Introduction: The Promise and Challenges of CAR-T and Immunotherapy
In 2012, six-year-old Emily Whitehead failed chemotherapy treatments after relapsing in her battle against acute lymphoblastic leukemia. While doctors told her family that there was nothing left that could be done, they refused to accept this outcome. However, after finding help at the Children’s Hospital of Philadelphia, Emily became the first pediatric patient to receive the experimental CAR-T cell cancer treatment. Shortly after treatment, Emily went into remission and, 12 years later, remains cancer-free. However, while CAR-T has proven to be an incredible, life-changing medical innovation, it has struggled to scale meaningfully to meet the demands of patients who need it. A 2023 study by Nausheen Ahmed, MD, of the University of Kansas Cancer Center and colleagues reported the mortality rate for patients waiting on CAR-T waitlists as high as 81%. Beyond just presenting a bleak prospect for individual patient outcomes, this mortality rate underscores a systemic failure resulting from a burdened public health system resulting from restricted access. Though development times for new technologies are unavoidable, the lack of access in the CAR-T space has been compounded due to the dense patent landscape which concentrates supply to six FDA-approved commercial entities. The extensive patent portfolios of these approved manufacturers create artificial barriers that limit market entry and prioritize monopolistic control over public benefit, contradicting the balance between innovation and consumer welfare established in antitrust and patent law precedents. Using Federal Trade Commission v. Qualcomm Incorporated (2020), I argue that the CAR-T landscape exemplifies how patent thickets violate antitrust principles established under Section 5 of the FTC Act and the Sherman Act by stifling competition, inflating prices, and restricting access to lifesaving treatments.
CAR-T Technology and Its Economic Challenges
As a cutting-edge immunotherapy, CAR-T technology is central to ongoing discussions about the patentability and commercialization of biotechnologies. CAR-T is a personalized immunotherapy treatment that collects T-cells from each patient, re-engineers them to produce proteins that bind to cancer cells, multiplies these new proteins into the millions, and then re-infuses them into the patient so that they may bind to targeted cancer cells and kill them. Some approved therapies have some extremely promising results, cutting the risk of relapse by 74% compared with the standard of care. However, this painstaking laboratory process comes at a massive cost. Treatment can cost more than $450,000 per patient, not including hospital fees. While extensive R&D and supply chain costs warrant a high price tag to recoup organizational investments, the dense U.S. patent landscape has undoubtedly maintained an inflated cost to consumers because of a lack of competition to drive prices down.
Patent Thickets as a Barrier to Competition
This disparity between accessibility and pricing reflects significant legal implications surrounding monopolization and “patent thickets,” a recurring issue in the discussion of biologics and biosimilars. A patent thicket is most commonly defined as “a dense web of overlapping intellectual property rights that a company must hack its way through in order to actually commercialize new technology.” The tactic of establishing thickets has helped some of the world’s largest pharmaceutical companies for years. AbbVie’s Humira drug is a prime example. While the original patent on Humira expired in 2016, their portfolio of over 100 additional U.S. patents on other parts of the drug’s lifecycle, from manufacturing to dosing regimens, allowed them to block similar drugs from entering the U.S. market for years, making Humira the most profitable product line in pharmaceutical history.
This level of intellectual property manipulation prevents drugs and treatments from fulfilling their potential benefits to the public and distorts market dynamics. Further, the legal power levied by these thickets to control prices and competition aligns closely with the definition of monopolies established by United States v. E.I. du Pont de Nemours & Co. (1956). While fundamentally against U.S. antitrust laws, monopolies controlling the administering of healthcare also inflict tangible, physical injuries on patients who are denied access to care due to exorbitant costs or limited supply. Such monopolistic practices have particularly severe consequences in healthcare, resulting in potentially fatal consequences when negligent business practices suppress the benefits of lifesaving technologies. Nevertheless, In re Humira (Adalimumab) Antitrust Litigation ruled in favor of AbbVie, setting a dangerous precedent that places patent protections above public benefit in the biotech market.
Evidence of Patent Thickets in the CAR-T Landscape
In the context of CAR-T, a significant number of patent litigation cases within the first ten years of commercialization, including Juno Therapeutics, Inc. v. Kite Pharma, Inc. (2020) and Trustees of University of Pennsylvania v. St. Jude Children’s Research Hosp. (2013), strongly suggests the existence of such thickets in the CAR-T space. With a proposed market size of $127 billion by 2033, these high-profile lawsuits are prolific in establishing the patent landscape that this life-changing technology will be building on in the following decades. Although individual patents are set to expire 20 years from the filing date according to 35 U.S.C. § 154(a)(2), Humira exemplifies how dense patent thickets held under the same entity will functionally delay the entry of alternatives by allowing companies to maintain market dominance and elevated prices even after the original patent expires. In contrast to the exorbitant prices of CAR-T cell therapy in the United States, India’s first approved treatment, NexCAR19 was expected to cost $50,000 as of February 2024—an order of magnitude less than its American counterpart. If the current patent landscape prevents competitive products like this from entering U.S. markets, there is no incentive for current companies to develop less-expensive treatments speedily.
Beyond its bottom-line price, CAR-T fails to meet consumer needs because of its difficulties with economies of scale. Unlike traditional pharmaceuticals, CAR-T therapy is tailored to each patient, meaning that large-scale manufacturing organizations face no prospects of better production efficiency than smaller ventures. Regarding the issue of access, the reality is that the production volume necessary to meet patient needs has, up to this point, been prevented through patent litigation. Treatments like NexCAR19 pose devastating threats to current U.S. providers whose competitive advantage comes not from efficient, cheaper manufacturing but from the legal leverage of their extensive patent portfolios. However, by mitigating the leverage of these portfolios and enabling fair competition to spark market growth, CAR-T technology can scale effectively in both price and supply, preventing injuries to patients caused by negligent monopolies.
