Search the archive.

It may have once been the case that being attacked by another country was a major threat to the lives of ordinary people. It may also be true that there are still some pretty serious dangers out there associated with the spread of nuclear weapons. For the most part, however, most of what you've been told about national security and all the big threats which can supposedly kill you is one big con designed to distract you from the things that can really hurt you, such as the poverty, inequality and structural violence of capitalism, global warming, and the manufacture and proliferation of weapons - among others. The facts are simple and irrefutable: you're far more likely to die from lack of health care provision than you are from terrorism; from stress and overwork than Iranian or North Korean nuclear missiles; from lack of road safety than from illegal immigrants; from mental illness and suicide than from computer hackers; from domestic violence than from asylum seekers; from the misuse of legal medicines and alcohol abuse than from international drug lords. And yet, politicians and the servile media spend most of their time talking about the threats posed by terrorism, immigration, asylum seekers, the international drug trade, the nuclear programmes of Iran and North Korea, computer hackers, animal rights activism, the threat of China, and a host of other issues which are all about as equally unlikely to affect the health and well-being of you and your family. Along with this obsessive and perennial discussion of so-called 'national security issues', the state spends truly vast sums on security measures which have virtually no impact on the actual risk of dying from these threats, and then engages in massive displays of 'security theatre' designed to show just how seriously the state takes these threats - such as the x-ray machines and security measures in every public building, surveillance cameras everywhere, missile launchers in urban areas, drones in Afghanistan, armed police in airports, and a thousand other things. This display is meant to convince you that these threats are really, really serious. And while all this is going on, the rulers of society are hoping that you won't notice that increasing social and economic inequality in society leads to increased ill health for a growing underclass; that suicide and crime always rise when unemployment rises; that workplaces remain highly dangerous and kill and maim hundreds of people per year; that there are preventable diseases which plague the poorer sections of society; that domestic violence kills and injures thousands of women and children annually; and that globally, poverty and preventable disease kills tens of millions of people needlessly every year. In other words, they are hoping that you won't notice how much structural violence there is in the world. More than this, they are hoping that you won't notice that while literally trillions of dollars are spent on military weapons, foreign wars and security theatre (which also arguably do nothing to make any us any safer, and may even make us marginally less safe), that domestic violence programmes struggle to provide even minimal support for women and children at risk of serious harm from their partners; that underfunded mental health programmes mean long waiting lists to receive basic care for at-risk individuals; that drug and alcohol rehabilitation programmes lack the funding to match the demand for help; that welfare measures aimed at reducing inequality have been inadequate for decades; that health and safety measures at many workplaces remain insufficiently resourced; and that measures to tackle global warming and developing alternative energy remain hopelessly inadequate. Of course, none of this is surprising. Politicians are a part of the system; they don't want to change it. For them, all the insecurity, death and ill-health caused by capitalist inequality are a price worth paying to keep the basic social structures as they are. A more egalitarian society based on equality, solidarity, and other non-materialist values would not suit their interests, or the special interests of the lobby groups they are indebted to. It is also true that dealing with economic and social inequality, improving public health, changing international structures of inequality, restructuring the military-industrial complex, and making the necessary economic and political changes to deal with global warming will be extremely difficult and will require long-term commitment and determination. For politicians looking towards the next election, it is clearly much easier to paint immigrants as a threat to social order or pontificate about the ongoing danger of terrorists. It is also more exciting for the media than stories about how poor people and people of colour are discriminated against and suffer worse health as a consequence. Viewed from this vantage point, national security is one massive confidence trick - misdirection on an epic scale. Its primary function is to distract you from the structures and inequalities in society which are the real threat to the health and wellbeing of you and your family, and to convince you to be permanently afraid so that you will acquiesce to all the security measures which keep you under state control and keep the military-industrial complex ticking along. Keep this in mind next time you hear a politician talking about the threat of uncontrolled immigration, the risk posed by asylum seekers or the threat of Iran, or the need to expand counter-terrorism powers. The question is: when politicians are talking about national security, what is that they don't want you to think and talk about? What exactly is the misdirection they are engaged in? The truth is, if you think that terrorists or immigrants or asylum seekers or Iran are a greater threat to your safety than the capitalist system, you have been well and truly conned, my friend. Don't believe the hype: you're much more likely to die from any one of several forms of structural violence in society than you are from immigrants or terrorism. Somehow, we need to challenge the politicians on this fact.

