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Fertility specialist Professor Shanna Swan has warned that fertility trends are declining so rapidly that most couples may need to use assisted reproduction by 2045. While many factors are in play, decades of research on endocrine disrupting chemicals such as phthalates and bisphenols has led her to conclude there is strong evidence that they play a major causal role. These chemicals are widely used in plastics and coatings and common household products and are present in most processed foods and drinks (due to the plastic containers and tubing used during production) – so almost everyone is exposed to them. They are also persistent and accumulative, building up in the animals and fish we eat, and in our own bodies.

Use of these chemicals is very lightly regulated due to the presumption in most countries that new chemicals are safe unless specifically proven not to be. This also means that where bans exist, they are limited and substitution with similar compounds (such as bisphenol S for BPA) is legally permitted, despite the fact that the health risks are likely to be similar.

Although the U.S. is considered a leader on the global stage, it is noteworthy that other countries have not followed the U.S. very far down this road of patent ineligibility. Isolated and purified forms of naturally-occurring products remain eligible for patenting everywhere else in the world, although some countries have specific exceptions for isolated genes.15 For example, the European Patent Office permits patenting of isolated genes and gene fragments as long as the patent’s description “indicate[s] the way in which the invention is capable of exploitation in industry.”16 Likewise, Australia, China, Japan, and Korea (for example) continue to grant patents on isolated natural products. Most countries permit patenting of diagnostic methods unless they are excepted on public policy grounds. For example, the European Patent Office permits patenting of diagnostic methods as long as they are not “practised on the human or animal body,”17 and so permits patenting of diagnostic methods conducted using saliva or blood samples (for example). Australia permits patenting of diagnostic methods without restriction (similar to the U.S. prior to Mayo), and methods of detecting specific markers of a disease or condition in a biological sample may be patented in China, Japan, and Korea (although methods of “diagnosing” a patient are excepted on public policy grounds).

This means that, since the changes in U.S. patent eligibility law flowing from Mayo, Myriad, and Alice,18 there are inventions that cannot be patented in the U.S. that can be patented in other countries. For example, as outlined above, isolated natural products that may be useful as medications, diagnostic agents, vaccines, antibiotics, or in industrial applications, can be patented around the world, except in the U.S. This leads to an imbalance in intellectual property rights that can be obtained in the U.S. versus elsewhere.

While many U.S. companies continue to innovate in the diagnostic space, many doing so are maintaining their discoveries as trade secrets. This will not have the same impact on driving innovation as patent protection would, because the discoveries are not being made known to others who might improve upon them or build new innovations on them. In his written and live testimony, Mr. Blaylock argued that PERA would undesirably “permit the privatization of natural phenomena in the form of knowledge of new biomarkers and their clinical relevance,” but it is the current state of Section 101 that incentives innovators to keep their discoveries to themselves. Mr. Blaylock’s position forgets that patent rights come with the cost of public disclosure, and only last for a limited time. Without PERA, innovators have little reason to share what they learn about newly discovered disease biomarkers and personalized medicine, and more reason to develop their technologies in-house while keeping the underlying methodology a trade secret. It is the trade secret paradigm, not the patent system, that rewards “privatization” of knowledge.

I am aware of an empirical study reported in 2022 in the Washington and Lee Law Review2 that determined that, “in the four years following Mayo, investment in disease diagnostic technologies was nearly $9.3 billion dollars lower than it would have been absent Mayo.” The study focused on venture capital investment in the United States, in particular. While it did not consider whether money was invested in other countries instead, it at least indicates reduced investment in specific U.S. industries impacted by Mayo, which is of grave concern.

c. In other words, how much is the current uncertainty costing our economy in terms of jobs, innovation, and development?

