Moderna Versus Pfizer – The Battle for mRNA

By Varun Lakshminarayanan

              After over a year of masks, Zoom calls, and indoor-exclusive hobbies, people across the globe could rejoice in late 2020, thanks to a massive roll-out of COVID-19 vaccinations.[1] Biotech companies were able to create these vaccines with unprecedented speed due, in large part, to the efforts of Drew Weissman, PhD, and Katalin Karikó, PhD, whose 2005 research into messenger ribonucleic acid (“mRNA”) technology served as the backbone for vaccines such as Moderna’s Spikevax® and Pfizer’s Comirnaty®.[2] It seemed like their work awarded the industry recognition, as not only were the two researchers retrospectively awarded for their groundbreaking work with the “America’s Nobel” award, but scientists everywhere were widely hailed as heroes.[3] However, as is unfortunately often the case, it now appears that corporate interests and money have thrown a wrench into that hero story. On August 26, 2022, Moderna sued Pfizer and its sister company BioNTech for patent infringement, claiming that the two companies infringed on patents that Moderna filed between 2010 and 2016, when making Comirnaty®.[4] Global sales of the COVID-19 vaccinations are expected to reach $107 billion by the end of the year, with Pfizer and BioNTech receiving two-thirds of that amount.[5] A Moderna victory in a patent war, however, could quickly change the financial landscape between the companies.    

            Dr. Drew Weissman and Dr. Katalin Karikó’s research into the DNA-like technology dates back to 1998.[6] mRNA technology is a synthetically-created molecule that, when integrated into a vaccine, can induce a protective immune response by instructing the host’s body to create proteins to fight-off infections.[7] While mRNA had existed before Drew Weissman and Katalin Karikó’s research, it was unstable, and the human body would recognize it as a threat and break down the mRNA before any intended effect could be achieved.[8] However in 2005, the two researchers had a breakthrough when they discovered that by altering a base aspect of mRNA, known as nucleosides, the technology could travel undetected through the body.[9] While the discovery was met with a muted response from the medical community, the two researchers decided to patent what they felt was a radical step forward for the future of vaccinations in 2006.[10]

            In 2010, Derrick Rossi, PhD, founded Moderna to create a company that worked exclusively in the mRNA space.[11] Rossi had made, what he at the time believed, was a new discovery that by replacing two nucleosides, uridine and cytidine, with pseudouridine and 5-methylcytidine, mRNA could successfully transverse the human body.[12] The only problem was that Drew Weissman and Katalin Karikó had already made that exact discovery.[13] At the time, Moderna was not interested in simply licensing the two researchers’ patent and pivoted to make something unique in that space which it could patent for itself.[14] In 2014, Moderna was granted its own patent for a discovery made by one of its employees, Jason Schrum, who found that a nucleoside called 1-methylpseudouridine created a more efficient mRNA than pseudouridine did.[15] Nevertheless, this new patent still covered much of the same ground that Drew Weissman and Katalin Karikó’s original patent did.[16] In 2015, Katalin Karikó, who now works for BioNTech, foresaw an eventual “fierce battle for licensing.”[17]

            It appears that Katalin Karikó’s prediction about the patent war has finally come to pass.  Moderna filed its complaint against Pfizer and BioNTech in the Massachusetts District Court, alleging that the sister companies infringed on “two critical features” of its mRNA process.[18] The first infringement claim is over the 1-methylpseudouridine method patent that Schrum discovered.[19] The second claim alleges that Pfizer and BioNTech copied the chemical-packaging process that Moderna uses to deliver the mRNA vaccine into the human body.[20] Moderna further alleges that Pfizer and BioNTech effectively acknowledged Moderna’s innovation by moving forward with a vaccine that infringed on Moderna’s patented technology, despite having four separate candidates during the clinical testing phase that did not.[21] Moderna states that these processes allowed Pfizer and BioNTech to expedite the development of Comirnaty®, and were thus the beneficiaries of a “substantial financial windfall.”[22] BioNTech responded with a press release on its website claiming that its work was original and, while lamenting the ire shown towards successful products like Comirnaty®, is prepared to “vigorously defend” itself if Moderna wants to go to war.[23] 

