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Reaching outer space requires Earthly infrastructure, which means that space launches have concrete footprints that change according to developments in launch technologies. The placement of outer space related infrastructure on Earth is a question of environmental (in)justice. Which sites are chosen, who is expropriated, and which environments are impacted is subject to strategic geopolitical calculations, which, more often than not, employ classical geopolitical reasoning (Hickman and Dolman 2002; Ingold 2006; Meira Filho, Guimarães Fortes, and Barcelos 2014; NDRI 2006). Launch sites are tightly controlled to reduce the risk of interference or failure, therefore situating launch sites in remote areas is often explained in terms of safety and security (Zapata and Murray 2008). No doubt this is important: rockets are composed of many tonnes of material and combustive fuel, so they must be launched in places where damage from routine as well as potentially catastrophic explosions can be contained. For humans to reach “the final frontier,” they must first find a frontier space on Earth that can be made into an empty space in which controlled explosions can be routine. Frontiers are seldom as empty as those aiming to conquer them would claim. Where they are not populated by people, they are filled with other sorts of meanings and life forms (Klinger 2017; Tsing 2005). Potential launch sites and testing ranges deemed by government authorities to be simultaneously remote, safe, and suitable to contain the risks of rocket launch must first be made empty of people, with prior land use regimes or territorial claims pushed beyond designated buffer zones (Gorman 2007; Mitchell 2017). Hence the placement of space infrastructure follows colonial geographies of extraction, sacrifice, and risk (Mitchell 2017; Redfield 2001). As Gorman (2007) put it: “because of their distance from the metropole, these places lend themselves to hosting prisons, detention camps, military installations, nuclear weapons, and nuclear waste. All of these establishments, including rocket ranges, have inspired reactions of protest.” These so-called ‘peripheral’ spaces are nevertheless central to their inhabitants and their neighbors, who question the logic of extraglobal conquest in the face of unresolved Earthly injustices. Consider, for example, the case of the launch site in Alcântara, Brazil, which has been well documented by Araújo and Filho (2006) and Mitchell (2017). Through a close examination of local, national, and international politics, these authors document how the government’s racialized approach to the subsistence communities displaced by space infrastructure deepened structural inequalities. Grassroots opposition to the launch site grew not out of an a priori ideological opposition of poor people to national progress in outer space, as some officials alleged, but rather resulted from the failure to account for the food insecurity generated by state resettlement projects. The resettlement schemes were themselves misinformed by impoverished notions of local livelihoods. Local claims against the deprivations caused by statesponsored space practices have deepened schisms between the military and civilian space programs at the federal government level. Through the lens of classical geopolitics, these structural inequalities scarcely register, with the result that the ‘crawling’ progress of Brazil’s space program is pathologized as poor management practices symptomatic of an inadequately implemented national development vision (Amaral 2010). Critical geopolitics helps deconstruct the nationalist performativity of such endeavors by considering the political and economic value placed on the spectacle of spaceflight (Boczkowska 2017; Macdonald 2008, 2010; Sage 2016). Feminist geopolitics draws our attention to the racialized and gendered dispossession advanced by the state, through the construction of space infrastructure and exercised through access to land. The fact that environmental and public health impacts were only considered by the authorities after years of mobilization by Black social movements, religious communities, and scholars highlights the ways in which inattention to the local in the pursuit of space power perpetuates environmental injustice, which in turn interrupts national plans for space progress. Rocket launches affect local and global environments through the construction of infrastructure, the exposure of local environments to toxic residues, and the dispersal of pollutants in land, air, and sea. Rockets are the only source of direct anthropogenic emissions sources in the stratosphere. Ozone-depleting substances (ODS) such as nitrous oxide, hydrogen chlorine, and aluminum oxide are emitted by rockets, and can destroy 105 ozone molecules before degrading (Voigt et al. 2013). The ozone layer prevents cancer and cataract-causing ultraviolet-b waves from reaching the Earth. As of 2013, rocket launches accounted for less than 1% of ODS emissions. As other ODS are phased out under the Montreal Protocol and the frequency of lower cost space launches increases, the proportion and quantity is likely to increase (Durrieu and Nelson 2013; Ross et al. 2009). GEOPOLITICS 13 Although affluent economies in the northern hemisphere are responsible for most ODS emissions (Polvani 2011; Rousseaux et al. 1999), the geography of exposure disproportionately affects an overall higher population in remote regions and in the southern hemisphere (Norval et al. 2011; Robinson and Erickson 2015; Thompson et al. 2011) because ozone depletion is most serious in regions where high altitude stratospheric clouds are most likely to form: above the polar regions and major mountain ranges (Carslaw et al. 1998; Perlwitz et al. 2008). This is an example of environmental injustice on a global scale, where the global south bears the environmental burden of actions predominately taken in the global north, rocket launches included. In the process, global power relations are reinscribed through the uneven distribution of harm to peripheral and southern bodies, mediated in this case through the redistribution of gases in the stratosphere that increase exposure to solar radiation. Coming closer to Earth, environmental geopolitics of outer space are manifest in the dispersal of particulate matter into ecosystems surrounding active launch sites. This is more than a strictly local environmental concern, because which spaces are subject to the hazards of launch sites involves careful calculations weighing financial cost, state power, and multifarious territorial interests. With each launch, surrounding areas are showered with toxins, heavy metals, and acids over a distance that varies widely with wind, weather, and precipitation patterns at the moment of lift-off.3 The most researched of these pollutants are hydrogen chloride, aluminum oxide, and various aerosolized heavy metals. Release of these pollutants from rocket launches results in localized regional acid rain (Madsen 1981), plant death, fish kills, and failed seed germination of native plants in launch sites (Marion, Black, and Zedler 1989; Schmalzer et al. 1992). These effects, and research on them, are mostly concentrated within one kilometer of the launch site. But they have been recorded several kilometers away under certain weather conditions (Schmalzer et al. 1998). Recent studies on the concentration of trace elements in wildlife in areas near NASA launch activities in Florida, USA, found that more than half of the adults and juvenile alligators had “greater than toxic levels” of trace elements in their liver (Horai et al. 2014). Both the subject, and the vague statement of findings, highlights the lack of research into the impacts on downstream human and non-human communities. In contrast to the precautions taken to protect workers in buildings adjacent to facilities where these technologies are developed (Bolch et al. 1990; Chrostowski, Gan, and Campbell 2010), much less consideration is given to communities within the dynamic pollutant shadow of rocket launches. In Kazakhstan, Russia, and China, researchers have begun examining the effects of the highly toxic liquid propellant, unsymmetrical dimethylhydrazine which has been in use since the dawn of the space age. It has noted carcinogenic, mutagenic, convulsant, teratogenic, and embryotoxic effects (Carlsen, Kenesova, and Batyrbekova 2007), and it has been found to cause DNA damage and chromosomal aberrations in rodents living near the Baikonur cosmodrome in Kazakhstan (Kolumbayeva et al. 2014). Despite these known hazards, methods to detect UDMH at the trace concentrations at which toxic effects begin to manifest in humans do not yet exist (Kenessov, Bakaikina, and Ormanbekovna 2015), meaning that there is no knowledge of how this circulates in the environment, bioaccumulates up the food chain, or could potentially be sequestered through soil or plant filtration. The lack of technology or methodology to adequately track the dispersal of hazardous pollutants that have been used for decades in the surrounding environment illustrates another aspect of environmental injustice: the preference on the part of political and economic elites to create spaces of waste rather than allocate adequate resources to maintain safe and non-toxic environments.4 The hyper-local politics of basic livelihood security shape long-term access to outer space and space geopolitics at multiple scales. Attending to the local matters is important, not just because it sheds light on broader geopolitical processes, but because failing to do so leaves the substantive matters of human engagement with outer space entirely overlooked, at best. At worst, ignoring local environmental conditions recasts them as places to be “left behind,” casualties in a Darwinian race to the cosmos in which the poor have no place. Attending to the environmental geopolitics of outer space on Earth shows the co-production of Earth and space. Earthly environments and social relations are remade in our evolving relationship with outer space and reconceived alongside evolving deliberations on the prospects for human survival.

