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Bellarmine Law Society Review 
 

Volume XIII | Issue I Article 1 

 
 
Intellectual Property Rights on COVID-19 Vaccines in the U.S. 
 
Sunderya Ulziibold 
Boston College, ulziibol@bc.edu  
  



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INTELLECTUAL PROPERTY RIGHTS ON COVID-19 VACCINES IN 
THE U.S. 

 

SUNDERYA ULZIIBOLD * 
 
 

Abstract: The global development and distribution of COVID-19 vaccines have 
raised concerns over intellectual property rights in the United States. In particular, 
the two pharmaceutical giants, Pfizer/BioNTech and Moderna, have been 
embroiled in a contentious dispute over the intellectual property rights surrounding 
their COVID-19 vaccine technology since August 2022. The stakes are high, as the 
outcome of this legal battle could determine who ultimately controls this newfound 
and lucrative market. This paper delves into the legal framework of intellectual 
property rights in the United States as they apply to COVID-19 vaccines. It also 
raises critical ethical questions about the implications of these rights for public 
health and access to lifesaving treatments. By examining these issues, this paper 
sheds light on the ongoing tension between incentivizing innovation and ensuring 
equitable access to crucial medical breakthroughs. 

 
 

Introduction 

This paper discusses the legal issue of intellectual property rights on COVID-19 

vaccines in the U.S. beginning with a description of the industry in the U.S. and the world. 

From there, I explain intellectual property and patent laws in the U.S. before moving on to a 

description of new mRNA technology used for COVID-19 vaccines and its patentability 

through an analysis of an ongoing patent infringement lawsuit filed by Modern against 

Pfizer/BioNTech. 

I. Description of the COVID-19 Vaccine Industry 

The U.S. COVID-19 vaccine industry was formed in early 2020 when the World Health 

Organization (WHO) declared the COVID-19 outbreak a pandemic. To battle the novel 

coronavirus, pharmaceutical companies like AstraZeneca, Moderna, Pfizer/BioNTech, and 

Johnson & Johnson were funded by WHO and many other donors to accelerate the research 

and development of vaccines. In December of 2020, the first COVID-19 vaccine was added 

to the Emergency Use Listing (EUL), overseen by the WHO, and distributed to healthcare 

 
* Sunderya Ulziibold is a second-year student at Boston College studying Political Science and Communications. 
She is interested in the role of mass media in the politics of developing countries. She would like to express special 
thanks to Professor Rachel Spooner who taught her Introduction to Business Law class that she much enjoyed and 
which further developed her interest in law. 



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workers, those with high-risk medical conditions, and people older than 65. Eventually, the 

vaccine became available for everyone, including ordinary citizens and children. Currently, 

11 vaccines are listed on the EUL and have been mass produced and distributed to countries 

all over the world. The U.S. alone has approved and authorized four vaccines: Moderna, 

Pfizer/BioNTech, Johnson & Johnson, and Novavax. As of November 2022, 15.477 billion 

vaccines were delivered worldwide,1 and the U.S. had distributed over 905 million doses and 

administered over 646 million doses. In the U.S., Pfizer/BioNTech makes up 56.2% of the 

COVID-19 vaccine market while Moderna makes up 37.8% and the remaining 6.0% belongs 

to Novavax and Johnson&Johnson.2 The size of the U.S. COVID-19 vaccine industry has 

grown dramatically over the past two years, increasing from a value of $190 million in 2020 

to $10.81 billion in 2021.3 

II. Intellectual Property: Patents 

IIa. Intellectual Property Rights 

Intellectual property (IP) is any product of human intellect that the law protects from 

unauthorized use by others, which effectively enables original creators to hold a monopoly 

on their IP.4 IP rights are crucial to our society as they encourage individuals and companies 

to be creative while offering them protection. There are four ways to protect intellectual 

property: trademarks, copyrights, trade secrets, and patents. Patents are the “exclusive right 

of its owner to exclude others from making, using, or selling the invention as defined in the 

claims of the patent for a period of time.”5 Trademarks and trade secrets are indefinite as 

long as they are in use. Copyrights are valid for 70 years plus the author’s lifetime and 95 

years after first publication if anonymous. Patents cover the shortest duration, as they span 

