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Skyrocketing prescription drug prices remain a pressing political issue. Polls show that a large majority of voters in both parties support efforts to reduce drug prices, and President Joe Biden’s reelection campaign highlights his administration’s efforts to do so under the Inflation Reduction Act. A major factor driving higher drug costs is the patent system, which grants pharmaceutical manufacturers a 20-year exclusive right to “make, use, sell, and import” their products. Although the government originally established the patent system to “promote the Progress of Science and useful Arts,” many patents are now deployed to protect and extend monopoly power. In the case of pharmaceuticals, complex patent strategies are regularly implemented to keep competitors and low-cost generics out of the market for as long as possible to maximize the profits of blockbuster drugs. Given this ongoing misuse of the patent system, any proposed changes to patent policy must be evaluated carefully to ensure that they deter, rather than reinforce, such practices. With this need in mind, this analysis assesses recently proposed patent legislation. It explains the strategies pharmaceutical companies use to prolong their drug patents, outlines measures lawmakers and the judiciary have taken to limit such practices, and considers how proposed legislation could undermine these efforts. “Gaming” the System Pharmaceutical companies have become adept at “gaming” the patent system to extend exclusivity and monopoly power to maximize profits. Tactics like “evergreening” (making minor modifications to existing drugs to obtain additional patent protections), “patent thickets” (filing many different patents on different aspects of a single drug), and “product hopping” (introducing a new version of a drug as a patent is expiring and encouraging doctors, pharmacists, and patients to switch to the updated version) are commonly used to extend monopolies even after the key patent expires. Celgene’s blockbuster cancer drug Revlimid is a prime example of this practice. Although a key patent expired in 2019, the drug will not see real competition in the marketplace until 2026. This is because Celgene, now a subsidiary of Bristol Myers Squibb, has been able to prolong the drug’s exclusivity by creating a patent thicket around it. The company filed for an additional 206 patents on the drug—117 of which were approved. The costs of such patent thickets can be substantial to consumers and the health care system: The price of Revlimid increased from $6,000 per month in 2002 to $24,000 per month in 2022, resulting in a total estimated cost of $45 billion for Americans. Getting Patents Right The strategic use of patent thickets in the pharmaceutical sector raises important questions about the role of patents and how to ensure that the patent system functions as a tool to support invention and innovation rather than to protect monopolies. The ideal patent system should include two key elements: (1) a process to ensure that the patents that are granted are truly warranted and (2) a mechanism to expeditiously challenge and remove invalid patents when they do make it into the system. This is more daunting than it may appear. In 2020 alone, the U.S. Patent Office received more than 600,000 patent applications, and a previous report estimated that patent examiners had, on average, only 18 hours to review a patent. Low-quality and overly broad patents may be erroneously granted under these constraints, so we must have a process in place to efficiently challenge them. Both Congress and the courts have worked to improve the patent system and address such concerns. In 2011, Congress passed the America Invents Act, which, among other things, established a new Patent Trial and Appeal Board (PTAB) in the U.S. Patent and Trademark Office. The PTAB was designed to curb excessive patent litigation by providing a more expeditious administrative review process for weeding out low-quality patents. The Supreme Court has contributed to this effort by addressing the question of what is patentable in a series of key decisions issued over the last 17 years. Problems with PREVAIL Unfortunately, recent bills introduced in Congress have the potential to undo these efforts and revert to a more litigious patent system that is easier to exploit and less conducive to innovation. A previous R Street analysis explored issues with the Patent Eligibility Restoration Act, which was introduced by Sens. Chris Coons (D-Del.) and Thom Tillis (R-N.C.) and would expand the definition of what is patentable in ways that could deter invention and innovation. This analysis looks at another bill introduced by Sens. Coons and Tillis, along with Sens. Dick Durbin (D-Il.) and Mazie Hirono (D-Hi.): the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. The PREVAIL Act narrows the patent review process, making it more difficult to eliminate invalid patents that should not have been granted in the first place. More specifically, provisions in this act would restrict the use of inter partes review (IPR) proceedings at the PTAB—a process designed to facilitate challenges of weak secondary or continuation patents like those commonly used in patent thickets in the pharmaceutical sector. Problematic IPR changes proposed in the PREVAIL Act include: Limiting the parties that can challenge a patent. Under current law, anyone has the right to challenge the validity of a patent with the PTAB. The act would restrict this ability to those who have been sued or directly threatened with a lawsuit over a patent. This would exclude third parties like generic manufacturers, patient advocacy groups, civil society organizations, and others from challenging poor-quality patents unless they are direct parties to a dispute (i.e., sued or threatened to be sued by the manufacturer). These third-party groups, however, typically lack standing to engage in litigation, so without the PTAB, their voice may not be heard. Limiting the number of potential challenges to any patent. Current law restricts a petition to the PTAB to 14,000 words. For a complex patent with many claims, this may not be sufficient. Yet the act proposes to go even further by limiting the number of petitions that may be filed, making it more difficult to effectively challenge a patent at the PTAB. Increasing the burden of proof for demonstrating that a patent is invalid. The act would raise the evidentiary standard for invalidating patent claims at the PTAB, shifting from the current “preponderance of the evidence” standard to a “clear and convincing standard” that favors the patent holder in any challenge. Reducing venues for challenging patents. The act includes requirements to choose a single forum for patent-validity challenges (either the PTAB or district court, but not both), which could complicate and potentially increase the cost of a patent challenge. Because PTAB trials are quicker and less expensive than adjudication in federal courts, limiting the PTAB’s role leaves litigation as the only option. Not only would these proposed changes make attempts to invalidate patents more costly in terms of time and money, but they would also reduce the overall incentive to improve patent quality, as the risk of a patent challenge would be lower. These changes would also embolden pharmaceutical companies to double down on the practice of creating patent thickets to wall off competition and generics. This is because the secondary patents that form patent thickets are typically of lower quality than a drug’s primary patent. (Primary patents cover the active ingredient, whereas secondary patents are typically related to elements like dosage, packaging, or delivery of a drug.) These secondary patents are currently more susceptible to challenge if they offer little therapeutic value above and beyond the original patent. The proposed act would make it more difficult to challenge these lower-quality, monopoly-extending patents, and the resulting broad patent protection of brand-name drugs would continue to block generic manufacturers from entering the market. This would have a direct negative effect on consumers and the health care system as a whole. Without competition from generics, monopoly prices for the branded drugs would remain artificially high for a longer time, negatively affecting patients who rely on lifesaving or life-changing medication as well as the public and private health care insurers who share the costs of those medications. In fact, one study looking at just five drugs over 20 years found that eliminating generic competition of those drugs imposed $4.7 billion in annual costs on the U.S. health care system. Another study estimated that evergreened reformulations increased Medicaid spending by $9.35 billion from 2008 to 2016 alone. Importantly, one empirical examination of drug pricing and patents found “a correlation between administrative patent challenge procedures, such as IPR, and lower drug prices due to generic entry.” This finding reinforces the importance of maintaining the current IPR process to deter lower-quality patents, enhance competition, and provide much-needed medication to patients and health care organizations at fairer costs.

