From January to November 2020, more than 150 vaccine candidates were developed around the world. A technological race began to obtain an effective vaccine able to stop the pandemic and minimize the effects of the imminent economic crisis in the world.

At the end, in December 2020, Pfizer-BioNTech won the race for the COVID-19 vaccine by being the first company to achieve the approval of its vaccine, based on messenger RNA (mRNA) technology. Subsequently, in April 2021, the vaccine from mRNA from Moderna was also approved.

In collaborations between institutions for the development of the vaccine, the negotiation of conditions on the intellectual property ownership of the products resulting from said collaborations was essential. Even though Moderna has had a great success with the commercialization of its mRNA vaccine, at the end of 2021 two legal battles were revealed that are overshadowing Moderna’s achievements during this pandemic.

On the one hand, one of its collaborators since 2015 in the development of mRNA technology (since the technological platform was developed years before the pandemic), the National Institute of Allergy and Infectious Diseases (NAID) of the National Institute of Health in USA (NIH) requested Moderna to include 3 of its researchers in a key patent application related to the mRNA sequence -1273, considered the “active principle” of the vaccine, alleging that these researchers helped Moderna in the selection of the sequence. Although Moderna has included NAID researchers in other patent applications related to the vaccine, Moderna argues that only its researchers selected the genetic sequence without help from NAID. Additionally, the US government, through these collaborations, has provided approximately $2.5 billion of dollars to Moderna, becoming the primary funder of Moderna’s vaccine. In November 2021, the NIH challenged Moderna’s decision of excluding the NAID researchers, after months of failed negotiations.

On the other hand, there is also a legal fight with the company Arbutus Bipharma Corp, a company that owns two patents related to lipid nanoparticles that encapsulate the mRNA coding for the spike protein of COVID-19 in a similar way to Moderna’s lipid nanoparticles.

It is important to mention that this is a pre-pandemic lawsuit, since Moderna demanded the invalidation of Arbutus’ patents in 2018. Apparently, Arbutus might be winning this battle which would mean a potential infringement lawsuit. against Moderna and the payment of a royalty to Arbutus for the commercialization of the COVID-19 vaccine.

These lawsuits are still in process, and we will have to wait to see what the courts decide. However, the future implications for Moderna could be huge. Losing the litigation would not only reduce Moderna’s profits from the sale of the COVID-19 vaccine, but Moderna could also lose control over the vaccine technology since, If it is confirmed that the NAID researchers should be co-inventors, the NAID could be a co-owner of the vaccine. Being the owner of the rights implies being able to make decisions on the manufacture, commercialization, and licensing of the patent, so that the government could, in any case, grant licenses to other companies to manufacture the vaccine with the mRNA-1273 sequence.

It is important to highlight that today it is difficult to conceive the development of a technological platform, such as mRNA vaccines, without collaboration with another company or institution. In addition, there is the Pfizer-BioNTech vaccine that uses the same platform and that may eventually interfere legally with Moderna, due to the cross-use of its patents.

The foregoing is just one example of the importance of intellectual property and its proper management to ensure the competitiveness of a company. Specifically, in this case we could be facing an omission or incorrect definition of all the people who, by law, must be recognized as inventor of the vaccine, this can cause Moderna to lose millions of dollars. In this sense, it is recommended to have the appropriate technical and legal advice from the early stages of the collaboration and technology transfer process in order to avoid intellectual property issues during the commercialization of any technology.