 
1 “Covid-19 Market Dashboard,” UNICEF Supply Division, accessed 15 November 2022, 
https://www.unicef.org/supply/covid-19-market-dashboard. 
2 “Covid Data Tracker,” Centers for Disease Control and Prevention, accessed 15 November 2022,  
https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-additional-dose-totalpop. 
3 “COVID-19 Vaccines,” statista, accessed 16 November 2022,  
https://www.statista.com/outlook/hmo/pharmaceuticals/vaccines/covid-19-vaccines/united-states. 
4 “Intellectual Property,” Legal Information Institute, Cornell Law School, accessed 16 November 2022, 
https://www.law.cornell.edu/wex/intellectual_property#:~:text=Overview,monopoly%20in%20the%20protected%2
0property. 
5 Rachel Spooner, “Intro+F22+IP,” PowerPoint presentation, Boston College, Chestnut Hill, MA. Accessed Fall 
2022. 



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from 14 to 20 years depending on the patent type. Once the patent is expired, the invention 

enters the public domain and anyone can make, use, or sell the product. 

IIb. Patent Law Under the Constitution 

Under Article I, Section 8, of the U.S. Constitution, Congress has the power to promote 

scientific progress by allowing inventors to secure exclusive rights to their discoveries for a 

limited amount of time.6 This law is important because it fosters innovation and incentivizes 

individuals and companies to make new scientific discoveries and advancements that may 

be helpful to the world. Moreover, inventors can gain profit due to the exclusive rights that 

protect their inventions.  

IIb(i). Patent Act of 1952 

The Patent Act of 1952 requires that a patent must be novel, non-obvious, useful, and a 

valid subject matter. “Novel” means the patent should propose something new, like an 

innovative technology or a scientific discovery. It must be non-obvious “to a person of 

ordinary skill and knowledge in the art or technology to which the invention is related.”7 The 

usefulness of the invention is determined by its intended purpose. A valid subject matter 

must not be abstract, the product of nature, or within the laws of nature. A patent can be 

found invalid if it does not fulfill all four requirements. 

IIc. Patent Infringement 

Patent infringement occurs when the owner of the patent files a suit for infringement for 

unauthorized use of their patent, and obtains appropriate monetary damages and injunctive 

relief.  

III. IP and COVID-19 Vaccines 

IIIa. mRNA and Patentability 

There are three main types of COVID-19 vaccines approved in the United States: 

“messenger RNA (mRNA), viral vector, and protein subunit.”8 While mRNA technology is 

new to the field, viral vector and protein subunit vaccine technologies have long been used 

 
6 Twomey, David P., “Chapter 9,” in Business Law: Principles for Today's Commercial Environment (Australia: 
Cengage Learning, 2017). 
7 Twomey, Business Law, Chapter 9. 
8 “Overview of COVID-19 Vaccines,” Centers for Disease Control and Prevention, updated 1 November 2022, 
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/overview-COVID-19-
vaccines.html?s_cid=11758:types%20of%20covid%20vaccines:sem.ga:p:RG:GM:gen:PTN:FY22.  



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and are considered the  “traditional” methods. “mRNA vaccines use mRNA created in a 

laboratory to teach our cells how to make a protein—or even just a piece of a protein—that 

triggers an immune response inside our bodies. This immune response, which produces 

antibodies, is what helps protect us from getting sick from that germ in the future.”9  While 

mRNA technology has been researched for decades, it was not implemented in vaccines until 

the COVID-19 pandemic. Similar to how viral vector and protein subunit vaccine methods 

have been used for effective vaccines in the past, the mRNA method can be a new way of 

making more effective vaccines in the future. Pfizer/BioNTech and Moderna were the first 

pharmaceutical companies to make effective mRNA vaccines for humans. With an 

expanding global vaccine industry, patenting this new technology will be profitable in the 

long run and allow patent holders to eventually shape the future of mRNA vaccines.  

IIIb. Association for Molecular Pathology v. Myriad Genetics Case 

The Association for Molecular Pathology and other medical associations sued the 

United States Trademark and Patent Office (USTPO) and Myriad Genetics to challenge its 

human- gene-related patents. Myriad Genetics discovered specific mutations in human 

genetics, called BRCA1 and BRCA2, that marked a high risk of breast and ovarian cancer. 

To test whether a person is at high risk, it is necessary to isolate their genes. Therefore, 

Myriad patented  the process that isolates BRCA1 and BRCA2, which would give them the 

exclusive right to breast and ovarian cancer testing as well as gene isolation. However, the 

U.S. Supreme Court ruled that Myriad’s patents are invalid because human genes are found 

in nature and merely isolating them is unpatentable.  

