In August 2020, we reported on the decision of the US Patent Trial and Appeal Board (PTAB) in relation to an inter partes review requested by the mRNA vaccine producer Moderna on U.S. Patent No. 8,058,069 B2 (“the ’069 patent”), owned by Arbutus Biopharma.
During this review, Moderna attempted to invalidate the ‘069 patent by arguing before the PTAB that the patent was neither novel nor inventive in view of the content of the prior art and the level of ordinary skill in the art. However, it was determined by the board that Moderna had failed to show on the weight of the evidence that the subject matter of the claims were unpatentable.
The decision of the PTAB has now been upheld by the U.S. Court of Appeals for the Federal Circuit, confirming the validity of the ‘069 patent.
The patent in question relates to lipid formulations for nucleic acid delivery and, in particular, “stable nucleic acid-lipid particles”. These nucleic-acid lipid particles may be used to deliver nucleic acids to cells for various therapeutic purposes. Nucleic acid lipid particles are known to be vital to much of Moderna’s vaccine technology, including their COVID-19 vaccine.
Interestingly, Moderna has asserted in court filings relating to the appeal proceedings that there is a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s COVID-19 vaccine. Indeed, Shaun Ryan, Moderna’s Senior Vice President and Deputy General Counsel submitted in a court declaration that Arbutus and its affiliates “have consistently taken the position with Moderna that [Moderna] requires a license to [Arbutus’s] patents, including the ’069 patent.”
Since our previous article on this matter, Moderna’s COVID-19 vaccine has gone on to acquire regulatory approval in multiple countries around the globe and now forms a pillar of our response to COVID-19. This is particularly the case in western countries that have primarily adopted mRNA vaccines for their immunisation programs. Consequently, Moderna have forecast that between 700-800 million doses of their COVID-19 vaccine will be produced in 2021, providing estimated sales of between $15-18 billion dollars.
In view of Moderna’s assertions, it appears plausible that confirmation of the validity of the ‘069 patent may pave the way for Arbutus to institute an infringement suit against Moderna in respect of its COVID-19 vaccine. If such an action were to favour Arbutus, a potential remedy is the retrospective awarding of royalty damages. Further, it may be the case that Moderna is required to pay licensing fees to Arbutus in order to utilise the lipid nanoparticle technology covered by the ‘069 patent in respect of their COVID-19 vaccine.
In practice, it remain to be seen whether such actions will be brought forward, let alone their outcome. Nevertheless, the case of Arbutus & Moderna again serves to underline the benefits of possessing a strong portfolio of intellectual property. This is particularly true for small or precommercial biotech companies, who may possess few or no marketable products, who can still look to profit from lucrative licensing agreements. Indeed, the monetisation of IP rights provides a robust means for companies of all sizes to generate significant financial revenues and maintain their competitive edge.
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