Few biological materials have influenced modern medicine as profoundly as the HeLa cell line. This immortal set of cells has fueled more than 70 years of research, driving advances from cancer therapies to vaccine development. Cited in tens of thousands of studies and patents, HeLa cells have become a cornerstone of the global biotechnology industry.
What are HeLa cells?
HeLa cells are the first immortal human cell line, taken in 1951 from the cervical cancer cells of Henrietta Lacks. They are the first human cells successfully grown and kept alive outside the body indefinitely, making them “immortal.
What are immortal cell lines?
Immortal cell lines are populations of cells that can divide indefinitely and be cultured over extended periods. This property allows scientists to study cellular processes in depth, free from the natural limits imposed by cellular aging. By contrast, most cells can divide only a finite number of times before reaching the Hayflick limit, the point at which they enter senescence and stop replicating.
Immortalization can be achieved artificially through genetic modifications that disrupt normal cell growth regulation. In other cases, it occurs naturally. The most famous example is the cervical cancer cells of Henrietta Lacks, which carried mutations that bypassed the aging process. In 2023, HeLa cells were among the top three cell lines in terms of market share and citations.
HeLa cells and a question of ethics
Behind this milestone, however, lies an important story about ethics. The cells were taken from Henrietta Lacks without her knowledge or consent. While her genetic legacy transformed medicine, her family went unrecognized and uncompensated for decades.
In August 2023, more than 70 years later, her family reached a confidential settlement with Thermo Fisher Scientific over allegations that the company had commercially profited from the cell line without permission or compensation.
Immortal cells and intellectual property
The legal framework for patenting biological innovations was established in 1980 with the U.S. Supreme Court’s ruling in Diamond v. Chakrabarty.The decision held that living organisms modified by human intervention could be patented, paving the way for intellectual property rights over engineered cell lines, genetically modified microbes, and other biotech inventions.
The distinction between artificially immortalized cell lines and naturally occurring cell lines are crucial in determining their patentability. Artificially immortalized lines are patentable, since the process of inducing immortality is considered an invention. Naturally immortal cell lines, such as HeLa, cannot be patented in their original form because they were not invented. However, once modified for specific applications, they can form part of patentable biotech innovations.
HeLa Cell Lines: Patenting Activity
An analysis of the patenting activity involving the usage of the HeLa cell line reflects key biomedical priorities and trends over the years.
HeLa Cells: Global Patent Filings
From 2015, filings related to HeLa cells remained steady, reflecting ongoing research in biomedical fields where the cells serve as a model system. Activity surged in 2018 and peaked in 2022, driven largely by pending applications. This spike coincides with intensified innovation in biotechnology, including gene-editing tools such as CRISPR/Cas9 and the global response to the COVID-19 pandemic.
In 2020, vaccine-related patents spiked, reflecting both the urgency of COVID-19 and broader advances in vaccine platforms. Some filings centered on coronavirus-neutralizing molecules and lipid-based delivery systems, while others focused on Shigella vaccine preparations, demonstrating HeLa cells’ ongoing relevance in a wide range of vaccine research.
Notably, cancer-related patents consistently led the filings throughout the period, with a marked increase in 2018 that focused on protein dimerization, identifying how proteins pair and interact, a process central to tumor progression and the development of targeted therapies.
By 2022, cancer-related applications still dominated. These included patents related to antibody development and a Lactobacillus strain with anti-cervical cancer potential, highlighting a direct connection to HeLa cells’ origins from cervical cancer tissue. That year also saw a broader expansion of HeLa cell use, including patents for drug safety testing and cell-based assays. For example, filings related to mitochondrial cryopreservation pointed to efforts in building standardized platforms to evaluate how new drugs affect cellular energy and metabolism.
Following the 2022 peak, filings declined significantly which may be due to delays in publishing recent patent data. It could also signal a shift toward other research models like organoids and increased awareness of the ethical issues tied to HeLa cells.
