DA - Public Interests - CNDI 2024

DA—Public Interest – CNDI 2024
AKA an “Injunctions Bad” DA or Case Turn
*1NCs*
1NC—Green Tech vs eBay
1NC—DA
Green tech innovation is coming now and is key to mitigate climate change—but only because IP protection law is balanced to enable innovation via the injunction analysis enabled by eBay.
Fowler 24—JD from Villanova University School of Law with experience in Patent Law, MS Bioengineering and B.Sc. Chemical Engineering (Addison. “No Need to Reinvent the Wheel: The Positive Relationship Between Green Technology and Patent Enforcement.” Villanova Environmental Law Journal, vol. 35, no. 1, Feb. 2024, pp. 151–52, https://digitalcommons.law.villanova.edu/elj/vol35/iss1/4)//mgm
2. Current Injunction Law Is Equipped to Maintain the Fight Against Climate Change
This Comment argues that the equitable discretion afforded to courts in injunction decisions, as bolstered by eBay, provides adequate assurance that patent infringement proceedings do not harm the public through a lack of access to green technology. Cases such as Siemens Gamesa, BASF, and the other above-discussed injunction decisions exemplify the highly practical, fact-specific analysis in which courts can engage when adjudicating an injunction request, especially within the public interest prong. Courts have extended this discretion to embrace sensitivity to public environmental concerns. The Siemens Gamesa decision is notable for its explicit invocation of climate science to inform its analysis and its subsequent tailored injunction. Because injunction cases have not often hinged on the public interest inquiry, the Siemens Gamesa decision will likely have outsized influence going forward when the public interest is threatened.
The fight against climate change depends on a robust market of sustainable innovation. Efforts to weaken patent protections for green technologies risk disrupting the motivations crucial to future progress. Courts have continued to grant injunctions to a significant majority of requests following a finding of infringement, thereby largely maintaining patent exclusivity. Even still, many commentators view eBay itself as a destructive decision for patent protection. Further steps to undermine patent rights, especially those specifically targeted at green technology, would be counterproductive to the continued advancement of these key areas of innovation.227 This Comment asserts strong patent rights, enforced by a court’s equitable discretion post-eBay, will best serve this innovative ecosystem, and thus, the fight against climate change.
But overruling eBay destroys that balance—removing eBay’s public interest prong means automatic injunctions wreck innovation. And, eBay’s good for patent protection—it doesn’t swing the pendulum too far.
Fowler 24—JD from Villanova University School of Law with experience in Patent Law, MS Bioengineering and B.Sc. Chemical Engineering (Addison. “No Need to Reinvent the Wheel: The Positive Relationship Between Green Technology and Patent Enforcement.” Villanova Environmental Law Journal, vol. 35, no. 1, Feb. 2024, pp. 135–37, https://digitalcommons.law.villanova.edu/elj/vol35/iss1/4)//mgm
III. NEW INDUSTRY-STANDARD: LEGAL LANDSCAPE POST-EBAY MAKES ROOM FOR ENVIRONMENTAL CONCERNS
eBay marked the demise of courts’ nearly automatic grant of injunctive relief based on the presumption of irreparable harm. As the Federal Circuit has since certified, “eBay jettisoned the presumption of irreparable harm as it applies to determining the appropriateness of injunctive relief.” Granted, the Federal Circuit has specified this development “does not swing the pendulum in the opposite direction,” noting the fundamental exclusivity of a patent property right must still be considered in the analysis. Nonetheless, a trend began in the post-eBay era for district courts to forgo permanent injunctions and instead award ongoing royalty damages.
Another noteworthy aspect of the eBay decision is that it requires district courts to affirmatively address public interest considerations in their injunction analyses. District courts have since deferred strongly to Justice Kennedy’s eBay concurrence in their own decisions.92 As such, some observers argue the concurrence is even more impactful than the unanimous majority.93
The Federal Circuit has since reflected on the public interest prong in several decisions. The court notably affirmed the public’s “strong” interest in maintaining patent property rights as a driver of innovation. Nonetheless, the court has expressed that the “touchstone” for adjudicating an injunction request involves “strik[ing] a workable balance between protecting the patentee’s rights and protecting the public from the injunction’s adverse effects.”
