costs American patients dearly. It’s time to stop Big Pharma’s patent games, restore balance to the Hatch-Waxman framework, and deliver the conservative solution: lower costs through real competition.
Scottie Nell Hughes is a Senior Fellow at Frontiers of Freedom.
