On August 26th, Modernatx, Inc. and Moderna US, Inc. sued Pfizer and Biontech SE, (Case 1:22-cv-11378 [D. Mass.]) for treble damages and attorney’s fees related to the alleged direct or indirect infringement of three of Moderna’s patents with claims directed to the mRNA vaccines developed by Moderna to prevent or lessen the symptoms of COVID-19 infections. The patents in suit are U.S. Pat. Nos. 10,898,574; 10,702,600 and 10,933,127. Claim 2 of the ‘574 patent is directed to lipid nanoparticles comprising an mRNA encoding a polypeptide, wherein the mRNA comprises one or more uridines, where substantially all of the uridines are modified. This is my compressed version of this patent claim, since the events leading to filing this suit are more interesting at this stage.
In its initial press release of October 8, 2020, “Statement by Moderna on Intellectual Property Matters During the COVID-19 Pandemic”, Moderna stated that it would not enforce its patents against those making vaccines intended to combat the pandemic.” Moderna stated that it would license the IP “for COVID-19 vaccines to others for the post-pandemic period.”
These “Global Commitments” were admirable but they were voluntary on Moderna’s part. So that meant that Moderna could decide for themselves when the pandemic had ended. As summarized in the Complaint:
“By early 2022…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 “Moderna’s Updated Patent Pledge” (March 7, 2022) it states that “Moderna will never enforce our patents against companies manufacturing in or for the 92 low- and middle-income countries in the Gavi COVAX Advance Market Commitment (AMC) provided that the manufactured vaccines are solely for use in the AMC 92 countries”. In other words, Moderna wants Pfizer to pay monetary damages for its domestic or “high income country” infringement post-March 7, 2022 when Moderna decided that COVID-19 had by then become endemic.
Now I am a birder and to birders “endemic” means found in a specific place and nowhere else, e.g., the Yellow-billed Magpie is endemic to California. So I poked around on the Internet and found an alternative definition: “The COVID-19 virus could become endemic, meaning it will persist in a less fearsome mode like the flu or the common cold. But that might not happen until 2024, says a new study from Yale published this week in PNAS Nexus, July 7, 2022.” (WebMD)
So the definition of an endemic pathogen is somewhat fluid, but does that really matter? Could Moderna’s Updated Patent Pledge simply have discarded the original pledge altogether and stated that Pfizer’s allegedly willful infringement say, occurred when Pfizer’s vaccine was first used in the U.S.? This complaint essentially contains a prayer for sympathy for a plaintiff that sued an alleged infringer at a time of its choosing. But will the defense of equitable estoppel come in to play? I am not going to expand on the elements of this defense, but refer you to J. M. Mueller, Patent Law, 4th ed. at pages 540-541. We may learn a lot more about this hoary doctrine from Pfizer.