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Pro-Copyright, Pro-AI: The Power of Collective Licensing
Full text linkThe aim of this Article is to showcase the emerging AI licensing solutions pioneered by RROs and to explore how these frameworks address the challenges posed by AI’s reliance on copyrighted works. The discussion begins with a primer on the structure and operation of collective management frameworks, highlighting their effectiveness in managing rights for secondary uses. Following this, the Article examines the necessity of licensing in the AI context, emphasizing why exceptions and limitations under current copyright regimes are insufficient to adequately address the complexities of AI training. This section underscores the limitations of existing legal frameworks and the potential harm to rightsholders if AI systems continue to use copyrighted works without appropriate permissions or compensation. Finally, the Article presents an analysis of the emerging licensing solutions tailored to AI, illustrating how these initiatives by RROs are not only meeting the demands of the AI market but are also paving the way for sustainable and equitable practices at the intersection of copyright and technology
Litigating Fair Use
Full text linkThis Article’s topic is “Litigating Fair Use.” What follows is a discussion of techniques a litigator can use to win a case and in so doing, help shape the development of fair use law.
Fair use is well-recognized as one of the “most troublesome” doctrines in all of copyright. There are many famous cases where the district court wrote a compelling opinion holding that something was or was not fair use, and then was reversed by a court of appeals in an equally certain-sounding and compelling opinion holding the opposite. Sometimes we have seen the Supreme Court take yet another view, or multiple views, where there is a dissent and perhaps a concurrence as well. Court after court has noted that fair use requires “case-by-case analysis” that carefully balances the four statutory fair use factors—plus sometimes other considerations as well—rather than rigid application of “bright-line rules.” The overall intent is to help judges reach a result that furthers the bedrock constitutional principle that copyright laws “promote the progress of science and useful arts.” The flexible nature of fair use provides an opportunity—and perhaps a challenge—for a copyright litigator to not only figure out how best to apply existing precedent to create a persuasive argument, but also how to invite the creation of new precedent.
Copyright law, and fair use specifically, starts from Congress’s statutory text, is informed by the Copyright Office’s guidance, is interpreted by the courts, and is analyzed by law professors. But litigators are not passive in this process; rather, they play an important role as well. In fact, the modern litigator often is in a uniquely good position to affect the development of fair use. These days, litigators practice all around the country, with admissions in many courts and pro hac vice appearances before others. This cross-country practice creates the opportunity—and in fact the necessity—to keep abreast of trends and splits across the various circuits, to figure out what best to argue in a given case, and thereby to hope to advance the law and their clients’ interests. Simply put, if the law of fair use is developed by case precedent, then the people whose arguments impact cases—that is, litigators—can help shape the law.
How do litigators do it? In this Article, I will discuss three of the primary tools in the litigator’s proverbial tool kit: law, facts, and persuasion. At the end of the day, these three things determine every fair use outcome. The art of litigating fair use is found in the gaps between precedent, when a litigator’s cutting-edge case is one about which reasonable minds may disagree. It is in those gaps where the litigator shines, because the law there is at its most malleable and the ability to persuade is most important. And with fair use, there are a lot of those gaps
Copyright Infringement Test (Re)visited: U.S. Spillover into China Yielding a Similar Test?
Full text linkOne of the most pivotal doctrines in copyright law is its infringement test, which determines whether a defendant’s acts violate reproduction rights. This test, which continues to plague U.S. copyright law, includes two widely adopted and influential prongs: (1) factual copying; and (2) improper appropriation. To establish factual copying, U.S. courts allow a sliding scale of proof between the defendant’s access to the copyrighted work and similarities between the defendant’s and plaintiff’s works. The improper appropriation prong requires the similarities to reach a substantial level than is deemed improper. However, both prongs are fervently discussed, questioned, and criticized by U.S. courts, scholars, and practitioners. These critics neither form a unified understanding of each prong nor share similar viewpoints on the test’s desirability and potential reform. Despite the test’s intricate complications, its influence extends to other jurisdictions due to the global “reach” of U.S. copyright law.
