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The vast majority of GMO crop production does not go towards direct food consumption; rather, it is used for the production of animal feed and ethanol. These are crops engineered to withstand, work in partnership with, and self-generate pesticides. They are not engineered to increase yield or face climate-related challenges to growth, such as drought tolerance. There is one variety of corn has been bred for drought resistance, but it is likely to only be effective in 15 percent of US corn fields and is not effective in severe or extreme drought, which we are expected to have more of in the coming years. Industrial agriculture isn't the answer. Increases in yield from GE crops are a result of a decrease in yield lost to pests from Bt crops, pesticides, and an increase in fertilizer use (made from petroleum, defeating the purpose of ethanol). Unfortunately, growing weed and pest resistance is already decreasing their effectiveness, requiring much more dangerous pesticides and making useless one of the most used organic pesticides, Bt. These minimal increases in yield have come with major externalities, including but not limited to water pollution, pollinator loss, and soil degradation, that put future food security at risk. After decades of attempts, Big Biotech has not been successful in breeding GE seeds that increase yield or reduce water use. Conventional breeding outperforms genetic engineering when it comes to nitrogen use efficiency (the ability for crops to pull nitrogen out of soil, developing a more efficient use of fertilizer, ultimately decreasing the demand for fertilizers) and water use efficiency (WUE). Overall, conventional breeding is responsible for most of the successful advances in yield. It also happens on a much shorter timeline at a much lower cost. Industry studies show that it takes a minimum of ten years to develop a GE crop and nearly $150 million; whereas conventional crops take only $1 million to develop, improvements WUE and drought resistance naturally occur at an estimated 1 percent each year. While Big Biotech develop GMOs in a lab, farmers are improving traditional crops in the field. Due to this drag rate by the time GE crops are finally released they are actually behind their conventional counterparts. Conventional crops could also be more effectively bred to work in partnership with the cultural food needs and geographical climate and soil challenges unique to specific regions. Forcing GE crops into developing countries with higher existing biodiversity puts that biodiversity and future food supplies at risk by threatening native species and practices. There are an abundance of types of crop varieties (both already in use and wild) accessible to breeders and growers. It is important that we tap into this vast resource to expand nutrient diversity and accessibility.

So, where has this proposal come from? Biotech firms seem to have succeeded in convincing the European Commission that we need new genetically modified crops to tackle climate change. They argue that by enhancing crops’ resistance to drought or improving their ability to capture carbon, climate change may no longer seem such a daunting challenge.

If this seems too good to be true, unfortunately, it is. Biotech firms have taken advantage of growing concerns about climate change to influence the European Commission with an orchestrated lobbying campaign.

Antibiotic-resistant infections are a substantial health and economic burden to the U.S. health care system, as well as to patients and their families.1 They commonly occur in hospitals, due to the clustering of highly vulnerable patients, extensive use of invasive procedures, and high rates of antibiotic use in this setting.1 Nearly two million Americans per year develop HAIs, resulting in 99,000 deaths, most due to antibacterial-resistant pathogens.1 In 2006, two common HAIs (sepsis and pneumonia) were found to be responsible for the deaths of nearly 50,000 Americans and cost the U.S. health care system more than $8 billion.1 Antibiotic-resistant infections add considerable costs to the nation’s already overburdened health care system. When first-line and then second-line antibiotic treatment options are limited or unavailable, health care professionals may be forced to use antibiotics that are more toxic to the patient and frequently more expensive.5,11 Even when effective treatments exist, data show that in most cases patients with resistant infections require significantly longer hospital stays, more doctors visits, and lengthier recuperations and experience a higher incidence of long-term disability.5 The duration of hospital stays for patients with antibiotic-resistant infections was found to be prolonged by 6.4 to 12.7 days, collectively adding an extra eight million hospital days.1 Estimates regarding the medical cost per patient with an antibiotic-resistant infection range from $18,588 to $29,069.1,14 The total economic burden placed on the U.S. economy by antibiotic-resistant infections has been estimated to be as high as $20 billion in health care costs and $35 billion a year in lost productivity.1 Antibiotic-resistant infections also burden families and communities due to lost wages and health care costs.

