What happens if a company attempts to block the sale and distribution of a newly developed and approved COVID-19 vaccine? In view of a recent PTAB decision, it might be a real issue. Moderna, who is developing a novel COVID-19 vaccine based on their mRNA (messenger RNA) technology platform just lost in their attempt to invalidate 3 Arbutus Biopharma (AB) patents. While they succeeded with invalidating US 9,404,127 and partially invalidating US 9,364,435, they failed to invalidate any of Claims 1-22 in US 8,058,069 (US '069). This is potentially a problem for Moderna as US '069 claims nucleic acid-lipid particle formulations (a nucleic acid and 3 types of lipids).
Back in January 2019, Moderna spent a great deal of time and money in an attempt to invalidate all three of AB's patents by filing three inter partes reexamination requests with the PTAB. With US '069 unscathed, we're now left with the question of whether or not mRNA-1273, Moderna's vaccine candidate that is in phase 3 clinical trials, would infringe this patent.
We don't know the answer to that question. We also don't know if AB would attempt to enforce this patent, much to the detriment of their public reputation (can you imagine the outcry if a vaccine were blocked from sale). I would expect Moderna to seek a license from AB if there is a real question of infringement for mRNA-1273. While the court of public opinion might stop AB from initially enforcing their rights, a good PR campaign and very reasonable licensing terms would put the onus on Moderna to accept or be blocked, at least temporarily, from manufacturing and selling their vaccine. Stay tuned.