Moderna has said it is suing rival vaccine maker Pfizer and its German partner BioNTech, citing infringement on its patents in developing the first COVID-19 vaccine approved in the United States, alleging they copied technology that Moderna developed years before the pandemic.
The lawsuits set up a high-stakes showdown between the leading manufacturers of COVID-19 shots that are a key tool in the fight against the disease.
“Moderna believes that Pfizer and BioNTech’s Covid-19 vaccine Comirnaty infringes patents Moderna filed between 2010 and 2016 covering Moderna’s foundational mRNA technology,” the US-based biotech firm said in a statement on Friday.
“Pfizer and BioNTech copied this technology, without Moderna’s permission, to make Comirnaty,” Moderna said.
Pfizer and BioNTech said they have not fully reviewed the complaint, but expressed surprise over the litigation.
“The Pfizer/BioNTech Covid-19 vaccine was based on BioNTech’s proprietary mRNA technology,” a statement said. “We will vigorously defend against the allegations of the lawsuit.”
When the news broke, Pfizer shares fell nearly 1 percent, while BioNTech US-listed shares were down about 1.5 percent and Moderna shares slipped 1.7 percent.
The lawsuit, which seeks undetermined monetary damages, was filed in the US District Court in the state of Massachusetts. Moderna said the lawsuit would also be filed in the Regional Court of Dusseldorf in Germany.
Just a decade old, Moderna, based in Cambridge, Massachusetts, had been an innovator in the messenger RNA (mRNA) vaccine technology that enabled unprecedented speed in developing the COVID-19 vaccine.
The mRNA technology used in the Moderna and Pfizer-BioNTech shots differs from that in traditional vaccines, which rely on injecting weakened or dead forms of a virus to allow the immune system to recognise it and build antibodies.
Instead, mRNA vaccines deliver instructions to cells to build a harmless piece of the spike protein found on the surface of the virus that causes COVID-19. After creating this spike protein, cells can recognise and fight the real virus, hailed as a major advancement in the development of vaccines.
Germany-based BioNTech had also been working in this field when it partnered with the US pharma giant Pfizer.
Lawsuits can take years to resolve
Moderna said it had begun building up the technology in 2010 and patented work on coronaviruses in 2015 and 2016, which allowed for the rollout of its shots in “record time” after the pandemic struck.
The virus has killed at least 6.48 million people worldwide since 2020 and made nearly 600 million ill, according to a Johns Hopkins University tracker.
In addition to death and suffering, the disease has led to a reshaping of life ranging from a change in norms on working from home to a scrambling of supply chains and workforces.
Moderna said it pledged in October 2020 not to enforce its COVID-19-related patents while the pandemic continued, but less than two years later changed that stance as the fight shifted gears.
“Moderna expected companies such as Pfizer and BioNTech to respect its intellectual property rights and would consider a commercially reasonable licence should they request one for other markets,” it said.
“Pfizer and BioNTech have failed to do so,” the firm added.
Pfizer and BioNTech are already facing multiple lawsuits from other companies which say the partnership’s vaccine infringes on their patents.
Germany’s CureVac, for instance, also filed a lawsuit against BioNTech in Germany in July. BioNTech responded in a statement that its work was original.
Moderna has also been sued for patent infringement in the US and has an ongoing dispute with the US National Institutes of Health (NIH) over rights to mRNA technology.
These types of lawsuits are not unheard of in the pharmaceutical industry, where patents can be worth billions of dollars, and can take years to resolve.