Emily Stark
*This Writing is a Blog Post. It is not an official IPTF Article Publication.
In 2020, the world desperately needed a vaccine to address the COVID-19 pandemic.[1] Three companies: Moderna, Pfizer, and Johnson & Johnson, developed and produced vaccines that would allow people to return to their ordinary lives.[2] Two of those companies, Moderna and Pfizer, both used mRNA to develop the platforms for their vaccines.[3] Researchers had been developing mRNA vaccines for years prior to the pandemic.[4] Moderna is responsible for much of the development of the mRNA vaccine technology, and Moderna filed for patents in 2010 and 2016 to protect its intellectual property rights.[5] During the pandemic, Moderna promised not to enforce these patents, so that other vaccine manufacturers could utilize this technology to contribute to the COVID response.[6] In reliance on that promise, Pfizer invested billions in developing and manufacturing its own mRNA vaccine with an eye towards ending the global health crisis.[7] Nevertheless, as the pandemic eased in 2022, Moderna reneged on its promise to not enforce its patents.[8] Moderna has since filed a lawsuit against Pfizer for patent infringement; it seeks to protect three patents related to its mRNA technology: U.S. Patent Nos. 10,898,574, 10,702,600, and 10,933,127.[9]
The basis for Moderna v. Pfizer is Moderna’s claim that Pfizer is infringing its mRNA technology patents.[10] Moderna asserts that vaccine access is no longer an issue in higher income countries, and that it therefore has a stronger interest in protecting its intellectual property.[11] Moderna argues that it pioneered the mRNA platform and invested billions of dollars into its development, and that Pfizer is now wrongfully using the platform.[12] Pfizer now finds itself embroiled in a lawsuit after it significantly relied on the ability to use Moderna’s intellectual property.[13] The doctrine of promissory estoppel may apply to Pfizer’s case, because Pfizer detrimentally relied on Moderna’s promise not to enforce its patent in Pfizer’s development of its own COVID-19 vaccine.[14] Pfizer’s reliance was arguably reasonable given the extenuating circumstance of the pandemic.[15] Pfizer relied on Moderna’s promise for two years before Moderna prematurely reneged.[16] The outcome of this lawsuit will undoubtedly influence future large scale vaccine development IP strategies in future years.[17]
[1] Burgos RM, Badowski ME, Drwiega E, Ghassemi S, Griffith N, Herald F, Johnson M, Smith RO, Michienzi SM. “The Race to a COVID-19 Vaccine: Opportunities and Challenges in Development and Distribution.” Drugs Context. 2021 Feb 16;10:2020-12-2. doi: 10.7573/dic.2020-12-2. PMID: 33643421; PMCID: PMC7889064.
[2] Id.
[3] Id.
[4] Scott Berinato, Moderna v. Pfizer: What the Patent Infringement Suit Means for Biotech, HARVARD BUSINESS REVIEW, (Sept. 16, 2022), https://hbr.org/2022/09/moderna-v-pfizer-what-the-patent-infringement-suit-means-for-biotech.
[5] Complaint at 4, Moderna v. Pfizer, MA District Court, Aug. 26 2022, 11378.
[6]Moderna, Moderna Sues Pfizer and Biontech for Infringing Patents Central to Moderna’s Innovative MRNA Technology Platform, Investors Moderna (Aug. 26, 2021), https://investors.modernatx.com/news/news-details/2022/Moderna-Sues-Pfizer-and-BioNTech-for-Infringing-Patents-Central-to-Modernas-Innovative-mRNA-Technology-Platform/default.aspx.
[7] Moderna, supra note 6.
[8] Berinato, supra note 4.
[9] Complaint, supra note 5 at 16; U.S. Patent No. 10,898,574 (filed Jan. 26, 2021); U.S. Patent No. 10,702,600 (filed Feb. 28, 2020; U.S. Patent No. 10,933,127 (filed May 5, 2020).
[10] Complaint, supra note 5 at 5.
[11] Id.
[12] Id. at 8.
[13] Id. at 4.
[14] Miriam Cherry, Promissory Estoppel, Contracts: A Real World Casebook, 2021; Moderna, Moderna Sues Pfizer and Biontech for Infringing Patents Central to Moderna’s Innovative MRNA Technology Platform, Investors Moderna (Aug. 26, 2021), https://investors.modernatx.com/news/news-details/2022/Moderna-Sues-Pfizer-and-BioNTech-for-Infringing-Patents-Central-to-Modernas-Innovative-mRNA-Technology-Platform/default.aspx.
[15] Berinato, supra note 4.
[16] Jorge Contretas, No Take-Backs: Moderna’s Attempt to Renege on its Vaccine Patent Pledge, Petrie-Flom Blog, (Aug. 29, 2022), https://blog.petrieflom.law.harvard.edu/2022/08/29/no-take-backs-modernas-attempt-to-renege-on-its-vaccine-patent-pledge/.
[17] Id.