Arbutus Biopharma (NASDAQ:ABUS) Corporation (Nasdaq: ABUS) (“Arbutus”), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, and Genevant Sciences (Genevant) today filed a lawsuit in the U.S. District Court for the District of New Jersey against Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq: NASDAQ:BNTX) seeking damages for infringement of U.S. Patent Nos. 9,504,651; 8,492,359; 11,141,378; 11,298,320; and 11,318,098 in the manufacture and sale of any COVID-19 mRNA-LNP vaccines. The patents relate to nucleic acid-lipid particles and their composition, manufacture, delivery and methods of use. The filed complaint is available on the Arbutus website.
With this suit, Arbutus and its licensee Genevant seek compensation for Pfizer’s and BioNTech’s unlicensed use of patented lipid nanoparticle (LNP) delivery technologies without which Pfizer-BioNTech’s COVID-19 vaccines would not have been successful.
William Collier, President and CEO of Arbutus, stated, “During the pandemic, there was an urgent need for LNP technologies to deliver mRNA-based COVID-19 vaccines to cells in the human body. 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.”
While scientists have been able to easily create mRNA molecules, they struggled to develop a delivery mechanism to ensure the mRNA molecule engages safely and effectively with human cells. This 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. Arbutus’ LNP technologies rely on microscopic particles built from four carefully selected types of 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, and then through the target cell’s membrane, before finally releasing the RNA. These particles are called lipid nanoparticles and their invention was widely recognized as a major achievement that is essential for mRNA vaccines. Without these crucial delivery technologies, the RNA would quickly degrade in the body and be ineffective.
Arbutus also developed the technologies needed to manufacture these LNPs. Previously, methods of manufacturing lipid encapsulants for RNAs used harsh and extreme conditions that would damage the fragile RNA payload. Arbutus developed new, sophisticated manufacturing methods that avoided these deleterious effects.
Arbutus remains committed to taking all legal actions necessary to defend and protect its intellectual property.