ModernaTX, Inc. and Moderna US, Inc. filed suit on Friday in the District of Massachusetts against defendants Pfizer, Inc., BioNTech SE, BioNTech Manufacturing GmbH, and BioNTech US Inc. The complaint for patent infringement alleged that the defendants willfully used Moderna’s patented technologies in developing their COVID-19 vaccine, a direct competitor to the Moderna vaccine.
Moderna’s COVID-19 vaccine, which boasted 94% efficacy, was approved by the Food and Drug Administration (FDA) in December 2020.
Moderna asserts in the complaint that since their founding, they have been “singularly focused on making mRNA medicines a reality through substantial investment and years of research and development.” In the early 2010s, the complaint says, Moderna was able to chemically change mRNA and deliver the cells in the human body in the form of mRNA vaccines, one of which was intended for the coronavirus called Middle East Respiratory Syndrome, or MERS.
When the COVID-19 pandemic hit, the plaintiffs claim that they benefited from their prior mRNA and MERS research and were uniquely prepared to respond. A partnership in 2017 with the National Institute of Health focusing on the MERS vaccine also allowed them to quickly respond to the crisis. In early 2020, Moderna “diverted resources away from other projects and hired and built new teams in order to take on the challenge presented by COVID-19.”
Defendants Pfizer and BioNTech also developed a mRNA vaccine for COVID-19, which the plaintiffs argue uses the technology that they had previously developed and patented. The complaint contends that the defendants knew they were following Moderna’s lead in the vaccine, with Pfizer’s CEO stating that they were choosing to pursue “the entire spike protein, which… Moderna is using.”
Specifically, the complaint alleges that the defendants copied the chemical modifications made to the mRNA and encoded for the same exact type of coronavirus protein as the plaintiffs, which they had patented years earlier. During the pandemic, Moderna pledged to not enforce their patented technologies “so as not to distract from efforts to bring the pandemic to an end as quickly as possible.” In early 2022, when the severity of the pandemic had somewhat lessened, the plaintiffs announced that they would expect other companies to respect Moderna’s intellectual property.
The plaintiffs conclude that their suit was filed in an effort to “protect the Company’s mRNA technology platform and ensure its innovations are respected.” The complaint cites three counts of infringement. Moderna is seeking favorable judgment, judgment that the infringement is willful, monetary damages, compensatory damages, a trial by jury, and any other relief deemed proper by the Court.
The plaintiffs are represented in the litigation by Wilmer Cutler Pickering Hale and Dorr.