Antibiotic-resistant genes that have been inserted into genetically modified food are able to withstand conventional wastewater treatments. The findings, contained in a research paper published recently in the journal, Biotechnology and Bioengineering, might point to a previously unknown way that bacteria may become resistant to life-saving antibiotics. The work is based on graduate work done at Duke University by Courtney Gardner, now an assistant professor in WSU’s Department of Civil and Environmental Engineering. She, along with Professor Tim Ginn in the Department of Civil and Environmental Engineering, have recently received a 3-year, USDA grant to continue the research. Antibiotic resistance, which bacteria adopt in response to interactions with the drugs, is increasing around the world and threatens the ability to treat many common infections and diseases. “We determined that extracellular DNA released from digestion appears to be ubiquitous in wastewater treatment in the U.S. – it’s much more persistent in the environment than we originally thought,” said Gardner. “Historically, I think it’s likely that this probably has contributed to the spread of antibiotic resistance in the environment. “The magnitude of that contribution is still unknown — it is something we are trying to determine,” she added. Unlike in Europe, which has largely banned the cultivation of genetically-modified crops for human consumption, GMOs are a common part of the food supply in the United States. Although the practice is becoming less common, companies have in the past added antibiotic resistant genes in their modifications as a helpful marker to differentiate genetically modified plant cells. About 130 lines of genetically modified crops contain such genes. Researchers have found that when people eat these foods, the incorporated genetic material moves through the digestive system, and that these genes can be released into the environment, including into wastewater treatment plants. Meanwhile, half of the biosolids produced in the U.S. after wastewater treatment are used as agricultural fertilizers every year, providing a potential pathway for moving the antibiotic resistant genes and bacteria through the environment. In the new study, funded by the National Science Foundation, the researchers added antibiotic resistant genes to reactors to mimic the most common wastewater treatment for 30- and 60-day treatments that generate class A biosolids. To the mix, they added common antibiotics, such as penicillin, that are also often found in wastewater. The researchers found that fragments of antibiotic resistance genes, especially longer strands, persisted through the treatment process. They believe that the DNA strands latch onto particles in soil or sediment in the digesters. There they lie protected from the processes that generally kill microbes and, instead, become a reservoir of genetic material. Furthermore, the researchers found that the genes appeared to be taken up by bacteria in the sludge. The researchers theorize that the bacteria in sewage, such as staphylococcus, are stressed when they encounter antibiotics. By picking up the strands of antibiotic-resistant DNA, they gain a selection advantage. In their new study, Gardner and Ginn will now be tracking and modeling the long-range transport of antibiotic resistant genes in agricultural fields. They will also be studying silencing RNA molecules, which are used in modern genetically modified crops to silence undesirable crop traits. The researchers want to know whether the remnant genetic material from silencing RNA molecules might bind with other bacteria in the environment to unintentionally silence desirable traits. “Our concern from a genetic and bacterial standpoint is that there are probably some non-target matching sequences between the silencing RNA and environmental microbes and that it could cause the loss of a gene and possibly a functional gene,” said Gardner.

As the health impacts of climate change become harder to ignore, biotechnology and pharmaceutical companies are facing increasing pressure from investors, employees, and government regulators to reduce their carbon emissions, and to make environmental sustainability a core part of their business. Globally, large public biotech and pharmaceutical companies are responsible for more than 200 million metric tons of carbon dioxide and equivalent emissions, . The bulk of those emissions are tied to companies’ products and supply chains, which can be hard to measure. In the U.S., about 8.5% of the national carbon footprint can be attributed to the health care industry at large.

Using biological agents as weapons is illegal, but an organism that scientists lawfully use for genuine research could be repurposed for an attack. Therefore, what is banned depends on what an actor plans to do rather than the actual pathogens.

“I think using this approach, called the general-purpose criterion, which defines weapons through intent, actually, you have quite a robust way at the international multilateral level of future-proofing the convention,” said James Revill, head of the weapons of mass destruction program at the United Nations Institute for Disarmament Research.