3. Some critics of PERA claim that restoring patent eligibility to gene-based technologies and diagnostics will impede scientific research, innovation, and access to diagnostics. But Europe has and continues to allow patents on all of these things, without any of these negative impacts. In fact, academic research in these areas thrives in Europe, and the diagnostics industry there now outcompetes the U.S. If eligibility for these technologies hasn’t led to any negative outcomes in Europe, why do you think it would lead to these outcomes here under PERA?

Invitae questions the assertion that Europe outcompetes the U.S. in clinical genetic diagnostics industry. For example, Invitae suggests that the subcommittee consider the data available in the NIH’s Genetic Testing Registry1, which is a global repository for the listing of genetic tests by providers from around the world. An analysis of the availability of genetic tests listed in the Genetic Testing Registry for the period from 2012 to 2022 showed that fully 49% of all of the listed clinical genetic tests in the world were associated with U.S. laboratories.2 Since the U.S. is less than 5% of the world population and accounts for about 15% of global GDP, this represents a disproportionate share of the global clinical genetic testing availability and counters the suggestion that Europe is outcompeting the U.S. Notably, the period under study matches very closely the post-Myriad.

PERA would slam the door shut on such innovation and also its clinical application in medicine. PERA would permit the privatization of natural phenomena in the form of knowledge of new biomarkers and their clinical relevance. Because the discernment of new (to us) biomarkers is highly distributed, patent filing on each new biomarker would proliferate with a very large and internationally dispersed group of patent applicants. Any one of those new patentees could stand in the way of a clinician’s effort to conduct an analysis of a patient’s genetic information because testing for a broad panel of possible variants would require permission from all of a large group of patentees, none of whom would be required to grant such permission.

From a policy perspective, we urge the subcommittee to think of natural phenomena such as biomarkers as pre-competitive information that is discovered and not invented and should be available to all. As noted above, this information is rapidly being developed now and privatization of such information is unnecessary to its discernment. Moreover, such privatization of natural phenomena biomarkers would impair patient self-knowledge about their own genetic make-up and critically an understanding of some of its implications.

Now that the Supreme Court decisions have helped to make a genetic diagnosis more affordable and accessible, we’ve also seen a corresponding boom in precision therapeutics with the availability of gene-linked therapies at an all-time high. They are bringing hope to patients battling diseases like cystic fibrosis, non-small cell lung cancer, and even hepatitis C. The number of both applications and approvals for orphan drugs with the Food and Drug Administration accelerated significantly after 201315 and in 2018 when drug approvals reached an all-time high, orphan drugs for rare, often genetic, disorders accounted for more than half of all approvals.16 The broad availability and low-cost of genetic sequencing is a core driver of this success because genetic screening is so often necessary to identify the patient population receptive to such drugs.

It is clear that after the Supreme Court decisions giving rise to the current patent eligibility jurisprudence, investment and innovation in diagnostics and precision medicine has increased dramatically. The benefit of these advancements lies not just in maintaining American leadership in the field, but also in the improved standard of care allowing many more patients to obtain an earlier diagnosis, prevent disease altogether, or receive a tailored more effective treatment. We hope that after reviewing the data presented that you will recognize that the current patent eligibility jurisprudence has greatly benefited and accelerated both clinical availability and continuing innovation in precision medicine which is rooted in an evolving understanding of the human genome and other biomarkers. And as such, that you will proceed cautiously with any legislative efforts to modify patent eligibility that would allow patents on laws and products of nature.