Several comparative country studies that measured the impact of patent regimes on time to drug launch found that more stringent patent provisions accelerate the market entry of new drugs, [81–83, 85, 94] especially ‘blockbuster’ drugs [82, 94]. Some of these studies found this phenomenon to be true only for high income countries and not low- and middle-income countries [82, 83]. This could reflect simple profit maximising behaviour, focusing on more lucrative markets and more lucrative drugs. Conversely, two studies found that higher levels of IP protection were associated with lower access to medicines [85, 87]. Even in studies that showed a positive association between longer IP protection and new drug availability, the high price of the patented pharmaceutical product resulted in a net effect of significantly reduced sales [85]. Hellerstein also found that countries with largely originator drug markets were paying significantly more for ARV than generic supply countries [86]. Relevant here is an important finding of studies on generic entry - this results in significant price falls only when there is competition among generics [113]. The findings of two comparative patent studies contrasted markedly with the studies above. Rozek and Berkowitz find that ‘improving’ IP regimes does not change the prices of branded pharmaceutical products and that countries with ‘improved’ IP regimes do not have higher priced drugs than countries without [88]. ‘Improved’ IP in this instance was equated with stronger protection of IP, but the exact meaning of this was not defined. Further, there were inadequate controls for other relevant variables [88]. Djolov also found that strong patent protection was associated with better access to essential drugs [89]. In the Djolov study [89] the essential drugs are almost all off-patent and therefore unaffected by the strength of the patent provisions. The time period studied was not long enough to capture the impact of new patent provisions [89]. To more accurately measure the relationship between patent and prices, only new previously unpatented drugs introduced after the new product patent regime should be included in the analysis [114, 115]. The nine single-country studies that focused on the impact of stronger patents all found negative implications for access to medicines. Patents were found to cause significant welfare loss [90, 91, 93] and a rise in drug prices in India [92]. Supporting these findings, the availability of generics and me-too drugs led to consumer welfare gains [80]. The studies focused on India are particularly pertinent to understanding the impact of introducing patents for pharmaceutical products. India took full advantage of the 10-year transition period to introduce such patents [116]. Further, India designed its patent legislation to ensure that closely similar medical compounds could not be patented unless there is a new therapeutic benefit. Prior to this, Indian manufacturers were legally producing generic versions of many medicines under patent in other countries. The Indian patent regime has implications for access to medicines not only in India, but around the world as it may inhibit the production of generic medicines. India is the world’s biggest producer of generic medicines and accounts for more than 80% of ARV annual purchase volumes [117]. Although these studies focused on the Indian market only, pharmaceutical product patents in India could potentially curtail generic drug supply for many of the world’s poorest countries. TRIPS-plus rules - patent term extensions and secondary patents The articles that measured the impact of TRIPS-plus rules focused on patent term extensions and secondary patenting. Ten of the 13 TRIPS-plus studies were from North America, two were from Australia and one was a multi-country study that included the USA. All patent term extension studies found negative impacts for access to medicines which included increased government health care expenditure [99–103], increased drug prices [98, 100] and delays in drug availability [100]. Similarly, all articles examining secondary patents found negative impacts for access to medicines including longer monopoly periods that delayed the market entry of cheaper generics [19, 104, 106, 107], increased costs to taxpayers [109] and social welfare losses [107]. The only article that included a focus on resource poor settings found that measures to restrict secondary patenting had limited effectiveness in Argentina and no measurable impact in India and Brazil [110]. The authors suggest that administrative and procedural features of patent systems may be a greater influence on the grant of secondary patents than patent laws themselves [110]. Tackling this issue would mean addressing the kind of technical assistance provided to patent offices in lower- and middle-income countries [118]. This is a priority issue given the expense of challenging granted patents and the impact that longer patent durations could have on access to medicines in countries less able to pay high prices for medicines. Secondary patenting in India could have negative ramifications for countries that depend on India for affordable generic drugs.

WASHINGTON, DC (September 6, 2023) — Today, the Association for Accessible Medicines (AAM), the leading trade association for generic and biosimilar manufacturers, released its 2023 U.S. Generic & Biosimilar Medicines Savings Report highlighting the value of generic and biosimilar medicines. According to the analysis, the U.S. health care system, including patients, employers, and taxpayers, saved $408 billion in 2022 by using FDA-approved generic and biosimilar drugs. More than 90 percent of prescriptions were filled in 2022 with generic or biosimilar medicines, but they accounted for less than 18 percent of total prescription drug spending and less than 2 percent of total U.S. health care spending. Generics also deliver value to patients. Ninety-three percent of generic drugs have copays under $20 (as compared to 59% of brand-name drugs), and their average copay is $6.16 (as compared to $56.12 for brands). But it is critical not to take these savings for granted, as growing challenges to a sustainable future for generic and biosimilar competition continue to rise. Amid daily news coverage of prescription drug pricing lies the under-appreciated success story of generic and biosimilar medicines,” said David Gaugh, Interim President and CEO of AAM. “This report provides a comprehensive review of the evidence that patients and the health care system rely on this industry to maintain vitality. Prescription drug spending is increasingly driven by a small group of biologic and specialty medicines that, although less than 2 percent of all prescriptions, are more than half of all spending. Biosimilars are lower-cost, equally effective versions of those high-cost brand biologics. Biosimilars launch at meaningfully lower prices. The average biosimilar price is more than 50 percent less than the brand price was at the time of biosimilar launch. Moreover, biosimilar competition is forcing brand biologics to reduce their prices. As such, they have saved patients over $9.4 billion dollars in 2022. Biosimilars result in lower prices and greater patient access,” said Craig Burton, Executive Director of the Biosimilars Council. “However, too many patients are being blocked from receiving lower-cost biosimilars. Additional highlights from AAM’s 2023 Savings Report include: Total Generic and Biosimilar Savings for 2022: $408 billion Total Generic and Biosimilar Savings for Past 10 years: more than $2.9 trillion Total Generic and Biosimilar Savings in Medicare for 2022: $130 Billion Total Generic and Biosimilar Savings in Commercial Plans for 2022: $194 Billion Generics represent 90% of prescriptions filled but only 17.5% of prescription drug spending Generics represent less than 2% of all health care spending As in the past, this year’s report was developed utilizing independent research from IQVIA, which quantified how much money America's patients and the U.S. health care system are saving due to the use of generic and biosimilar alternatives.