China, a jurisdiction that has adopted many doctrines and rules from U.S. copyright law, seemingly uses a similar copyright infringement test: the rule of “substantial similarity” plus “access.” The strikingly similar terminology, supported by anecdotal evidence, suggests a direct legal transplantation of this test from the U.S. to China. This observation implies that China essentially shares the same test as the U.S. due to this legal transplantation. However, positive discussions of China’s law in books andempirical explorations of the law in practice in this Article reveal substantial differences from the U.S. version, despite the similar terminology, which remain unnoticed and underexplored in current literature. Although some spillover from the U.S. test to China is acknowledged, the similarities noted in the current literature are quite superficial. These differences raise several unexplored questions: Should China’s test draw further from the U.S. to enhance future improvements? Does the Chinese version function effectively in practice and withstand theoretical scrutiny? If not, what should be the future direction for the Chinese version based on comparative insights? Should China consider a direct transplantation of the entire U.S. test in the future?
This Article unravels the differences between the U.S. and Chinese infringement tests and addresses these questions. It delves into the history of how the “substantial similarity” plus “access” test was introduced to Chinese copyright law and its relationship with the superficially similar U.S. test, indicating the potential spillover. It also offers some empirical evidence based on Chinese court cases applying the test to see how it functions in practice, with a particular focus on whether the Chinese test achieves similar outcomes to the U.S. test. The Article attempts to reveal whether the Chinese version achieves the intended function of copyright infringement tests and withstands theoretical discussions. This Article argues that the Chinese version is more desirable than the U.S. version for China. One reason is that the Chinese version better aligns with China’s civil procedure law, which differs significantly from U.S. law. Also, the Chinese version can address the issues and problems identified in the current U.S. tests. Therefore, there should be caution about suggesting any future transplantation from the U.S. However, this Article acknowledges the vagueness and problems of the Chinese version and proposes a reformed test for Chinese law to better achieve its intended functions
The Stock Photo Industry and Generative AI
Full text linkThis Paper presents the evolution of and the effect of generative AI on the image licensing industry. The Paper discusses the history of the image licensing industry, then analyzes the value of the contemporary image licensing market, with a focus on the metadata associated with the images. It will provide analysis into the effects of the emergence of generative AI technology on the image licensing industry. The Paper synthesizes ideas presented at the 2024 Symposium of the Kernochan Center for Law, Media and the Arts
An Anatomy of Algorithm Aversion
Full text linkPeople are said to show “algorithm aversion” when they prefer human forecasters or decision-makers to algorithms, even though algorithms generally outperform people (in forecasting accuracy and/or optimal decision-making in furtherance of a specified goal). Algorithm aversion also has “softer” forms, as when people prefer human forecasters or decision-makers to algorithms in the abstract, without having clear evidence about comparative performance. Algorithm aversion has strong implications for policy and law; it suggests that those who seek to use algorithms, such as officials in federal agencies, might face serious public resistance. Algorithm aversion is a product of diverse mechanisms, including (1) a desire for agency; (2) a negative moral or emotional reaction to judgment by algorithms; (3) a belief that certain human experts have unique knowledge, unlikely to be held or used by algorithms; (4) ignorance about why algorithms perform well; and (5) asymmetrical forgiveness, or a larger negative reaction to algorithmic error than to human error. An understanding of the various mechanisms provides some clues about how to overcome algorithm aversion, and also of its boundary conditions. These clues bear on the numerous decisions in law and policy, including those of federal agencies (such as the Department of Homeland Security and the Internal Revenue Service) and those involved in the criminal justice system (such as those thinking about using algorithms for bail decisions)
Overcoming Judicial Innumeracy: A Proposal to Bring the Venerable Process of Peer Review to the Enduring Problem of Courts' Scientific Illiteracy
Full text linkLawyers are not known for their proficiency in math and science. Most of us who went to law school reached a point in our math and science studies when we realized that neither medicine nor engineering were likely to be successful career paths. It is these lawyers who become judges. Yet, the United States Supreme Court has increasingly put the burden for deciding complex scientific and technical questions in the hands of judges.
