LAS VEGAS (KLAS) — Three pharmaceutical giants are accused of stealing a patented method to make the COVID-19 vaccine. Moderna, Pfizer and BioNTech are named as defendants in two separate lawsuits filed Tuesday.

Promosome LLC. alleges patent infringement. The small biotechnology firm claims that its scientists, including Nobel laureate Gerald Edelman, who died in 2014, Vincent Mauro, and two colleagues from The Scripps Research Institute, developed a method used in the COVID-19 vaccines, which they had previously shared with the pharmaceutical giants. The lawsuit alleges that Moderna, Pfizer and BioNTech did not license the patent and that reverse engineering confirmed its use in the COVID-19 vaccines.

Attorney Bill Carmody, of Susman Godfrey, told the 8 News Now Investigators the goal of the lawsuit is to get justice for Promosome.

“This is a case about the makers of the COVID vaccine using the public health emergency to make billions of dollars but not sharing any of it with the rightful developer of the key technology in these vaccines,” Carmody said.

Moderna generated a $35 billion profit from the vaccine, while the Pfizer-BioNTech vaccine generated $75 billion, according to the complaint.

Promosome scientists discovered a method for increasing mRNA protein expression by making small changes to the mRNA, according to the lawsuits. mRNA is genetic material that instructs the body how to produce proteins and it allows the body to fight coronaviruses without including the actual virus in the vaccine, the complaint stated.

“The body’s natural immune system will then recognize the newly minted spike protein as foreign and attack it,” the complaint read. “That learned defense will prepare the immune system to fight the actual virus in the future.”

Promosome filed a provisional patent application in 2009. A patent was issued in 2014, called “179 patent,” and Promosome marketed the practice under the trade name “RESCUE,” according to the complaints filed.

Both lawsuits were filed in U.S. District Court, the southern District of California because according to Promosome, the patented method was developed in San Diego County.

Moderna

Promosome claims that it engaged with Moderna about a potential licensing and business partnership from 2013 to 2016 which included a Confidential Disclosure and Non-Use Agreement in 2013, a visit by the current president of Moderna Dr. Stephen Hoge in 2013, a demonstration of how the patented method could be integrated into Moderna’s existing mRNA approach in 2015, and the sending of a copy of the patent to Moderna.

“Further, Promosome’s then-CEO Chris LeMasters emailed Moderna CEO Stephane Bancel to discuss potential uses of Promosome’s intellectual property in the mRNA space,” the complaint stated.

Despite the disclosures and interactions, Promosome claims that Moderna never reengaged Promosome to license the rights of the patent, but then used the method in the COVID-19 vaccine that it markets under the name “Spikevax.”

“Promosome applauds Moderna’s efforts to develop and sell a COVID-19 vaccine. Those efforts have saved innumerable lives,” the complaint stated. “[It] is now clear that Moderna incorporated the method of the ‘179 Patent – which it knew about years before the advent of COVID-19 – into the mRNA platform used to develop its COVID-19 vaccine. That vaccine alone has now generated for Moderna more than $35 billion in revenues… Promosome files this complaint to receive its rightful share of the tens-of-billions in revenues Moderna already has earned and countless billions it will earn by willfully infringing the ‘179 Patent.”

“Moderna’s now-President, Stephen Hoge, visited San Diego County under the terms of that contract and disclosures of the method underlying the ‘179 patient were made to Dr. Hoge in this district,” the complaint stated.

Pfizer and BioNTech

In the second lawsuit filed against Pfizer and BioNTech, Promosome alleges the companies violated committed patent infringement through their joint COVID-19 vaccine “Comirnaty.” Promosome disclosed the patented technology to BioNTech scientist Dr. Katalin Kariko in 2015 and provided additional information after Kariko inquired further the following year, but the companies did not pursue licensing, according to the complaint.

The 8 News Now Investigators have reached out to Moderna, Pfizer and BioNTech and are waiting for responses.

In 2022, Moderna filed a lawsuit against Pfizer and BioNtech alleging patent infringement.