As noted in the prior answer (Question 3(b)), the patent system fosters what economists call “dynamic efficiency” in the U.S. innovation economy through incentivizing the creation and commercialization of new inventions. Right now, we are all benefiting from research and development programs that began approximately a decade or more ago, such as in the initial investments in 5G, AI, and the CRISPR gene editing and mRNA technologies. These new products and services, and the economic activities, jobs, and overall growth in the innovation economy they created are the result of the reliable and effective patent rights secured to innovators—before the Supreme Court created the Mayo-Alice inquiry and the resulting quagmire in patent eligibility doctrine.

5. Some have claimed that even under current interpretation of Section 101 there is still a tremendous amount of innovation happening in the U.S. – that we aren’t really missing out on anything, and innovation will happen regardless of whether we pass legislation like the Patent Eligibility Restoration Act.

Would you agree with this assessment?

3. In your experience, does the state of Section 101 have a greater impact on smaller or larger companies and why?

In my experience, sole inventors and smaller companies are more impacted by the uncertainty, for several reasons. First, innovators may not realize the current state of the law, and may invest in their technologies before learning the technology cannot be patented. Many of the lines drawn are counter-intuitive, and do not make sense to scientists or engineers. Additionally, sole inventors and smaller companies do not have the resources to spread the risks or hedge their bets, and do not have the infrastructure or market position to commercialize their technologies without patent protection. While larger companies may be able to bring (non-pharmaceutical) products to market without a patent, smaller companies need patents to attract investors or for acquisition deals. Without patents, the technology may be shelved and companies shut down. Additionally, the expanding applications of the “judicial exceptions” can particularly impact sole inventors and small business, who may invest everything in technology protected by a patent, only to have it unexpectedly wiped out as a judicial exception.

As Chairman Coons and Ranking Member Tillis recognized in introducing PERA, “all 12 judges of the United States Court of Appeals for the Federal Circuit have lamented the state of the law” when it comes to patent eligibility under Section 101.1 The current state of the law is the result of many court decisions over the decades trying to determine whether modern technologies—such as computer software, DNA processing, and many others—fit into the categories for a patent defined in 1793, or whether they are subject to certain exceptions courts have imposed since then. The patchwork of decisions over time, struggling to keep up with fast-changing technologies, has created significant confusion and uncertainty as to what is in and what is outside the bounds of the statute. These court decisions also have resulted in certain de facto rules—such that diagnostic techniques, for example, are generally not eligible for a patent in the United States—that Congress has never considered, debated, or passed into law. If the United States Government is not to issue patents for certain categories of inventions that would otherwise be part of the categories outlined in Section 101, then it is up to Congress to make that rule. In other words, Congress defined the categories of patent subject matter; if there are to be exceptions to those categories, they must likewise come from Congress.

The current state of the law has caused profound uncertainty amongst inventors, investors, and patent-law practitioners alike. In turn, this uncertainty and confusion has hurt American innovation, competition, and the economy. It also has threatened the Constitutional right to patent protection—a right that James Madison and the Founders saw as vital to the economic strength and growth of our nation.

A world dominated by totalitarian states would be more incompetent, more war-prone, less cooperative, and more inhibitive of progress than one dominated by democratic states. Our current world is not particularly competent, peaceful, cooperative, or progressive—a totalitarian-dominated world would be worse. It would increase the risk of another collapse and extinction and could shape the future toward less desirable trajectories (Beckstead, 2013).

Totalitarian states are incompetent. They are bad at forecasting and dealing with disasters (Caplan, 2008).16 This can be seen most clearly in the great famines of Communist China and the USSR, in which millions died (Applebaum, 2017; Becker, 1996; Dikötter, 2010; Snyder, 2010). In comparison, functioning multiparty democracies rarely, if ever, experience famines (Sen, 2010). “Established autocracies” (or “personal”/“sultanist”) are particularly bad, as there are few checks or restraints on arbitrary rule and the whims and ideology of the single individual, even from other elites (Svolik, 2012). From the inside, the “inner circle” around Mao, Stalin, and Hitler seems incredibly chaotic, with elites strongly incentivized to conceal information and encouraged by the autocrat to squabble and feud—so they are divided (Conquest, 1992; Kershaw, 2008; Zhang & Halliday, 2006). If totalitarian states are worse at addressing social, environmental, and technological problems, then a world dominated by them would likely be worse at responding to risks of collapse and extinction.

