A colossal $104 billion legal battle has erupted between two of the world’s biggest Covid vaccine providers – with Moderna suing major competitors Pfizer and BioNTech for copyright infringement, claiming it copied technology that the firm pioneered.
The Moderna and the Pfizer-BioNTech Covid vaccines are both mRNA shots – a little used technology before its introduction to the mainstream during the pandemic. Moderna alleges that the competing firms copied the technology it had patented between 2010 and 2016.
The company is seeking unspecified damages from Pfizer and BioNTech for using its technology, and it is not seeking to have the vaccine removed from the market.
Pfizer tells DailyMail.com that it is ‘surprised’ by the complaint and claims the development of its shot was based on BioNTech’s proprietary mRNA technology.
Pfizer and BioNTech are projected to amass at least $104 billion in sales by the end of 2022 – and the figure is set to increase even further as the companies roll out a new Omicron-specific shot in the coming months.
One legal expert tells DailyMail.com that Moderna could likely claim royalties totaling in the billions on these sales, but its pledge to allow its IP to be infringed during some periods of the pandemic could hinder its case.
Moderna’s shot in comparison is projected to rake in $37 billion across 2021 and 2022.
As the pandemic triggered soaring infection rates and deaths in late 2020, Moderna chose not to enforce its patent rights during the rollout of the vaccines. But, it changed its policy in March – and only promised not to enforce its patents in ways that will harm low-and-middle income nations.
Moderna is alleging that its two major competitors in the rollout of the COVID-19 vaccines, Pfizer and BioNTech used its patented mRNA technology in the development of the jabs (file photo)
The Pfizer-BioNTech vaccine is America’s most popular jab, having been administered 360 million times, according to the CDC. Moderna’s follows, having been used 260 million times so far
‘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,’ Stephane Bancel, CEO of Moderna, said in a statement.
‘This foundational platform, which we began building in 2010, along with our patented work on coronaviruses in 2015 and 2016, enabled us to produce a safe and highly effective COVID-19 vaccine in record time after the pandemic struck.’
In response, Pfizer said: ‘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.
‘We remain confident in our intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the allegations of the lawsuit.’
BioNTech did not immediately respond to a DailyMail.com request for comment.
The complaint is in regards to three patents filed between 2010 and 2016 by Moderna. The firm says that it was one of the first to invest in mRNA technology over a decade ago, setting the stage for developments against Covid.
‘Over the past twelve years, Moderna has worked diligently in its laboratories to pioneer several fundamental breakthroughs in the field of mRNA technology,’ the complaint reads.
‘These discoveries span all aspects of mRNA medicines—from the characteristics and design of the mRNA itself and the protein it encodes, to the technologies to deliver mRNA to patients safely and effectively.’
Moderna alleges that Pfizer and BioNTech initially had issue developing an mRNA vaccine of its own, allowing the Massachusetts company to gain a lead in the development of the shots.
The complaint reports that Pfizer had 20 vaccine candidates, which was eventually narrowed down to four that entered clinical trials. Not all 20 candidates used Moderna’s patented findings, but the partnered firms eventually did center their efforts on those that did.
‘Unlike Pfizer and BioNTech, Moderna did not struggle with different approaches before designing its COVID-19 vaccine,’ the complaint says.
‘Instead, working from its research completed years earlier, Moderna knew how to design an effective COVID-19 vaccine and was able to respond rapid.’
It also alleges that the vaccines may have taken years to hit the market – as many had predicted at the time – if not for their initial innovations in the sphere of mRNA.
The Moderna complaint alleges that Pfizer and BioNTech infringed on three of its patents during the development of their COVID-19 shot (file photo)
In October 2020, two months before both the Moderna and Pfizer-BioNTech shots hit the market, the former said it would not enforce patents on its mRNA technology.
The move was seen as a show of good faith from the biotech company, though some critics said that by still holding the patents the company would always have the option to reverse the policy and begin file suits against other firms.
Rochelle Dreyfuss, a law professor at New York University, told DailyMail.com that this pledge could have major implications on the case. She is not sure if they courts will see it as legally binding – but if they then there is than Moderna may have trouble Pfizer infringed on their patents.
In March, the firm chose to reverse its policy. Citing increased access to the shots, Moderna announced that it would enforce its patents in ways that would not hurt 92 countries deemed low-or-middle income – where residents may have limited access to the shots.
Moderna is seeking damages for sales Pfizer made that were not in those 92 countries.
‘Outside of AMC 92 countries, where vaccine supply is no longer a barrier to access, Moderna expects Pfizer and BioNTech to compensate Moderna for [the shot’s] ongoing use of Moderna’s patented technologies,’ Shannon Thyme Klinger, Moderna’s chief legal officer, said in a statement.
‘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.’
Dreyfuss believes theses damages could be in the billions. While Moderna will not be able to claim a majority of profit earned by its competitors because it could not have matched its manufacturing capacity, it could claim royalties on many of the sales.
Pfizer and BioNTech have emerged as major winners of the vaccine rollout, projected to have amassed over $100 billion in revenue from sales of the shots by the end of 2022 (file photo)
Pfizer’s COVID-19 vaccine is available in 164 countries, only trailing the AstraZeneca shot in prevalence. Moderna is third, having been approved in 109 nations.
In the United States, the largest purchaser from private vaccine companies, the Pfizer jab has been administered more than 360 million times.
Moderna’s shot falls well behind, having been administered 230 million times, according to data from the Centers for Disease Control and Prevention (CDC).
Both companies have had booster doses approved by the Food and Drug Administration and CDC – along with fourth doses for the severely immunocompromised and for Americans over 50.