Generic drugs play a critical role in the U.S. health care system and allow patients greater access to needed medicines. The approval of generic drugs often means multiple manufacturers for medicines, which can help stabilize the supply chain and reduce risks from drug shortages. Americans may recognize the U.S. Food and Drug Administration’s regulatory role in approving generic drugs, but few may know our work to advance generic drug development and assessment through our regulatory science and research programs. We conduct, support, and encourage scientific research on new methods to help us assess generic drug applications, and we promote innovation that leads to the development of new and often more streamlined approaches for making generic medicines. Here are some highlights from the newest edition of the Office of Generic Drugs Annual Report. Reauthorization of the Generic Drug User Fee Amendments Congress enacted the Generic Drug User Fee Amendments (GDUFA) in 2012, and authorized the third iteration of GDUFA (GDUFA III) in October 2022, following negotiations between the FDA and industry, along with input from public stakeholders. The GDUFA program is designed to help ensure patient access to high-quality, safe, and effective generic medicines, and to enable industry and the FDA to carry out their important work advancing generic drug development and approval. Under GDUFA III in 2023, the FDA continued critical scientific research and expanded the number of scientific meetings available to companies seeking to submit abbreviated new drug applications (ANDAs), in particular for those working on harder-to-develop complex generic drug products. Scientific Research Advanced Generic Medicine Development The FDA’s generic drug science and research efforts help ensure regulatory standards, recommendations, and decisions that impact generic drugs are supported by current scientific insights and research tools. Each year, the FDA obtains public input, which helps the generic drug program identify regulatory science and research priorities that can expand and accelerate patient access to generics. The FDA then advances research in those scientific areas and publishes reports describing the corresponding activities and outcomes. In 2023, GDUFA-funded research helped expand our understanding of generic drug products, including complex products, and contributed to the development of advanced methods to characterize product quality and performance. These methods can play a critical role in determining how the FDA assesses the bioequivalence and quality of complex generic medicines, and they can establish the scientific basis for novel and more efficient paths to develop new generic medicine products. ANDAs and First Generic Approvals In 2023, the FDA continued to apply our rigorous review process for generic drug approvals and approved or tentatively approved 956 ANDAs including 90 first generics. For example, we approved the first generic naltrexone extended-release injectable suspension (referencing Vivitrol). This vital medicine addresses two major public health needs affecting millions of individuals in the U.S.: treating alcohol dependence and preventing opioid dependence relapse. It is a complex, long-acting, injectable drug product that uses biodegradable polymer-microsphere technology. The development, manufacture, and regulatory assessment of these biodegradable microspheres is generally more complicated than for a daily oral tablet, therefore, the FDA’s assessment of the generic drug application had greater complexity. International Collaboration As a global leader in generic drug regulation, the FDA Office of Generic Drugs collaborates with foreign regulatory authorities to foster the development of uniform, scientifically driven recommendations and guidelines that can help improve the efficiency of generic drug development by, among other things, preventing unnecessary duplication of studies and testing. In 2023, the FDA announced the availability of a harmonized draft guidance for generic drugs on bioequivalence for immediate-release solid oral dosage forms. Harmonization activities like this can help regulatory agencies with timely authorization and increase availability of quality, safe, and effective generic drugs that benefit patients. In partnership with the Office of Global Policy and Strategy and others, we will continue to explore opportunities with foreign regulatory authorities that strengthen regulatory systems in the oversight of generic medicines. Looking to the Future The FDA Office of Generic Drugs will continue to focus on operational modernization, workforce excellence, timely approval of generic medicines, and activities that advance the development and assessment of complex generics. We look forward to communicating through conferences and online education, engaging with generic drug stakeholders, and meeting our overall GDUFA program goals. The Office of Generic Drugs 2023 Annual Report provides a comprehensive look at what we accomplished in 2023 and illustrates how the agency is well-positioned to continue this critical work in 2024.

Martí Juanola Falgarona, 10-xx-2023, "Antimicrobial resistance is an existential threat on par with climate change," QIAGEN, -- MoState JG

Antimicrobial resistance is an existential threat on par with climate change For at least the past two decades, the medical community has warned of the looming threat of antimicrobial resistance (AMR). AMR has far-reaching impacts and curbing it requires collaboration from everyone involved – from governments, to industry, to healthcare, to individuals going about their daily lives. Martí Juanola Falgarona, Associate Director of Medical Affairs, explains that just as climate change has forced global collaboration between governments and industry, the same must be done to overcome this next great existential threat. Modern medicine on the brink AMR is the ability of microorganisms – including bacteria, fungi, viruses and parasites – to resist the effects of antimicrobial medications, such as antibiotics. Alexander Fleming himself hinted at the risk of penicillin resistance during his 1945 Nobel Prize speech (3). But we never could have predicted the global catastrophe that is unfolding today. A growing list of unsettling statistics paints the picture of a world on the brink. According to the World Health Organization (WHO), antibiotic-resistant bacterial infections were estimated to be directly responsible for 1.27 million deaths, and associated with 4.95 million deaths, in 2019 alone (4). Globally, there were an estimated 450,000 incident cases of multi-drug-resistant or rifampicin-resistant tuberculosis (MDR/RR-TB) with increasing trends in many regions (5). These numbers are staggering, and are expected to increase as antibiotic resistance continues to accelerate (1). AMR is a complex global problem with no single cause – and no single, easy solution. But the COVID-19 pandemic showed us what we can achieve when governments, international bodies and industries set clear priorities and cooperate on shared goals. The same approach must be applied to the AMR crisis. To effectively tackle AMR, we first need to understand the full scope of the problem. We can’t develop effective intervention strategies until we are able to fully understand the mechanisms that drive AMR and the epidemiological pathways of AMR. Of great importance, we need to invest in long-term, global strategies to enable routine molecular surveillance, especially in low- and middle-income countries (LMICs). This will require a global commitment to boost surveillance capacity so that all countries can provide quality-assured data. We should consider innovative and effective approaches to surveillance, such as wastewater analysis using whole genome sequencing and digital PCR. These approaches have been invaluable for tracking and predicting SARS-CoV-2 outbreaks during the COVID-19 pandemic (7). An equitable approach The burden of AMR is especially severe in LMICs where there is limited access to quality healthcare and antimicrobials, poor sanitation and hygiene and the overuse of antimicrobials in agriculture and animal husbandry. While AMR is a global threat that requires a global response, it is essential to focus on the needs of LMICs in order to reduce the burden of AMR worldwide. We need to ensure that everyone has access to the benefits of research and development, not just people in wealthy countries. The global community must invest in programs to improve affordable access to new and existing life-saving antibiotics to people in LMICs (8). The WHO promotes a “One Health” approach to tackling AMR, which acknowledges that human, animal and environmental health are intrinsically linked (9). A major focus of this approach is tamping down the overuse and misuse of antibiotics in agriculture, livestock and animal husbandry (10). However, the important role that animal agriculture plays in livelihoods in LMICs is often unknown or underestimated. It is therefore important to find ways to reduce the use of antibiotics in animal agriculture without jeopardizing food security or animal welfare. This will require a collaborative effort from all stakeholders, including governments, farmers, industry and consumers (10). Responsibility in the clinic Inappropriate use of antimicrobials in the clinic is yet another factor driving resistance. When antimicrobials are used unnecessarily or incorrectly, like when an antibiotic is used to treat a viral infection, it allows resistance to emerge. However, clinicians on the frontlines of care often lack the tools needed to differentiate between viral and bacterial infections. A recent study found that without laboratory diagnosis, clinicians could only identify respiratory tract infections 37% of the time (11). When AMR threatens modern medicine, we can no longer afford to guess when it comes to diagnosis – we must adhere to a “test and then treat” approach. Hospitals and other healthcare settings should invest in rapid, accurate diagnostic technology that can be used at the point of care. Many studies show that rapid diagnostics are most impactful when implemented in the context of an antimicrobial stewardship program. These programs, which support the judicious use of antimicrobials, are a linchpin of the World Health Organization’s Global Action Plan on AMR. They foster comprehensive policies and procedures to guide antimicrobial prescribing, track antimicrobial use and resistance patterns and help to identify areas where antimicrobials are being used inappropriately. Stewardship programs must become a global health priority, and be strengthened through adequate funding and resource allocation. Economic change and acting as one The creation of new antimicrobials has long lagged behind demand. This is due, in part, to the current economic model incentivizing drug development. Antibiotics are significantly less lucrative than other treatments, such as cancer drugs, and their development has been deprioritized by pharmaceutical companies (12). As a result, there is a shortage of new antimicrobials in the drug development pipeline. The last novel antibiotic class, oxazolidinones, was discovered in the 1980s, and the first antibiotic from this class, daptomycin, reached the market in 2003 (1). Some countries are creating new economic models for incentivizing de novo antibiotic development. In the U.S., a piece of legislation called the PASTEUR Act would pay pharmaceutical companies to invest resources into innovative antibiotic research (1). The AMR crisis is a complex global problem that threatens modern medicine and has no single, easy solution. It requires a coordinated global effort, involving healthcare, governments, industry and academia. We need to invest in research, improve access to antimicrobials and diagnostics, promote responsible use of antimicrobials and develop new economic models to incentivize the development of new antibiotics and diagnostic tools. By acting together as one, we can protect modern medicine and ensure that everyone has access to the healthcare they need.

