Moderna sues Pfizer, BioNTech over COVID-19 vaccine patents

COVID-19 vaccine maker Moderna is suing Pfizer and German drugmaker BioNTech, accusing its main competitors of copying Moderna’s technology to make their own vaccine.

Moderna said Friday that Pfizer and BioNTech’s vaccine, Comirnaty, infringes patents Moderna filed several years ago to protect the technology behind its preventative injection, Spikevax. The company filed patent infringement lawsuits in both the US federal court and a German court.

Pfizer spokeswoman Pam Eisele said the company hadn’t fully reviewed Moderna’s lawsuit, but the drugmaker was surprised, as their vaccine is based on proprietary technology developed by both BioNTech and Pfizer.

She said in an email that New York-based Pfizer Inc. would “defend vigorously” against all allegations in the case. BioNTech said in a statement late Friday that its work was “original” and that it would also defend itself.

Moderna and Pfizer’s dual vaccines both use mRNA technology to help people fight the coronavirus.

“When COVID-19 showed up, neither Pfizer nor BioNTech had Moderna’s level of experience 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 encapsulated in a ball of fat and instructs the body’s cells to make some harmless spike copies that train the immune system to recognize the real virus.

That approach is radically different from how vaccines are traditionally made.

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

By the end of that year, U.S. regulators had cleared the injections of both Pfizer and Moderna for use after clinical trials showed both to be highly effective.

Moderna CEO Stephane Bancel said in a prepared statement that the vaccine developer pioneered that 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 patent rights generated during that collaboration.

The company said it believes its rivals’ vaccine infringes on patents Moderna filed between 2010 and 2016.

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

Moderna said it recognizes the importance of access to vaccines and is not trying to remove Comirnaty from the market. Nor does it call for a ban to prevent future sales.

Moderna said in 2020 it would not enforce its COVID-19-related patents as long as the pandemic continued. But the company said in March, as vaccine stocks improve worldwide, it would update that promise.

It said it still would not uphold its patents for vaccines used in low- and middle-income countries. But it expected companies like Pfizer and BioNTech to respect their intellectual property, and would consider a “commercially reasonable license” in other markets if they asked.

“Pfizer and BioNTech have not done that,” Moderna said in a statement.

Vaccines have quickly become the best-selling products worldwide.

Pfizer’s Comirnaty brought in more than $36 billion in sales worldwide last year, and analysts expect it to bring in nearly $33 billion this year, according to FactSet.

Moderna Inc. posted $17.6 billion in revenue from its vaccine last year. Analysts predict more than $21 billion by 2022. Spikevax is Moderna’s only product on the market, but it is developing other vaccines using the mRNA technology.

Shares of the Cambridge, Massachusetts company are publicly traded under the ticker symbol MRNA.

———

Associated Press authors Lauran Neergaard and Frank Jordans contributed to this report from Washington, DC and Berlin, respectively. Murphy was reporting from Indianapolis.