The coronavirus pandemic has brought into sharp focus the possible benefits and potential pitfalls of biotechnology research. Although such research can be used to produce medical countermeasures to fight diseases and develop healthier crops and livestock, it can also be deployed to produce biological weapons. Even though the current pandemic, as argued by most , is believed to have originated from natural sources, the origin of this particular pandemic does not rule out the possibility that other future infections could emerge from laboratories.

Biotechnology has several negative impacts, including ethical concerns, unintended consequences, high research and development costs, limited access in developing countries, and potential harm to biodiversity and ecosystems. Additionally, the consumption of genetically modified organisms (GMOs) can pose health risks such as unexpected gene interactions, cancer risks, allergenic potential, antibiotic resistance, and horizontal gene transfer. Furthermore, biotechnology can negatively impact the environment by increasing the spread of introduced organisms, competing with native species, and causing environmental harm through the transfer of genetic material. These negative impacts highlight the need for careful consideration and regulation of biotechnological advancements to mitigate potential risks and ensure sustainable practices. Negative Impacts Of Biotechnology Biotechnology has undoubtedly revolutionized various fields, including agriculture, medicine, and environmental conservation. However, it is essential to acknowledge that alongside its numerous advantages, biotechnology also brings forth certain negative impacts that warrant our attention. This article explores some of the key negative impacts associated with biotechnology, including ethical concerns, environmental impact, and health risks. One of the major concerns surrounding biotechnology is its ethical implications, particularly regarding the use of genetically modified organisms (GMOs). GMOs involve manipulating an organism’s genetic material to enhance specific traits or achieve desired results. While these practices have enabled significant advancements in agriculture and medicine, ethical debates arise concerning the potential consequences of genetically modifying living organisms. The use of GMOs raises questions about the integrity of natural ecosystems and the potential disruption of biodiversity. Unintended consequences may arise, such as the development of invasive species or the alteration of natural food chains. Due to high costs associated with research and development in biotechnology, limited access to advancements in developing countries is another ethical concern that needs to be addressed. Biotechnology can have significant environmental impacts, both intended and unintended. While the field has introduced sustainable practices for various sectors, the potential harm it may cause to the environment cannot be overlooked. The introduction of genetically modified crops in agriculture may lead to the loss of biodiversity and disrupt ecosystems. These modified crops might outcompete native species, leading to a decline in biodiversity. The transfer of introduced genetic material to other organisms can result in unintended ecological consequences, potentially causing harm to the environment. Proper environmental risk assessment is crucial to ensure the responsible application of biotechnological products and to minimize any potential negative impacts on ecosystems. While biotechnology has enhanced healthcare in various ways, there are also health risks associated with certain biotechnological practices, particularly in relation to genetic modification and genetically modified organisms (GMOs). Unexpected gene interactions in genetically modified organisms can give rise to unforeseen health consequences. Concerns have been raised about potential cancer risks linked to the consumption of genetically modified foods. Allergic reactions may occur due to the introduction of novel proteins into genetically modified organisms. Horizontal gene transfer (HGT) can take place when genes are transferred between unrelated species. This process can potentially lead to the development of antibiotic resistance, posing a significant health concern. It is important to note that while biotechnology offers immense potential for advancements, it is essential to weigh its negative impacts and address them responsibly. By addressing the ethical concerns, minimizing environmental impact, and mitigating health risks, we can maximize the benefits of biotechnology while minimizing the potential harm it may cause. Ethical Concerns Biotechnology has raised ethical concerns, particularly in regards to the use of genetically modified organisms and potential unintended consequences. Additionally, high research and development costs and limited accessibility in developing countries are negative impacts. There is also a potential impact on biodiversity and ecosystems. Use Of Genetically Modified Organisms Biotechnology has raised ethical concerns, especially regarding the use of genetically modified organisms (GMOs). GMOs are organisms whose genetic material has been altered using biotechnology techniques. While many argue that GMOs have the potential to address global food security and increase crop yields, others worry about the long-term effects on human health and the environment. One of the main ethical concerns with GMOs is the lack of transparency and consumer choice. Many countries do not require GMO labeling, leaving consumers unaware of what they are buying and consuming. This lack of information raises questions about individual autonomy and the right to make informed decisions about the food we eat. Additionally, there is a fear that GMOs may have unintended consequences. Since genetically modified organisms are relatively new, the long-term effects and potential risks are unknown. Some worry that GMOs could