Prior to 2014 and the important Supreme Court decisions referenced above (Mayo, Myriad and Alice), people could, and did, patent not just genes but also each mutation or variation they detected along with its perceived significance for a patient’s health status. These numerous patents created a thicket preventing laboratories from analyzing and interpreting genetic information relevant to a patient’s health. This not only denied many patients the ability to access knowledge about their own health status but also hobbled innovation in precision medicine. At the time of Invitae’s founding in 2010 many investors questioned the viability of Invitae’s ambition to provide broad panels of genetic tests at an economical price precisely because of the existing patent thicket. Scores of patentees held numerous patents that claimed genes and mutations in genes covered by just the first modest panel planned by Invitae. For many, the patent thicket posed both economic and practical barriers to proceeding with even a small panel of genes to test. Testing the entire genome of a patient in the face of all of the then existing patents claiming aspects of human genes would be an impossibility as no one party would be able to assemble the rights to do so.

Invitae has long been committed to greatly expanding patient access to their genetic information, and in keeping with this commitment, Invitae filed an amicus brief in 2013 on behalf of the plaintiffs in AMP v. Myriad. When the AMP v. Myriad decision was handed down in June 2013, it unleashed a new era of precision where information gleaned from the Human Genome Project and other research could be more rapidly translated into medical approaches that work better for patients and their clinicians. It put an end to the practice of privatizing each incremental bit of knowledge about the significance of individual variations in a multitude of genes relevant to patient cancer risk or other diseases.

It has been estimated that by 2050, AMR could cause more than 10 million deaths per year [78]. If this trend will not be reversed, according to this prediction, the AMR will become the first cause of death worldwide [79]. Because of the AMR impacts on the health of animals and crops, it has been estimated that up to 24 million people could undergo extreme poverty by 2030 [80]. A significant portion of antimicrobials globally is also used in food-producing animals as prophylaxis or to promote faster growth [81], especially in LMICs [82, 83]. The antimicrobials used in agriculture, aquaculture, veterinary, and human healthcare are often the same [84, 85]. Therefore, the overuse and misuse of antimicrobials in human medicine, livestock, fisheries, and crop production have caused high AMR emergence and contributed to the development of resistance in humans. Therefore, it is of fundamental importance that the use of antimicrobials will become appropriate across the “One Health” universe including humans, animals, and environment [86].

The AMR issue has been typically addressed by searching and developing new antibiotics. Although many investments have been made in the research and development space, the development of new antibiotics is scientifically challenging and very expensive. Considering the rate of onset of resistance and the time needed for a new antibiotic to become obsolete, incentives will be needed for R&D to promote science independently by the investment returns from sale volumes. In this perspective, vaccines represent a very valid solution to prevent the spread of resistant pathogens and to reduce the incidence of disease and the need for antibiotic treatments. A recent review summarizes all vaccines which are already available and those that are in clinical or preclinical phases that can counteract the rise in antimicrobial resistance [87]. Interestingly, 61 new vaccines are in the development phase and 94 in the preclinical phase. This very high number of existing and potentially new vaccines shows how the advent of new technologies in the vaccine field is opening the way to the prevention of many infectious diseases and potentially to the reduction of AMR pathogens.

Antimicrobial resistance (AMR) is the process by which infections caused by microbes become resistant to the medicines developed to treat them. Microbes include bacteria, fungi, viruses and parasites. Bacterial infections alone cause one in eight deaths globally.

AMR is fueling the rise of drug-resistant infections, including drug-resistant tuberculosis, drug-resistant pneumonia and drug-resistant Staph infections such as methicillin-resistant Staphylococcus aureus (MRSA). These infections are killing and debilitating millions of people annually, and AMR is now a leading cause of death worldwide.

//DH

To address antibiotic resistance, we need more than new drugs, though. New antibiotics are necessary to treat resistant infections, but the enemy will develop resistance to them, too. To really make headway, we need new diagnostic tests, so we can swiftly detect the source of infection and pinpoint the right treatment. Some of the current tests are so slow, doctors feel obliged to prescribe antibiotics while waiting for the results. And many tests require a lab with running water and electricity, which hospitals in some countries can’t guarantee continuously.

Despite biomedical advances, nations remain profoundly vulnerable to pandemics. Even if every SARS-CoV-2 vaccine and therapeutic known at the time of writing had already been developed and approved at the beginning of the COVID-19 pandemic, the world would still have suffered millions of casualties due to the logistical challenges of manufacturing and distribution. As of 2023, no nation can plausibly keep a highly lethal and transmissible pandemic from bringing down society by threatening to infect the essential workers responsible for distributing food, water, power and law enforcement.