This Article explores this trend of putting greater responsibility for deciding scientific and technical issues on judges, particularly in the areas of evidence law, administrative law, and constitutional law. I do not, however, uniformly decry this trend. In many contexts, both as a matter of legal doctrine and as an empirical matter, judges are the appropriate decision makers for scientific and technical questions. The problem is that they, on the whole, are so unqualified for this task.
The question, then, is how courts might be better prepared to make informed decisions about scientific and technical questions. I propose a solution that comes from the scientific enterprise itself, peer review. While not a perfect solution, peer review has proved to be the best available option for evaluating the validity and value of scientific research. I explore how a formal procedure of peer review might be employed by courts to provide them with independent assessments of expert reports
Toward a Future-Facing Climate Policy: Shifting the Focus from Emission Regulation to the Energy Transition
Full text linkThis Article provides a systems analysis of climate change policy that links together subsystems relating to innovation, energy economics, interest group politics, and government regulation. It is easy but misleading to equate climate policy with emissions regulation. That is too narrow a frame. We urgently need a new energy system because of climate change, but regulating carbon emissions is only one part of a bigger project. We cannot assume that as carbon emissions decline a new energy system will build itself—nor will society be willing to eliminate fossil fuels without confidence in their replacements.
An effective climate policy requires much more than simply restricting fossil fuels and hoping the market will fill the gap. The energy transition requires incentives for energy research, development, and scaling up new energy technologies. For the energy transition to happen, we also need sufficiently large-scale deployment to trigger economies of scale and learning by doing. There is much to be gained, then, from shifting the paradigm from emissions reduction to the energy transition. To make a homely analogy: The reason for a kitchen renovation may be dry rot, and the first step is ripping out rotten wood. But the point of the remodeling is putting in a new kitchen, not just getting rid of the rot
From Catalyst to Clarity: Restoring the Intent of the Orphan Drug Act
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Introduction
Orphan drugs are therapeutics that treat rare diseases, defined as affecting 200,000 or fewer people in the United States, that normally would not receive investment given the small patient population. Passed in 1983, the Orphan Drug Act (ODA) promoted orphan drug development through incentives, including seven years of exclusivity.[1] However, a 2021 court decision undermined the original spirit of the ODA, resulting in fewer incentives for researching and developing critical therapeutics necessary for treating patients suffering from rare diseases, particularly children. The Retaining Access and Restoring Exclusivity Act (RARE Act),[2] would rectify the impacts of this decision and restore the ODA to its original intent. This would also fulfill the state’s obligations to justice under the application of the difference principle to drug development priority-setting.
Background
Under the ODA, drug companies obtain an orphan designation prior to clinical trials.[3] If the drug is proven to be safe and effective, then the FDA approves the drug for a specific use or indication. For example, the FDA could approve a cystic fibrosis drug for adults with a given genetic mutation. The exclusivity would then apply only to the use of the drug in that population.[4] The orphan drug designation gives the pharmaceutical company seven years of market exclusivity.
Catalyst v. Becerra
In 2009, Catalyst received an orphan drug designation for its drug Firdapse (amifampridine) for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS), an autoimmune disease that affects less than 0.001 percent of the population. The FDA approved Firdapse for adults with LEMS in 2018 and granted Catalyst exclusivity through 2025. Jacobus had developed Ruzurgi (amifampridine, the same drug) to treat LEMS and received an orphan drug designation in 1990. In 2019, the FDA approved Ruzurgi for patients less than 17 years old.[5] Catalyst sued the FDA, challenging the FDA’s long-standing interpretation of market exclusivity.
The case, Catalyst Pharmaceuticals v. Becerra, centered on how broad exclusivity is and sought to answer the question of whether or not the statutory phrase “same disease or condition” contained in the ODA was ambiguous.[6] The 11th Circuit determined that the phrase was not ambiguous, broadening the traditional FDA interpretation of “same disease or condition.” The court found that FDA approval of Ruzurgi for pediatric patients violated Catalyst’s exclusivity. The court held that Congress would have included specific language for “use or indication” if it had intended the statutory phrase to be interpreted to limit exclusivity to the specific use and indication and to allow other brands to market to subgroups after demonstrating safety and efficacy in those groups.[7]
Prior to Catalyst, the FDA interpreted the ODA to limit exclusivity to particular uses and indications. The FDA encouraged other companies to engage in clinical trials to serve subpopulations and approve existing drugs for additional subgroups within a disease. That way, FDA approval of a drug for adults would not discourage others from researching the same drug for pediatrics.[8] The RARE Act would clarify and codify the FDA’s long-standing interpretation of the ODA limiting exclusivity to use or indication.