Precision public health (PPH) is an emerging focus area. It can be described as providing the right intervention to the right population at the right time.Citation41 The advances in new technologies such as the availability of individual and ethnic level genetic risk information, Citation42 socioeconomic data,Citation43 the implementation of artificial intelligence to large medical datasets Citation44 and community social media posts Citation45 allow better direction of public health efforts to appropriate populations in the most acceptable format. This may lead to precision vaccines for smaller numbers of people and/or patient-groups. Indeed, Dr. Stanley Plotkin who is often referred to as the “Godfather of Vaccinology” emphasized that the next revolution in vaccinology is the development of vaccines for individuals (groups), rather than the population, that currently administered vaccines are not fully protective in certain populations, and that there is a need to evaluate vaccine safety and efficacy in specific populations.Citation26 During pandemics, mass policies are needed to quickly induce immunity among large populations to stop the spread of the pathogen. Early on during the COVID-19 pandemic, the European Commission introduced a vaccination certificate called the “Digital Green Certificate” (DGC) which has been shown to be very effective in slowing down the spread of the virus.Citation46 In the United States, the majority of early COVID-19 initiatives focused on large-scale policies like physical distancing, business and school closures, face-mask mandates, and mass vaccination of the elderly and the immunocompromised.Citation47 While these policies were effective for decelerating viral spread, hospitalization, and mortality among the most vulnerable, other more targeted and precise approaches, like equitable vaccine delivery, were needed to provide protection for essential workers, for those in low-income neighborhoods and among Latinx and Black communities who were less likely to work remote jobs.Citation47 During the early stages of the pandemic, these individuals were largely unprotected by policies like physical distancing and closures and thus, disproportionately affected by COVID-19 disease.Citation30 In addition, a few states in the United States, such as California, implemented precision public health measures, such as mass vaccination events in sports arenas, colleges and designated “hot-spot” zip codes to improve the access to the COVID-19 vaccine.Citation47 Recently, Fourati and colleagues conducted a large transcriptomic study (namely, microarray and RNA sequencing) to characterize the host pre-vaccine immune profile that is associated with the strongest antibody responses across 13 different vaccines.Citation48 They characterized the pre-vaccination peripheral blood immune transcriptional signature among 820 healthy individuals and observed that there was significant inter-individual heterogeneity in the inflammatory state of the peripheral immune system before the vaccination. They grouped the patients as inflam.hi, imflam.mid and imflam.lo by blood transcriptional signatures and a distinct distribution of cell subsets before vaccination. They observed that people with baseline high level activation of inflammatory genes, specifically those associated with IL-1 and NF-kB signaling, mounted a stronger antibody response.Citation31 In this study, the investigators did not evaluate the relationship between the transcriptional signatures and safety signals; however, transcriptomics may also be used to identify individuals who are at higher risk for vaccine adverse effects.Citation48 When clinical trials do not provide a sufficient amount of benefit data for a routine age or risk group, the Advisory Committee on Immunization Practices (ACIP) of the CDC may recommend “shared clinical decision-making (SCDM)” for vaccine administration.Citation49 During SCDM, the primary care provider and the patient (or parent of the patient) make a personalized vaccination decision based on the provider’s broader knowledge of the patient’s characteristics including risk factors, values, preferences and the family medical background.Citation49 The COVID-19 pandemic made it clear that we are moving from “herd” immunity of healthy infants to precision vaccination of smaller groups. Active communication between a trusted provider and the patient/caregiver and SCDM may help achieve precision in public health and vaccines. In 1892, Sir William Osler stated, “if it were not for the great variability among individuals, medicine might as well be a science and not an art.” Artificial intelligence (AI) has the computational power to collect, analyze and potentially identify the biological and socioeconomic profile of smaller groups within a large community and may be used to support precision in infectious diseases, vaccines and public health. AI, however, has limitations.Citation50 Granted that data security and patient privacy are achieved, the quality of data generated by AI is restricted with the amount and quality of input data and quality of the model. Similar to clinical trials, there is a need for data from a diverse range of people from different racial/ethnic and socioeconomic backgrounds, especially vulnerable populations, which is often challenging. AI findings need to be tested and confirmed, but most importantly, new interventions need to be designed and scientifically tested to fully achieve the benefits of AI. In conclusion, precision in infectious diseases and vaccine development will lead to the development of safer and more effective vaccines, and precision in AI and public health will improve the efficiency and prioritization to deliver the right vaccines to the most appropriate populations, leading to the restoration of trust in vaccines, healthcare, science and public health.

