![]() This complex matrix of patents, licenses and agreements between these entities highlights the intricacies involved in biopharmaceutical development. The NIH also has four other provisional patent applications on a novel coronavirus vaccine as disclosed in a recent publication 17. A report by Public Citizen identified a pending patent application on this modified spike protein that was filed by the NIH 19. Moderna, CureVac, Pfizer and BioNTech have all disclosed that the mRNA used in their vaccine candidates encodes a stabilized version of the spike protein that was developed by the NIH. The mRNA vaccine platform for COVID-19 relies on the production of the coronavirus spike protein to elicit an immune response. It is also important to note that the US National Institutes of Health (NIH) and Moderna entered into an agreement in 2019 to co-develop coronavirus vaccines however, this was before the identification and spread of SARS-CoV-2 17, 18. Genevant sublicensed the patents to BioNTech, who then entered into an agreement with Pfizer to develop a COVID-19 vaccine 14, 15, 16. Moreover, Arbutus also entered into an agreement with Roivant to spin out Genevant, which received a license for the patent portfolio on lipid nanoparticles 13. The litigation in Canada was eventually settled, but in 2018 Moderna began filing inter partes reviews (IPR), a procedure for challenging the validity of a US patent before the US Patent and Trademark Office, on three of Arbutus’s patents, which concluded with the cancellation of claims in two of the three challenges 12. Acuitas also granted a sublicense to Moderna however, in 2016 Arbutus declared that Acuitas’s sublicense to Moderna was improper and took to the Canadian legal system for remedy 10. In 2016, Acuitas entered into a development and option agreement with CureVac, which included access to patents on lipid nanoparticle technology 11. Further analysis reveals that in 2012 Arbutus licensed a set of patents relating to the delivery of nucleic acids to Acuitas Therapeutics. SEC filings show that patents relating to this early technology were solely assigned to the University of British Columbia and then licensed back to Arbutus 10. ![]() Some early work on lipid nanoparticles was done jointly by the University of British Columbia and Arbutus Biopharmaceuticals in 1998. 1.Īnother key aspect of an mRNA vaccine platform is the ability to deliver the mRNA to a cell using a lipid nanoparticle. ![]() A visualization of the landscape is shown in Fig. We identified patents that were relevant to various vaccine technology platforms and used US Securities and Exchange Commission (SEC) filings to highlight pertinent licensing deals. In an attempt to demonstrate the complexity involved in IP protections and licensing deals surrounding COVID-19 vaccine technology, we developed a preliminary patent network analysis. ![]() These larger entities are designated as innovators because they transform the foundational technology into the final market product. The foundational technology needed to develop a vaccine could have been invented in an academic lab setting or startup research firm, protected through patents, and subsequently licensed out to a larger entity for further development and commercialization. Therapeutic development programs tend to consist of an intricate relationship between an inventor and an innovator 2. For example, the underlying technology used to develop a vaccine can be protected by patents, while manufacturing methods and techniques (know-how) can be protected by trade secrets. Webs of intellectual property claims underpin the marketing of many vaccines. ![]()
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