Our analysis suggests that while civilisation-threatening Wildfire and Stealth pandemics are extremely unlikely to emerge from nature, accidental or deliberate release is disturbingly likely as a result of their development by a biological weapons programme or the dissemination of credible genomic blueprints by well-meaning scientists. Neither possibility can be ruled out. The Soviet Union attempted to weaponise smallpox even though the virus would also have devastated its own population. And as the physicist Richard Feynman famously remarked, “What I cannot create, I do not understand”.70 Given that researchers aim to understand and program biology, the life sciences community typically shares all its results through publication,71 the relevant harmful traits exist in natural pathogens, and artificial intelligence is widely expected to accelerate the rate of discovery, it would be surprising if humankind did not learn to build Wildfire and Stealth agents.

Historically, Pandemics have had a decimating impact upon human civilisation. For example, the bubonic plague killed an estimated 30-60% of the European medieval population, with cities and urban populations mainly being affected. Whilst a devastating 90% of the indigenous populations died following colonisation, of which the main cause was due to a previously uninfected population being exposed to measles, smallpox and influenza for the first time. Even in the 20th Century smallpox killed an estimated 100 million people around the world before it was totally eliminated in 1980; (Oldstone M, 2020). The COVID-19 pandemic has had a fatality rate of approximately 3% of those infected-a similar rate to the Spanish flu, whilst in comparison the mortality rate from Ebola was approximately 50%. The devasting impact of pandemics have altered the course of history and shaped our current geo-political landscape. The recent experience of COVID-19 with a relatively low mortality rate, reveals how disruptive pandemics are to human civilisation-even without the risk of decimating the human population.

Existential risks exist from pandemics that are allowed to spread widely, with new mutations emerging. A particular threat is from the increasing development of synthetic biology and 'gain of function' research, whereby infections are genetically engineered to enhance their lethality for research or for the purposes of biological warfare. The potential existential risks from engineering future pandemics are of particular concern, especially as the technology becomes increasingly available, combined with very variable and absent governance mechanisms. The widescale and rapid spread of the COVID-19 Pandemic revealed how unprepared individual countries and the global community were for dealing with an infection with relatively low fatality rates, and calls into question our current capacity and collective ability to deal with a more lethal pandemic in the future; (IAC, 2022).

When it comes to existential risk from pandemic threat, risk research has tended to attribute the bulk of the threat to engineered or lab-leaked pandemics. The threat from these materials has increased dramatically over the last half-century, with significant advances in biotechnology and particularly with the accessibility and sophistication of DNA sequencing tools.6 With this technological improvement we have seen a democratisation of biotechnology, but as noted by Ord, ‘democratisation also means proliferation’ (pg. 134) and consequently an increase in the probability of a malicious actor having access to the skills and technology necessary to craft deadly biological agents. This use of biotechnology to construct deadly pandemics is not new: Ord notes 15 countries who have employed biotechnology for these ends during the 20th century which saw the attempted weaponisation of diseases such as smallpox, anthrax and tularemia, and Leigh (2021) lists several examples of malicious, non-state actors who have employed bioweaponry to cause death and destruction.

The main concern about the possibility of an existential threat from pandemics comes from a combination of two facts I have presented here: we have observed very severe pandemics in the past which have killed a lot of people, and the proliferation and improvement of gene editing tools mean that bioweaponry will become more accessible for malicious actors and more deadly in their hands. In light of these two facts, it seems likely that actors with malicious intent and some knowledge of biological structures and human anatomy could eventually deliver a pandemic significantly worse than those which nature has stumbled upon so far.

An accident involving a biological weapons programme working with a sufficiently dangerous pathogen could also trigger a Wildfire scenario. Rates of civilian laboratory-acquired infections and the history of accidental bioweapon releases yield estimated annual likelihoods mostly in the single-digit percentages conditional on a nation-state bioweapons programme working with a Wildfire agent (see Appendix 1). This includes the possibility of a rogue state building a system to deliberately cause a Wildfire pandemic as a dead-hand switch to deter outside interference, which could accidentally leak. Given that the Soviet Union’s bioweapons programme apparently aimed at enhancing variola major,24 there are reasons to believe current and future programmes may pursue similar goals, particularly if other nations view a specific pandemic-class agent as a credible threat.