Wayne Brough, 4-3-2024, Wayne Brough is policy director for R Street’s Technology and Innovation team. He manages product flow on technology policy issues while also continuing his own research in competition policy and intellectual property. "Congress Wants to Revive Patents but May Strangle Innovation and Damage Health Care Access Instead," R Street Institute, -- MoState JG

Patent eligibility, or the fundamental question of what is patentable, is currently under congressional review. Sens. Thom Tillis (R-N.C.) and Chris Coons (D-Del.) have introduced the Patent Eligibility Reform Act (PERA) to reform Section 101 of the U.S. Patent Act, which defines what can be patented. But some of the proposed changes do much more than clarify patent eligibility, aiming instead to reverse a series of Supreme Court decisions issued in response to growing concerns over patent abuse and its chilling effects on innovation. More importantly, while the Supreme Court has consistently held that “laws of nature, natural phenomena, and abstract ideas” are not patentable, these legislative proposals attempt to upend that position and expand the scope of patent eligibility directly contra to court rulings. Enhancing Innovation or Creating Monopolies? In many ways, recently proposed changes would return the patent system to policies of the late 1990s and early 2000s, when the courts were beset with patent litigation originating from excessive claims of patentability. Allowing companies to patent abstract business methods or practices prompted a surge in lawsuits targeting other companies using similar business processes—even obvious or commonsense practices. While broader patent eligibility strengthens the hand of patent owners, the impact on innovation is less clear. Research has found that such overly broad patents generate excessive litigation while creating significant barriers to entry that limit competition. This ultimately sparked the Supreme Court rulings that established new limits on the possibility of patenting abstract concepts or inventions. The Patent Eligibility Reform Act Given the longstanding tension between innovation and monopolization, any legislative changes to patent policy must be evaluated carefully. The bill currently under consideration in the U.S. Senate proposes three key changes: Overriding recent court decisions: The bill seeks to revisit important Supreme Court decisions including Alice Corp. v. CLS Bank International (2014), Association for Medical Pathology v. Myriad Genetics (2013),and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012). These decisions narrowed the scope of patent-eligible subject matter by declaring naturally occurring gene sequences ineligible. The PERA would make it easier for patents to be issued for inventions that may be ineligible under existing law for being too abstract or for incorporating natural phenomena. Providing new guidelines: The PERA would also expand patent eligibility by eliminating existing judicial exceptions to patentability and replacing them with a narrow list of inventions that cannot be patented. These new exceptions include: A mathematical formula that is not part of a claimed invention; A process that is substantially economic, financial, business, social, cultural, or artistic, unless it cannot be performed without a machine or manufacture; A process that occurs in the mind or in nature, wholly independent of human activity; An unmodified gene, as it exists in the human body; and An unmodified natural material, as it exists in nature. While one of the PERA’s goals is to provide greater certainty with respect to patent eligibility, these exceptions are sure to pose legal questions. What, for example, is a process that is substantially economic, or business, or cultural that cannot be performed without a machine? Expanding patent eligibility: Importantly, the legislation states that claimed patents in areas like biotechnology, diagnostic testing, and artificial intelligence (AI) are eligible if they are incorporated into a “useful process, machine, manufacture, or composition of matter, or any useful improvement thereof.” Supporters seek to clarify that inventions involving natural phenomena, laws of nature, and abstract ideas are only eligible for patent protection if they are practically applied or integrated into a practical application. Expanding Patent Eligibility Limits Innovation and Competition Supporters claim that patent eligibility practices in the wake of the aforementioned Supreme Court decisions hinder innovation and investment in critical technologies like AI, personalized medicine, and diagnostic testing. On the other hand, critics assert that the PERA would restore an earlier patent regime that granted patent protections too broadly, making it difficult for true innovators to navigate complex and far-reaching patents that limit entry into the market. “Patent thickets” became prevalent in the late 1990s and early 2000s, particularly among pharmaceutical companies seeking to extend their exclusivity over blockbuster drugs in order to keep generic competitors at bay. This term refers to the practice of creating impenetrable walls of patents on different aspects of the same drug—from the primary patent covering the compound itself to secondary patents on characteristics like method of use, formulation, and other aspects of drug delivery—thereby creating a dense web, or “thicket,” of patents surrounding a single product. For example, I-MAK found that America’s top 10 best-selling drugs possess an average of 74 granted patents. These patent thickets extend the monopoly protection enjoyed by drug manufacturers well beyond the original patent while keeping low-cost generics out of the market. Another tactic for extending monopoly protection of brand-name drugs is “evergreening,” or adding new patents to a drug as existing ones expire. By pursuing patents on different aspects of a drug, such as packaging, dosage, or other properties, it is possible to extend its dominance in the marketplace. While some changes may be warranted, others may simply protect exclusivity. This makes it important to evaluate a patent’s validity—something proposed changes within the PERA would make more difficult. “Product hopping” is yet another way to game the patent system. Here, a company produces a reformulated version of a drug—by changing the dosage or introducing an extended-release version, for instance—and markets the new product heavily while urging prescribers to switch. They may even take the old product off the market. In one example, as the patent on its popular anti-ulcer drug Prilosec expired, AstraZeneca switched to Nexium, a drug with minimal modifications and an additional 13-year patent life. This product hop was estimated to cost the U.S. health care system over $2 billion annually. Expanding patent eligibility to allow companies to obtain patents on abstract ideas, natural phenomena, or even basic computing functions would significantly extend the monopolies of patent owners, stifling innovation and competition by giving patent holders greater authority to challenge new entrants for infringement as they try to access the market. It would abuse the tools of government to slow down competition and stifle innovation. Innovation, Not Litigation While the goal of the patent system is to “promote the Progress of Science and useful Arts,” a return to overly broad patents increases the threat of litigation while making innovation more difficult. Indeed, many non-practicing entities focus exclusively on litigation rather than practicing patents. These entities do not innovate or produce new products; rather, they acquire large portfolios of patents solely to assert them in infringement cases against true inventors attempting to bring new products to market. Consider, for example, the impact of the Supreme Court’s Myriad decision, which the PERA would overturn. Prior to this decision, gene patents were held on 20 percent of the human genome. The Court held that “genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.” Since that decision, genetic testing prices have dropped substantially: “Other labs began offering the tests for as little as a few hundred dollars, a small fraction of Myriad’s $4,000.” Creating monopolies over fundamental building blocks of life threatens to raise prices and limit access to vital medical treatments and diagnostic tools. Expanded Patents, Rising Health Care Costs In addition to economic and competitive issues, questions of eligibility can also raise important ethical concerns. Ultimately, overly broad patents may reduce access to affordable treatments. Patents on natural products or biological processes essential for drug development create government-protected monopolies that limit the development of alternative or generic versions of drugs, which could hinder patient access to affordable medicines. Consider some of the potential adverse effects of expanding patent eligibility: More costly cancer treatments. If patents are granted on isolated natural compounds or proteins involved in cancer pathways, it could limit the development of alternative or generic cancer drugs targeting those same pathways. This could prolong the exclusivity period for expensive branded cancer therapies, making them unaffordable for many patients—especially those without insurance coverage or financial assistance. Deterred innovation in antibiotics and antimicrobial resistance. Broad patents on naturally occurring antimicrobial compounds or mechanisms of antibiotic resistance could hinder research into new antibiotics or alternative treatments. This could exacerbate the growing public health crisis of antimicrobial resistance by limiting the availability of affordable and effective antibiotic options. More costly diagnostic tests and personalized medicine. Patents on isolated genes or biomarkers would create monopolies over diagnostic tests and personalized medicine approaches, driving up costs for patients and health care providers. These exciting new avenues for therapies may be delayed by a return to the problematic eligibility standards previously addressed by the courts. This could limit access to affordable and tailored diagnostic tools, hinder the adoption of precision medicine, and lead to suboptimal treatment choices. These examples illustrate the potential far-reaching consequences of overly broad patent eligibility criteria on drug affordability across various therapeutic areas and with distinct disease populations. Striking the right balance between incentivizing innovation and ensuring reasonable access to essential medical treatments remains a critical challenge in the ongoing debate over patent eligibility reform in the life sciences and biotechnology sectors. Unfortunately, proposed legislative changes opt not to strike that balance—reverting instead to a world characterized by higher costs, increased litigation, and less innovation. Conclusion A proliferation of patents in the life sciences and biotechnology fields could lead to more patent infringement lawsuits and costly legal battles over the boundaries of intellectual property rights. This situation was directly addressed by the Supreme Court in the wake of the litigation explosion in the late 1990s and early 2000s. Should the PERA’s new patent eligibility standards restore those circumstances, increased litigation costs may be passed on to consumers in the form of higher drug prices and reduced choices, further exacerbating affordability issues. Any proposed expansion of patent eligibility for inventions involving natural products or biological molecules and processes could have significant implications for drug prices and affordability. By allowing broader patenting of naturally occurring compounds, genes, proteins, and biological processes, pharmaceutical companies would gain stronger exclusive rights over these fundamental building blocks of drug development. This may be particularly problematic in rapidly evolving fields like AI, precision medicine, and genetic testing, where the closer a patent is to an abstract idea or natural phenomenon, the more stifling its impact will be on the development of new inventions and applications.

