Pfizer and its partner BioNTech have asked a U.S. court to revoke Moderna's patents for COVID-19 vaccine technology.
Pfizer and BioNTech said in new filings to the U.S. Patent and Trademark Office's Patent Trial and Appeal Board that Moderna's patents are so broad that they essentially "coopt the entire field" of messenger RNA technology, which is used in some COVID-19 vaccines.
The patents, obtained during the COVID-19 pandemic, are "unimaginably broad" and cover technology that was known long before 2015, when Moderna says it developed the technology, one filing stated.
Moderna didn't respond to a request for comment.
One Moderna patent being challenged covers messenger RNA vaccines with the spike protein or spike protein subunit of any betacoronavirus, such as COVID-19, delivered into the human body through a lipid delivery system. Another covers similar technology.
Pfizer and BioNTech are seeking an inter partes review of a trial at the board that would go over whether the technology Moderna patented was already described.
Scientists found in 1990 that messenger RNA could be used in ways that would improve vaccines, and in 1993, scientists found that vaccines with the technology produced an immune response, Pfizer and BioNTech told the court.
They pointed to experiments that Dr. Robert Malone and others reported in 1990 in Science magazine and tests described in a 1993 paper in the European Journal of Immunology.
Federal law governing patents says that a person shall be entitled to a patent unless the claimed invention was "patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention."
Inter partes reviews adjudicate challenges on that basis, an area of patent law known as "prior art."
Subsequent improvements to the technology, such as using lipid nanoparticles to deliver the messenger RNA, were also described in public materials before Moderna requested patents, the filings say.
That includes a patent filed in 2013 that outlined the delivery system.
The patent "is prior art" under the law, Pfizer and BioNTech said.
The patent court hasn't yet ruled on the filings.
Pfizer and BioNTech also used messenger RNA in their COVID-19 vaccine, one of the most widely used around the world, but say that the shot was based on proprietary technology.
"We remain confident in our intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the allegations of the lawsuit," they said in 2022, after being sued by Moderna over alleged patent infringement.
Earlier Suits
While the companies produced the first COVID-19 vaccines in the world, they have been feuding since, filing suits against each other.
Moderna sued Pfizer and BioNTech in August 2022, saying the Pfizer-BioNTech shot used features that were developed by Moderna scientists.
“Despite recognizing the importance of patents to innovators such as Moderna, Pfizer, and BioNTech have copied Moderna’s intellectual property and have continued to use Moderna’s inventions without permission. Moderna therefore brings this lawsuit to protect the mRNA technology platform it innovated, invested in, and patented, and to ensure that intellectual property is respected,” stated the litigation, filed in U.S. court in Massachusetts, where Moderna is headquartered.
Pfizer CEO Albert Bourla said during a conference in 2020 that the company’s mRNA vaccine was using an antigen “which is, I think, the same like the [one] Moderna is using,” the suit noted.
Moderna said it offered to consider selling licenses to its technology, but that neither Pfizer nor BioNTech ever made contact to request a license.
Moderna also filed a patent infringement suit in a court in Germany, where BioNTech is headquartered.
Pfizer and BioNTech countersued later in 2022, introducing the argument that Moderna's patents weren't valid.
The patents "far exceed" Moderna's "actual contributions to the field," the countersuit states.
Pfizer and BioNTech also said in the filing that they produced their vaccine independent of Moderna's technology.
Other Litigation
Moderna has also been sued by additional companies, which say that the firm infringed on their patent in its COVID-19 vaccine.
Arbutus Biopharma and Genevant Sciences filed the claim in U.S. court.
Moderna's attempt to dismiss the case, backed by the U.S. government, was rejected by a federal judge earlier this year.
Alnylam Pharmaceuticals, another firm, has accused both Moderna and Pfizer of violating a related patent.
Pfizer and BioNTech have also been sued in the United States by Arbutus and a separate company, CureVac, which alleges the companies infringed on its technology in their vaccine.
“Our scientists have pioneered fundamental breakthroughs in mRNA vaccine technology over the last two decades," CureVac CEO Dr. Alexander Zehnder said in a statement at the time. "These contributions underpin the rapid development of SARS-CoV-2 mRNA vaccines such as Comirnaty."
That case is poised to head to trial in 2024.