The Ramifications of Catalyst
The court’s interpretation of orphan drug development has created a policy landscape that deters orphan drug research, straying from the ODA’s intent. For example, a company that studies an existing drug with an orphan designation but for a different population subgroup, such as children, and demonstrates its safety and effectiveness, would be unable to receive a period of exclusivity.[9] Without that key incentive, many companies would likely focus on other areas of research. Exclusivity is meant to promote rare disease research and eventually lead to new treatments for patients, not constrain them. The court’s ruling has jeopardized the underlying purpose of the ODA in serving the needs of rare disease communities. The downstream effects of Catalyst on drug development are already being observed in FDA approval rates for new drugs. In the 16 months preceding the Catalyst decision, the FDA approved 217 orphan drugs.[10] After Catalyst, that dropped to only 95 drugs being approved.[11]
The interpretation proposed by Catalyst and held by the 11th Circuit also ignores important scientific truths recognized by both medical experts and Congress. Children are not simply “small adults.”[12] Children can have different manifestations of the same diseases as adults, as well as respond differently to treatment.[13] In the context of rare diseases, advancing drug treatments is especially important for pediatric populations, as many rare diseases develop during childhood.[14] Congress has sought to address the need to promote drug treatment research in children by passing both the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act.[15] The interpretation in Catalyst ignores this fact and errs in ignoring the critical need to distinguish indications for granting exclusivity.
Without clarification of the RARE Act, drug companies might also be deterred from future orphan drug development, given the existing confusion on the approval process and ambiguity in regulatory guidance. In Catalyst, the court ordered the FDA to set aside the drug in question. While the FDA complied with the court, it also posted a notification in the Federal Register in 2023 regarding its continued intent to grant approvals beyond the scope of Catalyst, using the standard of use or indication.[16] The FDA justified this decision by saying continued adherence to the ambiguous language of the statute would “best serve the public health by facilitating patient access to orphan drugs, especially for difficult-to-study patients such as young children.” The RARE Act would remove any confusion in the approval process by granting the FDA the explicit statutory authority to approve the same drug from different manufacturers if they are able to treat different patient populations. It would also remove the possibility of future drug sponsors challenging competing orphan drug approvals on the basis of the reasoning in Catalyst.
The Difference Principle in Context
Only about 5 percent of rare diseases have an FDA-approved therapy, and this is after four decades of targeted research and development incentives through the ODA.[17] Subgroups like pediatric populations fail to attract investment and research attention from industry because barriers like confusion over exclusivity exist. Some might argue that incentivizing research into subgroups for rare diseases is a misguided approach, as it encourages investment into drugs which would benefit only a very small population. Why should we promote the use of significant resources for these small populations when those resources could go to drug research that could benefit more people? The difference principle, as proposed by John Rawls, enriches and supports our understanding of the state’s obligations in the context of drug development and priority-setting in research incentives. The principle holds that social and economic inequalities are justified only if they benefit the least advantaged members of society.[18] Applied here, it supports prioritizing research for pediatric rare diseases—even if only a small group benefits—because doing so helps those who are most disadvantaged in the healthcare system, providing them with opportunities to live a good life, as they conceive it, that they would not otherwise have. Congresswoman Doris Matsui (CA-07), co-chair of the Rare Disease Congressional Caucus, answered the question more concisely by stating that “access to medicine shouldn’t be sacrificed for drug companies’ bottom line.”[19] If you believe that children with rare diseases deserve a fighting chance and should not be neglected for the sake of profit, the RARE Act is a necessary and urgent step to fulfilling that moral commitment.
