The suits, which were filed in the United States District Court for the District of Massachusetts (where Moderna is headquartered) and in the Regional Court of Düsseldorf in Germany (where BioNTech is based) allege that Pfizer and BioNTech copied the technology used to create Moderna's COVID-19 vaccine, Spikevax.
"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 Officer Stéphane Bancel said in an Aug. 26 news release.
Bancel said that Moderna had started building its “foundational platform” for the COVID-19 vaccine in 2010 and had done patented work on other coronavirus vaccines in 2015 and 2016, which “enabled us to produce a safe and highly effective COVID-19 vaccine in record time after the pandemic struck.”
In October 2020, Moderna pledged that it would not enforce its COVID-19-related patents “while the pandemic continued.”
It also promised never to enforce its patents for any COVID-19 vaccine in 92 low- and middle-income countries in the “GAVI COVAX Advance Market Commitment (AMC 92).” In March, with COVID-19 vaccines readily available in developed countries, Moderna “updated its pledge,” saying that it “expected companies such as Pfizer and BioNTech to respect its intellectual property rights and would consider a commercially reasonable license should they request one for other markets” outside the 92 poorest countries.
Moderna Chief Legal Officer Shannon Thyme Klinger said in the statement that the company believed “Pfizer and BioNTech unlawfully copied Moderna's inventions, and they have continued to use them without permission.”
Moderna’s patents were infringed in two ways, the lawsuits allege.
First, Moderna claims that Pfizer and BioNTech took four different vaccine candidates into clinical testing, but ultimately proceeded with a vaccine that has “the same exact mRNA chemical modification to its vaccine” as does Spikevax. Moderna says its scientists began developing this chemical modification, which avoids provoking an undesirable immune response when mRNA is introduced into the body, in 2010, and that the company was the first to validate it in human trials in 2015.
Moderna also alleges that Pfizer and BioNTech copied its “approach to encode for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus.” The pharmaceutical manufacturer said its scientists developed this approach when they created a vaccine for the coronavirus that causes Middle East Respiratory Syndrome (MERS) several years before COVID-19 first emerged, though that vaccine was never brought to market.
“When COVID-19 emerged, neither Pfizer nor BioNTech had Moderna's level of experience with developing mRNA vaccines for infectious diseases,” Moderna said in its statement, “and they knowingly followed Moderna's lead in developing their own vaccine.”
Pfizer-BioNTech’s “Comirnaty” vaccine against COVID-19 has reportedly been more commercially successful than the Moderna vaccine, earning revenues of about $22 billion this year compared to $10.4 billion for Moderna’s vaccine, according to a Reuters article.
Pharmaceutical patent litigation is not uncommon, and Pfizer, BioNTech and Moderna are all reportedly currently facing lawsuits for patent infringements.
“The litigation we most often see is between patentees (innovator pharmaceutical companies) and generics,” said Cynthia Tape, counsel at Lenczner Slaght LLP in Toronto, and whose practice focuses on patent and commercial litigation.
“Patent litigation between innovator companies — as in this case — is much less common,” Tape told The Lawyer’s Daily in an email. “Moderna’s lawsuits against Pfizer and BioNTech — along with a number of other lawsuits involving these and other companies in the mRNA vaccine space — undoubtedly reflect the high value of mRNA vaccine technology and an effort to stake out territory in this new market.
“Moderna’s strategy is interesting and seems to reflect a sensitivity to the unique circumstances of the past couple of years,” she continued. “In patent infringement cases where the alleged infringer is already on the market, as are Pfizer and BioNTech in this case, the patentee typically asks for monetary damages based on all the alleged infringer’s prior sales, as well as injunctive relief that could include a court order that the infringer stop selling the infringing product.
“A plaintiff can seek a narrower set of remedies, as it sees fit, and in this case Moderna is not asking for damages prior to March 2022 (that is, for the period when COVID-19 vaccines were not widely available), or for sales of the Pfizer and BioNTech vaccine to AMC 92 low- and middle-income countries (where vaccine access continues to be challenging). Moderna is also not seeking injunctive relief. In other words, if Moderna is successful, Pfizer and BioNTech would not be ordered to stop marketing their vaccine.”
Full details of Moderna’s claims “remain to be seen, and it is possible that Pfizer might assert patents of its own in response,” Tape said. “The Moderna claims will be a fascinating pair of cases to watch as they progress.”
If you have any information, story ideas or news tips for The Lawyer’s Daily on business-related law and litigation, including class actions, please contact Elizabeth Raymer at elizabeth.raymer@lexisnexis.ca or 905-415-5888.