BioNTech Hit with NIH Notice of Default over COVID-19 Vaccine COVID-19 Vaccine Royalties

2024-03-26

疫苗引进/卖出专利侵权信使RNA临床研究

Pictured: BioNTech's signage outside its headquarters in Germany/iStock, U.J. Alexander The National Institutes of Health has slapped BioNTech with a notice of default over alleged royalty payments the biotech owes the agency related to sales of its Pfizer-partnered COVID-19 vaccine Comirnaty, according to the company’s SEC filing. A notice of default informs a contract partner that they have failed to fulfill an obligation and that legal action will be taken if they continue to default. In this case, the National Institutes of Health (NIH) maintains that BioNTech breached its license agreement, under which the agency claims it is entitled to certain royalty payments on Comirnaty revenues since its commercialization. BioNTech in Friday’s SEC filing said that it “disagrees with the positions being taken by the NIH and intends to vigorously defend against all allegations of breach.” In developing Comirnaty, an mRNA vaccine that uses lipid particles to deliver a short stretch of modified messenger RNA, BioNTech and Pfizer obtained a non-exclusive license from NIH which allowed the partners to use specific technology related to the SARS-CoV-2’s spike protein and certain mutations that lock the protein “in an antigenically preferred perfusion conformation,” according to BioNTech’s annual report filed last week. In its annual report, the biotech pointed to its ongoing royalty disagreement with NIH, though the agency was still only threatening to send a notice of default at that point. “We cannot guarantee that our interpretation of these license agreements will prevail, or that we will not ultimately need to pay some or all of the royalty and other related amounts in dispute,” BioNTech noted in its annual report. In addition to its payment spat with NIH, BioNTech is also involved in a long-running patent dispute with Moderna. The contention covers betacoronavirus vaccine technology using at least one RNA polynucleotide with an open reading frame that encodes at least one betacoronavirus antigenic peptide. In November 2023, the European Patent Office ruled against Moderna and found that this claim was invalid. There have also been other COVID-19 vaccine COVID-19 vaccine payment disputes beyond the BioNTech-NIH feud. In February 2024, Novavax settled its ongoing disagreement with public-private partnership Gavi over the company’s COVID-19 vaccine NVX-CoV2373. To end all litigation surrounding the dispute, Novavax made an upfront $75 million payment and promised deferred payments of $80 million annually through 2028. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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