Who is to thank for the COVID vaccine? Many major biopharma companies are asking that question after a series of lawsuits over patent rights to the vaccine and its associated technology.
COVID-19 vaccines have saved approximately 1.1 million lives and prevented more than 10 million hospitalizations. But who should get credit -and money - for saving so many lives? Many major biopharma companies are asking that question after a series of lawsuits over patent rights to the vaccine and its associated technology.
Alnylam filed separate lawsuits against Pfizer and Moderna, claiming that their COVID-19 vaccines used Alnylam’s unique biodegradable cationic lipids. More than a decade ago, Alnylam developed liquid nanoparticle (LNP) technology as an effective, lipid-based mRNA drug delivery system. After the COVID-19 vaccines were developed using mRNA delivery systems, Alnylam believes that Moderna and Pfizer’s vaccines were possible because of its LNP technology.
Alnylam is demanding “fair compensation” for the apparent use of this LNP technology, although it noted that it would not take any kind of action that would affect the availability of the vaccine.
Moderna denied the allegations. In a company statement, Moderna said Alnylam’s LNP technology was developed for a different type of RNA, and that the COVID-19 vaccine used different lipids.
“Moderna’s LNPs do not resemble Alnylam’s work, and any assertion that the Alnylam patent covers Moderna’s COVID-19 vaccine is specious,” the company stated.
Pfizer is now facing another lawsuit over its vaccine, this time from Arbutus Biopharma and Genevant. Pfizer had a licensing agreement with a company called Acuitas, which develops lipids and LNPs essential for mRNA vaccines. Pfizer and BioNTech used Acuitas’ technology in the COVID-19 vaccine.
Much of Acuitas’ LNP technology was developed by three particular scientists. At the time, those researchers worked for the company that is now Arbutus Biopharma. Arbutus was not supporting the researchers’ LNP work, so in 2008, the researchers left and formed their own company, which later became Acuitas.
Now Arbutus and its partner Genevant are suing Pfizer, saying that the research at Acuitas should rightfully still belong to Arbutus.
Acuitas denied the allegations and said that Arbutus and Genevant had “nothing to do” with the success of the COVID-19 vaccine. Acuitas also pointed out that the lawsuit only appeared after Pfizer and Acuitas experienced massive success.
Last month, Arbutus and Genevant also sued Moderna, again alleging that Moderna had infringed upon patents in using the LNP technology to develop its Spikevax COVID-19 vaccine. Arbutus and Genevant claim that the liquid nanoparticle delivery system in the vaccine is very similar to their own LNP delivery system they had spent years developing and refining.
In a company statement, Moderna responded to the allegations, saying, “Moderna denies these allegations, and will vigorously defend itself against Genevant’s claims in Court. 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.”
Again, Arbutus and Genevant are only making this claim after a competitor finds success. Moderna reported $17.1 billion from sales of the vaccine in 2021, and any patent infringement would cost Moderna dearly.
In one instance, a major biopharma company was the one on the offensive. In an article in the BMJ, the kENUP foundation, a European nonprofit that represents Pfizer’s partner BioNTech, said that a technology transfer hub being developed in South Africa would likely infringe on Pfizer’s vaccine technology.
In June 2021, the World Health Organization launched a technology transfer hub in South Africa. The goal was to use publicly available information to create its own COVID-19 vaccine. The WHO saw this as a way to help get vaccines locally made and distributed in Africa. Africa has the lowest vaccination rate against SARS-CoV-2 of any continent, with only about 15% of the population having received one dose.
The technology transfer hub would be an international collaboration to help scale up vaccine production and would provide jobs and vaccines to many local countries. However, within five months of the WHO’s announcement, both Pfizer and Moderna announced their own plans to manufacture vaccines in Africa.
In the BMJ article, kENUP considered the project to be an infringement on both Pfizer and Moderna’s vaccine technologies.
As the lawsuits continue over who gets patents over the vaccine, there’s a lot of money still on the table. Pfizer’s vaccine sales are expected to top $32 billion by the end of this year, and Moderna’s vaccine is projected to earn $19 billion.