harm non-target organisms or disrupt ecosystems, leading to unforeseen ecological consequences. Unintended Consequences Unintended consequences are a significant ethical concern in the field of biotechnology. Despite the potential benefits of biotechnological advancements, unintended consequences can have severe and long-lasting effects on human health, the environment, and social structures. For example, the use of genetically modified organisms (GMOs) in agriculture has raised concerns about the impact on non-target organisms and ecosystems. The introduction of GMO crops can potentially harm beneficial insects, such as bees, and disrupt the delicate balance of ecosystems. This poses a threat to biodiversity, which is essential for the overall health and resilience of our planet. High Research And Development Costs The high research and development costs associated with biotechnology raise ethical concerns, particularly regarding access to advancements and treatments for developing countries. Developing countries often lack the financial resources to invest in biotechnology research and development, limiting their access to life-saving medications and breakthrough innovations. This creates a significant disparity between developed and developing nations, perpetuating global health inequalities. The high costs of biotechnology also contribute to soaring drug prices, making essential medications unaffordable for many individuals who require them. Limited Access In Developing Countries Biotechnology’s limited access in developing countries further deepens global health disparities. The high costs of biotechnology products, such as genetically modified crops and advanced medical treatments, often make them inaccessible to countries with limited resources. This lack of access not only hampers these countries’ ability to address pressing health and agricultural challenges but also perpetuates socio-economic inequalities. It is crucial to find ways to bridge this gap and ensure equal access to biotechnology advancements in order to promote global health and well-being. Impact On Biodiversity And Ecosystems Biotechnology can have a significant impact on biodiversity and ecosystems, which raises ethical concerns about the preservation of our natural environment. The introduction of genetically modified organisms (GMOs) can potentially disrupt ecosystems, harm native species, and reduce overall biodiversity. For instance, genetically modified crops that are engineered to be pest-resistant might unintentionally harm beneficial insects like bees, butterflies, and other pollinators. This loss of biodiversity can have far-reaching consequences, including reduced crop pollination, decreased agricultural productivity, and disruption of the delicate balance of ecosystems. It is essential to carefully consider the potential impacts on biodiversity and ecosystems when developing and implementing biotechnology practices. Striking a balance between innovation and environmental sustainability is crucial to ensure a harmonious coexistence with the natural world. To conclude, ethical concerns surrounding biotechnology focus on the use of genetically modified organisms, unintended consequences, high research and development costs, limited access in developing countries, and impact on biodiversity and ecosystems. Addressing these concerns is vital to ensure that the benefits of biotechnology are achieved while minimizing potential negative effects on human health, the environment, and social well-being. Environmental Impact Biotechnology, while promising numerous advantages, can also have negative impacts on the environment. This section will explore some of these impacts, focusing on the loss of biodiversity and ecosystem, competition with native species, and genetic material transfer. Loss Of Biodiversity And Ecosystem One of the most significant impacts of biotechnology is the unintentional loss of biodiversity and the ecosystem. Biotechnology techniques aim to save the environment and biodiversity, but unfortunately, they sometimes cause more losses than benefits. The introduction of genetically modified organisms (GMOs) can disrupt natural ecosystems and threaten the survival of native species. These GMOs, designed to possess specific traits like pest resistance or increased yields, may outcompete native species for resources, leading to a decline in biodiversity. Moreover, the unintentional release of GMOs into the environment can even result in the spread of modified genetic material to non-target organisms, further exacerbating the negative environmental impacts. Competition With Native Species Biotechnology can also contribute to increased competition with native species. When introduced into ecosystems, GMOs may possess advantageous traits that enable them to establish and spread more effectively. This enhanced fitness can lead to the displacement or elimination of native species, disrupting the natural balance of an ecosystem. For example, genetically modified crops engineered for herbicide tolerance can outcompete native plants, reducing the availability of food and shelter for native species. This can result in a reduction in biodiversity and a loss of valuable ecological services provided by native plants and animals. Genetic Material Transfer Another environmental impact of biotechnology is the transfer of introduced genetic material to other organisms. This can occur through processes such as gene flow or horizontal gene transfer. In some cases, this transfer may lead to unintended consequences and environmental harms. For instance, genetically modified crops can crossbreed with wild relatives, resulting in the transfer of modified genetic material into the gene pool of wild populations. This can potentially alter the genetic diversity and ecological functioning of these wild species, with unknown long-term consequences. It is essential to thoroughly evaluate the potential environmental impacts of biotechnology and