Moderna set to sue Pfizer, BioNTech for patent violations in COVID-19 vaccine

COVID-19 vaccine maker Moderna is suing Pfizer and BioNTech for allegedly copying Moderna’s mRNA research to make their own COVID-19 vaccine.

On Aug. 26, Moderna announced the lawsuits claiming patent infringement will be filed in the United States and Germany. Moderna, maker of the Spikevax vaccine, is not seeking removal of Pfizer-BioNTech vaccine Comirnaty from the market, or an injunction against future sales.

But now that vaccine supply is available in most parts of the world, Moderna said it wants Pfizer and BioNTech to respect its intellectual property rights and apply for a “commercially reasonable license” to use the technology.

"We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic," Moderna CEO Stéphane Bancel said in a news release.

"This foundational platform, which we began building in 2010, along with our patented work on coronaviruses in 2015 and 2016, enabled us to produce a safe and highly effective COVID-19 vaccine in record time after the pandemic struck,” Bancel said. “As we work to combat health challenges moving forward, Moderna is using our mRNA technology platform to develop medicines that could treat and prevent infectious diseases like influenza and HIV, as well as autoimmune and cardiovascular diseases and rare forms of cancer."

Making more

Pfizer’s media relations offered a statement responding to Moderna’s announcement.

“Pfizer-BioNTech has not yet fully reviewed the complaint but we are surprised by the litigation given the Pfizer-BioNTech COVID-19 Vaccine was based on BioNTech’s proprietary mRNA technology and developed by both BioNTech and Pfizer,” the company said in an email to Medical Economics. “We remain confident in our intellectual property supporting the Pfizer-BioNTech vaccine and will vigorously defend against the allegations of the lawsuit.”

It appeared Pfizer and BioNTech were not slowing efforts to create vaccine against COVID-19. On Aug. 26, both companies announced they completed their submissions to the European Medicines Agency for vaccines against the Omicron BA.4/BA.5 variants of the virus. This month, both applied to the U.S. Food and Drug Administration for emergency use authorization for that vaccine.

Apart from medical benefits to people, there are financial benefits as well. Pfizer “won the pandemic,” with its mRNA vaccine holding 70% of the U.S. and European markets. That company makes Paxlovid, the oral antiviral treatment for COVID-19 symptoms, and Pfizer forecasted $50 billion in global revenue from those two drugs, according to a Kaiser Health News analysis.

At least $3.2 billion could come from taxpayers. On June 29, the U.S. Department of Health and Human Services announced an order of 105 million doses of Pfizer’s COVID-19 vaccine for a fall booster campaign, with options for up to 300 million more.

Time to get vaccinated

In 2020, the three biotech companies joined others in the race to develop vaccines against COVID-19, which was spreading rapidly and, for some, causing severe infections that led to hospitalizations and deaths.

Moderna claims Pfizer and BioNTech copied its biotechnology that was patented between 2010 and 2016, years before anyone knew of SARS-CoV-2, the virus that causes the disease.

“None of the patent rights which Moderna is seeking to enforce relate to any intellectual property generated during Moderna's collaboration with the National Institutes of Health to combat COVID-19,” the company’s announcement said. “That collaboration began only after the patented technologies at issue here were proven successful in clinical trials in 2015 and 2016.”

Moderna claimed Pfizer and BioNTech “copied two key features of Moderna's patented technologies which are critical to the success of mRNA vaccines.”

“When COVID-19 emerged, neither Pfizer nor BioNTech had Moderna's level of experience with developing mRNA vaccines for infectious diseases, and they knowingly followed Moderna's lead in developing their own vaccine,” the Moderna announcement said.

Pfizer and BioNTech took four vaccine candidates into clinical testing, including options different from Moderna's formula. Then, Pfizer and BioNTech proceeded with a vaccine that has the same exact mRNA chemical modification to its vaccine as Moderna’s Spikevax COVID-19 vaccine, according to Moderna.

“Moderna scientists began developing this chemical modification that avoids provoking an undesirable immune response when mRNA is introduced into the body in 2010 and were the first to validate it in human trials in 2015,” the company’s announcement said.

Despite having other options, Pfizer and BioNTech also “copied Moderna's approach to encode for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus.” Moderna argued its scientists developed that approach when they created a vaccine for the coronavirus that causes Middle East Respiratory Syndrome (MERS), years before COVID-19 first emerged.

The U.S. Centers for Disease Control and Prevention state MERS was first reported in Saudi Arabia in 2012. It spread to the United States in 2014, but “represents a very low risk to the general public in this country,” with just two confirmed infections ever reported in the U.S.