There is no universal flu vaccine. There are no vaccines with long-lasting protection against malaria or tuberculosis. None for parasites like Chagas, elephantiasis, hookworm or liver flukes. None for some viral threats that could become pandemic, like Nipah, Lassa and Middle East Respiratory Syndrome. None for some that already have, including Lyme, West Nile, Zika and hepatitis C. None for respiratory syncytial virus, which kills infants, nor even for the dozens of causes of common colds. Vaccines are among the world’s greatest medical advances, like clean water, soap, bleach, sewage systems and antibiotics. In a rational world — one where budgets are built on lives saved per dollar — spending on vaccine research would rival that on defense research. And progress would be as rapid. When Louis Pasteur was born, soldiers carried muskets. Now, a Taliban fighter can be killed by a drone flown from a base in Arizona, but vulnerable Americans still have to rely on a flu-shot technology invented in 1931: growing vaccine in chicken eggs. And as with weaponry, fear changes everything. In epidemiologically quiet times, the anti-vaccine lobby sows doubts; when Ebola or pandemic flu strikes, Americans clamor for protection. There are two obstacles to faster progress, said Dr. Gregory A. Poland, director of the vaccine research group at the Mayo Clinic. “One is scientific, and one is embarrassing,” he said. The embarrassing part is the lack of investment. It takes 10 years and more than $1 billion to develop a vaccine — a small fortune for a medical advance but a pittance for a weapons system. While defense research is driven by one mega-customer, the Pentagon, vaccine researchers face a confusing hodgepodge of potential backers. Private industry largely pursues high-priced vaccines for American children, militaries and adventure tourists. Potential bioweapons like anthrax, plague and rabbit fever attract bioterrorism funds. But vaccines meant to protect only poor people in faraway countries usually must wait for donor governments and philanthropies like the Bill and Melinda Gates Foundation and the Wellcome Trust, even though we know these plagues cross borders. The scientific obstacles, though more intractable, are relatively rare. Many pathogens are genetically farther apart than rhinoceroses and bees: A defense against a horn does not protect against a sting, and vice versa. Most vaccines work by creating antibodies — Y-shaped proteins — that block the disease agent’s own proteins. While viruses have only handful of target proteins, bacteria have up to 6,000 and parasites even more, noted Dr. Paul A. Offit, director of vaccine education at the Children’s Hospital of Philadelphia. And even some smallish viruses, including H.I.V., flu and hepatitis C, mutate so rapidly that their surfaces change shape before antibodies can lock onto them. As a rule, if a disease normally leaves even a few survivors who are completely disease-free and immune for life, a vaccine against that disease is possible. “Natural infection is the mother of all vaccines,” said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases. Smallpox meets the criteria; H.I.V., malaria and tuberculosis do not. H.I.V. mutates as fast in one day as flu does in a year; it also survives by splicing its DNA into the very immune cells that hunt it. TB bacteria can survive even when “walled in” by white blood cells. And malaria, a shape-shifting parasite, never triggers lifetime immunity. People who survive repeated bouts get less sick each time, but that immunity disappears if they move out of the malarial region. If they return, the first mosquito bite may kill them. Other diseases are complex, with many subtypes. For example, Pneumovax 23, the anti-pneumonia shot given to middle-aged people, negates 23 strains of one bacterium.