7. Innovations in Generic Drug Manufacturing and Formulation Innovations in generic drug manufacturing and formulation have been a driving force behind the dramatic increase in generic drug competition in recent years. As patent protections expire on blockbuster drugs, generic drug manufacturers have been able to enter the market, offering consumers more affordable options for their medications. However, the process of developing and manufacturing generic drugs is not without its challenges. One of the major challenges in generic drug manufacturing is ensuring that the product is bioequivalent to the brand-name drug. This means that the generic drug must be identical in terms of dosage form, strength, route of administration, and intended use. To achieve this, generic drug manufacturers must conduct extensive testing to demonstrate that their product is equivalent to the brand-name drug. In recent years, there have been a number of innovations in generic drug manufacturing and formulation that have made this process easier and more efficient. Here are some of the most significant innovations: 1. Continuous manufacturing: Traditionally, pharmaceuticals have been manufactured in batches. However, continuous manufacturing allows for a more streamlined and efficient process, reducing the time and cost of production. 2. Complex generics: Complex generics are drugs that have more complicated formulations, such as injectables or inhalers. Developing these drugs requires specialized knowledge and expertise, but they can offer significant cost savings to consumers. 3. Biologics: Biologic drugs are derived from living cells and are used to treat a variety of diseases, including cancer and autoimmune disorders. Developing generic versions of these drugs is a complex process, but it has the potential to offer significant cost savings to consumers. 4. 3D printing: 3D printing has the potential to revolutionize drug manufacturing by allowing for the creation of personalized medications. For example, a patient could have a medication printed specifically for their needs based on their genetic makeup. Innovations in generic drug manufacturing and formulation have played a significant role in increasing competition in the pharmaceutical industry. While the process of developing generic drugs is not without its challenges, these innovations have made it easier and more efficient, ultimately benefiting consumers by offering more affordable options for their medications. 8. Future Directions in Generic Drug Competition and Regulation The landscape of generic drug competition and regulation has been changing rapidly in recent years. With the rise of blockbuster drug patents that can be worth billions of dollars, the need for effective competition and regulation in the generic drug market has become increasingly important. This section will examine the current state of generic drug competition and regulation, as well as explore some of the future directions that the industry may take. From the perspectives of healthcare providers, patients, and drug manufacturers, there are many different factors that influence the development of generic drugs and the regulations surrounding them. 1. Increased FDA Oversight: As the demand for generic drugs continues to grow, the FDA has increased its oversight of the industry. This includes more rigorous testing and approval processes, as well as increased scrutiny of the manufacturing and distribution practices of generic drug manufacturers. This increased oversight has led to a more reliable and trustworthy supply of generic drugs, which has helped to improve patient outcomes and reduce healthcare costs. 2. Patent Litigation: The process of challenging drug patents has become more complex in recent years, with many drug manufacturers engaging in lengthy and expensive litigation to protect their patents. This has led to delays in the availability of generic drugs, as well as increased costs for both patients and healthcare providers. However, recent changes in patent law have made it easier for generic drug manufacturers to challenge patents, which could lead to increased competition and lower drug prices in the future. 3. International Competition: The global market for generic drugs has been growing rapidly in recent years, with many countries around the world offering lower-priced generic drugs than those available in the United States. This has led to increased pressure on US drug manufacturers to lower their prices and compete more effectively with their international counterparts. However, concerns about the quality and safety of international generic drugs have also been raised, which could lead to increased regulatory oversight and higher costs for patients. 4. Increased Patient Choice: As more generic drugs become available, patients are gaining more choices in terms of their healthcare options. This has led to increased competition among drug manufacturers, which has helped to lower drug prices and improve patient outcomes. However, concerns have also been raised about the quality and safety of some generic drugs, which could lead to increased regulatory oversight and higher costs for patients. The future of generic drug competition and regulation is complex and multifaceted. While there are many challenges facing the industry, there are also many opportunities for growth and innovation. By staying up-to-date with the latest trends and developments in the industry, healthcare providers, patients, and drug manufacturers can work together to create a more effective and sustainable healthcare system for everyone.

