Moderna sues Pfizer for copying its patent on Covid-19 vaccine technology

Modern filed Friday lawsuits for patent infringement against Pfizer y BioNTech for “copying” the mRNA technology patent, on which the Covid-19 vaccines of both companies.

The lawsuit, filed before the United States District Court for the District of Massachusetts and the Düsseldorf Regional Court in Germany, states that Moderna considers that the Pfizer and BioNTech vaccine “infringes” the patents that Moderna filed between 2010 and 2016 on its mRNA technology.

“This innovative technology was central to the development of Moderna’s own mRNA Covid-19 vaccine. Pfizer and BioNTech copied this technology, without Moderna’s permission, to make their vaccine,” the company said in a statement.

Moderna and Pfizer/BioNTech were the first companies in the sector to manufacture vaccines against the new coronavirus, very shortly after the start of the pandemic, thanks to messenger RNA technology, which allows human cells to order the manufacture of proteins present in the virus to accustom the immune system to recognize and neutralize it.

Until then, vaccines were based on weakened or inactivated forms of the virus to train the body to defend itself, and the development of remedies, as well as clinical trials to verify their safety, could take several years.

The use of messenger RNA technology in Moderna and Pfizer/BioNTech vaccines, among the most injected in the world, was the culmination of four decades of research that has overcome numerous obstacles.

“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. This platform, which we began 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 after the pandemic.As we work to combat future health challenges, Moderna is using the mRNA technology platform to develop drugs that could treat and prevent infectious diseases such as influenza and HIV, as well as autoimmune and cardiovascular diseases and rare forms of cancer,” said Moderna CEO, Stephane Bancel.

Moderna has pledged not to enforce its Covid-19-related patents as long as the pandemic continues. In March 2022, as the pandemic entered a new phase and vaccine supply was no longer a barrier to access in many parts of the world, Moderna updated its commitment.

It made clear that while it would never enforce its patents for any Covid-19 vaccine used in COVAX’s 92 low- and middle-income countries, Moderna 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 have not done it,” he says.

Moderna’s chief legal officer, Shannon Thyme Klinger, said the company “believes that Pfizer and BioNTech illegally copied Moderna’s inventions, and have continued to use them without permission.” “Moderna expects Pfizer and BioNTech to compensate them for their continued use of 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 protect innovation,” he said.

Moderna clarified that “it does not intend to withdraw from the market” the Pfizer vaccine, and that it is not requesting “an injunction to prevent its future sale.” In addition, Moderna is not seeking damages in connection with Pfizer’s sales to low- and middle-income countries and is not seeking damages for Pfizer’s sales where the US Government would be liable for any damages. The company also does not claim damages for activities that occurred before March 2022.

This is how Pfizer copied Moderna’s technology, according to the company

Moderna believes that Pfizer and BioNTech copied two key features of Moderna’s 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 lead to develop their own vaccine,” Moderna explained.

First, the company argues that Pfizer and BioNTech “brought four different vaccine candidates to clinical trials, including options that would have strayed from Moderna’s innovative path.” “However, Pfizer and BioNTech ultimately decided to proceed with a vaccine that has the same chemical modification of the mRNA as Moderna’s vaccine. Moderna scientists began developing this chemical modification that avoids triggering an undesirable immune response when the mRNA is introduced into the agency in 2010 and were the first to validate it in human trials in 2015,” they allege.

Second, Moderna claims that “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 appearance of Covid-19,” he added.

Finally, Moderna clarified that “none of its patent rights it purports to assert is related to intellectual property generated during Moderna’s collaboration with the United States National Institutes of Health to combat Covid-19.”

Such collaboration began only after the patented technologies in question proved successful in clinical trials in 2015 and 2016.

(With information from AFP)