Congressional momentum on drug patent reform, tabled at the end of the 118th Congress, is building again. Bipartisan support is coalescing behind House legislation targeting “patent thickets,” which brand-name drugmakers use to keep competing, lower-cost products from entering the market.
The measure, along with a related Senate bill, reflects long-overdue progress on patent reform.
In the House, the Judiciary Subcommittee on Courts, Intellectual Property, Artificial Intelligence, and the Internet heard testimony in June on the Eliminating Thickets to Increase Competition (ETHIC) Act (H.R. 3269). The bill takes aim at the strategies that brand-name drug makers use to create legal impediments — so-called patent thickets — that keep lower-cost generics out of the market.
In the Senate, the Medication Affordability and Patent Integrity Act (S. 2658) would make it a violation of federal law to withhold information from the U.S. Patent and Trademark Office (USPTO) about their drugs or biologics and give generic companies a powerful tool in patent litigation.
The current patent system is rife with barriers to entry for generic competitors, to the detriment of patients. Nearly 60 percent of Americans report feeling somewhat worried or very worried about being able to afford their prescriptions, and just over four in 10 adults report not taking their medication as prescribed due to cost concerns, according to a 2026 survey by health policy research and polling organization KFF.
Generic competition lowers costs for patients and taxpayers
It is well documented that generics and biosimilars are more affordable than their branded counterparts. Over time, generics can drive prices for branded drugs sharply lower. A 2025 report from the U.S. Department of Health and Human Services found that brand-name drug prices dropped up to 80 percent in Medicare Part D markets with 10 or more generic competitors. These findings indicate that removing barriers to entry for generic and biosimilar products is an effective cost-cutting strategy.
The Congressional Budget Office (CBO) estimated in 2024 that the Affordable Prescriptions for Patients Act (S. 150), a 2023 bill aimed at limiting the number of patents that manufacturers could assert in patent litigation for biologics, would have reduced mandatory Medicare spending by $1.5 billion over 10 years. Biologics are medications made from living organisms.
In the House, the ETHIC Act would cover both biologics and small-molecule drugs, which are made of chemical compounds and represent the majority of the drug market. Although the CBO has yet to score the bill to estimate its likely impact, its broader application suggests that its fiscal impact could be larger than the previous Senate bill.
Other estimates of patent reform outcomes show significant cost savings in both Medicare Part B and Medicare Part D programs. Biosimilar competition of eight Medicare Part B-covered drugs resulted in a 62 percent reduction in program spending and out-of-pocket costs. Additionally, a 2025 study in the American Journal of Managed Care reported that the absence of extended market exclusivity of four top-selling drugs over a two-year period would have saved $1.6 billion in Medicare Part D payments. As the national debt continues to climb, Medicare cost-savings like these are important for Congress to promote and prioritize.
How patent gaming delays generic and biosimilar competition
A good pharmaceutical patent system spurs innovation and competition by allowing inventors a reasonable period of exclusivity on the market in order to recoup their research and development costs, while also ensuring timely access to affordable medicines for consumers. Seminal legislation, such as the Hatch-Waxman Act of 1984 and the Biologics Price Competition Innovation Act of 2009, reinforced the balance among innovation, competition, and patient access. Yet many experts believe that these laws are no longer functioning as intended, and that in some cases they incentivize the gaming that forestalls generic competition.
A particularly effective form of gaming known as evergreening occurs when brand manufacturers artificially lengthen the life of a patent by obtaining additional protections that prolong their exclusive control over a pharmaceutical product. This is often accomplished by applying secondary patents, which make only relatively minor changes to an existing invention — for example, new formulations or methods of use. The new formulation or methods may be novel and nonobvious, and thus able to secure patent protection, without providing significant clinical benefits. Layering multiple secondary patents on a product can produce a patent thicket, where brand-name drugmakers create a portfolio of sometimes overlapping, complicated patents and patent claims to block as many avenues for competitors’ entry as possible.
Despite brand manufacturers’ claims to the contrary, patent thickets do exist and have proliferated. To build a thicket of secondary patents, brand manufacturers may submit a patent application to the USPTO as a continuation, which expands the claims of a previously filed patent application. Continuation patents are approved, but they come with an important stipulation: terminal disclaimers, which require that the continuation patents expire at the same time as the original patent.
One study published in JAMA found that the ratio of continuation patents per new brand-name drug approval increased by 200 percent between 2000 and 2015. In contrast, the ratio of original patents increased by only 15 percent over the same period. There’s also evidence that the number of patents with terminal disclaimers involved in litigation dramatically spikes just as the Food and Drug Administration’s statutory period of market exclusivity for a branded product is about to end, suggesting that brand-name companies deploy this strategy to extend their monopoly and delay generic entry.
