‘Moderna, Inc… today is filing patent infringement lawsuits against Pfizer and BioNTech in the United States District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany,” the press release read.
“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the Covid-19 pandemic,” the statement added.
Moderna accused Pfizer and BioNTech of making “the exact same chemical modification to their mRNA that Moderna scientists first developed years earlier.”
“Pfizer and BioNTech copied this technology, without Moderna’s permission, to make Comirnaty,” the statement continued.
In the Press release, Moderna said its aim is not to remove Pfizer’s vaccine from the market or prevent further sales of the vaccines. The organization said it would not seek damages for the sales of Pfizer’s vaccines in 92 low-income countries where it was difficult to have access to vaccines.
While Moderna will not also seek damages for activities before March 8, a date used by the company to mark the end of the virus, the company is calling on the court to grant the payment of compensation for activities after that date.
“Moderna expects Pfizer and BioNTech to compensate Moderna for Comirnaty’s ongoing use of Moderna’s patented technologies,” Moderna Chief Legal Officer Shannon Thyme Klinge said.
Moderna’s Patent Pledge
Although Moderna has maintained the ownership of mRNA technology, the company pledged not to exercise its patent rights so that other companies producing vaccines can contribute to the fight against the pandemic.
“While the pandemic continues, Moderna will not enforce our COVID-19-related patents against those making vaccines intended to combat the pandemic,” Moderna said in 2020.
Fast-forward to March 2022, Moderna updated its pledge, saying the reason for the vow was to ensure that vaccines were available to fight the pandemic.
“We felt and continue to believe that we have a special obligation to remove any perceived impediments created by our intellectual property rights so that the world could be vaccinated during the pandemic,” Moderna said in a statement in March.
The updated pledge would mean unlicensed companies using the Moderna vaccine technology to make vaccines for developed nations will now pay for a license to use it.
“In non-AMC 92 countries, vaccine supply is no longer a barrier to access. In these countries, the Company expects those using Moderna-patented technologies will respect the Company’s intellectual property,” the statement added. “Moderna remains willing to license its technology for COVID-19 vaccines to manufacturers in these countries on commercially reasonable terms.”
Pfizer and BioNTech Ready for Defense
Both Pfizer and BioNTech have vowed to defend themselves against the allegations by Moderna.
Pfizer said it has not reviewed the complaint but was surprised by the lawsuit by its competitor.
“We remain confident in our intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the allegations of the lawsuit,” Pfizer said in a written statement to CNN.
On the part of BioNTech, the company dismissed any patent infringement and vowed to defend its actions.
“BioNTech’s work is original, and we will vigorously defend against all allegations of patent infringement. BioNTech also values and respects valid and enforceable intellectual property rights of others and remains confident in its intellectual property. It is an unfortunate but rather regular occurrence that other companies make allegations that a successful product potentially infringes their intellectual property rights, even more so here after witnessing the historic accomplishments of a vaccine like COMIRNATY®,” BioNTech said in a statement.
“Please understand that BioNTech will not comment on the company’s legal strategy,” the statement added.
A Legal Perspective of the Case
Although Moderna could have an edge in the court case, legal experts think the lawsuit was unnecessary. Jorge Contreras, a law professor at the University of Utah and an expert on patent pledges, said the earlier pledge by Moderna not to enforce its patent during the pandemic is a solid defense for BioNTech.
“Public promises are viewed as binding commitments under the law, and the tweaking of the pledge that Moderna did earlier this year doesn’t negate the original one,” Contreras said, as reported by Bloomberg.
“This was a public, formal statement from a public company through a press release, so it’s reasonable for other companies to rely on it. It’s possible Moderna is using the lawsuit to prod Pfizer and BioNTech into licensing Moderna’s technology, a “classic way” to pressure companies into making such agreements,” he added.
Professor Lawrence, a professor of global public health law at Georgetown University, believes the case was unnecessary and feels “Moderna is just playing hardball.”
“Instead of thinking of mRNA technology as a global public good, and being the heroes of the Covid pandemic, you know, Moderna is just playing hardball,” Lawrence Gostin said.