The last potential source of a Wildfire pandemic is a deliberate release. Zealots of many different ideologies aim to inflict mass death and civilisational collapse, from omnicidal cultists,25 to apocalyptic terrorists,26 anti-civilisation or suffering-focused ideologues,27 deep ecologists,28 nihilists,29 and those who see no future for their own value system and way of life.30 While the capabilities of these non-state actors are severely limited relative to those of nation states, civilian research will eventually provide widespread access to genomic blueprints: many well-meaning research programmes explicitly aim to identify credible pandemic pathogens and share their genome sequences and pathogen-specific reverse genetics protocols.31 Even if they were to refrain from such activities, other advances in biotechnology and artificial intelligence will provide widespread access. Scientists will continue to seek to understand and program biology, including pandemics, and therefore will eventually learn to create them.

By the end of 2022 SARS-CoV-2 had infected most of humankind and directly or indirectly killed perhaps 20 million people – an effective global fatality rate of 0.25% inclusive of reinfections.8 Many viruses are far more lethal. Variola major, the causative agent of smallpox, killed approximately 30% of patients while maintaining high transmissibility (estimated R0=3.5-6);9 the virus was responsible for the deaths of 500 million people in the century before its eradication.10 The 1971 Aralsk outbreak, which involved a potentially weaponised strain, was transmitted by vaccinated individuals and exhibited 100% lethality in the three unvaccinated patients.11 More devastating pathogens exist in other animals that live in tight-knit groups: rabbit haemorrhagic disease virus (RHDV) is highly contagious, transmitted asymptomatically in young animals, and 80-100% lethal in adults.12 If such a virus were to sweep the world anywhere near as quickly as the Omicron variant of SARS-CoV-2, billions would perish.

Even at the height of the Cold War, a city-targeting nuclear exchange would not have seriously threatened the viability of most nations in the southern hemisphere.13 Given humankind’s demonstrated failure to reliably contain the moderately transmissible SARS-CoV-2 virus and the dearth of large-scale subsequent investments aimed at halting pandemic transmission by any government, a sufficiently severe pandemic-class agent would threaten the stability of every unprepared nation. Today, this includes every country in the world. Thankfully, most of the technologies required to mount a reliable defence already exist. With dedicated preparations, many nations could become highly resistant to catastrophic pandemics – but only if they anticipate more severe threats than a reprise of COVID-19.

The magnitude of a risk is the product of severity and likelihood. A global collapse of modern civilisation would constitute the greatest disaster in human history. In addition to the direct casualties from Wildfire or Stealth pathogens, the loss of the essential workers who currently generate and distribute industrially produced fertiliser – to name just one essential process – would cause 3 billion people to starve.20 Unlike comparably severe natural disasters such as major asteroid impacts and supervolcanic eruptions,21 the likelihood of a civilisation-threatening pandemic is non-trivial and growing as access to advanced biotechnology increases.

The relationship between pandemics and war is as long as human history. Past pandemics have set the scene for wars by weakening societies, undermining resilience, and exacerbating civil and inter-state conflict. Other disease outbreaks have erupted during wars, in part due to the appalling public health and battlefield conditions resulting from war, in turn sowing the seeds for new conflicts. In the post-Cold War era, pandemics have spread with unprecedented speed due to increased mobility created by globalization, especially between urbanized areas. Although there are positive signs that scientific advances and rapid innovation can help us manage pandemics, it is likely that deadly infectious viruses will be a challenge for years to come.

