Pfizer Gets a Dose of their Own Medicine from Moderna…Legally.

Juhi Desai

Associate Editor

Loyola University Chicago School of Law, JD 2024

As if the world has not had enough of its fair share of COVID-19-related matters, news regarding the virus has topped headlines once again. On August 26, 2022, Moderna, a pharmaceutical and biotechnology company, publicly announced it was filing two patent-infringement lawsuits against its rival, Pfizer, Inc., and its development partner, BioNTech. Moderna claims Pfizer duplicated its vaccine technology that was later used to administer doses to help combat the COVID-19 virus. This suit comes nearly two years after the Food Drug Administration (FDA) permitted both pharmaceuticals to roll out the first vaccine against COVID-19.

The root of it all

After reports of a mysterious illness causing severe pneumonia in residents of Wuhan, China, in January of 2020 the World Health Organization (WHO) announced a global health emergency. Several weeks after that announcement, the world began seeing a surge of cases of varying severity of the SARS-CoV-2 virus, commonly known as coronavirus. The emergency was quickly promoted to a global pandemic. Though the origin of the virus has yet to be confirmed, the viral outbreak left the world in distress.

The United States initially ordered what it thought would only be a two-week “lockdown,” but that soon turned into months of at-home quarantining. However, it wasn’t long until Moderna, a biotechnology company focused on producing mRNA technology, and Pfizer, a well-known biopharmaceutical company, shed some light on the situation. During the height of the pandemic, pharmaceutical companies announced a possible solution as they worked on producing a vaccine that would help slow the spread of the disease. The Department of Health and Human Services (HHS) created a plan to efficiently and rapidly roll out vaccine doses and other countermeasures through Operation Warp Speed. Pfizer-BioNTech and Moderna spearheaded the production of vaccines and were able to start administering vaccines in phases at the close of 2020.

As of August 24, 2022, a total of nearly 12.5 billion vaccine doses have been administered globally. With 608 million vaccine doses being administered in the United States alone.

The lawsuit and the vaccine technology

Millions of vaccine doses later, Moderna is now claiming Pfizer imitated their COVID vaccine technology and have initiated this intellectual property dispute.

Moderna’s argument is a relatively simple one. Moderna’s COVID-19 vaccine utilizes its patented technology, Spikevax, which is composed of a “spike protein” that creates “the same chemical modification to their messenger RNA” that its scientists developed years prior. Pfizer’s Comirnaty vaccine contains a similar genetic makeup that “mimics one of the proteins in the virus that causes COVID-19.”

Moderna explains Pfizer’s infringement is not due to competition, but rather due to Moderna’s groundbreaking research, which they conducted and successfully completed prior to the pandemic. The pharmaceutical company recalls the trials and tribulations it had to go through before Spikevax officially had a breakthrough. That is why Moderna is serious in bringing action against Pfizer. Moderna claims it is this innovative research prior to the pandemic that Pfizer copied.

Pfizer-BioNTech refutes Moderna’s claim and states it is confident in its original technology and has been in compliance with intellectual property regulations. Thankfully for Pfizer, it has created a big name for itself. This lawsuit is likely not going to tarnish the reputable image it has maintained throughout the healthcare and pharmaceutical industry.

Moderna is claiming sole proprietary ownership over the vaccine technology. Not only does Pfizer’s involvement split the company’s profits; but being partnered on such an invention will also grant the winning company greater decision-making power. Whichever pharmaceutical prevails will be able to determine how and when they’d like to utilize future inventions.

Though Pfizer may not have expected this suit, this is not the first time Moderna was in a legal dispute with a company regarding the COVID-19 vaccine. Moderna was also in a legal battle with the National Institute of Health (NIH) over patent rights. Moderna filed an application in July 2021 with the United States Patent and Trademark Office to get sole credit for the technology behind their vaccine invention to no avail.

What’s next?

Moderna’s decision to sue Pfizer may have an influence on the future of public health. Though it likely will not hinder people’s ability to obtain either company’s COVID-19 vaccine due to the high necessity for it still, it will likely dictate which pharmaceutical company gains fiscal control over future medical inventions.

Although Moderna has claimed competition is not the motive behind the suit, I find it difficult to believe Moderna is truly engaging in this legal battle only to gain praise for their innovative research. Pfizer reported “almost $37 billion in sales from Comirnaty” while Moderna collected “roughly $18 billion of revenue from Spikevax.” Due to Operation Warp Speed and the affairs that led to the emergency vaccine roll out, I do not believe Moderna should be seeking financial gains. Rather, both pharmaceutical companies should be applauded with their quick inventions that ended up saving countless of lives and continue to prioritize conducting life-saving research. Additionally, due to the reputation Pfizer-BioNTech has garnered thus far, Moderna’s suit may be futile.

Despite the controversy, the technology developed by these two major pharmaceutical companies managed to save around 20 million lives since the start of the pandemic. Now the question remains as to which pharmaceutical company will prevail as the lengthy legal battle over the alleged unique invention of the vaccine technology takes its course in court.