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PublishedMay 10, 2024

How Challenging Low Quality Patents is Lowering Drug Prices

The FTC made headlines in May when it announced it was challenging over 300 “junk” patents in the FDA’s “Orange Book,” including patents on popular drugs like Ozempic and Victoza. With this in the news, it’s important to remember that the USPTO’s inter partes review (IPR) process has made it possible for generic drug manufacturers, or any member of the public, to challenge invalid patents for years, bringing down drug prices as a result. 

Given that high drug prices can be a matter of life and death for millions of Americans, IPR is a vital tool for consumers, manufacturers, and researchers to challenge flawed patents, and in doing so, foster a fairer pharmaceutical landscape with more space for innovation, competition, and lower prices for consumers. In IPR proceedings, three administrative patent judges, who have legal and technical expertise, decide whether patents challenged by members of the public cover truly new and useful inventions, and cancel those that do not.

IPR is especially valuable for addressing harm caused by wrongly granted patents in the pharmaceutical sector. Brand-name drug companies often acquire patents on minor or obvious variations of existing medications and use them to block entry and competition from generic drug manufacturers and biosimilar producers. Because these patents do not claim genuine inventions, they are invalid, and should never have been granted. But unless they are challenged, they can continue to keep drug prices unjustifiably high and access is inequitably restricted as a result.

The Public Interest Patent Law Institute (PIPLI) recently released case studies on five medications whose prices dropped significantly following successful IPR challenges before the Patent Trial and Appeal Board (PTAB), based on research by Professor Charles Duan. These case studies demonstrate the direct impact IPR has on lowering drug prices for American consumers: 

First, abiraterone acetate, a prostate cancer medication marketed as Zytiga, faced a patent challenge by Argentum Pharmaceuticals in 2017, leading to invalidation of the patent by the PTAB in 2018 for being obvious. Before the invalidation, Janssen Biotech charged approximately $88 per dose of Zytiga, while after, prices for comparable drugs fell to between $2 and $19 per dose, amounting to savings of 80% to 98%.

Second, following the expiration of its primary patent, Daiichi Sankyo’s patent on Prasugrel – an anti-blood clot drug used to treat cardiovascular disease – was challenged and invalidated by the PTAB when IPR proceedings found the combination of Prasugrel with aspirin was an obvious application and therefore not deserving of patent protection. This decision allowed generic competitors to enter the market, resulting in a drastic 97% reduction in prices below the original brand price.

Third, Yeda Pharmaceuticals’ patents on Copaxone, a treatment for multiple sclerosis, were invalidated through IPR proceedings, which found that the patented dosing regime was obvious. After the Federal Circuit affirmed the PTAB’s ruling, prices of competitor drugs dropped by approximately 75%, making the treatment more affordable for patients with MS.

Fourth, drug-maker Novartis held patents on rivastigmine – a treatment for dementia – based on the use of a so-called “Exelon Patch” for delivering the drug. The patents were successfully challenged and invalidated through the PTAB in 2017, when IPR proceedings found that the patch application was based on obvious scientific evidence. As a result, generics entered the market for dementia drugs swiftly, and prices for rivastigmine patches fell by roughly 75%.

Finally, PIPLI points to the case of buprenorphine, an opioid addiction treatment marketed as Suboxone by the British pharmaceutical company Reckitt Benckiser. When Reckitt Benckiser’s exclusive rights to market Suboxone ran out in 2009, the firm patented a new “sublingual film” formulation to prevent competition, despite this formulation being no better than prior tablet formulations of the drug. An IPR review deemed the sublingual film product obvious – and therefore invalid – opening up the market to at least thirteen generic opioid addiction treatments today, whose prices are 50% less than the peak brand price for Suboxone. 

As these case studies show, IPR proceedings are on the frontline of fighting the high cost of prescription drugs in the U.S., saving patients and payers up to 98% in health care costs. By eliminating undue barriers to research and competition in the pharmaceutical sector, these efforts enhance both access to essential medicines and space for future innovations that benefit us all.

Going forward, we must continue to protect the accessibility and efficacy of IPR proceedings as a means to eliminate monopolies premised on wrongly granted patents, in the pharmaceutical industry and beyond.

Alex Moss

Executive Director, Public Interest Patent Law Institute

Alex Moss is the executive director of the Public Interest Patent Law Institute. Alex previously worked as a staff attorney and the Mark Cuban Chair to Eliminate Stupid Patents at the Electronic Frontier Foundation and continues to serve as a Special Advisor. Before joining EFF, she was an attorney at Sullivan & Cromwell and Durie Tangri. After graduating from Stanford Law School, she served as a judicial clerk to the Honorable Timothy B. Dyk of the U.S. Court of Appeals for the Federal Circuit. She has argued cases in state, federal district, and appellate courts. In 2019, she spoke at the National Academy of Sciences and testified before the Senate Judiciary Committee on the state of patent-eligibility law in the U.S. Before law school, Alex worked for independent record label Rough Trade.

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