Second, China’s illiberal campaign capitalizes on a disturbing global trend: As Freedom House reports, authoritarianism has spread during every year since 2006, while democracy has retreated. This “democratic recession” has given China a window of ideological opportunity to promote a vision of a hierarchical and harmonious society and a critique of a disorderly and decadent West. Around the world, public faith in democratic institutions has sunk to lows not seen since the 1930s. The political soil has grown ripe for authoritarianism to take root, and China, Russia, and other authoritarian states are fertilizing this antidemocratic plant with digital disinformation that their propagandists pump into the social-media feeds of billions worldwide.21

The third and most important factor supercharging China’s efforts is the ongoing digital revolution.22 The CCP possesses data-collection and messaging power to rival that of Apple, Amazon, Facebook, Google, and Twitter.23 By combining artificial intelligence (AI) and “big data” with cyber, biometric, and speech- and facial-recognition technologies, Beijing is pioneering a system that will allow dictators to know everything about their subjects—what people are saying and viewing, whom they hang out with, what they like and dislike, and where they are located at any given time—and to discipline citizens instantly by restricting their access to credit, education, employment, medical care, telecommunications, and travel if not to hunt them down for more medieval forms of punishment.

In addition to its internal struggles, the Western alliance now faces an “axis of resistance” – centered around Russia and China – that might be tempted to threaten its hegemony with a simultaneous, coordinated challenge. Like sharks, they undoubtedly smell blood in the water.

VIENNA – Ukraine has about a month before it runs out of artillery shells, and the US Congress cannot agree to ship more. Russian opposition leader Alexei Navalny is dead. The slaughter in Gaza continues with no end in sight. The Yemeni Houthis are attacking ships in the Red Sea. The North Koreans are testing intercontinental ballistic missiles. In normal times, pessimism can look like an intellectual fad. In times like these, it becomes a starker form of realism.

Strategy documents invariably recognize the importance of science and technology to the US way of life, prosperity and security. Those pronouncements tend to be generic, however—when they get specific, advanced technology policies emphasize the role that science and technology play in honing military capabilities, and the accompanying need to develop and maintain a National Security Innovation Base.

That significantly understates the importance of these technologies. Technology has not only been an agent of change within countries, but it has also redistributed power among nations and transformed international relations themselves. It is one of the main factors shaping relations among states, and in many ways science and technology have created the modern international system. Technological capacity—the ability to innovate and then to apply those innovations—is a determinant of global power. The wealth it creates yields status and influence, accelerating the race between countries to be first movers and early adapters. According to the OECD, “technology leadership has long underpinned the economic prosperity and security” of member countries.4 If those innovations alone prove insufficient to advance the interests of technologically advanced nations, then those countries will rely on the economic and military power which technology gives them. Plainly, technological superiority equates with geopolitical pre-eminence.

Like it or not, the United States and China are locked in high-stakes global competition over trade, technology, and national security. Ironically, at this crucial time, China appears to have found an unwitting ally in the US Supreme Court.

The challenge couldn’t be more serious. But if Congress can move with bipartisan resolve, a legislative solution is at hand. Sen. Thom Tillis of North Carolina has a plan for that.

6. An article was published late last year analyzing a decade’s worth of patent eligibility decisions by the Federal Circuit, and they concluded that “under one of the most well-established metrics for measuring the predictability in the law, [Section] 101 proved to be more predictable than other areas of patent law over the past decade.” This is the opposite of what is claimed by many industry experts and even some current and former federal judges. How do you explain this disconnect?