            The battle lines seem to have been drawn and it is likely that the courts will finally have to untangle Moderna’s patent over Jason Schrum’s 1-methylpseudouridine method and determine if it is unique from Drew Weissman and Katalin Karikó’s work. In the 2013 Supreme Court case, Ass’n for Molecular Pathology v. Myriad Genetics, the Court held that DNA is patent-eligible when it is not natural.[24] However, the Court stopped short of making a ruling on method patents for DNA technology and only clarified that a party cannot patent what is already a “well understood” process.[25] Nevertheless, the Supreme Court has also held that methods which increase the efficiency of a previously patented method, particularly when pertaining to “medicine techniques”, warrant separate patents.[26] mRNA is an ever-evolving technology and Moderna believes, even as far back as 2015, that its work has left Drew Weissman and Katalin Karikó’s research in the rearview mirror.[27] Moderna believes that it is firmly ahead of everyone else in the mRNA space and as Moderna’s Chief Executive Officer Stéphane Bancel once said when asked about Moderna’s ambition to become the only mRNA game in town, “I understand people are not happy. I understand people are jealous. I understand all that. It’s life.”[28]

[1] Angelica Peebles, Moderna Sues Pfizer, BioNTech over Covid Vaccine Despite Pledge, Bloomberg (Aug. 30, 2022, 6:45 AM),

[2] Penn mRNA Scientists Drew Weissman and Katalin Karikó Receive 2021 Lasker Award, America’s Top Biomedical Research Prize, Penn Med. News, (last visited Aug. 31, 2022); see also CDC Centers for Disease Control and Prevention, Overview of Covid-19 Vaccines (Aug. 24, 2022),

[3] Maggie Fox, Researchers who Developed the mRNA Technology Behind COVID Vaccines Win “America’s Nobel”, CNN (September 24, 2021, 9:22 PM),; see also Alice Park & Jamie Ducharme, The Miracle Workers, Time, (Dec. 13, 2021, 7:41am),

[4] See Adrianna Rodriguez, This Week in COVID: Moderna Sues Pfizer-BioNTech, Paxlovid Study Shows no Benefit for Certain Adults, Fauci to Retire, USA Today (Aug. 27, 2022, 5:00 AM),

[5] Ryan Cross, Moderna Sues Pfizer and BioNTech over COVID Vaccine Patents, Boston Globe, (Aug. 26, 2022),

[6] Thomas Schlake et al., Developing mRNA-Vaccine Technologies, 9 RNA Biology 1319, 1330. (11th ed. 2012).

[7] Id.

[8] Ting Yu, How Scientists Drew Weissman (MED’87, GRS’87) and Katalin Karikó Developed the Revolutionary mRNA Technology Inside COVID Vaccines, Bostonia, (Nov. 18, 2021),

[9] Id.

[10] Id.

[11] Julia Kollewe, Covid Vaccine Technology Pioneer: ‘I never Doubted it Would Work’, The Guardian, (Nov. 21, 2020),; see also Yu, supra note 8.

[12] Elie Dolgin, The Billion-Dollar BioTech, 522 Nature, 26, 26-27 (2015)

[13] Id. at 27.

[14] Id.

[15] Id.

[16] Id. at 27-28.

[17] Id. at 27.

[18] Complaint at 21, Modernatx, Inc. and Moderna US, Inc., v Pfizer Inc. BioNTech SE, BioNTech Manufacturing GMBH, and BioNTech US Inc., No. 1:22-cv-11378 (Mass. Dist. Ct. Aug. 26, 2022).

[19] Id. at ¶ 57.

[20] Id.

[21] Id. at ¶ 19.

[22] Id. at ¶ 80.

[23] Press Release, BioNTech, Statement on Patent Infringement Lawsuit Filed by Moderna, (Aug. 26, 2022) (on file with author).

[24] Ass’n. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 579 (2013).

[25] Id.

[26] Bilski v. Kappos, 561 U.S. 593, 605-06 (2010).

[27] Dolgin, supra note 12.

[28] Id. at 28.