mRNA rival Moderna sues

mRNA rival Moderna sues

By Christiane Truelove • [email protected]

Although Pfizer has dominated the headlines with Comirnaty, it’s not the only company that has created a COVID-19 vaccine using mRNA technology. The biotechnology company Moderna received FDA authorization for its own mRNA COVID-19 vaccine, Spikevax, in December 2021 for administration in individuals 18 years old and older.

“2021 was a year of monumental impact and change for Moderna. After a decade of pioneering the development of our mRNA platform, we were ready and well-positioned to play a critical role in combating the COVID-19 pandemic globally with our mRNA vaccine,” says Stéphane Bancel, CEO of Moderna. “Our COVID-19 vaccine has been granted emergency use authorization (EUA) or emergency use listing by the World Health Organization (WHO) and health agencies in more than 60 countries, to which we shipped approximately 800 million doses in 2021. This was no small task for a team of 2,700 people.”

Like Pfizer, Moderna has received additional approvals and emergency use authorizations for the use of its vaccine in children and as booster shots. The company also developed and gained authorizations for Spikevax in teens and children, and for a bivalent BA.4/BA.5 Omicron booster version.

With the success of the vaccine, 2021 saw Moderna become a commercial company. In September 2021, the company defined its strategic pillars for impact – core franchises summarizing Moderna’s focus for 2022 and beyond. These include a pan-respiratory annual single-dose booster vaccine; first-in-class vaccines against latent viruses; therapeutics based on the company’s mRNA-encoded proteins; and therapeutics based on mRNA-encoded gene editing enzymes.

Spikevax propelled the company from $200 million in 2020 revenue to $17.69 billion in 2021 revenue; net loss of $747 million to net income of $12.2 billion; and net loss per share of $1.96 to diluted earnings per share of $28.29.

Moderna is now using some of that funding to go toe to toe with Pfizer. In August 2022, Moderna filed a complaint against Pfizer and BioNTech alleging that Comirnaty infringes patents Moderna filed between 2010 and 2016 covering Moderna’s foundational mRNA technology. The company asserts that Pfizer and BioNTech copied this technology, without Moderna’s permission, to make Comirnaty.

“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,” Bancel said.”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. 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.”

Moderna had pledged in October 2020 not to enforce its COVID-19 related patents while the pandemic continued, to ensure equitable global access of its vaccine. In March 2022, however, when the collective fight against COVID-19 entered a new phase and vaccine supply was no longer a barrier to access in many parts of the world, Moderna updated its pledge. Management said the company would not enforce its patents for any COVID-19 vaccine used in the 92 low- and middle-income countries in the GAVI COVAX Advance Market Commitment (AMC 92), but expected companies such as Pfizer and BioNTech to respect Moderna’s intellectual property rights and would consider a commercially reasonable license should they request one for other markets. 

“We believe that Pfizer and BioNTech unlawfully copied Moderna’s inventions, and they have continued to use them without permission,” said Moderna Chief Legal Officer Shannon Thyme Klinger. “Outside of AMC 92 countries, where vaccine supply is no longer a barrier to access, Moderna expects Pfizer and BioNTech to compensate Moderna for Comirnaty’s ongoing use of Moderna’s patented technologies. Our mission to create a new generation of transformative medicines for patients by delivering on the promise of mRNA science cannot be achieved without a patent system that rewards and protects innovation.”

Moderna is not seeking to remove Comirnaty from the market and is not asking for an injunction to prevent its future sale. In addition, Moderna is not seeking damages related to Pfizer’s sales to AMC 92 countries and is not seeking damages for Pfizer’s sales where the U.S. government would be responsible for any damages. Consistent with Moderna’s patent pledge, the company is also not seeking damages for activities occurring before March 8, 2022.

Moderna believes Pfizer and BioNTech copied two key features of the company’s patented technologies that are critical to the success of mRNA vaccines. Management asserts that 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.

Moderna believes that Comirnaty has the same exact mRNA chemical modification as Spikevax. Company executives also believe that Pfizer and BioNTech copied Moderna’s approach to encode for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus. Moderna scientists developed this approach when they created a vaccine for the coronavirus that causes Middle East Respiratory Syndrome (MERS) years before COVID-19 first emerged.

Pfizer told NPR that it is “confident in our intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the allegations of the lawsuit.”