Covid vaccine litigation by Moderna against Pfizer and BioNTech

In connection with the creation of the initial Covid-19 vaccines, Moderna announced that it is suing Pfizer and its German partner BioNTech for patent infringement. The US biotech firm claims that mRNA technology that it created prior to the pandemic was stolen. The complaint was filed in both the US district court in Massachusetts and the Regional Court of Düsseldorf, Germany, and asks for unspecified monetary damages.

“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,” Moderna chief executive Stephane Bancel said in the statement.

Moderna contends that the COVID-19 vaccination Comirnaty violates patents it filed between 2010 and 2016 that are related to its core mRNA technology. These patents were filed by Pfizer and BioNTech. The creation of Moderna’s proprietary mRNA COVID-19 vaccine, Spikevax, depended heavily on this ground-breaking technique. Without Moderna’s consent, Pfizer and BioNTech replicated this technology to create Comirnaty.

Pfizer/BioNTech allegedly plagiarised two significant pieces of Moderna’s intellectual property, according to a statement. One involves a “chemical change,” which according to Moderna, its researchers were the earliest to display in human trials in 2015. This modification ensures that the vaccine “avoids eliciting an undesired immune response. The second claimed violation has to do with how both vaccines target the unique spike protein on the virus’s outer surface.

Moderna further states in order to incorporate the full-length spike protein in a lipid nanoparticle formulation for a coronavirus, Pfizer and BioNTech mimicked Moderna’s strategy. Years before COVID-19 originally appeared, modern scientists used this strategy to build a vaccine for the coronavirus that causes Middle East Respiratory Syndrome (MERS).

Let’s first clarify what an mRNA vaccine is

Simply said an mRNA vaccine is a specific kind of vaccine that stimulates an immunological response by using a mimic of the messenger RNA molecule. Moderna, a firm that was only established in 2010, was a forerunner in creating the mRNA technology that was utilized for the first time in Covid vaccinations.

mRNA vaccines use mRNA produced in a lab to instruct our cells how to produce a protein—or simply just a portion of a protein—that incites an immunological response in our bodies. We are able to prevent getting infected by that bacterium in the future because of this immunological response, which generates antibodies.

Early in the pandemic, Moderna declared that it would waive its patent rights in order to assist other pharmaceutical companies in creating their own vaccines, especially for low- and middle-income nations.
Rivals like Pfizer and BioNTech would have to respect their intellectual property rights in select higher-income countries, it was stated in March 2022, albeit it would not seek compensation for actions taken before that time.

Pfizer issued a statement in which it stated that although it had not yet thoroughly examined Moderna’s claims, it was “surprised” considering that its vaccine was built using its own mRNA technology. A company representative stated: We will vigorously defend against the allegations of the lawsuit and remain confident in our intellectual property backing the Pfizer/BioNTech vaccine.

Moderna is involved in a public legal battle over intellectual property rights with the National Institutes of Health in addition to its action against Pfizer. Arbutus Biopharma and Alnylam Pharmaceuticals, two other biotech businesses, are suing Moderna for the same thing that Pfizer is accused of doing: patent infringement. These businesses assert that Moderna made the crucial lipid nanoparticles for mRNA delivery into cells using the technology they invented.

In that instance, Moderna is arguing that it was given permission to violate patents under a legal provision that permits the government to forego patent protection for businesses that create items in times of national emergency. The non-profit Knowledge Ecology International, or KEI, requested Moderna’s legal brief under the Freedom of Information Act.

The mainstay of the US immunization program has been the mRNA Covid-19 vaccine from Moderna and Pfizer, with Pfizer providing the majority of doses given out. One of the pinnacles of contemporary science is the creation of mRNA vaccines for COVID-19. The shots were developed and evaluated by experts in less than a year, and the first dosages will be distributed to medical professionals in December 2020. According to a recent analysis, the COVID-19 vaccinations saved around 20 million lives in the first year they were in use.