Moderna Pharmaceutical today filed lawsuits for patent infringement against Pfizer and BioNTech in a court in Massachusetts (United States) and another in Düsseldorf (Germany).
The firm believes that Pfizer and BioNTech's Comirnaty covid vaccine infringes patents Moderna filed between 2010 and 2016 covering Moderna's foundational mRNA technology.
"Pfizer and BioNTech copied this technology, without Moderna's permission," the company says in a note made public this Friday.
The statement does not specify the amount claimed by Moderna.
The covid vaccine has become the main source of income for the pharmaceutical giant Pfizer, accounting for half of its turnover.
Pfizer expects to enter more than 30,000 million dollars in 2022 (a similar figure in euros) from sales of the vaccine.
For Moderna, it has been its first relevant product on the market.
“We are filing these lawsuits to protect the groundbreaking mRNA technology platform that we pioneered, spent billions of dollars creating, and patented over the decade before the COVID-19 pandemic,” the statement said. Moderna boss Stéphane Bancel.
Its General Counsel, Shannon Thyme Klinger, said: “Moderna expects Pfizer and BioNTech to compensate Moderna for Comirnaty's continued use of Moderna's proprietary technologies.
Our mission to create a new generation of transformative medicines for patients by fulfilling the promise of mRNA science cannot be achieved without a patent system that rewards and protects innovation.”
Moderna believes that Pfizer and BioNTech copied two key features of their proprietary technologies that are critical to the success of mRNA vaccines.
"When COVID-19 emerged, neither Pfizer nor BioNTech had Moderna's level of experience in developing mRNA vaccines for infectious diseases, and knowingly followed Moderna's path to develop their own vaccine," the company states.
messenger RNA
RNA is an essential molecule for life.
Both the Moderna vaccine and those of Pfizer and BioNTech are based on this molecule, specifically on a subtype known as messenger RNA.
Its job is to transmit the message of life contained in the DNA and convert it into all the proteins that allow us to carry out all the vital functions.
Any vaccine is a simulation of an infection to provoke an immune system response to a pathogen without letting it cause disease.
Moderna and BioNTech vaccines use a different technique than conventional ones, based on complete attenuated viruses —measles—, deactivated —flu— or fragments of it.
Messenger RNA vaccines use the body's cells as bioreactors so that they produce copies of the coronavirus's protein S and these are located by the immune system.
According to Moderna's arguments, Pfizer and BioNTech brought four different vaccine candidates to clinical trials, including options that would have strayed from Moderna's path.
However, Pfizer and BioNTech ultimately decided to proceed with a vaccine that has the same chemical modification of the mRNA as Spikevax, their own vaccine.
Moderna scientists began developing this chemical modification that avoids triggering 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 says.
“Second, and again despite having many different options, Pfizer and BioNTech copied Moderna's approach to encoding the full-length spike protein in a lipid nanoparticle formulation for a coronavirus.
Scientists at Moderna developed this approach when they created a vaccine for the coronavirus that causes Middle East Respiratory Syndrome (MERS) years before the emergence of COVID-19."
The company assures that due to its commitment to equitable global access to vaccines, in October 2020 it promised not to enforce its covid-related patents while the pandemic continued.
In March 2022, when the collective fight against covid entered a new phase and the supply of the vaccine was no longer an obstacle to access in many parts of the world, Moderna updated its commitment, he explains.
The company says it made it clear that while it would never enforce its patents for any Covid-19 vaccine used in the 92 low- and middle-income countries, it expected companies like Pfizer and BioNTech to respect its intellectual property rights and would consider a commercially reasonable license should they request it for other markets.
“Pfizer and BioNTech haven't done it,” he concludes.
“This foundational platform, which we started building in 2010, coupled with our proprietary work on coronaviruses in 2015 and 2016, enabled us to produce a safe and highly effective vaccine against COVID-19 in record time post-pandemic.
As we work to combat future health challenges, Moderna is using our mRNA technology platform to develop medicines that could treat and prevent infectious diseases such as influenza and HIV, as well as autoimmune and cardiovascular diseases and rare forms of cancer." Bancel in the statement.
