Moderna sues Pfizer; says Pfizer ripped off its patents for Covid-19 vaccines

Covid-19 vaccine maker Moderna, founded in Cambridge in 2010, this morning sued Pfizer, which has research facilities here, for patent infringement, alleging Pfizer and its German partner copied its patented mRNA technology to make their competing vaccine.

In a suit filed in US District Court, Moderna charges that Pfizer and BioNTech tried other mRNA techniques that would not have infringed on Moderna patents to develop their own vaccine, but rejected those in favor of simply copying Moderna's work.

Unlike past vaccines, which relied on mass producing a particular virus and then releasing a weakened or killed form to stimulate an immune response - a process that can take a long time - mRNA technology gets part of the immune system to generate a protein from the surface of a given virus, which another part of the immune system then recognizes as "foreign" and begins to produce antibodies against it.

In the case of Covid-19, that's a "spike" protein on the surface of the virus. Key to the technique is using lipids, or fats, to create a sort of container that surrounds and protects the RNA until it gets to the right cells, where the fat basically melts away as mRNA leads to the creation of the protein in the cytoplasm that surrounds the cell nucleus.

In the suit, Moderna notes it had earlier used mRNA technology to develop a vaccine against Middle East Respiratory Syndrome, like Covid-19, a coronavirus, but unlike Covid-19, a virus that did not cause a worldwide pandemic. Between 2011 and 2016, Moderna says, it obtained patents on the techniques for building mRNA vaccines in general and for coronaviruses in particular.

Moderna says that when it learned about Covid-19, it shifted its focus from developing a vaccine aimed at reducing birth defects in fetuses, to adapting the lessons it had learned from MERS to develop a Covid-19 shot, even though it says that was risky for a company that at the time had no products bringing in revenue.

When COVID-19 emerged, neither Pfizer nor BioNTech had Moderna's level of experience with developing mRNA vaccines for coronaviruses. Upon information and belief, be- fore the emergence of COVID-19, unlike Moderna, neither Pfizer nor BioNTech had ever devel- oped an mRNA vaccine for a coronavirus.xxx Pfizer and BioNTech started with a number of different options when they considered how to design their vaccine. In fact, they took four different candidates into clinical testing, including options that would have steered clear of Moderna's innovative path by using unmodified mRNA. ... Ultimately, however, Pfizer and BioNTech discarded those alternatives and copied Moderna's patented technology.

And they did so knowing that they were following Moderna's lead. Pfizer's CEO, Albert Bourla, acknowledged that the vaccine design Pfizer and BioNTech ultimately chose to pursue uses "the entire spike protein, which . . . Moderna is using." ...

Pfizer and BioNTech copied two critical features of Moderna's patented mRNA technology platform. First, out of numerous possible choices, they decided to make the exact same chemical modification to their mRNA that Moderna scientists first developed years earlier, and which the Company patented and uses in Spikevax®. Second, and again despite having many different options, the Pfizer and BioNTech vaccine encoded for the exact same type of coronavirus protein (i.e., the full-length spike protein), which is the coronavirus vaccine design that Moderna had pioneered based off its earlier work on coronaviruses and which the company patented and uses in Spikevax®. The Moderna inventions that Pfizer and BioNTech chose to copy were foundational for the success of their vaccine.

Moderna says it knew about the patent violations right away but publicly declared in October, 2020 it would not seek to enforce its patents while the pandemic raged and killed people by the millions around the world. Now, however, things are different, the company says.

By early 2022, however, the collective fight against COVID-19 had entered a new endemic phase and vaccine supply was no longer a barrier to access in many parts of the world, including the United States. In view of these developments, Moderna announced on March 7, 2022, that it expected companies such as Pfizer and BioNTech to respect Moderna's intellectual property and would consider a commercially-reasonable license should they request one. This announcement was widely publicized, including through coverage in The Wall Street Journal. Critically, however, and to further its belief that intellectual property should never be a barrier to access, as part of this announcement, Moderna committed to never enforce its patents for any COVID-19 vaccine used in the 92 low- and middle-income countries in the Gavi COVAX Advance Market Commitment ("AMC"). This includes any product manufactured outside the AMC-92 countries, such as the World Health Organization's project in South Africa, with respect to COVID-19 vaccines destined for and used in the AMC-92 countries. Although they have continued to use Moderna's intellectual property, Pfizer and BioNTech have not reached out to Moderna to discuss a license.

In the suit, Moderna asks a judge to order Pfizer and BioNTech to "stop infringing" on its patents, at least in non-poor countries, and to make the two companies pay Moderna suitable damages for violating those patents.

Moderna is not seeking an injunction: it is not seeking to remove Comirnaty® from the market or to prevent its future sale. Consistent with Moderna’s patent pledge, Moderna is not seeking damages for activities occurring before March 8, 2022. And Moderna is not seeking damages related to Pfizer and BioNTech’s sales to the 92 low- and middle-income countries in the Gavi COVAX Advance Market Commitment.