As is common with many academic articles, the conclusion by Professors Nikola Datzov and Jason Rantanen only appears superficially to contradict the many complaints about the Mayo-Alice inquiry by Federal Circuit judges, lawyers, inventors, and representatives from companies that rely on patents in their business models. On closer inspection, the Datzov and Rantanen analysis confirms the legitimate calls for reform by these numerous judges, lawyers, industry stakeholders, and commentators. For example, Datzov and Rantanen state that “the rate at which the Federal Circuit reaches an ultimate outcome that the patent claims are not directed to eligible subject matter has fairly consistently remained around 90% since 2014.”23 I and many other witnesses who testified at the hearing on January 23, 2024, as well as a majority of the witnesses who testified at the three days of hearings in 2019, reported the same number—because this excessive rate of patent invalidation under the Mayo-Alice inquiry is a problem. Economists and empirical researchers have long recognized in civil litigation that if appeals courts are reaching the same decision in 90% of the cases, this represents an unbalanced doctrine or legal decision-making institution that is not properly functioning according to normal operating conditions in a legal system.24 In sum, something is out of whack institutionally, legally, or both; in this case, it is the Mayo-Alice inquiry.

As I have stated in past scholarship, testimony before Congress, amicus briefs, and agency comments, the U.S. patent system has been under an extensive amount of stress from all branches of the federal government for over fifteen years. The Supreme Court has been deciding patent cases at a rate not seen for almost a hundred years,2 changing the law in all aspects of the patent system. Among these numerous changes were four decisions between 2010 and 2014 on patent eligibility doctrine under § 101.3 These decisions severely restricted the inventions and discoveries that have long been considered patentable for over two centuries in the U.S. patent system.

These four decisions culminated in the “Alice-Mayo inquiry”—a two-factor legal framework that courts and the U.S. Patent & Trademark Office (USPTO) have applied since 2014 in assessing whether an invention or discovery is patentable subject matter under § 101.4 The Alice-Mayo inquiry has created a tremendous amount of uncertainty for innovators and severely restricted the patent eligibility of high-tech and biopharmaceutical innovations. It has had a negative impact on both inventors and the companies working in the innovation industries that invest millions of dollars in creating the new products and services that drive economic growth, job creation and higher standards of living. Thus, it is undermining the longstanding comparative advantage by the U.S. in the world in securing reliable and effective patent rights for all innovators.

A huge part of this area of the topic is patents good/bad, and I feel like I only scratched the surface of the literature. The same is true for prizes and R&D.

There is a possible international law advantage – the Rader evidence in the 1ac makes a broader claim about international law in that article, and there are many articles that talk about patent eligibility in the context of US international IP leadership.

Patent thickets / anti-commons – these terms are interchangeable, and they refer to the fact that some sectors of the economy have so many patents that innovation is impossible. For example, the iPhone has 1298 patents, which makes it hard for a new market entrant to develop a competing product. The fragmentation of patents across different types of technology means someone trying invent would have to license dozens or hundreds of patents first.

Evergreening – companies will design follow-up products that are extremely similar to their patented products in an attempt to extend the term of their patent

It is based on a proposed law called the “Patent Eligibility Restoration Act”. This law would do three things (the plan doesn’t do all of it):

Removes the word “new” from § 101 because it’s already addressed in § 102. This plan doesn’t do that because the argument in favor of doing this is dumb.

§ 101 – this is the most important, it governs “subject matter eligibility”. It states:

Whoever invents or discovers any new and useful (1) process, (2) machine, (3) manufacture, or (4) composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