But so far this year, just 14 percent of adults have received a dose of the new vaccine formulation that became available in September — compared to 28 percent who have gotten a flu shot. This raises a question that would have seemed unthinkable three years ago: What if we make a miraculous vaccine and nobody wants it? Ever since that first shot, the public’s interest in subsequent Covid-19 vaccines has been steadily dropping. Less than 70 percent of the US finished their initial two-dose vaccine series. Less than 20 percent of the country received last year’s bivalent booster shot. Experts say the public’s disinterest in the latest Covid shots is likely a combination of poor messaging from authorities, a diminishing fear about a virus that three years ago was wholly unknown, and the political polarization of the pandemic itself. But whatever the reasons, that vaccine ambivalence still poses a health threat. Elderly people and very young infants continue to have a higher chance than the rest of the population that they will be hospitalized with Covid-19. Vaccination rates have fallen off for the former group, who are also most likely to die from an infection, and they were never strong to begin with for the latter; 95 percent of children under 4 are unvaccinated. About half of seniors being hospitalized for Covid-19 these days have never gotten a vaccine, experts say, affirming that the unvaccinated continue to be hit much harder by the virus. Infectious disease experts saw 2023 as a pivotal year for the country’s transition out of the pandemic. It would test whether the US health system could marshal a strong response to the winter Covid-cold-and-flu season, specifically through a successful vaccination campaign. The dismal start to that campaign may force a difficult question upon the public health community: If Americans don’t care about getting vaccinated against Covid-19 anymore, what do we do now? Why Americans aren’t getting their Covid-19 shots Part of the story is simply human nature. Covid-19 arrived in 2020 behaving strangely (with so much asymptomatic transmission) and incurring a deadly toll (the first iteration of the virus was notably more virulent than the flu). Much of the economy shut down and people were confined to their homes. It was a scary time and vaccines offered hope for a future in which not only would you be less likely to get seriously ill but that life could get back to normal. When shots went out to hospitals, pharmacies, and vaccination clinics in December of 2020, Americans were eager to get them. But three years and multiple new vaccine formulations later, the novelty is gone. Americans aren’t as worried about Covid-19 now. More than 70 percent of US adults said they were not concerned about getting seriously ill from Covid-19 in a November survey from the KFF health policy think tank. That figure has been about the same for the flu and RSV, suggesting Americans have come to view the novel coronavirus as a similar health risk to other cold-weather illnesses that have been circulating for a long time. Half of the people who were previously vaccinated but do not plan to get the updated Covid-19 vaccine cited a lack of concern about the virus as a reason for skipping the latest shot, per KFF. “People aren’t scared of this virus anymore,” Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, told me. As evidence, he recounted that he had ridden the subway with “100 screaming, maskless” football fans heading to the Eagles-Cowboys game. “No one on that subway car had a mask on,” he said. “We are close to winter, and this is in theory a winter virus.” Familiarity is one part of that change in attitudes. Another is political polarization: Republicans, both the rank-and-file and their political leaders, have grown more and more hostile toward the Covid-19 vaccines, with a general skepticism toward government mandates spilling into conspiracy theories and disinformation. (Offit marveled at that turn of events: These vaccines are “the most amazing medical and scientific accomplishment” of his lifetime and “the greatest accomplishment of the Trump administration.” And yet.) Only 23 percent of Republicans said in KFF’s November poll that they had or would get the latest version of the Covid-19 vaccine this fall or winter. Another 43 percent of the party said they received an earlier dose but will not get the new shot and 34 percent said they have never been vaccinated at all. To compare, 40 percent of independents said they had or would get the new shot and 72 percent of Democrats said the same. While reality does not exactly match up to those responses, the gap between Republicans and the rest shows partisanship is driving vaccine attitudes. “It’s become part of somebody’s identity that they’re not somebody who gets Covid shots in particular,” said Dr. Céline Gounder, a senior fellow at KFF and editor-at-large for Public Health at KFF Health News. “That may spill over to vaccines, but it starts with Covid.” There are worrying signs of a more general resurgence in vaccine skepticism: 3 percent of US schoolchildren reported a vaccine exemption for the coming school year, the highest share on record according to the CDC. Ten states have an exemption rate above 5 percent; only two did three years ago.

Disease X is not any particular virus, bacteria or other germ, but a term used as a stand-in for whatever pathogen will sweep the globe in the next pandemic. And there will indeed be a next pandemic, experts say. For the vaccine experts, one thing is clear: No matter the form Disease X takes, they'll be called on to get to work and develop the vaccine. Such a task could feel insurmountable, given the vast unknowns. Should they focus on particular viruses now to get a head start? Should they look at pathogens that so far are found only in animals, but could someday spill over into humans and cause widespread disease, like Covid did? Big and important questions, yes, but simple enough for this group of vaccine researchers and developers. They know the science. They understand how viruses evolve and spread. They know how to make safe and effective vaccines against them. But — as has become evident more than a year and a half into the U.S. vaccination campaign — one essential piece of information is missing: how to convince hesitant people to be vaccinated. "There's something about human behavior that we're still not really understanding," Dr. Nicole Lurie, U.S. director of the Coalition for Epidemic Preparedness Innovations, told the World Vaccine Congress. Since the first shots went into arms in December 2020, just over 66 percent of the U.S. population is now fully vaccinated, according to the Centers for Disease Control and Prevention. "There's all this emphasis on science and labs. It's one thing to do that, but it's a whole other thing to get what you develop in the lab into people's arms," said Richard Carpiano, a public health scientist who studies issues surrounding vaccine uptake at the University of California, Riverside. Scientists at the World Vaccine Congress acknowledged that, for all of their education and training, one issue has remained frustratingly hard to overcome: the growing anti-vaccine movement. U.S. Surgeon General Vivek Murthy told NBC News that there is no doubt that vaccine misinformation is harming Americans, and could be detrimental in years to come. "It's certainly one of the issues we must address to prepare for the next pandemic, whenever that may come," he said. "This is absolutely critical from an emergency preparedness standpoint." If people are refusing vaccines in the face of an ongoing pandemic, widespread deaths will occur in future pandemics, warned Dr. Julie Morita, executive vice president of the Robert Wood Johnson Foundation. "If we continue to have poor acceptance of vaccines, we will see millions of lives lost in the case of another pandemic as big as this one," she said. Dr. Peter Hotez, co-director of the Center for Vaccine Development at Texas Children's Hospital and dean of the National School of Tropical Medicine at the Baylor College of Medicine in Houston, addressed conference attendees, saying, "If you really want to save lives, it's not only about making vaccines." "We continue to underestimate what I call anti-vaccine, anti-science aggression," he said, adding that until it's met head-on, "this will continue to haunt us."

Recent agency actions have helped lower costs, increase care quality for consumers and promote competition across the health care market

Anticompetitive acquisitions and practices can chill fair competition, leading to higher health care costs, degraded working conditions, and less innovation across the health care and pharmaceutical industries. Through regulatory and legal actions, the Federal Trade Commission (FTC), Department of Justice (DOJ), and Department of Health and Human Services (HHS) are each working to promote competition to lower health care costs for families and taxpayers and improve the quality and availability of health care for patients.