The Federal Circuit, in Amgen, Inc. v. Sanofi, described the public interest prong as its own independent requirement. There, the Federal Circuit went so far as to characterize the injunction the district court granted despite a finding it would be a disservice to the public interest, as a “clear violation of eBay.” To that end, the Federal Circuit has favored injunctions tailored to avoid unduly disrupting markets and consumer interests.
Extinction—nuclear war and ecological breakdown—feedback loops make adaptation impossible
Spratt & Dunlop 18—David Spratt, Research Director for Breakthrough, climate-policy analyst, co-founder of Carbon Equity; and Ian Dunlop, senior Advisory Board member at Breakthrough, Former Chair of the Australian Coal Association (What Lies Beneath: The Understatement of Existential Climate Risk. The Breakthrough Institute, Aug. 2018, pp. 13–15, https://52a87f3e-7945-4bb1-abbf-9aa66cd4e93e.filesusr.com/ugd/148cb0_a0d7c18a1bf64e698a9c8c8f18a42889.pdf)//mgm
Climate change is an existential risk to human civilisation: that is, an adverse outcome that would either annihilate intelligent life or permanently and drastically curtail its potential.
Temperature rises that are now in prospect, after the Paris Agreement, are in the range of 3–5°C. At present, the Paris Agreement voluntary emission reduction commitments, if implemented, would result in planetary warming of 3.4°C by 2100,30 without taking into account “long-term” carboncycle feedbacks. With a higher climate sensitivity figure of 4.5°C, for example, which would account for such feedbacks, the Paris path would result in around 5°C of warming, according to a MIT study.31 A study by Schroder Investment Management published in June 2017 found — after taking into account indicators across a wide range of the political, financial, energy and regulatory sectors — the average temperature increase implied for the Paris Agreement across all sectors was 4.1°C.32 Yet 3°C of warming already constitutes an existential risk. A 2007 study by two US national security think-tanks concluded that 3°C of warming and a 0.5 metre sea-level rise would likely lead to “outright chaos” and “nuclear war is possible”, emphasising how “massive non-linear events in the global environment give rise to massive nonlinear societal events”.33 The Global Challenges Foundation (GCF) explains what could happen:
“If climate change was to reach 3°C, most of Bangladesh and Florida would drown, while major coastal cities — Shanghai, Lagos, Mumbai — would be swamped, likely creating large flows of climate refugees. Most regions in the world would see a significant drop in food production and increasing numbers of extreme weather events, whether heat waves, floods or storms. This likely scenario for a 3°C rise does not take into account the considerable risk that self-reinforcing feedback loops set in when a certain threshold is reached, leading to an ever increasing rise in temperature. Potential thresholds include the melting of the Arctic permafrost releasing methane into the atmosphere, forest dieback releasing the carbon currently stored in the Amazon and boreal forests, or the melting of polar ice caps that would no longer reflect away light and heat from the sun.”34
Warming of 4°C or more could reduce the global human population by 80% or 90%,35 and the World Bank reports “there is no certainty that adaptation to a 4°C world is possible”.36 Prof. Kevin Anderson says a 4°C future “is incompatible with an organized global community, is likely to be beyond ‘adaptation’, is devastating to the majority of ecosystems, and has a high probability of not being stable”.37 This is a commonly-held sentiment amongst climate scientists. A recent study by the European Commission’s Joint Research Centre found that if the global temperature rose 4°C, then extreme heatwaves with “apparent temperatures” peaking at over 55°C will begin to regularly affect many densely populated parts of the world, forcing much activity in the modern industrial world to stop.38 (“Apparent temperatures” refers to the Heat Index, which quantifies the combined effect of heat and humidity to provide people with a means of avoiding dangerous conditions.) In 2017, one of the first research papers to focus explicitly on existential climate risks proposed that “mitigation goals be set in terms of climate risk category instead of a temperature threshold”, and established a “dangerous” risk category of warming greater than 1.5°C, and a “catastrophic” category for warming of 3°C or more. The authors focussed on the impacts on the world’s poorest three billion people, on health and heat stress, and the impacts of climate extremes on such people with limited adaptation resources. They found that a 2°C warming “would double the land area subject to deadly heat and expose 48% of the population (to deadly heat). A 4°C warming by 2100 would subject 47% of the land area and almost 74% of the world population to deadly heat, which could pose existential risks to humans and mammals alike unless massive adaptation measures are implemented.”39 A 2017 survey of global catastrophic risks by the Global Challenges Foundation found that: “In high-end [climate] scenarios, the scale of destruction is beyond our capacity to model, with a high likelihood of human civilization coming to an end.”40 84% of 8000 people in eight countries surveyed for the Foundation considered climate change a “global catastrophic risk”.41 Existential risk may arise from a fast rate of system change, since the capacity to adapt, in both the natural and human worlds, is inversely proportional to the pace of change, amongst other factors. In 2004, researchers reported on the rate of warming as a driver of extinction.42 Given we are now on a 3–5°C warming path this century, their findings are instructive:
• If the rate of change is 0.3°C per decade (3°C per century), 15% of ecosystems will not be able to adapt.
