A complex web of inventors, companies and their patent holders from the Vancouver area are trying to stake claims in inventions that have saved millions of lives over the past year and a half: the Moderna and Pfizer-BioNTech COVID-19 vaccines.
A pile of recent legal filings pit Arbutus Biopharma Corp. and Genevant Sciences GmbH, both of which originated in British Columbia’s Lower Mainland, against Moderna Inc. And on Friday, a Vancouver-based Pfizer Inc. partner called Acuitas Therapeutics Inc. filed a lawsuit in Manhattan to ward off a separate legal challenge that Arbutus and Genevant had threatened against Pfizer.
The innovation under dispute is the way the vaccines’ key ingredient is smuggled into cells: with a special group of fat-like nanoparticles called lipids that guide immunity-boosting mRNA particles in and prevent the mRNA from breaking down – like an armoured limo carrying a VIP through a voracious crowd.
The multisided legal showdown illustrates the extent to which ideas and intellectual property underpin the modern economy – and how battles over those ideas can actually put a chill on future innovation.
The litigation is making it hard for other organizations to harness the lipid-nanoparticle technology for medicines or vaccines, because it’s difficult for them to figure out who to approach to acquire a licence for the technique, said Matthew Herder, director of the Health Law Institute at Dalhousie University in Halifax. That could include organizations trying to combat COVID-19 in places such as Africa, which struggle to access and pay for vaccines that are widely available in the developed world.
“Because of the potential of these technologies in terms of future drug development,” Dr. Herder said, the Canadian companies are motivated to keep sparring. “None of it is helping make sure people trying to re-engineer an mRNA vaccine for other parts of the world ... have the underlying knowledge” to develop one.
Richard Gold, director of McGill University’s Centre for Intellectual Property and a collaborator of Dr. Herder’s, said “the entire industry is worse off” because of these kinds of disputes.
Though COVID-19 has recently raised the global stakes of the lipid-nanoparticle dispute, the conflict had its origins three decades ago when a company called Inex Pharmaceuticals was spun out of the University of British Columbia by three scientists: Pieter Cullis, Thomas Madden and Michael Hope.
In 2008, the Manhattan legal filing says, Dr. Madden and Dr. Hope felt that the company, by then called Arbutus, was “no longer interested in supporting their work,” and they left to found Acuitas. There, they hoped to focus on using lipid nanoparticles to deliver mRNA. The filing says Arbutus largely worked on nanoparticles to transport a different kind of mRNA molecule.
Arbutus’s main focus shifted to developing treatments for Hepatitis B, and it moved its base of operations to Pennsylvania, though it kept a presence in Burnaby, B.C. The company still has many lipid-nanoparticle patents that were filed over the past 11 years, but the patents’ exclusive licensing rights are held by Genevant – a company that was spun out of Arbutus, and that is largely based in Vancouver, with 37 full-time employees there.
In a lawsuit filed last month in a U.S. District Court in Delaware, lawyers for Arbutus and Genevant praised the speed with which Moderna was able to produce its mRNA vaccine – an “unprecedented accomplishment” that “was made possible by Moderna’s use of breakthrough technology Arbutus had already created and patented.” They’re seeking “fair compensation for the use of patented technology they developed with great effort and at great expense, without which Moderna’s COVID-19 vaccine would not have been successful.”
But it is Acuitas that has garnered the most attention for its lipid-nanoparticle transportation technology for mRNA, and the company announced in January that Pfizer had licensed that technology for its COVID-19 vaccine. Dr. Cullis was named a co-winner of the 2021 Prince Mahidol Award for medicine, for his work on lipid nanoparticles, and he was named an Officer of the Order of Canada in December.
In Acuitas’s new lawsuit, filed on Friday, the company alleges that Arbutus and Genevant recently sent a letter to Pfizer “threatening to assert nine patents against the sale and use” of its vaccine, but that the two companies “had nothing to do” with the vaccine’s success.
“Neither has commercialized [a lipid nanoparticle] that can effectively wrap and protect any mRNA molecule,” Acuitas alleges. “Only after [the Pfizer-BioNTech vaccine] achieved worldwide commercial success did Arbutus and Genevant emerge to make the spurious claim that [it] may infringe Arbutus’s patents, and, on information and belief, to demand hundreds of millions, if not billions, of dollars in wholly unjustified payments.”
The filing says Arbutus’s focus on a different kind of lipid nanoparticle made it less well-suited than Acuitas to work on the kind of mRNA delivery system COVID-19 vaccines need. Acuitas scientists, the filing adds, “identified appropriate formulation conditions to allow efficient encapsulation of mRNA” into lipid nanoparticles.
This is not the first time Acuitas, Arbutus and Moderna have sparred over patents. In the Delaware filing from February, Arbutus and its licence-holding partner Genevant describe a battle going back to 2015. At the time, the filing says, Acuitas had a sublicence for Arbutus’s lipid tech. Moderna sought rights to use that tech, but a legal agreement blocked that from happening.
Acuitas later tried to sue Arbutus in the British Columbia Supreme Court, and the dispute was eventually settled. Then, the legal document says, Moderna attempted to convince the U.S. Patent and Trademark office to cancel some of Arbutus’s patents. After more than three years of disputes, the U.S. appeals court said last December that it would uphold a ruling by the Patent Trial and Appeal Board that declined Moderna’s cancellation attempts.
In an e-mailed statement, Dr. Madden, now Acuitas’s chief executive officer, said that “our purpose continues to be the advancement of human health through our development of delivery systems for safe and effective nucleic acid therapeutics based on” lipid nanoparticles. He declined to comment on the litigation before the courts.
Genevant also declined to comment on the continuing litigation, while Arbutus and Moderna did not respond to comment requests.
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