For more than a decade, the Patent Trial and Appeal Board has occupied an unusual place in the American innovation system. Created under the America Invents Act of 2011 to be a faster, cheaper venue for challenging questionable patents, the PTAB became something far beyond its original mandate: a patent tribunal rife with abuse.
Now, the U.S. Patent and Trademark Office is attempting to instill balance.
Under Director John Squires, the USPTO has signaled two important reforms. First, the director asserts his statutory authority to review inter partes review petitions rather than allowing PTAB to run on autopilot. Second, the agency proposes rules to curb serial and duplicative patent challenges, a practice that allows challengers to attack the same patent repeatedly through multiple petitions and coordinated challenges.
Predictably, the corporate interests that have long benefited from PTAB’s status quo are pushing back. Big Tech companies, which rank among the most aggressive users of PTAB proceedings, have fought fiercely against efforts to impose fairness and due process.
Increasingly, a new argument has emerged against reform: that limiting PTAB challenges will raise drug prices.
That claim deserves substantial skepticism.
America already has one of the world’s most successful frameworks for balancing pharmaceutical innovation and affordability in the Hatch-Waxman Act of 1984. That landmark law created the modern generic drug industry by establishing a pathway for lower-cost copies of brand-name drugs once patents expire. The system works. Today, generic drugs account for more than 90 percent of prescriptions filled in the United States. Also, the competition among multiple generic entrants routinely drives prices down dramatically.
The success of Hatch-Waxman should be acknowledged and defended. It created a robust generics market that has saved American consumers enormous sums of money while preserving incentives for the costly, high-risk research needed to develop new medicines.
PTAB was never part of that original bargain.
Generic drug manufacturers already possess multiple legal means to challenge pharmaceutical patents. Hatch-Waxman created a carefully calibrated litigation framework that allows generic firms to contest patents in federal court while balancing the interests of innovators and consumers alike.
PTAB simply added another weapon — one that is often cheaper, faster, and procedurally advantageous for challengers.
Little evidence shows PTAB has reduced drug prices beyond the savings already generated by Hatch-Waxman’s framework. PTAB proceedings have generally not invalidated the core patents covering active pharmaceutical ingredients. More often, disputes involve secondary patents related to formulations or methods of use.
If PTAB were truly indispensable to affordable medicine, Americans should reasonably ask why drug prices have continued to rise during the PTAB era.
The reality is that the current debate is not simply about consumers. It is also about corporate economic interests.
Generic drug companies have incentives to use PTAB challenges because being first to market can be extraordinarily lucrative. Hatch-Waxman grants the first successful generic entrant a period of exclusivity, allowing that company to capture significant profits before additional competitors arrive and prices fall further.
Firms may seek the least expensive route to invalidate patents standing in their way. PTAB proceedings can provide that. And yet, just one generic drug firm ranks in the top 25 users of PTAB.
Policymakers should recognize who these beneficiaries are. The generic manufacturing sector is dominated by multinational firms headquartered abroad, including companies based in Switzerland, India, and Israel. India alone supplies roughly half of the generics consumed in the United States, while China and India together account for a substantial share of the pharmaceutical supply chain.
Meanwhile, American biopharmaceutical innovators invest more than $100 billion annually in research and development. Drug discovery remains one of the most uncertain and capital-intensive enterprises in the economy. Only a tiny fraction of compounds ever become approved medicines, and most research investments fail.
Weakening patent protections through endless administrative challenges may marginally benefit certain generic manufacturers, but it also risks undermining the economic foundation that supports future medical innovation—leading to the next rounds of generic medicines.
Nor is this problem confined to pharmaceuticals. PTAB abuse has harmed startups and innovators across sectors, particularly in technology, where large incumbent firms use repeated patent challenges as a strategic weapon against smaller competitors.
That’s why Director Squires’ reforms matter. Reining in serial challenges and injecting accountability in PTAB review doesn’t eliminate patent disputes. It prevents the abuse of multiple attacks against a patent being weaponized to bleed smaller inventors dry.
The United States can support both affordable medicines and strong patent protections. Hatch-Waxman already strikes that balance.
Policymakers should resist the attempt to use drug pricing rhetoric as cover for preserving a PTAB system that serves entrenched corporate interests rather than the broader goals of innovation, competition and American technological leadership.
