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Pictured: Sign above the entrance to a U.S. courthouse/iStock,Mariakray

GSK on Thursday sued Pfizer and BioNTech, alleging that the pharma partners have infringed patents related to the mRNA technology of their COVID-19 vaccine Comirnaty, according to Reuters.

In its complaint, filed with the U.S. District Court of Delaware, GSK claims Pfizer and BioNTech made use of seminal mRNA research from Christian Mandl, who in 2008with a team of researcherssuccessfully addressed long-standing hurdles regarding the use of mRNA molecules as vaccines.

The Mandl team successfully overcame the many challenges and discovered the novel lipid and mRNA formulations and methods for their use to raise an immune response against immunogens, GSKs filing noted, adding that the company obtained exclusive rights to the Mandl research in 2015, when it bought a substantial portion of Novartis vaccines unit.

Despite its ownership, GSK alleges that Pfizer and BioNTech knowingly used the Mandl research to develop Comirnaty. BioNTech has cited the work of Mandls team in its patent applications, while Pfizer has likewise pointed to the Mandl research in at least one of its presentations.

Pfizer and BioNTechs mRNA vaccines exploit the fundamental technologies invented by the Mandl team, GSK wrote in its lawsuit, noting that the defendants did not acquire a license to practice the GSK inventions before or since commercializing their COVID-19 shots.

As compensation for the alleged patent infringement, GSK is seeking damages including an on-going license fee as well as related attorney fees and other expenses.

A Pfizer spokesperson in a statement to Reuters said that the company is confident in our IP position around Comirnaty and that it will vigorously defend its position against GSK. BioNTech declined to provide comment.

Thursdays lawsuit adds to Pfizer and BioNTechs legal troubles surrounding Comirnaty. The partners are also locked in a patent battle with Moderna, which in August 2022 claimed infringement on certain patented mRNA technology. Modernas lawsuit focuses on the specific chemical modifications to the mRNA molecule used in Comirnaty, as well as the process of encoding the full-length spike protein contained in a lipid nanoparticle.

Pfizer and BioNTech fired back in August 2023 and asked the U.S. Patent Trademark Office for an inter partes review, claiming that some of Modernas patents were invalid for being too broad and for seeking to claim ownership of established knowledge.

Last week, the U.S District Court of Massachusetts granted Pfizer and BioNTech motion to pause Modernas lawsuit until after the resolution of the inter partes proceedings.

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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GSK Sues Pfizer and BioNTech Over Alleged COVID-19 Patent Infringement - BioSpace

Pictured: Facade of Moderna's building in Massachusetts/iStock, hapabapa

A Delaware District Court on Wednesday sided with RoivantsubsidiaryArbutus Biopharma and Genevant Sciences in their ongoing patent infringement case against Moderna regarding the lipid nanoparticle delivery system used in the latters COVID-19 vaccine.

The patents were licensed to Genevant, a joint venture between Arbutus and Roivant. Judge Mitchell Goldberg in a 37-page opinion agreed with Arbutus and Genevants interpretation of two out of the three disputed claims in the case.

One claim concerned the total percentage of lipids present in the delivery particle. Moderna argued that the particle should refer to the finished lipid particle, which does not require further processing. The pharma also insisted that the lipid percentages must be understood as the exact ranges recited in the claim, unless the language of the patent explicitly implies some uncertainty.

Arbutus and Genevant made the case for the plain and ordinary meaning of the word particle and that the lipid percentages encompass their standard variation based on the number of significant figures recited in the claim.

Goldberg agreed with Arbutus and Genevant on both points, writing that the language of the patent claim does not require the lipid particle to be a finished particle that is completely free from further processing.

On the question of the precision of lipid percentages, Goldberg noted that Moderna has not established that Plaintiffs removal of the word about constituted a clear and unmistakable disclaimer of the rules of rounding, adding that a person with an ordinary skill in the art would understand that the rules of rounding and significant figures apply to the claimed ranges.

Goldberg also ruled in favor of Arbutus and Genevant regarding the second claim, agreeing that the claim of a cationic lipid having a protonatable tertiary amine should be interpreted using its plain and ordinary meaning, instead of Modernas proposal to include other qualifiers.

Arbutus and Genevant first filed their patent infringement lawsuit against Moderna in February 2022, alleging that the vaccine developer had used their lipid nanoparticle technology without license or proper compensation.

The plaintiffs seek fair compensation for Modernas use of our patented technology without which Modernas COVID-19 vaccine would not have been successful, Arbutus CEO William Collier said at the time.

The trial for the case is set to begin in April next year, according to Reuters.

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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Judge Rules Against Moderna in COVID-19 Patent Fight with Roivant Subsidiary - BioSpace

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 companys 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 Fridays 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-2s spike protein and certain mutations that lock the protein in an antigenically preferred perfusion conformation, according to BioNTechs 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 payment disputes beyond the BioNTech-NIH feud. In February 2024, Novavax settled its ongoing disagreement with public-private partnership Gavi over the companys 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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BioNTech Hit with NIH Notice of Default Over COVID-19 Vaccine Royalties - BioSpace