• If the rate should exceed 0.4°C per decade, all ecosystems will be quickly destroyed, opportunistic species will dominate, and the breakdown of biological material will lead to even greater emissions of CO2.
At 4°C of warming “the limits for adaptation for natural systems would largely be exceeded throughout the world”.43 Ecological breakdown of this scale would ensure an existential human crisis. By slow degrees, these existential risks are being recognised. In May 2018, an inquiry by the Australian Senate into national security and global warming recognised “climate change as a current and existential national security risk… defined as ‘one that threatens the premature extinction of Earth-originating intelligent life or the permanent and drastic destruction of its potential for desirable future development’”.44 In April 2018, the Intelligence on European Pensions and Institutional Investment think-tank warned business leaders that “climate change is an existential risk whose elimination must become a corporate objective”.45 However the most recent IPCC Assessment Report did not consider the issue. Whilst the term “risk management” appears in the 2014 IPCC Synthesis Report fourteen times, the terms “existential” and “catastrophic” do not appear.
Existential risks require a particular approach to risk management. They are not amenable to the reactive (learn from failure) approach of conventional risk management, and we cannot necessarily rely on the institutions, moral norms, or social attitudes developed from our experience with managing other sorts of risks. Because the consequences are so severe — perhaps the end of global human civilisation as we know it — “even for an honest, truth-seeking, and well-intentioned investigator it is difficult to think and act rationally in regard to… existential risks”. 1NC—AI vs eBay
1NC—Medical Tech vs eBay
1NC—DA
Medical technology advancements are coming now that enable disease prevention—but, continued innovation is necessary.
Sabeti & Botti-Lodovico 22—Dr. Pardis Sabeti, Professor at the Center for Systems Biology and Department of Organismic and Evolutionary Biology at Harvard University and the Department of Immunology and Infectious Disease at the Harvard School of Public Health; and Yolanda Botti-Lodovico, Policy Lead of the Sabeti Lab, Masters in Public Policy (“Breakthrough Technologies for Pandemic Preparedness.” Breakthrough: The Promise of Frontier Technologies for Sustainable Development, edited by Homi Kharas et al., Brookings Institution Press, 2022)//mgm
Biomedicine has undergone a recent revolution that transformed our ability to identify and characterize a virus—that is, detection—as well as our ability to treat and prevent it—that is, countermeasures. One of the key technologies that underlies this revolution is genome sequencing, which allows us to detect and characterize novel threats and informs the design of targeted diagnostics, treatments, and vaccines.
