Moderna Tries to Send Message That It Owns the Commercial Rights to mRNA Technology in Suit Against Pfizer
In August 2022, COVID-19 vaccine manufacturer Moderna sued pharmaceutical giant Pfizer and German biotechnology company BioNTech in the United States District Court for Massachusetts for patent infringement.[1] The company is also suing for patent infringement in the Regional Court of Düsseldorf in Germany.[2]
More specifically, Moderna alleges that Pfizer/BioNTech infringed on several Moderna patents obtained between 2011 and 2016 for its mRNA platform and disease-specific vaccine designs.[3] In its complaint, the company cites prior successes in developing mRNA vaccines for infectious diseases, including its development of a vaccine for the virus that causes Middle East Respiratory Syndrome (“MERS”), another coronavirus in 2015, as evidence that it pioneered the mRNA platform that COVID-19 vaccines use.[4] This foundational research, per Moderna’s complaint, positioned the company to quickly develop its COVID-19 vaccine.[5] Both the MERS and COVID-19 mRNA vaccines encode a full-length spike protein, mimicking a key feature of coronaviruses, and encapsulates it in a lipid nanoparticle.[6]
Moderna alleges that Pfizer/BioNTech copied two essential features of its mRNA technology when developing their own vaccine, Comirnaty.[7] First, Moderna says that their vaccine competitors borrowed the “exact mRNA chemical modification” found in Moderna’s Spikevax.[8] The company complains that Pfizer/BioNTech chose this particular chemical modification despite testing other therapeutic candidates in humans that did not infringe on Moderna patents.[9] Secondarily, Moderna argues that Pfizer/BioNTech copied the full-length spike protein code and lipid nanoparticle formulation.[10]
For its part, Pfizer believes the Moderna suit is unfounded and contends that Comirnaty was developed using BioNTech’s own proprietary pioneering mRNA research and platform.[11] Both Pfizer and BioNTech expect to fight the lawsuit.[12]
Moderna’s suit against Pfizer/BioNTech resembles previous patent infringement litigation filed against Moderna by Canadian pharma corporations Arbutus Biopharma and Genevant Sciences earlier in 2022.[13] There, Arbutus/Genevant sought fair compensation for the use of delivery technologies related to the vaccines, rather than an injunction.[14] Moderna denied Arbutus’ allegations.[15] Here too, the patent holder (Moderna) does not seek to remove the Pfizer/BioNTech vaccine from the market. Rather, Moderna hopes to force Pfizer/BioNTech into licensing its mRNA platform technology for their vaccine.[16]
The suit also marks what some believe is a return to normalcy in patent infringement litigation in the biotechnology space after a ceasefire during the pandemic.[17] In 2020, Moderna itself pledged that it would not enforce its patents during the pandemic.[18] However, the company set the stage for its suit against Pfizer/BioNTech when it amended that pledge in March 2022.[19] Although Moderna is not seeking to collect monetary damages from the billions that Pfizer/BioNTech collected earlier in the pandemic when billions of doses of the two vaccines were administered, the outcome of the cases might have broader implications for the biotechnology industry.[20] Although Spikevax and Comirnaty were among the first mRNA-based therapeutics, many more potential vaccine applications for respiratory diseases and latent viruses like Epstein-Barr and HIV are on Moderna’s global public health strategy.[21] The resolution of the patent claims in this case could have broader implications for ownership over one of biotechnology’s next great therapeutic platforms.
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