implement stringent risk assessment protocols to mitigate any adverse effects. Striking a balance between harnessing the benefits of biotechnology and safeguarding the environment is crucial for sustainable and responsible innovation. Health Risks Biotechnology, while offering numerous advancements and benefits, also presents certain health risks that need to be acknowledged. It is crucial to thoroughly understand the potential negative impacts associated with biotechnology in order to make informed decisions about its implementation. Some of the key health risks include unexpected gene interactions, cancer risks, allergenic potential, horizontal gene transfer, and antibiotic resistance. Unexpected Gene Interactions Unexpected gene interactions can occur when genes from different species are combined through biotechnology. These interactions can lead to unpredictable outcomes, potentially resulting in adverse health effects. The introduction of foreign genes into an organism may disrupt its normal genetic functioning and could even lead to the expression of harmful traits. Cancer Risks Biotechnology has raised concerns regarding the potential risks of developing cancer. Some genetically modified organisms (GMOs) may contain altered genes that could potentially trigger the growth of cancer cells or promote the development of tumors. It is essential to thoroughly assess the safety of genetically modified products to minimize the risks associated with cancer. Allergenic Potential Another health risk associated with biotechnology is the allergenic potential of genetically modified products. Introducing foreign genes may result in the production of proteins that could trigger allergic reactions in susceptible individuals. It is crucial to carefully evaluate the allergenic properties of genetically modified products before their widespread consumption to protect individuals with allergies. Horizontal Gene Transfer Horizontal gene transfer (HGT) is a process in which genetic material is transferred between different organisms. Biotechnology, specifically genetic engineering, has the potential to facilitate HGT, which can lead to unintended consequences. Transfer of genetic material to unrelated organisms can not only alter their characteristics but also introduce new risks to human health. Antibiotic Resistance Biotechnology can also contribute to the development of antibiotic resistance among bacteria. Some genetic engineering techniques involve the use of antibiotic marker genes to identify successful transformations. This widespread use of antibiotics in biotechnology can contribute to the proliferation of antibiotic-resistant bacteria, posing a significant public health concern. In conclusion, while biotechnology offers various benefits, it is important to recognize and address the potential health risks associated with its implementation. By acknowledging and properly evaluating these risks, we can ensure the safe and responsible use of biotechnology for the betterment of society. Examples Of Negative Impacts Biotechnology can have negative impacts, including ethical concerns, unintended consequences, high research costs, limited access in developing countries, and potential harm to biodiversity and ecosystems. Additionally, the consumption of genetically modified organisms may pose health risks such as unexpected gene interactions, cancer, allergies, and antibiotic resistance. The environment can also be negatively affected through the spread of modified organisms, which can compete with native species and cause harm. Genetically Modified Crops In Agriculture Genetically modified crops have been a controversial aspect of biotechnology in agriculture. While proponents argue that these crops enhance productivity and reduce the use of pesticides, critics believe that they have negative impacts on both human health and the environment. One of the major concerns with genetically modified crops is the potential for unintended consequences. The introduction of genetically modified organisms (GMOs) can lead to unexpected gene interactions, which may have long-term effects on both human and animal health. There is also a risk of transferring the modified genes to other organisms, causing environmental harm and disrupting natural ecosystems. This can result in a decrease in biodiversity and the loss of native species. Harm To The Environment Biotechnology can have harmful effects on the environment in various ways. The increased ability of genetically modified organisms to establish and spread in the environment can lead to competition with native species, ultimately reducing native biodiversity. The introduction of genetically modified genes into the environment can also result in unforeseen consequences, such as the development of superweeds or insect resistance to certain pesticides. To assess the impact of biotechnology on the environment, thorough environmental risk assessments are crucial. These assessments evaluate the potential risks associated with the products of biotechnology and help mitigate any negative impacts. It is essential to carefully monitor and regulate the introduction of genetically modified organisms into the environment to prevent adverse effects on ecosystems. Bioterrorism The application of biotechnology also raises concerns about the potential for bioterrorism. As biotechnology enables scientists to manipulate and engineer microorganisms, there is a fear that these techniques could be misused to develop dangerous biological agents or weapons. Bioterrorism poses a significant threat to national security, public safety, and global health. To address these concerns, countries have implemented strict regulations and protocols to control the access and handling of potentially dangerous biological materials. The establishment of a robust biosecurity framework is crucial to prevent the malicious use of biotechnology and ensure the safe and responsible practice of biotechnological advancements.