Unlike this case, the technology of mRNA in vaccines is novel. mRNA can be found in 

nature as it is “genetic material that tells your body how to make proteins,”10 but for COVID-

19 mRNA vaccines, the mRNA is laboratory-made. Moreover, it is nonobvious to an 

ordinary person without any knowledge of mRNA and it is useful because it triggers the 

immune system against a virus. It is also a valid subject matter, fulfilling all four criteria and 

rendering the mRNA technology patentable.   

 
9 “Understanding How Covid-19 Vaccines Work,” Centers for Disease Control and Prevention, updated 3 February 
2023, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/how-they-work.html.   
10 “Understanding How Covid-19 Vaccines Work,” CDC. 



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IIIc. Moderna v. Pfizer/BioNTech Ongoing Case 

In August 2022, nine months after the first mRNA vaccine, Moderna sued 

Pfizer/BioNTech for three patent infringements related to mRNA technology. The company 

stated that “Pfizer and BioNTech’s COVID-19 vaccine Comirnaty infringes patents Moderna 

filed between 2010 and 2016 covering Moderna’s foundational mRNA technology. This 

groundbreaking technology was critical to the development of Moderna’s own mRNA 

COVID-19 vaccine, Spikevax. Pfizer and BioNTech copied this technology, without 

Moderna’s permission, to make Comirnaty.”11 Under the Patent Act of 1952, Moderna has 

the right to sue Pfizer/BioNTech for patent infringement and seek appropriate monetary 

damages and injunctive relief. Moderna is seeking damages, including royalties and lost 

profits incurred since March 2022 and license fees from high-income countries. However, 

the company chose not to seek damages from Pfizer’s sales of its vaccine to the world’s 

poorest countries and the U.S. government, which bought Pfizer/BioNTech vaccines.12 

To Moderna’s claim, Pfizer/BioNTech responds that their “work is original, and [they] 

will vigorously defend against all allegations of patent infringement.” 13  The case has 

important ramifications for the future profitability of both companies. Experts have already 

started speculating on the matter and believe that it could either come to a relatively quick 

decision or drag on for years.14 The ruling of this ongoing lawsuit will likely shape the future 

of mRNA technology, not only in the COVID-19 vaccine industry, but also in the medical 

industry.  

Conclusion 

Intellectual property rights promote and incentivize the COVID-19 vaccine industry to 

flourish and develop groundbreaking technology. However, patents on COVID-19 vaccines, 

 
11 “Moderna Sues Pfizer and BioNTech for Infringing Patents Central to Moderna’s Innovative mRNA Technology 
Platform,” Moderna, 26 August 2022, https://investors.modernatx.com/news/news-details/2022/Moderna-Sues-
Pfizer-and-BioNTech-for-Infringing-Patents-Central-to-Modernas-Innovative-mRNA-Technology-
Platform/default.aspx.   
 
12 Rebecca Robins and Jenny Gross, “Moderna Sues Pfizer and BioNTech Over Covid Vaccine Technology.” New 
York Times, 26 August 2022, https://www.nytimes.com/2022/08/26/business/moderna-covid-vaccine-lawsuit.html.  
13 “Press Release: Statement on Patent Infringement Lawsuit Filed by Moderna,” BioNTech, 26 August 2022, 
https://investors.biontech.de/news-releases/news-release-details/statement-patent-infringement-lawsuit-filed-
moderna.  
14 Jon Cohen, “Scientists question Moderna Invention claim in covid-19 vaccine dispute.” Science, 29 August 2022, 
https://www.science.org/content/article/scientists-question-moderna-invention-claim-covid-19-vaccine-dispute.  



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specifically mRNA technology, can be a hindrance to inoculation during the ongoing 

pandemic as patent license fees can increase the price of vaccines. It is important to 

remember that the public is still at risk,  with 33% of the U.S. and 39% of the world 

population not fully vaccinated.15 One might argue that the Moderna lawsuit is justifiable 

because they are protecting their rights under the U.S. Constitution. In reality, however, the 

case brings awareness to the ethical dilemma of whether intellectual property rights should 

be prioritized over life-saving technology. 

 
15 The Visual and Data Journalism Team, “Covid vaccines: How fast is progress around the world?” BBC News, 1 
June 2022, https://www.bbc.com/news/world-56237778.  