Monopolization also tends to discourage research spending and depress innovation. One reason: merging companies tend to cut research spending. Both Pfizer and Valeant Pharmaceuticals, for example, cut their R&D spending after acquisitions. Academic studies confirm that mergers tend to depress innovation among drug companies. Indeed, many drug companies have turned to mergers and acquisitions to make up for their lack of innovation—acquiring firms with promising or profitable drugs rather than developing such drugs in house.

These developments and tactics have created the current American pharmaceutical landscape. Drug companies grow larger, pursue more mergers and acquisitions, and raise prices. Nearly all Americans have felt the effects of this skewed and unequal market.

On April 30, 2024, the US Federal Trade Commission (“FTC”) announced that it had sent “warning letters” to 10 branded pharmaceutical manufacturers, alleging that the companies had made “improper or inaccurate listing of patents” in the Food and Drug Administration’s (“FDA”) “Orange Book.” The FTC also stated that it had submitted patent listing dispute letters to the FDA challenging the “accuracy or relevance of more than 300 Orange Book patent listings across 20 different brand name products.” The FDA has publicly expressed its support for the FTC’s recent efforts in its press release.

According to the FTC, warning letters were sent last week to companies manufacturing injectable obesity and type-2 diabetes drugs, asthma and COPD inhalers, and a nasal spray to treat severe hypoglycemia in type-1 diabetics. The patent listing dispute letters are confidential, and these patent listing disputes have not yet been listed on the FDA’s database.

On November 7, the Federal Trade Commission announced that it is challenging more than 100 patents held by 10 branded drug companies as improperly or inaccurately listed in the Food and Drug Administration’s Orange Book. The Commission has notified FDA that it disputes the accuracy or relevance of the listed information for the targeted patents. Once FDA receives the dispute notice, it will send the statement of dispute to the New Drug Application holder, who will then have 30 days to withdraw or amend the listings or certify under penalty of perjury that the listings comply with the applicable statutory and regulatory requirements.

This enforcement action follows the Commission’s release of a policy statement concerning improper listing of patents in the Orange Book in September 2023. There, the Commission stated that improper Orange Book listings harm competition in pharmaceutical markets by delaying generic and follow-on product entry. Specifically, the Commission alleges that by improperly listing a patent in the Orange Book and timely filing an infringement suit, a branded drugmaker can rely on the automatic 30-month stay to block FDA’s approval of a competing drug product regardless of the validity or scope of the patent and regardless of whether the patent meets the statutory listing criteria. The Commission maintains that improper Orange Book listings may constitute an unfair method of competition.

The Federal Trade Commission has challenged more than a hundred medical device patents listed in the Food and Drug Administration's Orange Book, claiming the improper listings stifle competition and further increase the price of drugs. The Orange Book - officially the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations" - is the agency's authoritative guide to approved prescription drugs. Along with publishing all FDA-approved medications, the Orange Book includes a drug's active ingredients, dosage forms, strengths and approval dates, as well as information on therapeutic equivalence for generics. Additionally, the book includes pertinent patent information for the listed drugs. But as Sara Koblitz, director at the law firm Hyman, Phelps & McNamara, told Medtech Insight, the Orange Book also lists medical devices such as inhalers and injectors that deliver drugs. These device patents, however, are not listed separately in the Orange Book but as part of the patented drug. "If the drug is used with the device, then the device can be listed with the drug," Koblitz said. Patent Protection Koblitz further explained that listing device patents in the Orange Book provides companies with pre-approval enforcement of their patents, which allows them to bring patent infringement litigation against a potential competitor before that competitor's product has been approved. For example, as Koblitz pointed out in a recent FDA Law Blog post, Teva Pharmaceutical initiated pre-launch patent litigation against Amneal Pharmaceuticals in March for infringement of five of its Orange Book-listed patents related to Teva's combination product, ProAir HFA, which is the brand name of the drug albuterol sulfate used with a metered dose inhaler. "Wrongfully listed patents can significantly drive up the prices Americans must pay for medicines and drug products while undermining fair and honest competition." - Lina Khan In response to Teva's patent litigation, Amneal filed a counter claim seeking a declaratory judgment of non-infringement and asked the court to invalidate the five Teva patents and have them removed from the Orange Book. Amneal further sought relief from "allegedly anticompetitive conduct in violation of state and federal antitrust laws." The FTC, Koblitz pointed out, filed an amicus brief in that suit arguing that the Teva patents "do not claim" any FDA-approved drug. SARA KOBLITZ In her blog, Koblitz cites the FTC's view: "Device patents that do not mention any drug in their claims do not meet the statutory criteria for Orange Book listing, and a device patent that is improperly listed in the Orange Book must be delisted." Last month, the District Court of New Jersey ruled Teva's patents were improperly listed and ordered their removal from the Orange Book. Moreover, the court also ruled that Teva's patents, which only covered the inhaler component of the ProAir HFA drug, are not properly listed either. Koblitz quotes the court's opinion: "The inhaler patents do not claim the drug for which the applicant submitted the application." As Koblitz later explained, this means that while the court acknowledged that the definition of a drug is broad enough to include the device used to deliver it - in this case the inhaler - the court also found the definition too narrow to establish the claim on the inhaler patents without specifying the drug used with the inhaler. In other words, because the FDA identified "albuterol sulfate HFA inhalation aerosol" as the drug on Teva's new drug application (NDA) to the agency, albuterol sulfate must be claimed in the inhaler patent for it to be eligible for Orange Book listing. Teva has appealed the ruling. More Aggressive Posture In November 2023, the FTC sent letters to 10 of the biggest pharmaceutical companies, including Teva, challenging more than one hundred patents of brand-name asthma inhalers, epinephrine autoinjectors, and other combination products as improperly or inaccurately listed in the Orange Book. The FTC also notified the FDA that it disputes the accuracy of these patents. "The FTC has now taken the position that device patents that do not include the specific drug product that is delivered by that device shouldn't be listed," Koblitz said, noting this issue is one the FDA would rather not deal with and has kicked down the road for some time. "The FDA has never opined on it," she added. "They've been asked the question since 2005 and have refused to answer. So, everybody has been listing their device patents assuming they are integral to the use of the drug product listed in the book." But while the FDA has not been clear on the patent question, the FTC now has.

