Arbutus, Genevant sue Moderna over COVID-19 vaccine tech
Arbutus Biopharma and Genevant Sciences are jointly suing Moderna over royalties from the sales of its COVID-19 vaccine, which allegedly uses their tech for a drug-delivery system without authorisation.
The companies filed the complaint at the US District Court for the District of Delaware on Monday, February 28.
According to the complaint, Moderna’s breakthrough vaccine would not have been possible without the use of the technology Arbutus had already created and patented—a revolutionary lipid nanoparticle (LNP) delivery platform.
The companies argued that medicines using messenger ribonucleic acid (mRNA) technology, including Moderna’s COVID-19 vaccine, rely on synthetic mRNA that enters the body’s cells and instructs them to make proteins they would not necessarily make on their own.
Moderna’s COVID-19 vaccine, in particular, uses mRNA to cause cells to make a small piece of the virus that causes COVID-19, called the “spike protein”.
Groundbreaking tech
That small piece, which is harmless in isolation, prompts the body’s immune system to produce antibodies that will recognise and destroy the spike protein if it is encountered in the future. In this way, the vaccine equips a person’s body ahead of time with antibodies to fight the COVID-19 virus if that person experiences a subsequent exposure.
According to the complaint, ever since the vast potential for mRNA-based vaccines and other mRNA-based medicines began to catch the attention of scientists 20 years ago, the biggest technological hurdle to developing and deploying them has been devising a safe and effective way to deliver the mRNA to the cell.
This is because, without adequate protection, mRNA quickly degrades in the body. For mRNA vaccines like Moderna’s to work, they must incorporate a mechanism for protecting the fragile mRNA, delivering it through cell membranes, and then releasing it inside the cells.
According to the complaint, Arbutus scientists discovered a solution in the form of microscopic particles that can shelter and protect an RNA molecule on a voyage through the human body to a target cell, and then through the target cell’s membrane, before finally releasing the RNA.
Arbutus argued that the US Patent and Trademark Office issued several patents for its groundbreaking LNP technologies.
The filing contended that LNPs identified through Arbutus’s pioneering work have been described as“crucial” to Moderna’s COVID-19 vaccine, the first mRNA product the company was able to commercialise and the keystone of its financial success.
Painstaking work
The complaint argued that it took Arbutus scientists years of painstaking work to develop and refine this technology and Moderna was well aware of Arbutus’s LNP patents and licensed them for other product programmes, but it chose not to do so for its COVID-19 vaccine.
Instead, it attempted to invalidate several of the patents before the United States Patent Trial and Appeal board, said the complaint. But, the companies argued, when those efforts largely failed, Moderna simply used the patented technology without paying for it or even asking for a licence, they said.
Arbutus and Genevent said they do not seek an injunction or any relief in this case that would impede the sale or manufacture of Moderna’s life-saving vaccine, but seek only fair compensation for the use of patented technology they developed with great effort and at great expense.
“Moderna has remained unwilling to pay for its use of Arbutus’s technology in a vaccine that has earned Moderna billions of dollars in profits. Moderna’s intransigence has forced Arbutus and Genevant, a company spearheaded by former Arbutus scientists, to bring this infringement action,” said the complaint.
In a statement released to the media, Moderna denied the claims. “Our Covid-19 vaccine is a product of Moderna’s many years of pioneering mRNA platform research and development, including the creation of our own proprietary lipid nanoparticle delivery technology, which has been pivotal to combat the Covid-19 pandemic,” said a spokesperson.
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