Conflicts around water are increasingly in the headlines: clashes between farmers and herders in the Horn of Africa, disputes over large dam projects in Central Asia and the Nile River Basin, violence in the Lake Chad region, and state fragility in Iraq and Iran (driven at least in part by water issues). These examples show some of the many ways that conflict can arise around water and how water can trigger or exacerbate conflict, acting as a “threat multiplier”.

Numerous policymakers from national governments, regional organisations and international institutions have underlined the risks associated with conflict due to water scarcity. Many have called for targeted action to counter the threat. The media, too, has picked up on this issue. Journalists point out – often in alarmist terms – the perceived direct links between water scarcity (and other climate change-related water challenges) and violence and instability. Some even suggest that water wars between countries are just around the corner, or that the world will soon be at war over water.

Defense ministers, military generals, NGOs, UN Secretaries-General and environment-focused academics all repeat the misguided hypothesis that increasing resource scarcity leads to conflict. Since Al Gore’s Inconvenient Truth movie, the narrative keeps expanding to include climate-induced mass migration, climate disasters, and even climate wars.

Indian geostrategist Brahma Chellaney has recently argued that water is the new oil and claims that water will be the centerpiece of power struggle in Asia. This year, tensions between Ethiopia, Sudan, and Egypt over filling the enormous Grand Ethiopian Renaissance Dam on the Nile River has also refueled water war theories. After the summer floods in Germany, Belgium, and the Netherlands, European Commissioner Frans Timmermans repeatedly predicted that there will be future wars over food and water unless there are 55 percent reductions in carbon dioxide emissions by 2030. Military analysts such as retired Dutch General Tom Middendorp, chairman of the International Military Council on Climate and Security, has repeatedly aligned himself with the water wars (and climate-induced mass migration) discourse. The Water, Peace, and Security Partnership was set up by the Netherlands Ministry of Foreign Affairs, the German Agency for International Cooperation and a consortium of six partners to forecast and understand water-related conflicts and organized violence.

A quick look at the contemporary international order reveals that the collective security system established by the United Nations Charter and put into place following the end of World War II has failed to protect international peace and security. The tragedy last year in Aleppo and throughout Syria at present is the biggest proof of this failure. For many years, the system’s inability to achieve peace has been attributed to the Cold War. So when the Berlin Wall fell in 1989 and the Soviet Union collapsed, there was a wave of optimism that mirrored the preamble to the UN Charter which states: “We the peoples of the world are determined to save succeeding generations from the scourge of war.” This was essentially the purpose of founding the United Nations, whose main objective was “to maintain international peace and security, and to that end: to take effective collective measures for the prevention and removal of threats to the peace, and for the suppression of acts of aggression or other breaches of the peace.” Hopes were high that these lofty goals would see the light of day after the end of the Cold War, and that the world would renounce the law of the jungle so that peace and justice would finally prevail. Indeed the first ever Security Council summit meeting following the end of the cold war on January 31, 1992 saw world leaders ask the new UN Secretary-General, Boutros Boutros-Ghali, to report on the nature of post-Cold War international relations. Boutros-Ghali presented his famous report “An Agenda for Peace”. In May 1992 the general assembly appointed a committee of the whole, which I presided, to put the proposed contained in the “Agenda for Peace” into effect. However, it soon became clear that the maintenance of world peace would not come about with the end of the Cold War, because the interests of the great powers still conflicted with one another. Thus the Security Council’s inability to take effective and urgent measures to impose peace will, regrettably, continue. *** To understand the reason for this we must look back at what I call the “grand design” that was concluded in 1945 at the San Francisco Conference when the UN Charter was adopted. It was agreed then to establish a Security Council that would oversee the protection of international peace and security. The Council was given unprecedented wide powers to eliminate all threats to peace. It was also agreed that the five permanent members would have the power to veto substantive resolutions but not procedural resolutions. Unfortunately, the Charter did not clearly delineate the nature and delimitation of the procedural resolutions that could not be impeded. More importantly, the Charter granted the five permanent members veto power, which means that they could block resolutions even with the majority vote needed to pass. The argument behind this open-ended unprecedented license was that it was the responsibility of these five great powers to protect world peace, not their own narrow interests. The five great powers at the San Francisco Conference tried moreover to gain the right to veto non-procedural resolutions regardless of their content, and to incorporate this right explicitly into the charter, but they failed because of the opposition of most countries. At present, it is clear that the interlocking political and economic interests of the five great powers make it inconceivable that any action taken by the Council would directly or indirectly affect those interests. Simply put the Security Council, with its present structure, has been made to be in a state of permanent paralysis the recent deliberations in the council on Ghouta-Syria reflect this paralysis. As a result, the international protection system enshrined in the UN Charter no longer exists. This is what the Arab countries have struggled with over the past seven decades when it came to Palestine, and what the region is struggling with now when it comes to Syria. *** It is noteworthy that the Security Council’s paralysis [failure] does not hinge solely on the actual use of the veto power. I was the representative of Egypt in the Security Council in 1996 and 1997. I chaired the Council in June 1996 and witnessed first-hand the five great powers threatening in the negotiation phase to veto many crucial resolutions. Ultimately, when the G-5 accept to pass a resolution, it usually ends up formulated as follows: Refraining from taking the action required to end the conflict, and merely appointing an envoy to manage the conflict. The best example of this are the resolutions on Palestine. Imposing sanctions that do not change the situation much but often harm many innocent people. Using distorted ineffective verbal formulations such as the repeated condemnations and denunciations we see now in the Council’s resolutions that do not call for any action that would change the tragic situation in question. The net result is that the Council is being confined to managing conflicts, not ending them.

Today, such optimism looks more than a little naive. Even as the international legal system has ostensibly grown increasingly robust—underpinned, for example, by United Nations conventions, global accords like the 2015 Paris climate agreement, and the International Criminal Court—the rule of force has continued to trump the rule of law. Perhaps no country has taken more advantage of this state of affairs than China.

Consider China’s dam projects in the Mekong River, which flows from the Chinese-controlled Tibetan Plateau to the South China Sea, through Myanmar, Laos, Thailand, Cambodia and Vietnam. By building 11 mega-dams near the border of the Tibetan Plateau, just before the river crosses into Southeast Asia, China has irreparably damaged the river system and wreaked broader environmental havoc, including saltwater intrusion in the Mekong Delta that has caused the delta to retreat.

It is simply astonishing that in approaching a new course of relations with Russia, President Biden should have called Vladimir Putin “a killer” and lacking “a soul.”

