Moderna sues Pfizer over patents behind COVID-19 vaccine

Moderna sues Pfizer and BioNTech, alleging they copied its COVID-19 vaccine technology

By TOM MURPHY

Associated Press

Aug. 26, 2022 Updated 4:47 PM PT

Moderna is suing Pfizer and BioNTech, accusing its main competitors of copying its technology in order to make their own COVID-19 vaccine.

Moderna said Friday that Pfizer and Germany-based BioNTech’s COVID-19 vaccine, Comirnaty, infringes on patents Moderna filed several years ago protecting the technology behind its preventive shot, Spikevax. The company filed patent infringement lawsuits in U.S. federal court and a German court.

Pfizer spokeswoman Pam Eisele said the company had not fully reviewed Moderna’s lawsuit but was surprised by it, given that Comirnaty is based on proprietary technology developed by Pfizer and BioNTech.

She said in an email that Pfizer Inc., based in New York, would “vigorously defend” itself against the suit. BioNTech said in a statement late Friday that its work was “original” and that it too would defend itself.

Moderna and Pfizer’s two-shot vaccines both use mRNA technology to fight the coronavirus.

“When COVID-19 emerged, neither Pfizer nor BioNTech had Moderna’s level of experience with developing mRNA vaccines for coronaviruses,” Moderna said in a complaint filed Friday in the U.S. District Court for the District of Massachusetts.

The mRNA vaccines work by injecting a genetic code for the spike protein that coats the surface of the coronavirus. That code, the mRNA, is encased in a ball of fat and instructs the body’s cells to make harmless spike copies that train the immune system to recognize the real virus.

That approach is radically different from how vaccines have traditionally been made.

Moderna said it started developing its mRNA technology platform in 2010, and that helped the company quickly produce its COVID-19 vaccine after the pandemic arrived in early 2020.

By the end of that year, U.S. regulators had cleared shots from Pfizer-BioNTech and Moderna for use after clinical research showed that both were highly effective.

Moderna Chief Executive Stephane Bancel said in a statement that his company pioneered the technology and invested billions of dollars in creating it.

Moderna worked with scientists at the National Institutes of Health to test and develop its COVID-19 vaccine. The company said its lawsuit is not related to any patent rights generated during that collaboration. Moderna said it believes its rivals’ vaccine infringes on patents it filed between 2010 and 2016.

Moderna said in its complaint that Pfizer and BioNTech copied critical features of its technology, including making the “exact same chemical modification to their mRNA that Moderna scientists first developed years earlier” and went on to use in Spikevax.

Moderna said it recognizes the importance of vaccine access and is not seeking to remove Comirnaty from the market. It is not asking for an injunction to prevent future sales.

Moderna said in 2020 that it would not enforce its COVID-related patents while the pandemic continued. But in March, with vaccine supplies improving globally, the company said it would change its stance.

Moderna said it would still not enforce its patents for vaccines used in low- and middle-income countries. But it expects Pfizer and BioNTech to respect its intellectual property and would consider “a commercially reasonable license” in other markets if they request one.

“Pfizer and BioNTech have failed to do so,” Moderna said in a statement.

The vaccines have swiftly become top-selling products globally. Comirnaty brought in more than $36 billion in sales last year, and analysts expect it to bring in nearly $33 billion this year, according to FactSet. Moderna Inc. booked $17.6 billion in revenue from its vaccine last year; analysts project more than $21 billion in 2022.

Spikevax is Moderna’s only product on the market, but it is developing other vaccines using the mRNA technology.