Biotechnology Governance in a Time of New Risks and Opportunities The benefits of biotechnology are tangible and obvious to the world. COVID-19 vaccines have saved millions of lives, and CAR-T cell therapies are bringing the concept of personalized medicine to successful cancer treatment. Beyond the medical applications of biotechnologies, it is common to have biological enzymes in laundry detergents for stain removal, plant-based “meats” in burgers that “bleed,” and direct-to-consumer genetic testing ancestry services. These biotechnology advances are not just the result of sustained biological research and hard work by scientists around the world, but also the convergence of advances in computing, machine learning, and the accessibility of powerful research tools that accelerate discovery, allowing important scientific questions to be asked and answered. These sustained advances have influenced consumer expectations, and will lead to more biotechnology products used in everyday life. However, there are also risks to biotechnological progress. Even in the early days of recombinant DNA technologies, it was understood that there were inherent risks in understanding biological mechanisms, as that improved understanding could be used to cause harm. Accidents are also possible if some biotechnology product “escapes” from containment, causing harm to people, animals, or the environment. In response to the potential safety concerns of this new field, a group of scientists, government officials, and journalists met at California’s Asilomar Conference Center in 1975 to discuss the possible risks of manipulating genetic material and to declare a moratorium on the work until safety questions were methodically addressed. Fortunately, there was little cause for the specific safety concerns that spurred the meeting, and biotechnology as a field rapidly progressed. Different conceptions of the risks of biotechnology development, however, did lead to divergent national governance approaches—especially regarding genetically modified organisms (GMOs)—as well as different oversight mechanisms for biological research that involved manipulating genetic material. Those divergent governance mechanisms persist for the regulation of laboratory research and the fielding of GMO crops. More on: Public Health Threats and Pandemics Biotechnology World Health Organization (WHO) COVID-19 Now, with synthetic biology tools like CRISPR, which allows for precise gene editing and gene-synthesis technologies, biotechnology is a more powerful and accessible technology than ever before. Biotechnology is also a truly international endeavor, practiced in laboratories and companies around the globe, complicating the implementation of any governance mechanism that could prevent or mitigate misuse. Nations have evolved their own systems to govern laboratories and biotechnologies, and there is no one place at the international level that harmonizes those different approaches. Still, it remains important to examine how responsible governance could be achieved and to advance the development of workable governance systems to prepare for biotechnology developments in the coming years. While recent advances in science and technology have been amazing—demonstrated in the rapid scientific response to SARS-CoV-2—the apex of biotechnological use and understanding is far off. While it is now possible to “read” and “write” DNA, using that genetic language for “expression,” particularly of new functions important for engineering biology, remains a work in progress. Understanding the language of DNA still requires considerable research and development, trial and error, and basic research. A great deal is not yet understood about the natural world, such as infectious diseases that afflict animals, plants, and humans and the responses to those pathogens by the human immune system. The function of many genes is still difficult to know just by looking at the genetic sequence. In 2016, J. Craig Venter and colleagues published a “minimal bacterial genome,” which was a pared-down version of Mycoplasma genitalium, containing only those genes essential for life. To date, the functions of many of these “essential genes” are unknown. When the omicron variant first started causing a rapid rise in COVID-19 cases in the winter of 2020–21, researchers observed that the omicron variant was significantly different from the delta variant in its sequence. Yet how those differences translated into actual differences in transmissibility or clinical impact was impossible to determine until cases of illness could be observed; they could not be reliably predicted. The fact that there is much to learn about biology should be a source of optimism and a call to action. The foundations for governance built now could have lasting and beneficial influences on the future trajectory of biotechnology so that its advantages are realized while minimizing risks

