Arbutus’ Lawsuit Against Moderna: Who Owns the COVID-19 Vaccine?
In March 2022, Canadian pharmaceutical corporations Arbutus Biopharma and Genevant Sciences sued Moderna in the US District Court for the District of Delaware for the alleged infringement of US patents linked to the creation of Moderna’s COVID-19 vaccine, mRNA-1273.[1] Arbutus’s president and CEO, William Collier, noted that Arbutus and its licensee, Genevant, do not seek an injunction from Moderna[2] Rather, they seek fair compensation for its use of the patented delivery system that was developed with great effort without which the vaccine would not have been successful.[3] Moderna denies the allegations and will vigorously defend itself in court.[4] Arbutus’s complaint states: “[The vaccine] accomplishment was made possible by Moderna’s use of breakthrough technology Arbutus had already created and patented—a revolutionary lipid nanoparticle (“LNP”) delivery platform that took the scientists of Arbutus years of painstaking work to develop and refine.”[5]
While Arbutus’ patents do not cover genetic material, mRNA, the patents cover lipid nanoparticles (LNP) that enclose mRNA.[6] While mRNA-based vaccines and medicines were discovered decades ago, the hurdle was in its delivery to target cells in the human body.[7] Without protection, the fragile mRNA degrades quickly in the body.[8] For Moderna’s mRNA vaccine to work, the mRNA must have a protective mechanism as it is deployed in the body and delivered through cell walls until it is finally released.[9] LNPs serve as the vehicle through which the mRNA vaccine is delivered to its target after being injected into the arm muscle.[10] Enclosed by LNPs, the mRNA blueprint for the vaccine, can travel through the human body from the injection site to a target cell before being released.[11] Without such a fatty acid delivery system, the mRNA would degrade quickly in the body and would be ineffective in providing the immune response needed to create antibodies against COVID-19. In other words, without LNP delivery, the vaccine would not work. Arbutus thus demands Moderna compensate it for using its patented discovery without any permission.[12]
Arbutus alleges that Moderna knew about Arbutus’ LNP patent and its importance to mRNA-based medicines.[13] Before the pandemic, Moderna obtained licenses to use Arbutus’ LNP patents for mRNA products.[14] However, the licenses did not grant Moderna the right to use LNP delivery for mRNA products that target COVID-19.[15]
Moderna, on the other hand, has consistently denied that its vaccine uses LNP delivery technology.[16] Instead, Moderna asserts that it has “moved beyond the delivery technology owned by Arbutus.”[17] Moderna maintains that it has created its own proprietary LNP delivery system, but has yet to disclose such invention.[18] With the lawsuit hanging over its head, Moderna would be required to disclose details regarding its LNP delivery system early in the case, which would significantly impact the direction of the suit. While patent infringement cases are lengthy and convoluted, this will be an interesting one to watch especially given the essential role Moderna’s COVID-19 vaccine played during this pandemic. Who owns the vaccine?
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