The U.S. Federal Trade Commission (FTC) is not done with its crackdown on what it views as improper listing of patents with the FDA. After an initial round of challenges launched in November against more than 100 patents by nine drugmakers, the FTC is back targeting another 300-plus patent listings by eight pharma firms in the FDA's Orange Book. The FTC argues those patents for altogether 20 brand-name products are “junk” listings that could be used by pharma companies to stymie competition and inflate drug prices. AstraZeneca, Boehringer Ingelheim, GSK and Teva once again found themselves in the crosshairs of the U.S. antitrust watchdog. But the most high-profile products involved in this wave of disputes, as spelled out by the FTC, are perhaps Novo Nordisk's GLP-1 drugs Ozempic, Saxenda and Victoza. In response to a Fierce Pharma request for comment, Novo said it's reviewing the warning letter received from the FTC. The antitrust agency in a Tuesday release mistakenly identified Ozempic as a weight loss drug when it's only approved by the FDA to control Type 2 diabetes. Novo's Wegovy, which contains the same GLP-1 receptor agonist semaglutide as Ozempic, is approved for obesity. The two brands, while both coming in an injectable pen administered weekly, are available in different maintenance dose strengths.   The FDA Orange Book records branded drug patents that serve as reference for generic drug developers. The FTC argued that by putting up sham patents, biopharma companies have exploited a policy that blocks the FDA from approving a generic drug for 30 months if an originator timely files an infringement lawsuit against a generic over a patent listed in the Orange Book. The FTC first warned in September that it would scrutinize improperly listed drug patents in the FDA database. Then, in November, it challenged more than 100 patents for several drug products that deploys special delivery devices, such as an inhaler or an injector. In response, GSK, Amneal's Impax Laboratories and Kaleo have delisted some patents. GSK also voluntarily removed certain patents that were not challenged by the FTC. Earlier this year, Boehringer Ingelheim, AZ and GSK all committed to capping their inhalers' monthly out-of-pocket costs at $35. This time around, the FTC is once again eyeing some drug-device combos. Besides the Novo drugs, AstraZeneca's Bydureon pen for diabetes is also part of the FTC's challenge. Four GSK inhalers using the Ellipta device, such as the chronic obstructive pulmonary disease and asthma therapies Breo and Trelegy, were included. A GSK spokesperson confirmed receipt of the new warning letter and said the company will do its own analysis as the law requires. Previously, GSK retracted four of five patents flagged by the FTC from the Orange Book back in November. “Once complete, we will respond to the FDA and FTC in accordance with the FDA's process,” the GSK spokesperson said of the latest review. For Novartis, its COPD drugs Seebri and Utibron landed on the FTC's radar. Boehringer saw patents for its Striverdi and Stiolto inhalations using the Respimat technology under the agency's microscope. In a statement shared with Fierce Pharma, Boehringer said it has “never wrongfully submitted patents for listing in the Orange Book—not for any of our inhaler products or any other products in our portfolio.” The company believes its patents in the FDA database are “valid, enforceable and properly listed.” “Drug-and-device combination products are complex and costly to develop and manufacture, and we file patents to protect our investment in innovations like these that benefit people and improve their lives.” Teva had the most patents implicated among the drugmakers, with about 60 patents targeted across five brands using the Respiclick, Digihaler or Redihaler platforms between it and its Norton Waterford subsidiary. The company did not immediately reply to a request for comment. Covis Pharma and Amphastar Pharmaceuticals round out the eight companies, The FTC is currently challenging the patents under the FDA's regulatory dispute process, but the antitrust agency warned that it retains the right to take any further action. The FTC has yet to bring any additional sanctions against companies that have refused to remove patents in the agency's first round of scrutiny.

CITC proposes releasing more than 10GHz of additional spectrum across a wide range of frequency bands by 2024 and inputs are welcomed from interested parties both from Saudi Arabia and internationally. The regulator is keen to stress that it is seeking ideas and innovations for wireless communications and applications from a wider base than traditional telecoms players, an approach that sets the regulator apart from its more conservative peers in the Middle East.In our view, this move further enhances Saudi Arabia's appeal as an investment target for technology companies. Firstly, the ambitious USD500bn NEOM 'cognitive city' project will depend on a broader range of technologies and applications than can be provided by traditional wireless networks and infrastructure operators. While the 5G networks currently being rolled out by STC, Mobily and Zain will be instrumental in providing low-latency connectivity, supplementary wireless and wired technologies will be supporting a host of in-building and back-office functions and applications. Opening up spectrum to non-telecoms companies will accelerate the development, testing and commercialised deployment of these applications.Secondly, our assessment of 'Industry Risks' in Saudi Arabia, as part of our assessment of the Middle East telecoms market from an investment risks and rewards perspective has improved significantly over the last three years as a result of a rapid unlocking of the country's spectrum resources, and this assessment will likely improve as it moves to finalise its spectrum allocation plan. In 2016, Saudi Arabia was one of the most bandwidth-deficient markets in the world; since then, it has increased spectrum availability by 226%, from 340MHz in 2017 to 1,110MHz in 2020.Fixed-line players such as Go Telecom ( Atheeb Etihad) and Integrated Telecom Company (ITC) have been able to acquire spectrum in recent times, reinforcing our view that the CITC will be able to think outside traditional silos when developing regulations for smart city applications and solutions such as autonomous vehicle tracking and management as well as setting up localised computing grids (based on edge computing processes) to support smart power load balancing, among many other applications.

Still, while the surveillance tech that forms a key part of any smart city project is clearly a thorny subject, the fear that Beijing can export authoritarianism around the world through the sale of surveillance tech is about as credible as the idea that the U.S. can export democracy by selling more Big Macs and getting more people to watch Hollywood films. To be sure, there are troubling ethical questions around the use of surveillance tech. But the best solution is to have a global regulatory framework to address them, such as the EU's General Data Protection Regulation. But when it comes to seeing more technological innovations coming out of China, the rest of the world should relax. As the mobile internet era showed, China can innovate on its own without inflicting much harm.