Legal Barriers in Patent Thickets Stifling Change
However, it is unreasonable to assume that patent law itself can fix this problem. While some decisions have ruled against patent enforcement, such as in the case of Juno Therapeutics, Inc. v. Kite Pharma, Inc. when the court ruled against Juno’s ‘190 patent for lack of specificity in its written description, decisions that rule against patent law as a framework are exceedingly rare, even nonexistent. Historically, patent law has stood as the most effective way for Congress to fulfill its constitutional responsibility, according to U.S.C.A. Const. Art. I § 8, cl. 8, to promote the development of science and the arts. There exists a plethora of strong judicial reinforcements of the federal intellectual property and patent system, such as in Bonito Boats, Inc. v. Thunder Craft Boats, Inc., which affirmed that federal law held exclusive authority in balancing individual rights with commercial interests to adequately promote creativity and innovation. However, while these principles and rulings apply well in their application to individual patents, they do not apply in the case of patent thickets in the CAR-T. Using thickets, companies can strategize and impact market conditions with intentions beyond just commercial protections. Instead, they can become tools for commercial aggression against competitors. While some may argue patents are inherently pro-competitive by rewarding innovation, patent utilization to fix prices and block more efficient developments overwhelmingly harms consumers and stifles competition.
A Solution: Antitrust Principles as a Safeguard to Fair Competition
While patent law offers one avenue to fight monopolization, antitrust policy has proven to be the most robust framework for standing against it. Though patent thickets constitute a legal expression of patent precedent, they pose compelling antitrust concerns since they establish barriers to competition and provide market exclusivity beyond the intention of the patent’s provisions. Though the 2019 Humira antitrust case provides difficult obstacles in biotech-specific litigation, the case Federal Trade Commission v. Qualcomm Incorporated from 2020 provides alternative litigation arguments from an example in the tech market. In this case, the FTC brought action against Qualcomm for using its patent portfolio and practices to exclude competitors and harm competition. The court found that by requiring phone manufacturers to pay excessive royalties on their patented technologies, Qualcomm’s practices were anti-competitive and illegal in violation of the FTC Act (15 U.S.C. § 45(a)) and the Sherman Act (15 U.S.C. §§ 1, 2).
Since the FTC Act declares that unfair methods of competition are unlawful, FTC vs. Qualcomm exemplifies how patent portfolios can be exploited for anti-competitive means, leading to extravagant prices and reduced competition. This sets a valid precedent that can be applied to CAR-T. Qualcomm’s royalty stacking parallels how patent thickets use overlapping claims to maintain control over the T-cell therapy market, preventing biosimilar or alternative therapies from entering the market. Like Qualcomm’s use of standard-essential patents to stifle competition, CAR-T patent portfolios create exclusionary barriers by aggregating overlapping patents that discourage new market entries, which is unlawful under FTC vs. Qualcomm’s precedents.
Another relevant precedent is FTC v. Actavis (2013), where the government filed suit against the pharmaceutical company Actavis for the antitrust implications of their “pay-for-delay” agreements in the drug industry. This involved Actavis paying other manufacturers not to release generic alternatives for one of their testosterone treatments so that they could maintain their monopoly on the drug. While the ruling did not necessarily deem Actavis’s practices as unlawful, it emphasized that antitrust scrutiny applies even when practices involve valid patents. This has significant applications to CAR-T because it breaks down the immunity of the patent system from anti-competitive review. Even if individual patents do not prevent competitive markets, the fact that thickets do constitutes an unlawful practice under the Sherman Act.
With the Supreme Court essentially establishing that patent exclusivity must coexist with antitrust principles, precedents from FTC v. Actavis reinforce the argument that the cumulative effect of excessive overlapping CAR-T patents can resemble an exclusionary practice, regardless of the defensibility of the patents themselves. As it applies to CAR-T, the Sherman Act suggests that patent thickets are anti-competitive and illegally undermine affordability and access in critical health markets. By holding CAR-T suppliers to these strict standards, courts can address unfair market practices unfolding in the industry that may, in the future, lead to detrimental patient conditions.
Addressing the Imbalance Between Innovation and AccessThe CAR-T patent landscape reveals a critical legal tension between fostering innovation through biotechnology patenting and ensuring healthcare markets remain competitive and accessible to patients. The proposition of navigating immense patent portfolios for new market entrants demonstrates how patent thickets can serve as exclusionary tools, delaying competition, inflating costs, and limiting access to therapies with lifesaving treatment effects. Courts can actively reassess the implications of thickets under antitrust principles, as demonstrated by FTC v. Actavis, Inc. and Federal Trade Commission v. Qualcomm Incorporated. Instead of addressing patent claims in isolation, courts should examine whether overlapping claims and extensive portfolios violate the Sherman Act. Specifically, the courts should expand the patent misuse doctrine to address intentional strategies that block competition, restoring the original intent of patent law to advance innovation while promoting public welfare. The judicial understanding of exclusionary tactics and anti-competitive behavior must include using patent litigation or settlement strategies to block market entry. These reforms would ensure that patent law allows CAR-T therapies to fulfill their promises of lifesaving treatment opportunities to those needing them, not an inaccessible, monopolized product.