Featured patents incorporating HeLa cells
Recent patents show the role of HeLa cells in developing Zika virus-like vaccines, testing mRNA therapy potency, and modeling lung cancer, highlighting their lasting impact on medical research and technology.
Immortal cell lines for development of Zika virus-like particles
Zika virus (ZIKV) is a mosquito-borne virus associated with congenital disorders such as microcephaly. Despite its public health threat, there remains no widely approved ZIKV vaccine. Traditional approaches to measure immune protection, such as plaque reduction neutralization tests (PRNT), are labor-intensive, costly, and require handling live virus in biosafety level 2 facilities. This creates an urgent need for an efficient strategy to both develop vaccines and assess antibody responses.
U.S. Patent No. 11,286,502 discloses a system for producing ZIKV virus-like particles (VLPs) and reporter virus particles (RVPs) that mimic the structure of ZIKV without being infectious. These particles can then be used both as candidate vaccines and as safer alternatives to PRNT for microneutralization assays.
The VLPs and RVPs are created by using host cells, such as HeLa, Vero, or MDCK cells, that are engineered to produce ZIKV structural proteins. These proteins naturally assemble into particles that resemble the real virus but without the ability to replicate. This allows the particles to be used in two ways: as vaccine candidates that may trigger protective immunity, and as safe tools for antibody testing. The inclusion of immortalized cell lines like HeLa ensures a stable, renewable production platform that enhances scalability and reproducibility.
The patent, titled “Zika Virus Like Particle (VLP) Based Vaccine and Microneutralization Assay” was filed on June 20, 2018 and granted on March 29, 2022 to Texas Tech University System. The patent lists Himanshu Garg and Anjali Joshi as inventors. Legal representation was provided by Chalker Flores LLP, with attorneys Edwin Flores, Daniel Chalker, and Charles Claunch listed in the application.
Immortal cell lines for potency assays
Messenger RNA (mRNA) vaccines and therapeutics rely on lipid nanoparticles (LNPs) to deliver genetic material into cells, where it is translated into proteins that trigger immune responses. Because mRNA is fragile and LNPs can change over time, it is challenging to ensure that each manufactured batch remains potent.
U.S. Pat. App. No. 2022/0404338A1 discloses a cell-based potency assay that measures how effectively an mRNA-LNP composition drives protein expression compared to a reference standard. In this method, a population of cells, such as HeLa, Vero, or Hep-G2 cells, is transfected with a test sample, while an identical cell type is transfected with a reference sample. By detecting the amount of protein produced from each, manufacturers can determine the relative potency of the test batch. The assay can be refined by using antibodies to detect the expressed protein and by generating dose–response curves to calculate potency. These results help determine whether a batch meets quality standards or should be rejected.
Overall, the invention offers a consistent and scalable way to test mRNA-LNP products. By using immortalized cell lines like HeLa, it provides a stable platform for high-throughput testing, supporting reliable manufacturing and regulatory approval in the growing field of mRNA vaccines.
The patent application, titled “In vitro cell based potency assay” was filed on November 30, 2020 with Merck Sharp and Dohme LLC as assignee. The patent lists Peter A. DePhillips, Nisarg M. Patel, Jingyuan Xu, and Zhi-Qiang Zhang as inventors. Legal representation was provided by Merck’s in-house counsel, with attorneys Mary Morry, John Todaro, Sylvia Ayler, et al. listed in the application.
Immortal cell lines for lung cancer modeling
Traditional cancer models often fail to capture the complexity of human tumor development. Many factors limit their accuracy and applicability such as species differences, immune rejection, and ethical concerns. To address this gap, an organoid-based system has been developed to model lung cancer progression in a physiologically relevant way.
U.S. Pat. App. No. 2023/0416687A1 presents a method of creating lung cancer models by fusing cancer cells with normal lung organoids. These organoids, which are three-dimensional cultures of lung tissue, provide a realistic microenvironment in which tumor initiation, progression, and metastasis can be observed. Cancer cells, whether derived from patients or established cell lines such as HeLa, H1299, or K-562, are co-cultured with lung organoids in varying ratios. The resulting fusion produces a cancer model that closely mimics in vivo disease.