At the same time, there are bad actors exploiting the patent system. While the “patent troll” narrative may be overstated, some organizations do weaponize the patent system to shake down legitimate businesses. At the same time, some large companies with vast resources, including several major technology companies, also abuse the patent system to stifle innovation and maintain their own market positions.

Second, the proposal to only allow patenting of human genetic mutations circumvents issues over both basic scientific research as well as concerns over gene patents exacerbating the next global pandemic. The majority of basic research in the field of genetics involves the study of animal genes that, through evolution, share a function with human genes.327 By preventing animal genes from qualifying as patentable subject matter, basic genetic research can continue unobstructed. Likewise, by limiting gene patents to human genes, the genomes of pathogens like that of the SARS-CoV-2 virus would be ineligible for patent protection. Were the world to face another viral pandemic, no single researcher could attempt to patent the virus’s genome and then block others from working on it.

SUMMARY. The researchers who determined the genomic sequence of the SARS-CoV-2 virus did not seek to patent it, but instead released it in the publicly-accessible GenBank data repository. Their release of this critical data enabled the scientific community to mobilize rapidly and conduct research on a range of diagnostic, vaccine, and therapeutic applications based on the viral RNA sequence. Had the researchers sought patent protection for their discovery, as earlier research teams had during the SARS, H1N1 and H5N1 outbreaks, global research relating to COVID-19 would have been less efficient and more costly. One of the reasons that patents are no longer sought on genomic sequences is the U.S. Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics, Inc., which established that a sequence of naturally occurring nucleotides is an unpatentable “product of nature” (Association for Molecular Pathology v. Myriad Genetics, 2013). Yet, in the midst of the COVID-19 crisis, patent advocates are calling on Congress to overturn the Myriad decision and once again allow patenting of genomic sequences. This Chapter argues that the COVID-19 pandemic illustrates why the “product of nature” exclusion under patent law, which prevents the patenting of genomic sequence data, should be preserved and strengthened under U.S. law.

Finally, opponents raise a salient point on the effect of gene patents as they relate to research, particularly in light of the recent COVID-19 pandemic.313 As noted, research that infringes on patents can sometimes defeat claims of infringement through the research use exception.314 However, courts have construed this exception narrowly, meaning that even basic research into a patented gene by a nonprofit group, such as a university, might still be considered infringement.315 Although several studies have found that gene patents did not actually have a strong impact on follow-on innovation,316 the concern still exists that patent holders who aggressively enforce their patents might stymie research into important genetic information. This concern is particularly acute given the recent COVID-19 pandemic and the fact that many who were on the forefront of researching SARS-CoV-2 were companies attempting to profit through the development of tests and vaccines.317 Clearly, some protection must be afforded to safeguard research into topics of global significance like viral genomes. This concern weighs in favor of a more limited scope of viable subject matter for gene patents than was previously enjoyed before Myriad.

In sum, any future regime of gene patent eligibility in the United States must address the dual concerns of encouraging investments by promoting economic stability and avoiding placing unreasonable limits on genetic research. Properly balancing these concerns will ultimately prove vital to the success of any future gene patent regime.

