Statement of Luis Gil Abinader on the ETHIC Act

Generation Patient was created and is led by young adults living with chronic and rare health conditions. We are one of the few patient groups that has declined all private industry funding, including from brand drug companies, generic drug manufacturers, and insurance companies, to retain the integrity of our policy priorities. Our community depends on medications that can cost tens or hundreds of thousands of dollars a year and the patent system directly shapes whether those treatments are affordable to the millions of young adults across America who need them.

Drug patent policy must strike a balance between incentivizing genuine biomedical innovation and enabling competition after limited exclusive rights expire. Achieving this balance is crucial for ensuring affordable access to medicines for young adults with chronic conditions, many of whom rely on high-cost therapeutics. However, brand companies typically exploit gaps in the patent system to disrupt that balance and delay generic competition long beyond the expiration of foundational exclusive rights. One of the primary mechanisms that drug companies use to delay competition is filing patent applications claiming inventions that are patentably indistinct from earlier patents filed by the same applicant. When these overlapping patent applications are detected, examiners at the U.S. Patent and Trademark Office (USPTO) reject the later claims under double patenting grounds because they are too similar to one or more earlier patents.

Applicants can overcome these rejections by agreeing to shorten the term of the later-filed patent so that it expires on the same date as the earlier patent. These agreements are formalized through terminal disclaimers. When a terminal disclaimer is entered, the USPTO withdraws the double patenting rejection, and the patent is cleared for issuance if other office actions have been resolved. With terminal disclaimers, the applicant does not extend the length of exclusive protection but does increase the number of patents that can be asserted against competitors.

1.Terminal disclaimers have increased over time and are now routinely made on drug patents

Research by Sean Tu, Aaron Kesselheim, and Bernard Chao found that 45 percent of small-molecule drug patents filed between 2002 and 2023 had obviousness-type double patenting rejections resolved through terminal disclaimers. Their study combined openly available data with commercial legal analytics platforms. Relying on open data sources, Generation Patient independently replicated these findings. Our analysis of 7,836 drug patents filed from 2002 to 2022 and listed in any edition of the Orange Book shows that 50 percent had both a double patenting rejection in their prosecution history and a terminal disclaimer approved by the USPTO.

Expanding to all 2002–2022 patents in the Orange Book regardless of whether the prosecution history clearly shows that the USPTO issued a double patenting rejection, we found that 59 percent have terminal disclaimers. In the Orange Book edition available as of March 2026, which includes 6,247 patents listed, the share with a confirmed terminal disclaimer is 59.4 percent.

Graph 1. Share of Orange Book patents with terminal disclaimers, by patent filing year

Drug companies have steadily increased double patenting and terminal disclaimers practices over the past two decades. Roughly 36 percent of the drug patents in our analysis with a 2002–2006 filing date had an approved terminal disclaimer. By 2012–2016, the share of drug patents with terminal disclaimers climbed to 62 percent and then rose again to nearly 70 percent among those with 2017–2021 filing dates. The rise in terminal disclaimers coincides with the well-documented growth of patent continuations, a practice that increases the likelihood that the USPTO will find the resulting claims substantially indistinguishable from earlier filings by the same applicant.

2.Drug companies create patent thickets to increase litigation costs and deter competition

Research by Generation Patient shows that drug companies ramp up patent filings as generic competition approaches. Generation Patient reviewed the Orange Book patent listings for 529 active ingredients with at least one Paragraph IV Abbreviated New Drug Application (ANDA) filed from 2010 to 2025. Our analysis shows that a third of Orange Book patents filed a decade before the first generic challenge have a terminal disclaimer. In the years immediately surrounding and following the first challenge, the share of Orange Book patents that have terminal disclaimers increases sharply. More than 80 percent of patents filed after the first generic challenge carry a terminal disclaimer. Drug companies probably secure these patents to increase litigation costs and discourage generic challenges. The large share of disclaimers after the first ANDA challenge also suggests that drug companies adjust their thickets in response to how the first case unfolds.

Terminally disclaimed patents surge around the first generic challenge and continue long after

Young adults with chronic and rare conditions rely on innovation and strong incentives to promote meaningful research and development. However, thickets of late-stage patents with terminal disclaimers reflect something entirely different. Brand drug companies file overlapping applications to expand their patent arsenal and deter competition. Each of these patents can be asserted independently against prospective competitors, deterring some generic manufacturers from challenging the thicket altogether and forcing others to endure years of costly litigation before they can enter the market. Young adult patients who are balancing finances, education, and employment while living with a chronic condition face the impossible reality of paying high prices for medications they need or risking serious health consequences by going without them.

3.Drug companies routinely assert patents with terminal disclaimers to delay competition

Generation Patient has also analyzed data compiled by the USPTO Office of the Chief Economist to study how often drug companies assert terminally disclaimed patents in district courts. We reviewed 3,214 distinct district court dockets between 2003 and 2020 involving 1,914 unique patents in our compilation of historical Orange Book editions with a 2002–2022 filing date. Across those 1,914 litigated patents, 50 percent have a confirmed double patenting rejection in their prosecution history and terminal disclaimer approved by the USPTO. Expanding to all the litigated Orange Book patents regardless of whether the prosecution history clearly confirms a double patenting rejection from the USPTO, our study shows that 62 percent have terminal disclaimers.