This model enables researchers to track how cancer develops over time in a controlled and reproducible system. It also provides a powerful tool for testing anticancer drugs, as it can reveal effects on both cancerous and healthy lung cells. Notably, the innovation may extend beyond lung cancer. By pairing other tumor cells with corresponding organoids (e.g., breast, liver, or colorectal), the platform can serve as a versatile cancer modeling system.
The patent application, titled “Lung cancer modeling using normal lung organoid with lung cancer cells” was filed on May 30, 2023 with Industry Academic Cooperation Foundation of Catholic University of Korea as assignee. The inventors are Sung Won Kim, Ayoung Jo, Min Jae Lim, Jung Eun Lee, and Seung Ho Yang. Legal representation was provided by Riverside Law LLP, specifically by attorneys Kirk Baumeister, Thomas McWilliams, Quan Nguyen et. al.
HeLa Cells: Top Jurisdictions
Patent filings involving HeLa cells are concentrated in China, the United States, Japan, South Korea, and international filings under WIPO, reflecting both global competition and cross-border protection strategies.
China has emerged as the leading jurisdiction for HeLa cell-related patents. This dominant position reflects China’s aggressive investment in biotechnology and stem cell research over the past decade. The World Intellectual Property Organization (WIPO) follows, reflecting applicants’ use of the PCT system to secure cross-border protection for inventions involving HeLa cells.
Japan, South Korea, and the United States also show high levels of patent activity, with each jurisdiction recording more than 100 filings. These numbers reflect the robust biomedical research ecosystems in these countries, particularly in cell-based assays, gene editing, and diagnostic development.
Other jurisdictions such as India, Australia, Canada, Taiwan, and the European Patent Office show moderate but notable levels of activity, likely driven by their growing pharmaceutical and vaccine manufacturing sectors.
HeLa Cells: Top Assignees
Regeneron Pharmaceuticals leads with 36 HeLa-related patent filings, reflecting its strong focus on biologics and immuno-oncology. The company has consistently relied on HeLa cells as a testing platform for drug development, particularly in understanding protein interactions and immune responses relevant to cancer therapies.
Other major international players include Celltrion in South Korea, Evonik in Germany, and MedImmune (a subsidiary of AstraZeneca) in the U.S. These organizations demonstrate the breadth of HeLa applications, from biopharmaceutical manufacturing (Celltrion) to specialty chemicals and delivery systems for advanced therapies (Evonik). Genmab (Denmark) and Sanofi Genzyme (France/US) emphasize oncology and rare disease therapies.
Other notable assignees include CureVac, a pioneer in mRNA-based medicines, and emerging biotech firms like Scribe Therapeutics and Sana Biotechnology, which are advancing CRISPR gene editing and engineered cell therapies. Public-sector institutions also appear in the list, such as the Korea Disease Control and Prevention Agency, reflecting how governments integrate HeLa cell research into public health priorities like vaccine development.
HeLa Cells: Top Legal Representatives
The leading representatives of HeLa-related patents reflect a strong Asian presence, with Japan and South Korea at the forefront. Japanese attorneys such as Hatsushi Shimizu and Hidenaka Yamamoto, along with Norihito Yamao, collectively represent a substantial share of filings, underscoring Japan’s active role in biomedical patenting. From South Korea, Young Jun Yang and the Hanyang Patent Firm also rank highly, mirroring the country’s robust biotechnology sector driven by firms like Celltrion and public health agencies.
China also emerges prominently, with Beijing Preintell IP and Jiaquan IP Law among the top representatives. Meanwhile, Chang-Wen Chen stands out for representing numerous patents from Taiwan, reflecting the region’s niche but steady contributions in cell-based biotechnology.
Western firms maintain visibility as well, particularly Smart & Biggar (Canada) and Gowling WLG (Canada/UK), which serve as key players for global patenting strategies, especially for companies pursuing protection across multiple jurisdictions.