Evergreening and patent thickets force generic manufacturers to litigate each allegation of patent infringement. This drives up costs, stalls the availability of cheaper generics, and imposes financial and health costs on patients. Evidence suggests that secondary patents are more often the subject of litigation than primary patents.
Barriers to entry may be stronger for biologic drugs, with denser patent thickets resulting in longer delays to market competition. Another JAMA study found that between 2009 and 2023, biologics with litigated patents were protected by a median of 14 patents, ultimately resulting in biosimilar competition 20.3 years after FDA approval. Small-molecule drugs over the same period were protected by a median of three patents, with generic competition 12.6 years after FDA approval.
Taken together, gaming by brand manufacturers demonstrates that the status quo patent system is hindering rather than promoting innovation in pharmaceutical markets.
Momentum in Congress: Recent history and current efforts
This isn’t the first push for patent reform. In 2024, the Senate unanimously passed the bipartisan Affordable Prescriptions for Patients Act, which would have limited the number of patents a biologic drug maker can claim were violated by a competing biosimilar manufacturer during litigation. Around the same time, the USPTO proposed a rule that would have allowed generic drugmakers to invalidate patents linked through terminal disclaimers if a court found any one of them invalid.
These efforts would have significantly reduced the barriers to market entry for lower-cost drugs and would have incentivized drugmakers to focus on quality and novelty in their patenting decisions. Neither, however, became law. Congress cut the Affordable Prescriptions for Patients Act from the end-of-year legislative package, and citing “resource constraints,” the USPTO scrapped its 2024 proposed rule on terminal disclaimers. This came after its June 2024 report cautioning policymakers against “simply quantifying raw numbers of patents and exclusivities” as evidence of gaming. However, that report was narrowly scoped — covering just 25 drug applications and explicitly declining to assess anticompetitive behavior or the effect of patents on drug pricing, making it a thin basis for concluding that patent gaming is not a meaningful problem as some have claimed.
The bipartisan ETHIC Act, sponsored by Representative Jodey Arrington (R–Texas), would limit brand manufacturers’ litigation for patent infringement to one lawsuit per patent group, which is made up of the original patent and an array of related secondary patents linked through terminal disclaimers. This would reduce the effectiveness of a patent thicket.
Patents for Humira, a blockbuster drug for conditions such as rheumatoid arthritis, illustrate the dynamic. Humira’s patents expired in 2016, yet biosimilars weren’t introduced until 2023 partly because of patent system gaming. In the interim, patients paying out of pocket were forced to pay an estimated $70,000 a year for the drug. Insurance companies also footed major expenses. The state of Tennessee, for example, spent $48 million in 2022 to cover 775 patient dosages — about $62,000 per patient covered by the state’s employee health insurance program.
Under the ETHIC Act’s provisions designed to decrease the number of litigation-eligible patents, Humira’s 105 patents eligible for litigation would have fallen to just 24, clearing the path for lower-cost drugs to enter the market sooner.
These limits on patent litigation benefit defendants, including generic and biosimilar drug companies that are making or selling drugs that are either approved or pending approval. Patent reforms such as the ETHIC Act can mitigate the anticompetitive strategies of evergreening and patent thickets, in turn promoting innovation in the form of clinically meaningful additions to existing patents and novel inventions.
The Senate’s Medication Affordability and Patent Integrity Act, co-sponsored by Senators Maggie Hassan (D–N.H.) and Josh Hawley (R–Mo.), addresses a different kind of gaming: brand manufacturers submitting inconsistent information for their initial patent to the FDA and USPTO in order to obtain successive patents they would not otherwise qualify for.
The bill would require formal certification that patent-related information sharing is consistent between the FDA and USPTO and makes withholding information a violation of federal law that generic companies could invoke as a defense in patent litigation. Overall, this bill attempts to make it more difficult for brand manufacturers to game the patent system and delay generic entry.
Still, critics argue that the certification requirement could shift patent disputes away from questions of validity and infringement toward more procedural paperwork, potentially creating new litigation risks. The ETHIC Act, in contrast, targets the litigation mechanism rather than the information-sharing process, making it a more direct path to reducing patent gaming strategies.
Looking ahead
Bipartisan and bicameral interest in targeted reforms that crack down on patent gaming is growing. The ETHIC Act could move the needle toward increasing generic competition, lowering costs for consumers, and minimizing the fiscal burden of high drug costs on the Medicare program. Congress should continue to focus on policies that lower prices by fostering a competitive and robust market for pharmaceuticals.