Some argue that without broad exclusivity for an entire disease, companies might not invest in orphan drug development at all. But this concern is overstated. The FDA’s earlier approach still gave companies meaningful protection for specific indications, like adults, while allowing others to step in and develop treatments for different groups, such as children. Broad exclusivity shuts that down, blocking follow-on research that could reach patients with no other options. The RARE Act would fix this by restoring a more practical balance between rewarding innovation and expanding access.
Conclusion
The House passed the RARE Act in September 2024, although it fell short of being signed into law. Although there has been consistently strong bipartisan support for the legislation, confounding political tensions concerning government inefficiency have caused these provisions to be left in a state of legislative suspension. The language of the RARE Act has been introduced once again as a part of the Give Kids a Chance Act and introduced to the House by Representative Michael McCaul (R-TX) this March. Catalyst has jeopardized the original spirit of the ODA as a means of helping those who need it most. Congress must pass the RARE Act to realign the function of the ODA with its intended purpose and fulfill the state’s obligations under an ethical framework that is committed to prioritizing the most vulnerable and worst-off.
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[1] Katie Cohen, “A Catalyst For Reform: Charting A Future For Orphan Drug Exclusivity,” University of Pennsylvania Law Review vol. 173, iss. 3 (2025): 909. https://scholarship.law.upenn.edu/cgi/viewcontent.cgi?article=9883&context=penn_law_review
[2] Now included as Section 6 of the Give Kids a Chance Act (H.R. 1262),
[3] Karin Hoelzer, “Congress should protect the intent of the Orphan Drug Act and pass the RARE Act,” NORD, https://rarediseases.org/pass-the-rare-act/
[4] Ibid.
[5] Catalyst Pharmaceuticals, Inc. v. Becerra, No. 20-13922 (11th Cir. 2021), 7-9.
[6] Catalyst Pharmaceuticals, Inc. v. Becerra, No. 20-13922 (11th Cir. 2021), 2.
[7] Catalyst Pharmaceuticals, Inc. v. Becerra, No. 20-13922 (11th Cir. 2021), 13.
[8] “FDA’s Overview of Catalyst Pharms., Inc. v. Becerra,” https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/fdas-overview-catalyst-pharms-inc-v-becerra
[9] Ibid.
[10] Katie Cohen, “A Catalyst For Reform: Charting A Future For Orphan Drug Exclusivity,” University of Pennsylvania Law Review vol. 173, iss. 3 (2025): 920. https://scholarship.law.upenn.edu/cgi/viewcontent.cgi?article=9883&context=penn_law_review
[11] Ibid.
[12] Thomas R. Welch, “Children are not Small Adults,” Journal of Pediatrics vol. 271(2024).
[13] Ibid.
[14]Apoorva Kakkilaya, Mahnum Shahzad, and Florence T. Bourgeois, “FDA Approval of Orphan Drug Indications for Pediatric Patients, 2011-2023,” JAMA Pediatr. 179, 2 (2025): 203-205. https://doi.org/10.1001/jamapediatrics.2024.5280
[15] Michael Christensen, “Best Pharmaceuticals for Children Act and Pediatric Research Equity Act: Time for Permanent Status,” J Pediatr Pharmacol Ther. 17 (2) (2012):140.
[16] “Clarification of Orphan-Drug Exclusivity Following Catalyst Pharms., Inc. v. Becerra; Notification,” Federal Register, https://www.federalregister.gov/documents/2023/01/24/2023-01179/clarification-of-orphan-drug-exclusivity-following-catalyst-pharms-inc-v-becerra-notification
[17] Hannah-Alise Rogers, “The Orphan Drug Act and Catalyst Pharmaceuticals, Inc., v. Becerra,” Congressional Research Service (2023). https://sgp.fas.org/crs/misc/R47653.pdf
[18] John Rawls, “A Theory of Justice,” Harvard University Press (1971): 65.
[19] “Legislation Included as Part of Rare Disease Package,” https://matsui.house.gov/media/press-releases/house-passes-matsuis-rare-ac
Letter from the Editors-in-Chief
No full textLetter from Isabel Andreatta and Linda Qin, Editors-in-Chief of Volume IV, Issue 1 of the Columbia Journal of Asia