The end result is that, despite all the handwringing over the prospect of SEP holders using injunctions and exclusion orders to suppress competition and extract above-FRAND licensing fees, we have not found even one injunction or exclusion order that actually kept a product off the shelf because it infringed a SEP. Gupta and Snyder's recent study of cases filed since 2000 in the "smart phone wars" found no injunction and only one exclusion order imposed for infringing a patent that was pled as a SEP, but even that exclusion order was vetoed by the U.S. Trade Representative as contrary to the public welfare.  n17 The one example commonly invoked by concerned commentators, Commonwealth Scientific & Industrial Research Organisation v. Buffalo Technology Inc.,  n18 involved a patent the holder did not plead as a SEP. In any event, the judge granted an injunction only after expressly considering the competitive conditions in the market and concluding the "public interest would not be disserved by a permanent injunction because [standardized end] products are obtainable from multiple sources other than [the infringer]."  n19

If a SEP holder cannot eliminate (or credibly threaten to eliminate) competition by getting an injunction, then it cannot distort licensing negotiations, contrary to what some commentators have suggested,  n20 and contract law should provide SEP users with sufficient means for protecting their interests in a FRAND licensing rate. Antitrust enforcement is therefore an unnecessary response to a SEP holder seeking an injunction.

If open source innovation has great social benefits in fostering competition and innovation, it also has particular vulnerabilities. First, precisely because open source development takes place in a network and allows both small and large players to participate by building on a common technology, it is particularly susceptible to attack and disruption. A proprietary monopolist fully internalizes both the costs and benefits of policing its technology and its intellectual property. Members of an open innovation network, however, do not. Individual members can be “picked off,” forced to abandon promising lines of technological development, or to pay ruinous “stacked” royalties because the costs of litigation are too burdensome for any one member of the network to bear. It is in this context that the threat of injunctions is particularly worrisome. In fast-moving technology markets, the dead stop forced by an injunction can be enough to doom a product. An entire network of innovation could be shut down by an injunction obtained against a single small participant who lacks the resources necessary to challenge the patent or defend against the injunction.

Second, most of these markets are characterized by strongly cumulative innovation. A finished product may “read on” literally thousands of potential patents. In these markets, as Justice Kennedy noted in eBay, there are considerable concerns with low patent quality and with the vagueness of the patents themselves.5 Even the most scrupulous respecter of intellectual property can be subject to hold-up by a company claiming its patent has been infringed. To quote the Federal Trade Commission

“Monetary remedies will usually be adequate to fully compensate a [patent] holder for infringement,” the agencies say in the revised policy.

Bad for innovation

Seriously, be mad about your internet bill In 2019, New York University economist Thomas Philippon did a deep dive into market concentration and monopolies in The Great Reversal: How America Gave Up on Free Markets. And one of his touchpoints for the book is the internet. Looking at the data, he found that the United States has fallen behind other developed economies in broadband penetration and that prices are significantly higher. In 2017, the average monthly cost of broadband in America was $66.17; in France, it was $38.10, in Germany, $35.71, and in South Korea, $29.90. How did this happen? In his view, a lot of it comes down to competition — or, rather, lack thereof. To a certain extent, telecommunications companies and internet service providers are a sort of natural monopoly, meaning high infrastructure costs and other barriers to entry give early entrants a significant advantage. It costs money to install a cable system because you have to dig up streets, access buildings, etc., and once one company does that, there’s not a ton of incentive to do it all over again. On top of that, telecom companies paid what were often super-low fees — maybe enough to create a public access studio — to wire up cities and towns in exchange for, essentially, getting a monopoly. But that’s where the government could come in by regulating the network or forcing the company that built it to lease out parts of it to rivals. As Philippon notes, that’s what happened in France: An incumbent carrier was compelled to lease out the “last mile” of its network — basically, the last bit of cable that gets to your house or apartment building — and therefore let competitors have a chance at also appealing to customers. In 2017, the average monthly cost of broadband in America was $66.17; in France, it was $38.10, and in South Korea, $29.90 In the US, however, just a few big companies, often without overlap, control much of the telecom industry, and the result is high prices and uneven connectivity. In 2018, Harvard law professor Susan Crawford examined the case of, what do you know, New York City in an article for Wired. The city was supposed to be “a model for big-city high-speed internet,” she explained, after then-Mayor Mike Bloomberg struck a deal with Verizon to install its FiOS fiber service in residential buildings in 2008, ending what was then Time Warner Cable’s local monopoly. In 2015, a quarter of New York City’s residential blocks still didn’t have FiOS, and one in five New Yorkers still don’t have internet access at home. “New York City could be in a very different position today if those Bloomberg officials had called for a city-overseen fiber network. The creation of a neutral, unlit ‘last mile’ network that reaches every building in the city, like a street grid, would have allowed the city to ensure fiber access to everyone,” Crawford wro Instead, multiple states (though not New York) have put up roadblocks to municipal broadband to keep cities from providing alternatives to and competing with local entities. It’s an example of lobbying at its finest, so that powerful corporations can keep competitors out and charge whatever they want. And it’s hardly just the internet. Philippon found similar phenomena in cellphone plans, airline prices, and multiple other arenas, due to a lack of competition. In an interview with the New York Times, he estimated that corporate consolidation is costing American households an extra $5,000 a year. “Broadly speaking, over the last 20 years in the US, we see profits of incumbents becoming more persistent, because they are less challenged, their market share has become both larger and more stable, and at the same time, we see a lot of lobbying by incumbents, in particular to get their mergers approved or to protect their rents,” Philippon told me. Incumbents have gotten good at keeping out competitors — and they’ve been allowed to do it The government is supposed to use antitrust law to ensure competition and stop companies from becoming so big that they push everyone else out. Basically, antitrust is supposed to prevent anticompetitive monopolies. In the US in recent decades, regulators, enforcers, and the courts have taken a laxer attitude toward antitrust, which has resulted in more mergers, or companies growing to the point that it’s hard for rivals to stay in the game. “We basically had a whole legal framework prior to the 1970s that was dedicated to making sure that our businesses were protected from concentrated capital, and so producers were allowed to collaborate in a lot of different ways through unions or coops or various associations, and they got help in the form of lending, supports, patents, copyrights, etc.,” said Matt Stoller, research director at the American Economic Liberties Project, an organization aimed at combating corporate power, and author of Goliath: The 100-Year War Between Monopoly Power and Democracy. “Those were all things that were dedicated to protecting the producer from the capitalist, and we just reversed those assumptions.”