The COVID-19 is the most demonic pandemic threat in modern history. It has erupted at a juncture of other existential global threats, most importantly, accelerating climate change and resurgent nuclear threat-making. The most important issue, therefore, is how the coronavirus (and future pandemics) will increase or decrease the risks associated with these twin threats, climate change effects, and the next use of nuclear weapons in war.Footnote5

Since the first known pandemic- Antonine plague (165–180) which affected about five million people, the world has been hit by several pandemics affecting millions of people. In the current century, these pandemics are happening so frequently, covering wide areas of the world and affecting millions of people (1). Despite huge scientific and medical advances, the potential for diseases to spread is actually increasing, and the risk of outbreaks escalating into epidemics or pandemics. Several factors do play role for the increase in frequency and coverage of pandemics. A huge increase in globalization and connectivity has meant that disease agents can spread from one side of the world to another within a few hours. The major factors contributing to the increased occurrence of pandemics are (2):

Travel: because of increased ground, water and air transportation connectivity, more people are travelling from one country to another.

2. Legal Limitations on the Enforcement of Patents During Public Health Crises

Some might argue that pathogen patents need not be limited because patent holders are already constrained from enforcing their patents, especially during global health crises. For example, in the United States, a patent holder cannot obtain a permanent injunction preventing an infringer from practicing a patented invention unless it demonstrates that the public interest would not be disserved by the entry of the injunction.172 Likewise, the International Trade Commission, when assessing the appropriateness of an exclusion order barring the importation of infringing goods into the United States, must take into account "the effect of such exclusion upon the public health and welfare."173 These limitations have significantly reduced the number of injunctions and exclusion orders that are issued with respect to medical and health-related technologies.174 And under 28 U.S.C. §1498, injunctions may not be obtained for patent infringement against the U.S. federal government or its contractors the remedy for such infringement is limited to monetary damages as assessed by the Court of Federal Claims.175

In the United States, Congress is constitutionally authorized to enact a patent system to incentivize the creation of new and useful inventions.125 The exclusivity conferred by patents has played an important role in encouraging private biopharmaceutical firms to make large investments in costly R&D, clinical trials and regulatory approvals.126 Yet this instrumentalist rationale does not justify patents that claim pathogen genomic sequences.127 First, the identification of new pathogens in disease outbreaks is rarely undertaken by private parties seeking to develop commercial products.128 Instead, the identification of emergent pathogens is typically undertaken by public health authorities and academic institutions in geographic proximity to the outbreak. Unlike vaccines and therapeutics, the development of which is costly, risky, and [*561] time-consuming,129 sequencing a new pathogen genome is relatively inexpensive and requires little unique expertise.130 Thus, the financial incentives offered by patent exclusivity are not necessary to incentivize this activity, which is performed primarily by state actors in their public capacities.131

4. There Are Ample Opportunities to Patent Downstream Innovations Beyond Pathogen Sequences

It is not necessary to patent underlying pathogenic sequences in order to protect novel and innovative technologies such as diagnostics, vaccines, therapeutics, and genetic modifications. There are, in fact, numerous innovative aspects of these technologies that can be and routinely are patented.132 [*562] For example, the manufacture and delivery of vaccines involves multiple complex technologies and processes including active ingredients, adjuvants, delivery vectors and manufacturing, storage, and transport processes.133 According to a 2012 WIPO study, there were more than 50,000 patents and published patent applications in fifty-seven countries that claimed the active ingredients of vaccines for pneumonia, typhoid and influenza alone.134 Similar levels of variety and opportunities for innovation exist in the area of therapeutics.135 For instance, Regeneron filed more than one hundred patent applications around the world for its Ebola drug Inmazeb,136 even though the viral sequence was publicly available in GenBank.

PERA will not improve America’s global competitiveness in the life sciences.

Patent law is a species of government regulation of the economy within the U.S. A patent is not a fundamental property right. Rather it is a limited right defined by and granted by the federal government. Notably, the innovation giving rise to a U.S. patent can occur anywhere in the world and therefore a more permissive U.S. patent policy would encourage and reward innovators outside the U.S. as much as within the U.S. By contrast, the constraint on economic activity resulting from a U.S. patent occurs almost entirely within the U.S. Broadening patent eligibility to produce more U.S. patents means greater constraints on domestic economic activity but the beneficiaries could just as easily be foreign patent-holders who reside in countries that are economic competitors and who could then have a meaningful impact on American healthcare economy through their patent position. If this subcommittee has an industrial policy goal of improving American competitiveness with respect to China or other countries in the field of genomics and medical diagnostics, there are many possible productive opportunities to explore, but PERA is not one of them.