Promosome filed lawsuits Tuesday against Moderna and Pfizer/BioNTech, alleging that the vaccine developers used patent-protected mRNA technology without a license.
Pictured: Scales of justice/Kanizphoto, iStock
Tuesday, New York-based Promosome filed separate lawsuits against Moderna and Pfizer, accusing both companies of violating patent protections related to mRNA technology, according to a report by Reuters.
In the filings submitted to the Southern District Court of California, Promosome claims that in 2009 company-affiliated scientists “discovered a method for increasing protein expression by making small changes to the mRNA that could affect the amount of protein produced without altering the amino acid sequence encoded by the mRNA.”
This method is protected by U.S. Patent No. 8,853,179, also known as the ’179 Patent. Promosome scientists, including Nobel laureate Gerald Edelman, gave the company exclusive license to the ’179 Patent.
Promosome eventually disclosed the protected technology to Moderna—which ultimately declined to license it—and to Katalin Karikó, who served as senior vice president and top mRNA scientist at BioNTech at the time of the disclosure. Like the Moderna lawsuit, neither BioNTech nor Pfizer sought to license the technology, according to Promosome.
However, years later, both Moderna and Pfizer/BioNTech used Promosome’s patented method to produce their COVID-19 vaccines, according to the filings.
“The sequence underlying Defendants’ COVID-19 vaccine tells a straightforward story: Defendants used the method of the ’179 Patent in their COVID-19 vaccine,” Promosome alleges in its lawsuit against Pfizer and BioNTech.
As recompense, Promosome is seeking payment at an “amount yet to be determined” but which should be “in no event less than a reasonable royalty” from the revenues of the COVID-19 vaccines allegedly developed using the company’s technology.
In 2021, when pandemic profits were highest, Pfizer/BioNTech’s COVID-19 vaccine Comirnaty made nearly $37 billion, accounting for more than half of Pfizer’s revenue that year. Moderna’s Spikevax earned $17.7 billion the same year.
COVID Patent Lawsuits
Promosome’s Tuesday filings are the latest in the intellectual property battle over COVID-19 vaccines.
In April 2023, Arbutus Biopharma sued Pfizer and BioNTech, alleging that their coronavirus vaccine used proprietary lipid nanoparticle (LNP) technology protected by five patents. The lawsuit claims that the delivery system that Comirnaty uses could not have been produced without Arbutus’ technology.
Alnylam also filed patent infringement lawsuits against Pfizer and Moderna in March 2022, accusing both companies of formulating their vaccines using Alnylam’s proprietary LNP drug delivery technology. The Massachusetts biopharma is seeking “fair compensation” for this infringement.
Moderna and Pfizer are also locked in a legal tussle with each other. In August 2022, Moderna sued Pfizer and BioNTech, claiming that the companies “unlawfully copied Moderna’s inventions, and they have continued to use them without permission,” Shannon Thyme Klinger, chief legal officer, Moderna, said at the time.
Pfizer hit back with a countersuit in December 2022, seeking to dismiss Moderna’s lawsuit.
Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