Basically, the prevailing view has been that the market, by and large, can take care of itself, and the government doesn’t need to take such a hands-on approach. And that’s led to gradual concentration over time. For example, traditional economic thinking is that if profits in a certain industry become very high, it becomes attractive for new incumbents to enter the market, and those excess profits get competed away. But that’s become less and less true over time in the United States. “It’s true sometimes, you could even argue that it’s true often, but it’s not always true — and if you’re not careful, you can end up in a situation where it’s not true anymore, and that’s exactly where we are today,” Philippon said. Incumbents have a lot of mechanisms to make it hard for competitors to enter, and they use a variety of tactics to keep them out — predatory pricing, patents, contracts, etc. In 2016, Lina Khan, now counsel on the House subcommittee on antitrust, penned an influential paper on the antitrust issues surrounding Amazon. In it, she used the example of Amazon and Quidsi, an e-commerce company that ran Diapers.com. Amazon tried to buy Quidsi in 2009, and after its founders declined, Amazon cut its prices for diapers and other baby products and launched a new service, Amazon Mom. Quidsi couldn’t keep up — Amazon has the resources to drop prices and take a hit in order to compete, Quidsi does not. And so it wound up selling to Amazon in 2010. Regulators looked at what happened but didn’t pursue a case against Amazon, and Amazon later scrapped the discounts and went back to what it was charging before. By dropping its prices, it basically pushed Quidsi out. Varsity Brands, which is owned by the private equity firm Bain Capital, has a monopoly on the cheerleading industry. Stoller recently laid out the tactics it’s engaged in to achieve its position and maintain it. The company has managed to vertically integrate multiple levels of the cheerleading industry, ranging from competitions to apparel, and has gobbled up competitors big and small. Its rivals aren’t allowed to showcase their apparel at Varsity events, and it offers contracts to gyms that give them a cash rebate if they send cheerleaders to its competitions and get them to buy its equipment. It took a copyright case over its uniforms to the Supreme Court. In the 2020 Netflix series Cheer, Varsity’s monopoly is featured, and the consequences of it are evident: To see cheerleading competitions, people have to pay for a specific Varsity app. They’re no longer shown on ESPN. “Varsity uses the great aspects of cheerleading to generate incredible revenue that only benefits them,” said Kimberly Archie, founder of the National Cheer Safety Foundation. Amazon declined to comment for this story, and Varsity Brands did not respond to a request for comment for this story. This isn’t all to say that anticompetitive behavior is always allowed, and mergers aren’t sometimes blocked. In February, the Federal Trade Commission sued to block the personal care company Edgewell from acquiring razor startup Harry’s. The Justice Department has also probed Live Nation on its practices after its 2010 merger with Ticketmaster and alleged that the combined company pushed venues into using Ticketmaster over other ticketing companies. This is about prices, but there’s also more to it A lot of the concern about corporate concentration comes down to its potential to drive up prices. The fewer options there are, the fewer places consumers have to shop, and the less pressure there is to keep prices low. Antitrust enforcers and regulators, when examining a potential merger or acquisition, or considering if a company is engaging in anticompetitive behavior, are supposed to apply a consumer welfare standard. Basically, it’s fine for a company to be really big, as long as a consumer isn’t harmed. The concept was first introduced by conservative judge Robert Bork in 1978, and it’s guided a lot of US antitrust policy ever since. Court rulings over time have been more permissive in antitrust cases, rendering practices that were once illegal legal. And the DOJ and the FTC, the two federal regulators most involved in antitrust matters, have also become more lax. Basically, it’s fine for a company to be really big, as long as a consumer isn’t harmed Most directly, the consumer welfare standard has translated directly to whether they’re paying higher prices. But a lot of the time, prices go up anyway. Sometimes, as Philippon’s book shows, the price hikes are gradual. With fewer players in a space, there’s no one to compete to drive them back down. Or competitors will raise prices in tandem — for example, in the pharmaceutical industry, the prices of competing drugs will sometimes go up at the same time. When companies merge, they’ll often argue that “efficiencies” — combined supply chains, shared resources, or worker redundancies that can translate to layoffs — will make things better for consumers and bring costs down, but if there’s no one to compete with them, the opposite can occur. A New York Times report in 2018 found hospital mergers raised prices for hospital admission in the majority of cases. But beyond consumer pricing, antitrust advocates note that there are other factors to consider. Corporate concentration means companies have to compete less for workers, and therefore could push wages down. Monopolies and oligopolies can also harm suppliers — if Amazon gets big and powerful enough, it could control what shippers such as FedEx and UPS can charge it. Consumers also lose the ability to vote with their wallets and eyeballs — basically, to say, I don’t like what a company is producing, what it’s charging, or how it’s behaving and go somewhere else. Just look at Facebook. “As soon as they achieved monopoly, they said forget the rules, and they were right. Every time they were caught cheating, nothing happened because there was nowhere else to go,” Philippon said. Amazon does drive prices down, and Facebook’s services are free for consumers, but that doesn’t mean that their dominance is good. More and more research is connecting concentration to higher prices for consumers, lower wages for workers, and other developments you wouldn’t expect to see in a competitive economy. Just as the shift toward monopolization has been gradual, getting more competition could take a long time, too There’s no one remedy for getting more competition back into the US economy, and even sector by sector, it’s really complicated. It’s one thing to call for Instagram to be broken away from Facebook, but no one agrees on how to fix virtually anything in the American health care system. It’s a good thing that antitrust is getting more airtime, with politicians, the press, and the public paying more attention to corporate concentration and its effects. Tech giants have been a main area of focus as of late, with regulators and lawmakers at the state and federal levels launching probes and holding hearings. Sens. Elizabeth Warren and Bernie Sanders have railed against powerful corporations on the campaign trail, and on the right, Republican Sen. Josh Hawley has taken on a crusade against Big Tech. But it’s going to take a lot more than public pressure for things to change. For one thing, it’s often hard to recognize how monopolized the economy has become. Dozens of brands can be housed under a single umbrella, and a lot of people don’t even realize it. But as I noted in 2018, monopolies are really everywhere: Four companies, for example, control 97 percent of the dry cat food sector: Nestlé, J.M. Smucker, Supermarket Brand, and Mars. According to the report, Nestlé has a 57 percent hold on the industry, owning brands such as Purina, Fancy Feast, Felix, and Friskies. Altria, Reynolds American, and Imperial have a 92 percent market share of the cigarette and tobacco manufacturing industry. Anheuser-Busch InBev, MillerCoors, and Constellation have a 75 percent share of the beer industry. Hillenbrand and Matthews have a 76 percent share of the coffin and casket manufacturing industry. Experts and advocates have laid out a range of ideas for restoring healthy competition in the economy and reviving regulators. Some of it would entail new laws and frameworks, which, given the current state of affairs in Washington, seems unlikely — Congress can barely agree to fund the government, let alone enact a major overhaul of the workings of the US economy. But it has happened in the past, and as recently as the 20th century. “What happened in the New Deal was a systemic attack on every aspect of the old order, and the old order was somewhat similar to what we have now,” Stoller noted. But even without sweeping legislation, there’s a lot that regulators, enforcers, and the courts can do now under existing law. The FTC and DOJ can be more active in their scrutiny of mergers and companies’ practices, and judges can strike down deals. After the FTC approved the pharmaceutical company Bristol-Myers Squibb’s acquisition of fellow drugmaker Celgene in November of last year, Democratic Commissioner Rohit Chopra in his dissent warned of the dangers of regulators ignoring obvious risks and instead clinging to the status quo. “When watchdogs wear blindfolds or fail to evolve with the marketplace, millions of American families can suffer the consequences,” he wrote.

