Vials of Moderna COVID-19 vaccine sit on a table at a COVID-19 vaccination clinic on April 06, 2022 in San Rafael, California.
The tech startup behind a widely used vaccine against the coronavirus has sued a major competitor over what it says is improper and unlawful use of the company’s patented vaccine technology.
Pharmaceutical company Moderna filed a complaint against Pfizer and its German-based partner BioNTech in federal court in Massachusetts on Friday. Moderna alleges that Pfizer and BioNTech copied Moderna’s patented vaccine technology, and while Moderna had allowed this for a certain period of time during coronavirus pandemic, the companies are now using patented technology without permission.
The complaint focuses on Moderna’s messenger RNA (mRNA) technology at the heart of its vaccine. According to Moderna, mRNA was a “new and unproven technology” as of 12 years ago, but it was Moderna’s main focus: according to the complaint, Moderna filed patents for its mRNA technology between 2011 and 2016.
That focus, the complaint says, put Moderna in a unique position to help fight back against the coronavirus as it grew into a global pandemic.
“When the COVID-19 pandemic struck, Moderna had already conducted a decade of foundational research in the area of mRNA medicines, including specifically on coronaviruses, and was uniquely positioned to respond to the crisis,” the complaint says, noting that the company had planned to bring its first product to marked in “the mid-2020s” but pivoted when the pandemic emerged.
“[W]hen it became clear that the virus that causes COVID-19 had the potential to create a pandemic, Moderna answered the call,” the complaint says. “For a company as small as Moderna, with fewer than 1,000 employees at the time, this was no small feat.”
Moderna acknowledged that several months into the pandemic, it pledged to refrain from enforcing its patents so that as many people could access the vaccine as possible.
Moderna says, however, that time has passed.
“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,” the complaint says. “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.”
According to Moderna, Pfizer and BioNTech haven’t been in touch.
“Although they have continued to use Moderna’s intellectual property, Pfizer and BioNTech have not reached out to Moderna to discuss a license,” the complaint says. “Despite recognizing the importance of patents to innovators such as Moderna, Pfizer and BioNTech have copied Moderna’s intellectual property and have continued to use Moderna’s inventions without permission.”
The complaint notes that Moderna had committed to never enforce its patents for the COVID-19 vaccine used in 92 low- and middle-income countries, including vaccine made outside those countries for use in those countries.
Moderna alleges that Pfizer and BioNTech copied the smaller firm’s technology in two key ways, according to the complaint:
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.
“We believe that Pfizer and BioNTech unlawfully copied Moderna’s inventions, and they have continued to use them without permission,” said Moderna Chief Legal Officer Shannon Thyme Klinger in the press release. “Outside of AMC 92 countries, where vaccine supply is no longer a barrier to access, Moderna expects Pfizer and BioNTech to compensate Moderna for Comirnaty’s ongoing use of Moderna’s patented technologies. Our mission to create a new generation of transformative medicines for patients by delivering on the promise of mRNA science cannot be achieved without a patent system that rewards and protects innovation.”
Moderna also filed a lawsuit in Germany, the press release said.
Moderna is seeking a court judgment that Pfizer and BioNTech have infringed on one or more of Moderna’s patents and an order that it stop doing so in countries where the vaccine is readily available.
“Compensating Moderna with monetary damages for using its patented technology will enable the Company to continue investing in its mRNA technology platform so that it can develop medicines that can treat and prevent a wide range of diseases,” the lawsuit says.
Moderna is not asserting its patent rights stemming from its collaboration with the National Institutes of Health in fighting COVID-19; nor is it seeking to remove Pfizer’s Comirnaty medication from the market or prevent its future sale.
“Consistent with Moderna’s patent pledge, Moderna is not seeking damages for activities occurring before March 8, 2022,” the complaint added.
In a statement, Pfizer indicated confidence that it would defeat Moderna’s claim.
“Pfizer/BioNTech has not yet fully reviewed the complaint but we are surprised by the litigation given the Pfizer/BioNTech COVID-19 Vaccine was based on BioNTech’s proprietary mRNA technology and developed by both BioNTech and Pfizer,” Pfizer said in a statement emailed to Law&Crime. “We remain confident in our intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the allegations of the lawsuit.”
Read the complaint here:
[Image via Justin Sullivan/Getty Images.]