It is similarly astonishing to have chosen an important opening moment in our delicate relationship with China to employ derogatory language. Did Blinken believe that flashing testosterone at the first high-level meeting of Beijing’s foreign policy leadership would help achieve the diplomatic goals Washington seeks? One wonders who the secretary of state was trying to impress — Beijing or a U.S. domestic audience?

In “Subjective and Objective Measures of Democratic Backsliding,” the political scientists Andrew Little of the University of California at Berkeley and Anne Meng of the University of Virginia find that the post-Cold War expansion of democracy in nations around the world has, on average, held. “Recent studies that find evidence of global backsliding,” they observe, “rely heavily if not entirely on subjective indicators” — such as asking experts to rate, based on their own judgment, the extent to which an election was “free and fair.”

Little and Meng instead measure democracy based on quantifiable factors less susceptible to individual bias. They find, for example, no overall decline in electoral competition. Across the world, “The rate of leader and ruling party turnover has remained fairly constant since the late 1990s,” the paper says. “If anything, the vote shares of incumbent leaders in executive elections and incumbent parties in legislatures have decreased in recent years.”

Resolution of this controversy is fundamental to the study and practice of international relations. The observation of democratic peace is ‘‘the closest thing we have to an empirical law’’ in the study of global politics (Levy, 1988: 662), and carries the profound implication that the spread of democracy will end war. New economic norms theory, on the other hand, yields the contrary implication that universal democracy will not end war. Instead, it is market-oriented development that creates a culture of contracting, and this culture legitimates democracy within nations and causes peace among them. The policy implications could hardly be more divergent: to end war (and support democracy), the contractualist democracies should promote the economies of nations at risk (Krieger and Meierrieks, 2015; Meierrieks, 2012; Mousseau, 2000, 2009, 2012a, 2013; Nieman, 2015).

In the literature are five factual claims for why we should continue to believe that democracy causes peace: (1) an assertion that in three of the five studies that overturned the democratic peace (Mousseau, 2013; Mousseau et al., 2013a, b), the insignificance of democracy controlling for contractualist economy is due to the treatment of missing data for contractualist economy (Dafoe et al., 2013, henceforth DOR); (2) a claim of error in the measure for conflict (DOR) that appears in one of the five studies that overturned the democratic peace (Mousseau, 2013); (3) an alleged misinterpretation of an interaction term that appears in one of the five studies (Mousseau, 2009) that overturned the democratic peace, along with in inference of democratic causality from an interaction of democracy with contractualist economy (Dafoe and Russett, 2013; DOR); (4) a claim of reverse causality, of democracy causing contractualist economy (Ray, 2013); and (5) a report of multiple regressions with most said to show democratic significance after controlling for contractualist economy (DOR).

For one, despite the popular consensus that robot war as inevitable, future conflicts might look more like those of the past than some care to let on. Many of the aforementioned challenges are not only present today, but with NATO’s increased focus on joint, multinational exercises and operations following Russia’s 2014 annexation of Crimea, they have assumed a greater degree of complexity.

In response, most Western nations have taken up the crusade of militarized robotics and Artificial Intelligence (AI) as a means of remaining competitive. There is, however, potential for advances in these fields to add to this complexity rather than reduce it. Furthermore, while America’s competitors promote visions of a robot war, their massive human armies are not a reflection of this alleged epiphany. In light of these concerns, a critical look at such initiatives is essential in developing a realist future war policy.

Media reports of an AI arms race between the U.S. and China have proliferated in 2017,153 and leading thinkers have identified AI as a technology that could provide a decisive strategic advantage in the international security realm.154 In contrast, much of the Chinese academic literature discussing military possibilities for AI technology has been largely abstract and speculative, and a majority of it references or focuses on the U.S. Defense Advanced Research Projects Agency’s activities.155 Chinese military institutions, such as the NUDT, have increased their research efforts on intelligent robotics.156 In the short-term, the People’s Liberation Army (PLA) will likely continue to adopt a range of unmanned vehicles into all four services (Army, Navy, Air Force, and Rocket Force).157 Combined with breakthroughs in UAV swarming and intelligentized missiles, these developments could challenge the U.S. military presence in the Pacific theater.

In the long-term, China’s AI development could revolutionize its conduct of military affairs. Although material evidence for Chinese militarization of AI is limited, some rhetorical evidence does show that China sees AI as a revolutionary military technology. In a statement on the central government’s work report by Lieutenant General Liu Guozhi, director of the Central Military Commission’s Science and Technology Commission, he states, in reference to military applications of AI, that the world is “on the eve of a new scientific and technological revolution,” and “whoever doesn’t disrupt will be disrupted!”158 Combined with AI’s dual-use nature, China’s high degree of civil-military fusion has raised concerns about the military applications of AI. Li Deyi, as a quintessential example, is both the director of the Chinese Association for Artificial Intelligence and a major general in the PLA.159 To emphasize, many of these projections are largely speculative as the most sensitive military AI applications are not publicly disclosed. There is not a coherent consensus of ideas on AI in warfare within the PLA. Moreover, the influence of the PLA is not overwhelming, as other bureaucratic entities often have diverging views and the central party apparatus possesses final decision-making powers.

Is Xi’s dream of a world-class PLA realistic? His vision largely depends on PLA efforts to increase jointness and achieve intelligentization.

By all accounts, the Chinese military is on the march. The PLA’s annual budget grows at a rapid pace year after year. The PLA Navy is now larger than the U.S. Navy. “Carrier-killer” missiles attempt to threaten America’s ability to project power in the Indo-Pacific. The PLA’s increasingly sophisticated nuclear arsenal grows at an alarming pace. But these raw numbers alone do not capture some of the more subtle measures of warfighting capabilities, such as organization, training, education, and doctrinal concepts. These seldom noted yet critical measures of military power may tell a different story about the PLA’s pace of growth and ability to achieve its ambitions.

However, the concept of an “arms race” is too simplistic a way to think of the coming AI revolution. To confront its challenges wisely requires reframing the current debates.

First and foremost, AI is not a weapon, nor is “artificial intelligence” a single technology but rather a catch-all concept alluding to a range of techniques with varied applications in enabling new capabilities. Just in the near term, the utility of AI in defense may include the introduction of machine learning to cyber security and operations, new techniques for cognitive electronic warfare, and the application of computer vision to analyze video and imagery (as in Project Maven), as well as enhanced logistics, predictive maintenance, and more.

“For 20 years-plus we’ve been in a judicial emergency,” Chief District Judge Kimberly Mueller of the Eastern District of California testified to the Subcommittee on Courts, Intellectual Property, and the Internet.

The Judicial Conference of the United States — the policymaking body of the federal courts — has proposed that Congress create 65 new permanent judgeships across certain district courts to provide relief to 663 existing positions, as well as convert eight temporary seats to permanent. California should get 23, the conference said, including four in the Southern District of California, which encompasses San Diego and Imperial counties.