Restrictions on ex post opportunism are needed to prevent a wealth transfer from implementers and their customers to SEP holders as a result of monopoly pricing.17 But much more is at stake. A. Underlying Economic Principles Basic economic principles instruct that ex post monopoly pricing by SEP holders harms consumers by raising the cost of products that comply with the standard. Ex post monopoly pricing also creates welfare-reducing deadweight loss in three respects. First, it increases the cost of, and thus reduces the output of, standard-implementing products. Second, and perhaps more important, supracompetitive pricing by SEP holders increases the cost of follow-on inventions that build on or improve the technologies claimed by the SEPs. This cost acts as a tax on follow-on innovation, reducing such innovations and impairing the very process of invention that the patent laws are intended to promote. Third, the prospect of ex post monopoly pricing by SEP holders exaggerates incentives for firms to obtain patents that might become SEPs and, perhaps more important, to jockey for inclusion of their patented technologies in industry standards. The latter incentive in turn could cause delays and induce expensive rent-seeking conduct in the standard-setting process and distort the standards-development process away from optimal technical solutions in ways that further the interests of rent seekers. These concerns are not universally shared. Indeed, a heated debate regarding the desirability of efforts to prevent ex post opportunism by SEP holders has persisted for the past twenty years. Those who do not share these concerns argue that the greater risk lies in inhibiting monetization of the inventions claimed by SEPs and thus discouraging innovation by SEP holders and those who expect to become SEP holders. We believe that those who share our concerns have by far the stronger argument. The risk of ex post opportunism is very real. Implementation typically precedes resolution of patent issues, and for good reason. Deferring implementation until the patent issues are resolved would delay the commercialization and innovation process. Implementers are therefore usually locked in to the allegedly infringing technologies well before the issue of patent royalties is addressed. The 17. The implementers, which pay the royalties to the SEP holders, will in the first instance suffer the wealth transfer. Depending on competition in the markets in which implementers sell their standard-compliant products, some or all of the wealth transfer is likely to be passed on to final consumers. how antitrust law can make frand commitments more effective 2117 real question is thus how best to prevent opportunism, not whether it is a genuine danger. Absent rigorous enforcement of effective FRAND commitments or a suitable alternative, SEP holders could take advantage of lock-in to exploit their substantial ex post market power by charging royalties far above the ex ante value of the patented technology, tying non-SEPs to SEPs, and implementing other means discussed below.18 Economic theory predicts that SEP holders will exploit their positions, and both anecdotal evidence and litigated cases suggest that they have done so.19

“Innovation is like a manna from heaven,” over which policymakers have little control, according to Robert Solow’s model. Despite this, if we look at the computer industry, antitrust seems to have achieved some important results. In this article, I will briefly review how antitrust enforcement against AT&T, IBM, Microsoft and Intel spurred innovation in the computer hardware and software industries.

AT&T, probably the most famous case in United States antitrust history, is well-known for the decision in 1982 that required the telecommunication monopoly to break up into several companies. However, the AT&T antitrust story is much more complex and fascinating with clear fundamental effects on the computer economy we live in today. Historically, AT&T owned Bell Labs—also called the “idea factory”— which was the birthplace of several Nobel Prize-winning inventions. Probably the most famous invention at Bell Labs was the 1947 invention of the transistor, for which  Bell Labs scientists William Shockley, John Bardeen and Walter  Brattain won the Nobel Prize in Physics in 1956. The transistor represents the beginning of the digital age and is present in all our modern digital devices.  

Over the next decade, the Biden-Harris Administration, led by the U.S. Commerce Department’s National Telecommunications and Information Administration (NTIA), will work to catalyze the development and adoption of open, interoperable, and standards-based networks through the Public Wireless Supply Chain Innovation Fund. Authorized under the FY 2021 National Defense Authorization Act and funded through the CHIPS and Science Act of 2022, this ten-year grant program[to] will help drive wireless innovation, foster competition, and strengthen supply chain resilience. It will also help unlock opportunities for companies from the United States and its global allies, particularly small and medium enterprises, to compete in a market historically dominated by a few suppliers, including high-risk suppliers that raise security concerns.