The House Judiciary Committee recently convened a hearing on pharmaceutical patents as lawmakers consider proposals that could fundamentally reshape the U.S. patent system.The stakes are enormous. For decades, strong intellectual property protections have helped make the United States the global leader in biomedical innovation, fueling investment in new medicines and treatments that save and improve patients’ lives.Yet, rather than clarifying the tradeoffs at stake, the hearing obscured them. That’s because many of the witnesses sought to misconstrue and mislead legislators on basic facts about the patent system. If Congress acts on this misinformation, millions of patients could lose out on future new medicines that could save and improve their lives and prevent disease.
The United States simultaneously leads the world in the introduction of and access to new medicines. We also boast the highest generic drug utilization rate of any developed country.
That’s no coincidence. Decades ago, lawmakers from both parties crafted a policy framework that balanced incentives for innovation with a clear pathway for generic ― and later biosimilar ― competition. The framework provided manufacturers with regulatory certainty while establishing well-defined processes for resolving patent disputes.Patent protections provide the certainty needed to support long-term R&D investments (often 10 to 15 years and $2.6 billion for a new medicine), even though only about one in 10 medicines in development ultimately receives FDA approval.
At the same time, existing patent laws incentivize generic manufacturers to bring cheaper, competing products to market as soon as legally possible. About 90% of prescriptions dispensed in the United States are already filled with generic medicines. According to the Association for Accessible Medicines, generics generated roughly $467 billion in savings in 2024 alone.Many of the hearing witnesses seemed oblivious to this reality. One witness, Rachel Goode, repeated a talking point long-circulated by anti-patent activist groups. She claimed that drug companies are filing “dense webs of often overlapping patents,” linked by “terminal disclaimers,” to construct “patent thickets” that block the arrival of cheaper generic and biosimilar medicines.This talking point has been thoroughly debunked. A recent joint study from the U.S. Patent and Trademark Office and the Food and Drug Administration concluded that “the number of patents [on a drug] may not be predictive of the timing of actual launch of competing products” and that “a higher number of patents may not necessarily delay a generic launch.”
That study also clarified that terminal disclaimers ― which require related patents to expire at the same time ― are a tool that the USPTO uses to deter patent abuse. The USPTO and FDA explained that terminal disclaimers prevent the “improper timewise extension of patent term” so that drug companies “cannot extend the duration of exclusivity.”Another witness, Michael Carrier, advanced a similarly misleading narrative, arguing that companies patent changes to their medicines ― such as creating a pill version of a previously intravenous drug ― to “evergreen” their product and extend the exclusivity period.Indeed, drug companies often continue to invest in R&D related to existing medicines to improve them, as well as to determine if they have potential to treat different stages of disease or, in many cases, completely different diseases or conditions. That’s true of companies in every industry, though. Ford updates the F-150 annually. Apple launches new iPhones regularly.In the pharmaceutical industry, the ongoing pursuit to treat new diseases and conditions, develop new formulations that improve patient adherence or require less frequent administration, benefits patients through expanded treatment options and often spurs increased brand-to-brand competition on price and clinical effects. In contrast to what legislators were told, the patents on the original version of drugs still expire on schedule, regardless of whether companies have subsequently patented any new medical advances.
And when they do expire, generic companies are quick to launch competing products. That’s why the typical drug enjoys about 13 years of market exclusivity before competing knockoffs arrive versus the 20-year granted patent term, a figure that has remained relatively constant for decades.Witnesses spent much of the hearing urging lawmakers to pass the ETHIC Act, which would make it harder for drug companies to enforce valid patents, particularly those covering improvements made after a drug’s initial FDA approval. That would naturally disincentivize companies from investing in additional lengthy and costly research.Such a drop-off in innovation couldn’t come at a worse time. The United States still leads the world in the development of new medicines. But China has made biotechnology a strategic priority and is investing heavily to challenge U.S. leadership.Critics of the patent system keep promising that their proposals will lead to more and cheaper medicines. But Americans already use generic drugs more frequently than patients in any other nation, and generic launch times haven’t changed in decades. Instead, critics’ proposals would weaken patents, strengthen China and reduce medical breakthroughs for patients.Anne Pritchett, Ph.D., is a senior associate at the Center for Strategic and International Studies (CSIS) Renewing American Innovation Project and the founder of Pritchett Policy Associates.
This article originally appeared on The Detroit News: Weakening drug patents won’t lower costs; it will slow innovation | Opinion
Reporting by Anne Pritchett / The Detroit News
USA TODAY Network via Reuters Connect
By Anne Pritchett | USA TODAY Network
