Posts Tagged: "Moderna"

The biggest vaccination effort in the history of medicine is underway to eradicate the global pandemic, with several strong prospects appearing poised for regulatory approval. As of December 2020, data from the World Health Organization showed over 50 vaccine candidates in clinical research, and 163 more in the preclinical stage. The wait could soon be over. Two separate vaccines – one from Pfizer and BioNTech and one from Moderna – are pending emergency use authorization from the U.S. Food and Drug Administration. The former is already being administered for the first time outside of clinical trials following its approval by the UK government. That’s why recent calls to strip away intellectual property protections are so dangerous. Specifically, some nations have asked the World Trade Organization (WTO) to waive intellectual property protections related to COVID-19 – including not only vaccines, treatments, diagnostics, and medical technologies, but all forms of IP – until the majority of the world’s population has developed immunity. They argue that the current global intellectual property system is a barrier to accessing said COVID-19 vaccines, treatments, diagnostics, and medical technologies.

As Pfizer and BioNTech announced this week that results of their COVID-19 vaccine have exceeded expectations, the technology behind the vaccine (messenger RNA, or mRNA) has taken center stage. Last month, Moderna Therapeutics, one of the global leaders in the race to produce a COVID-19 vaccine using mRNA, made the following statement regarding enforcement of its patents: “We feel a special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible. Accordingly, while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic. Further, to eliminate any perceived IP barriers to vaccine development during the pandemic period, upon request we are also willing to license our intellectual property for COVID-19 vaccines to others for the post pandemic period.” This post examines why Moderna made this patent pledge by examining its mRNA technology, go-to-market status, patent landscape, and market position.

IPWatchdog’s most recent webinar focused on the role of IP in the development of the most promising vaccines to combat COVID-19 and included speakers from the medical community, the U.S. Food and Drug Administration (FDA) and the biopharmaceutical industry. The upshot was: wear masks, get the vaccine when it’s available to you, trust the FDA, and stop targeting IP rights, since there’s no evidence they have hindered the process and, in fact, IP has so far played a crucial role in collaboration efforts.

On January 9, 2019, Moderna Therapeutics, Inc. (“Moderna”) filed a petition requesting inter partes review of U.S. Patent No. 8,058,069 (the ‘069 patent) owned by Arbutus Biopharma. The ‘069 patent is directed to lipid nanoparticle technology, the same technology that Moderna is using in its efforts to develop a vaccine for COVID-19. The Patent Trial and Appeal Board (PTAB) instituted review, but in their decision last week, determined that Moderna had not shown, by a preponderance of the evidence, that claims 1-22 of the ‘069 patent are unpatentable under 35 USC § 103.