The FTCU.S. Federal Trade Commission. An independent regulatory agency charged with consumer protection and competition policy, which conducted several influential studies on how patents work in practice. Authored several key studies: 2003’s To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy [PDF] and 2011’s The Evolving IP Marketplace: Aligning Patent Notice and Remedies with Competition [PDF]. 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 (IPRIntellectual Property Rights. Usually associated with formal legal rights such as patent, trademark, and copyright. Intellectual property is a broader term that encompasses knowledge, information, and data considered proprietary whether or not it is formally protected.) 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, IPRIntellectual Property Rights. Usually associated with formal legal rights such as patent, trademark, and copyright. Intellectual property is a broader term that encompasses knowledge, information, and data considered proprietary whether or not it is formally protected. 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 IPRIntellectual Property Rights. Usually associated with formal legal rights such as patent, trademark, and copyright. Intellectual property is a broader term that encompasses knowledge, information, and data considered proprietary whether or not it is formally protected. 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.
IPRIntellectual Property Rights. Usually associated with formal legal rights such as patent, trademark, and copyright. Intellectual property is a broader term that encompasses knowledge, information, and data considered proprietary whether or not it is formally protected. 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 IPRIntellectual Property Rights. Usually associated with formal legal rights such as patent, trademark, and copyright. Intellectual property is a broader term that encompasses knowledge, information, and data considered proprietary whether or not it is formally protected. challenges before the Patent Trial and Appeal Board (PTABPatent Trial and Appeal Board. Reviews adverse decisions of examiners on written appeals of applicants and appeals of reexaminations, and conducts inter partes reviews and post-grant reviews. The Board also continues to decide patent interferences, as it was known as the Board of Patent Appeals and Interferences (BPAI) before the AIA.), based on research by Professor Charles Duan. These case studies demonstrate the direct impact IPRIntellectual Property Rights. Usually associated with formal legal rights such as patent, trademark, and copyright. Intellectual property is a broader term that encompasses knowledge, information, and data considered proprietary whether or not it is formally protected. 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 PTABPatent Trial and Appeal Board. Reviews adverse decisions of examiners on written appeals of applicants and appeals of reexaminations, and conducts inter partes reviews and post-grant reviews. The Board also continues to decide patent interferences, as it was known as the Board of Patent Appeals and Interferences (BPAI) before the AIA. 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 PTABPatent Trial and Appeal Board. Reviews adverse decisions of examiners on written appeals of applicants and appeals of reexaminations, and conducts inter partes reviews and post-grant reviews. The Board also continues to decide patent interferences, as it was known as the Board of Patent Appeals and Interferences (BPAI) before the AIA. when IPRIntellectual Property Rights. Usually associated with formal legal rights such as patent, trademark, and copyright. Intellectual property is a broader term that encompasses knowledge, information, and data considered proprietary whether or not it is formally protected. 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 IPRIntellectual Property Rights. Usually associated with formal legal rights such as patent, trademark, and copyright. Intellectual property is a broader term that encompasses knowledge, information, and data considered proprietary whether or not it is formally protected. proceedings, which found that the patented dosing regime was obvious. After the Federal CircuitSee CAFC 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 PTABPatent Trial and Appeal Board. Reviews adverse decisions of examiners on written appeals of applicants and appeals of reexaminations, and conducts inter partes reviews and post-grant reviews. The Board also continues to decide patent interferences, as it was known as the Board of Patent Appeals and Interferences (BPAI) before the AIA. in 2017, when IPRIntellectual Property Rights. Usually associated with formal legal rights such as patent, trademark, and copyright. Intellectual property is a broader term that encompasses knowledge, information, and data considered proprietary whether or not it is formally protected. 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 IPRIntellectual Property Rights. Usually associated with formal legal rights such as patent, trademark, and copyright. Intellectual property is a broader term that encompasses knowledge, information, and data considered proprietary whether or not it is formally protected. 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, IPRIntellectual Property Rights. Usually associated with formal legal rights such as patent, trademark, and copyright. Intellectual property is a broader term that encompasses knowledge, information, and data considered proprietary whether or not it is formally protected. 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 IPRIntellectual Property Rights. Usually associated with formal legal rights such as patent, trademark, and copyright. Intellectual property is a broader term that encompasses knowledge, information, and data considered proprietary whether or not it is formally protected. proceedings as a means to eliminate monopolies premised on wrongly granted patents, in the pharmaceutical industry and beyond.