Graph 2. Share of district court cases involving at least one Orange Book patent with terminal disclaimer, by case filing year

District court litigation data shows that drug companies are increasingly asserting patents with terminal disclaimers. The chart above explores what share of district court drug litigation between 2011 and 2020 involved at least one patent with terminal disclaimer. Approximately 74 percent of all drug patent cases filed in 2020 involved at least one patent with terminal disclaimer, up from 45 percent a decade earlier. Across this period, 60 percent of all drug disputes involved at least one patent with terminal disclaimer. This indicates that the growing number of terminally disclaimed drug patents have also translated into more infringement assertions. To prevail, defendants in drug patent lawsuits must offer evidence of noninfringement or invalidity for every claim asserted against them. Each extra patent requires defendants to allocate additional resources to navigate the infringement allegations. Therefore, the growing assertion of terminally disclaimed patents increases litigation complexity, time, uncertainty, and costs. These added costs and risks discourage generic entry, prolonging the period during which patients face higher drug prices.

4.Patent thickets covering Xifaxan have delayed the entrance of cheaper generic competition

Rifaximin illustrates the mechanics of patent thickets in practice and how they delay affordable access for young adult patients. Rifaximin (Xifaxan) was discovered by Italian scientists over four decades ago and licensed to Salix Pharmaceuticals in 1996. The Food and Drug Administration (FDA) has approved rifaximin for various indications since 2004, including the treatment of irritable bowel syndrome (IBS) with diarrhea in 2015. The earliest Orange Book patent associated with rifaximin expired in 2019. However, Salix built a thicket with more than 34 patents, 25 with terminal disclaimers, to assert against prospective competitors seeking to enter the U.S. market.

When Norwich filed an ANDA to market generic rifaximin in 2020, Salix asserted 26 patents, including 19 with terminal disclaimers. Judge Richard Andrews presided over the case and, in 2022, issued an order invalidating four of the seven patents that reached trial, including two that claimed methods of treating IBS. In 2023, the USPTO granted Salix two new patents claiming methods of treating IBS in females. These patents were initially rejected under double patenting grounds and then issued after Salix made terminal disclaimers to resolve the office actions. Salix then asserted the newer patents claiming methods of treating IBS against Norwich in 2024.

American patients pay among the highest prices in the world for Xifaxan, largely because Salix has been able to assert their patent thickets to deter generic competition. With retail prices for sixty 550 mg tablets exceeding $2,500, many Americans struggle to access Xifaxan and delay treatment during flare-ups. Other American patients discontinue treatment due to high prices. In 2025, the Medicare Drug Price Negotiation Program announced that it had negotiated a maximum price for Xifaxan of $1,000 for a 30-day supply. This negotiated price will be effective in 2027. By contrast, comparable quantities of rifaximin are available in Canada for approximately $240 and generic versions of this drug can be bought in countries like India for less than $100.

5.Symbravo similarly illustrates how patent thickets increase uncertainty and litigation costs

Axsome Therapeutics has listed 94 patents in the Orange Book entry for Symbravo, a drug combination approved by the FDA in 2025 for treating migraines. Symbravo combines meloxicam and rizatriptan, two active ingredients first patented decades ago. Research by Generation Patient shows that 82 of the 94 patents listed in the Orange Book entry for Symbravo carry terminal disclaimers. Although most are interconnected through a complex terminal disclaimer linkage that traces back to a dosage form patent issued in 2017 and are therefore expected to expire in 2036 together with their earlier filed references, Axsome Therapeutics can assert each one of them individually against prospective generic manufacturers seeking to enter the market.

Court documents show that Axsome has already asserted 1,856 claims across 75 patents from their thicket against Apotex, a generic manufacturer seeking to enter the U.S. market. That case was filed in September 2025 and is still ongoing as of May 2026. Apotex has sought to narrow the scope of this case, arguing that litigating 1,856 claims at once “will become a cost-prohibitive endeavor” instead of a “reasonable inquiry” into whether their ANDA infringes legitimate patent rights. Apotex has argued that litigating all the asserted claims at once would subject them to a “Kafkaesque and cost-prohibitive nightmare requiring it to expend enormous amounts of money and resources to defend against what can only be described as a ‘patent thicket.’” Public records indicate that Apotex’s motion to narrow the scope of this case is pending as of May 2026.

How the ETHIC Act would cap patents asserted in litigation

Patent with terminal disclaimer Patent without terminal disclaimer

Seventy of the 75 patents asserted by Axsome against Apotex are interlinked through disclaimers. Under the Eliminating Thickets to Increase Competition Act (ETHIC) (S. 2276; H.R. 3269), Axsome would have been able to assert no more than five patents against Apotex in this ANDA litigation.

6.ETHIC is a targeted and balanced solution to increase competition and reduce drug prices

Congress must find bipartisan solutions to reduce high drug prices and healthcare costs. This will require solutions that strike a balance between incentivizing genuine biomedical innovation and enabling competition after limited exclusive rights expire. The ETHIC Act (S. 2276; H.R. 3269) offers a targeted solution to one of the primary types of patent gamesmanship that companies use to delay generic competition and impose high drug prices on American patients. Under the ETHIC Act, brand companies may assert no more than one patent per group interlinked through terminal disclaimers. Brand drug companies would still retain the prerogative to select which patent from their terminal disclaimer group they choose to assert. This is the type of solution that will promote competition while striking a balance between innovation incentives and access.