Patents Are Not Needed to Incentivize the Discovery of Genomic Sequences

As noted above, today a vast body of human and non-human genomic sequence data is available to researchers in public repositories (Contreras & Knoppers, 2018). The discovery of this data was largely supported by government and philanthropic funding sources. With advances in sequencing technology and a global recognition that genomic sequence data represent a scientific resource for all, the sequencing of new biological entities such as emergent viral strains can be, and is, accomplished quickly and efficiently through existing government-funded programs. The sequencing of the SARS-CoV-2 virus by a coalition of Chinese university and public health agencies (Wu et al., 2020), with no attempt to patent their results, demonstrates this reality. Since then, substantial scientific advances have been made as new variants and mutations of the SARS-CoV-2 virus have emerged during the course of the pandemic. As such, arguments that patenting is required to induce private actors to invest in this work are simply not applicable to the derivation of genomic sequence data today

There is Ample Opportunity for Patent Protection of Medical Innovations Without Claiming Genomic Sequences

A large number of patents exist and continue to be obtained on innovations relating to COVID-19, including protective equipment, medical devices, tracing and modeling algorithms, diagnostic kits, vaccines, and therapeutics (Tietze et al., 2020). As such, ample private incentives — both in terms of patent royalties and procurement payments — exist to promote the development of needed technologies like these. Basic genomic structures, however, are research tools, not products or product components. As such, allowing them to be patented does no more than enable the holders of those patents to impose a tax on the industry that is developing products that rely on this basic scientific information. Had the basic genomic sequence of the SARS-CoV-2 been patented, as had the sequences of the SARS, H1N1 and H1N5 viruses, the development of desperately needed vaccines and therapies would have been delayed or, at best, made more costly to consumers and health care providers.

On the other hand, the biotech sector is also experiencing a significant wave of layoffs. Major biotech and pharmaceutical firms like Amylyx Pharmaceuticals, Novartis, Genentech and Sanofi are among those affected. As Jonathan Norris, a managing director with HSBC Innovation Banking, noted in a January , “It’s the have and have-nots right now in terms of access to capital.” Additionally, Kenvue, which spun out from Johnson & Johnson in 2023, has revealed plans to lay off about 4% of its workforce. Bristol Myers Squibb (BMS) also announced one of the largest workforce reductions of the year thus far, signaling plans to cut roughly 2,200 employees, or about 6% of its employee base. Meanwhile, Bayer is letting 1,500 workers go on top of a management shakeup. Biopharma layoffs have generally increased since the beginning of 2024. Big layoffs at Big Pharma driving surges in the numbers In the second quarter, a number of Big Pharma companies announced significant layoffs contributing to the surge in numbers. Bristol Myers Squibb led the pack with 2,200 layoffs on March 15. Bayer followed with 1,500 layoffs on May 14 as part of CEO Bill Anderson’s vision for a simpler organization under the new “dynamic shared ownership” operating model, which aims to reduce bureaucracy. Other Big Pharmas making significant cuts include Biogen (1,000 announced in March) and Kenvue, a consumer health company spun out of J&J, laid off 920 employees (4% of its global workforce) in May.

1.Navigating the Patent Examination Process in Biotech[Original Blog]

Patent examination Examination process

The United States: IP Is in the Crosshairs at a Critical Time

In contrast to China’s gradual strengthening of IP protections, the United States has seen the robustness of its IP system steadily erode.

The Promoting and Respecting Economically Vital American Innovation Leadership Act

While the Supreme Court was establishing the Alice/Mayo framework, Congress implemented a second major reform to the patent system: the America Invents Act of 2011, which created the Patent Trial and Appeal Board (PTAB). The PTAB was established as a faster and cheaper alternative to district court for deciding patent validity. However, according to detractors, lawmakers unintentionally included several design flaws that are being exploited today to harass start-ups, small businesses, and individual inventors, making the system more complicated and expensive. Critics of the PTAB refer to it as a “death squad” killing property rights, as it invalidates over 80 percent of patents it agrees to review.

Ultimately, IP protections must strike a balance. PERA and the PREVAIL Act attempt to do so. The outcome of these legislative initiatives can influence the United States’ standing in the global race for technological advancement, opening the door for policymakers to take stock of ways to help promote innovation and maintain a global lead in critical and emerging technologies.