1. A rules-based trade system is needed for climate action The WTO is the backbone for international, rules-based commerce. Sure, its dispute settlement function is . But the organization is still a powerful source of rules and norms for the way countries regulate goods, services and investment moving across borders. Companies appreciate that. In recent debates around the green transition and economic support, or on supply chain resilience, few executives suggest that a rules-based system needs to be upended. There is a general recognition that trade can help the world combat climate change and biodiversity loss, through spreading innovations, generating economies of scale for new technologies, among other things. However, many companies would like to see WTO members work together for more consistency on subsidy rules—including working to phase out fossil fuel subsidies—or to address slow permitting processes for foreign investment in renewable energy projects. These wishes need to be balanced with countries’ interests and debated, and that leads us to the next point. 2. Conversation is helpful The green transition is taking place against a period of geopolitical turbulence. One has not caused the other, but the two are related, and will likely become more intertwined in the future. Further, if not wisely navigated, trade could hinder individual countries’ efforts to combat climate change through offshoring emissions. Equally, the industrial transition needed to combat climate change creates competitive and protectionist dynamics which might also undermine climate action in the long run. The World Economic Forum has mapped four to think through potential trends. According to those consultations around the scenarios, avoiding an “exponential disasters” scenario where climate policies precipitate trade wars — flanked by resource nationalism — can be helped by government discussions in a few areas. One of these is carbon accounting and reporting standards. These have proliferated and may continue to do so, creating an uneven landscape on which countries will inevitably base trade policies. Japan’s G7 effort in 2023 around emissions measurement methodologies for a net-zero steel industry was a good push; these discussions need to be brought into wider international fora. Countries could use the WTO for exchange, or at least for sharing knowledge on key developments occurring in this space. Building up wider government knowledge and building institutional bridges ultimately helps the private sector deal with a less fragmented landscape. 3. Facilitate the green economy Companies benefit from the WTO Trade Facilitation Agreement (TFA). It addresses practical challenges that occur on a daily basis when goods are moved across borders. Through initiatives such as the (GATF), companies have also been able to work with governments on implementing the TFA, homing in on specific difficulties and working to address these. WTO members should use the institution to look at ways they can facilitate green economic activity. Of course, “facilitation” can mean different things to different people, and that’s ok. For some WTO members, there might be appetite to apply the proposed Investment Facilitation for Development (IFD) Agreement to focus specifically on . The Forum is already working with investment promotion agencies in Brazil and Namibia on actions to facilitate climate FDI into their economies. Targeted investment facilitation on climate-aligned investment projects can be a helpful way to ground investor interest in climate action into specific country needs and activity. For other WTO members, facilitation could mean working to boost goods and services trade essential for low-carbon economic activity. There are some politically sensitive products in this space — like — but there are also other items where non-tariff barriers like conformity assessment procedures and different technical requirements slow down market growth and vital technology diffusions. The Trade and Environment Sustainability Structure Discussions () have made a good start in digging into these issues. For example, static converters used to convert solar energy to electricity face . These requirements may be important and do not necessarily need to be eliminated, but governments could work on regulatory cooperation to maintain the outcome and reduce trade friction. Addressing environmental challenges through the WTO WTO members can even look at how existing tools like trade facilitation can be applied to environmental challenges. Improving waste management and material recycling in some countries might require trade. Countries need to track waste movement to avoid trade being used for dumping. This is all covered by the , but as an environmental treaty, policymakers there could benefit from border expertise and new developments that make managing the process of trade easier. The GATF has worked with the International Plant Protection Committee to help countries roll out for safe plant and food trade. Could WTO members encourage the same type of collaboration with relevant fora for more material circularity? These are not necessarily topics or work that make headlines. It’s also not yet a package for a “green WTO”. Members are not there yet; they may not be for some time. But business models that are low-carbon, based on re-using and surfacing alternative materials and have nature-positive outcomes are worth encouraging. Trade has a role to play in these new economic activities, and the WTO is a good avenue for countries to collaborate through.

Rising tensions between India and Pakistan could spike into a “water war” if India fails to follow through on a treaty that regulates a river that flows between the two countries, a Pakistani official said Tuesday.

The divisions between the two nations have again mounted despite attempts to create pace. Many had hoped that 2016 would be a year of unity after Pakistani Prime Minister Nawaz Sharif met with Indian Prime Minister Narendra Modi late last year, but old tensions have dashed some of those hopes.