Detection Technologies
When a virus first enters a human population, containment hinges on rapid and accurate detection. Once it is detected and characterized, a distributed and reliable diagnosis is the foundation of pandemic preparedness and response. This is partly because many infectious diseases present with overlapping symptoms, so precise, an early diagnosis is necessary to prescribe appropriate clinical or public health measures. It is also because some infectious diseases spread through asymptomatic or presymptomatic carriers, like COVID-19, of which 20 percent of transmission comes from cases that are asymptomatic and 30–40 percent from those who are presymptomatic, meaning that those infected may spread the virus without knowing. Thus, widespread early detection efforts are critical to containment.9, 10 Moreover, early detection can reverse the course of a disease by signaling the need for lifesaving treatment, like in the case of Lassa fever, where early treatment has reduced case fatality from 55 percent to 5 percent.11
The first major breakthrough in our ability to detect viruses is genome sequencing, which allows us to identify and characterize the genome of viruses circulating in clinical and environmental samples and to gain continual insights into their genetic diversity, evolution, and transmission. For example, within a month of COVID-19 entering the human population, genome sequencing allowed Chinese scientists to identify and characterize SARS-CoV-2—the causative agent. Since then, there have been over 3.4 million genome submissions and counting, as of September 2021, to GISAID, the publicly accessible global database, which have helped uncover patterns of transmission (for example, super-spreader events, increases in virus transmissibility) and identify variants of concern.12
Traditionally, scientists have relied on two kinds of diagnostics—polymerase chain reaction (PCR) and antibody tests. A classic molecular diagnostic, PCR works by extracting genetic material (DNA, RNA) from a sample, which is then copied several times over to confirm or negate the presence of a virus. It is sensitive and specific, suitable for clinical testing, and readily adaptable to new infectious pathogens.13 Alternatively, antibody tests can detect either the virus or antibodies to a virus. This group includes antigen capture tests, often used as point-of-care tests, which use antibodies that bind to viral proteins and other elements to signal if they are present in a patient’s body.14 Another type of antibody test, classic serology tests, determine if a patient is currently mounting an immune response or previously had an infection that left memory antibodies. Both classes face barriers to implementation (see table 2-2). PCR requires sophisticated machinery, thereby limiting its deployability; and antibody tests—like the U.S. FDA- approved antigen test for COVID-19—require bespoke development, which often takes several months.15
New technologies are emerging that have enabled increased diagnostic development and operability in lower-resource settings worldwide. Thanks to genomic advancements and new discoveries around isothermal amplification, CRISPR, and synthetic biology, scientists have developed a range of new, ultrasensitive, low-cost, rapidly programmable, and widely deployable point-of-care diagnostics. Isothermal amplification technologies such as LAMP (Loop-Mediated Isothermal Amplification) operate similarly to PCR, but at a single lower temperature, so that they can be performed with minimal equipment. As a test, LAMP was found to be highly specific, scalable, and cost-effective, and can produce results within an hour (compared to the four to eight hours required by PCR methods).16, 17 CRISPR, which consists of a guide protein and nuclease originally discovered in nature as a bacteria’s immune system to viruses, has been paired with isothermal amplification to enable the development of even more sensitive, fast, and portable diagnostic tests, such as SHERLOCK, DETECTR, and HOLMES.18, 19 The synthetic biology-based INSPECTR—a molecular diagnostics platform—has also enabled accurate and specific viral detection on a portable and affordable lateral flow test strip.20 Meanwhile, efforts to accelerate the development of antibody tests have been underway to prepare for new and emerging threats, and could provide a viable option for household testing kits by 2030.21
Countermeasures
Prior to the genomic advancements described above, the development of medical countermeasures was slower, more experimental, and less precise. Traditionally, therapies were often discovered in nature and had to undergo a long evaluation process to understand effects on patients. Classic vaccines required a complex process of inactivation of the antigen or viral protein—that is, the part of the virus that induces production of antibodies—to trigger a natural immune response, and development generally took up to a decade before safe public deployment was possible.22 Today, with the unprecedented ability to target pathogens based on their genome, countermeasure development has been faster, more innovative, and more specific than ever before. Examples of treatment and vaccines made possible by genomic advancements include monoclonal antibodies, messenger RNA (mRNA) vaccines, and universal vaccines to target all types of flu and coronavirus.
But overruling eBay destroys that innovation—removing eBay’s public interest prong means automatic injunctions take key tech off the market.
Wyatt 13 Lance Wyatt, attorney Lance Wyatt at Fish & Richardson via law news provider JD Supra extensive experience practicing in U.S. District Courts around the country, Rebuttable Presumption of Public Interest in Protecting the Public Health --The Necessity for Denying Injunctive Relief in Medically-Related Patent Infringement Cases after Ebay v. Mercexchange, 13 Chi.-Kent J. Intell. Prop. 298 (2013). Available at: https://scholarship.kentlaw.iit.edu/ckjip/vol13/iss1/12
REBUTTABLE PRESUMPTION OF PUBLIC INTEREST IN PROTECTING THE PUBLIC HEALTH-THE NECESSITY FOR DENYING INJUNCTIVE RELIEF IN MEDICALLY-RELATED PATENT INFRINGEMENT CASES AFTER EBAY V. MERCEXCHANGE Lance Wyatt INTRODUCTION The public's interest in medicine and good health is subs

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