HQ Team
April 5, 2023: Arbutus Biopharma Corporation and Genevant Sciences filed a lawsuit in a US court seeking compensation for Pfizer and BioNTech’s unlicensed use of its patents in making COVID-19 vaccines.
The plaintiffs filed the lawsuit in the District Court for the District of New Jersey seeking damages for infringement of their five patents in manufacturing and selling any COVID-19 mRNA-LNP vaccines.
The patents relate to nucleic acid-lipid particles and their composition, manufacture, delivery, and methods of use. The plaintiffs argued that the defendants’ vaccines would not have been successful without using their patented lipid nanoparticle (LNP) delivery method in humans.
“During the pandemic, there was an urgent need for LNP technologies to deliver mRNA-based COVID-19 vaccines to cells in the human body,” said William Collier, President and CEO of Arbutus.
“We believe that Pfizer and BioNTech could not have created and manufactured effective vaccines at such an unprecedented speed without the existing, proven, and patented LNP technologies owned by Arbutus and licensed to Genevant.
“Therefore, we are pursuing legal action against both Pfizer and BioNTech for the unlicensed use of our patented technologies in their COVID-19 vaccines,” he said in an Arbutus statement.
Delivery struggle
While scientists have been easily able to create mRNA molecules, they struggled to develop a delivery mechanism to ensure the mRNA molecule engages safely and effectively with human cells.
The delivery challenge persisted for decades until a team of Arbutus scientists, many of whom are now at Genevant, developed and refined LNP delivery technologies, for which they were awarded many patents, according to the statement.
Arbutus’ LNP technologies relied on microscopic particles built from four carefully selected fat-like molecules that are stable enough to shelter and protect fragile RNA molecules as they move through the human body to a target cell. They then exited the target cell’s membrane before finally releasing the RNA.
These microscopic particles are called lipid nanoparticles, and their invention was widely recognized as a major achievement essential for mRNA vaccines. Without these crucial delivery technologies, the RNA would quickly degrade in the body and be ineffective.
‘Never paid’
Arbutus also developed the technologies needed to manufacture these LNPs. Previously, manufacturing lipid encapsulants for RNAs used harsh and extreme conditions that would damage the fragile RNA payload.
According to the statement, Arbutus developed new, sophisticated manufacturing methods that avoided these harmful effects.
Pfizer and BioNTech could not have accomplished the feat of creating and manufacturing a vaccine at speed unprecedented in the history of medicine but for their use of the plaintiffs’ existing and proven LNP technologies.
Yet the defendants never paid plaintiffs to use those technologies. And defendants continue to knowingly use the technologies to make and sell the vaccine, amassing tens of billions of dollars in revenues.
“The plaintiffs have thus filed this case to obtain fair compensation for their inventions, without which the vaccine would not exist,” a court filing stated.
Technological barrier
“The biggest technological barrier to messenger RNA-based medicines is not the mRNA itself—BioNTech’s CEO designed the mRNA over a weekend. The biggest barrier is delivering the mRNA to cells safely and effectively.”
In 2018, BioNTech paid for a license granted by Genevant to use the LNP technology in specific cancer and rare liver disease treatments and did not extend to uses for infectious diseases like COVID-19.
“Despite Genevant’s repeated efforts to discuss reasonable terms for a license, defendants have refused to take a license from, partner with, or otherwise compensate plaintiffs for their contribution to defendants’ vaccine,” according to the court filing.
Pfizer or BioNTech could not be reached for comment.
