The SARS-CoV2 virus has proven to be nothing if not tenacious. While its virulence has been tempered by vaccines, boosters and treatments, it remains a force to be reckoned with. And even though many have tried to predict the pandemic’s eventual conclusion, let’s just say that reports of the coronavirus’ death have been greatly exaggerated.
Given that backdrop, more than a few pundits must have raised an eyebrow upon hearing that, with its recent COVID-vaccine intellectual property lawsuit against Pfizer and BioNTech, Moderna was, in effect, declaring the end of the pandemic.
In the suit, filed in the U.S. District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany, Moderna asserts that multiple patents were infringed upon. One involves chemical modifications to the mRNA molecule, which reduce the body’s immune response against the mRNA itself. Another involves mRNA encoding for a full-length coronavirus spike protein.
Together they form the foundation of the mRNA platform in Spikevax, Moderna’s COVID-19 shot. The technologies underlying the patents were invented by the company years before the pandemic began. Moderna alleges that Pfizer and BioNTech ultimately chose to adopt the same vaccine design and chemical modification for their COVID-19 shot, Comirnaty.
Not surprisingly, Moderna is seeking monetary damages. But the timing of the lawsuit is what has piqued the broader industry’s curiosity.
Back in October 2020, Moderna issued a statement on IP-related matters. In it, the company acknowledged there are “other COVID-19 vaccines in development that may use Moderna-patented technologies,” but vowed not to enforce its COVID-19 related patents against makers of those other vaccines “while the pandemic continues.”
Then in March of this year, Moderna issued an updated pledge, saying in effect that the situation had changed. Its August 26 lawsuit, then, was “a de facto recognition of the end of the COVID-19 pandemic by [Moderna], as the company previously signaled reluctance to pursue patent litigation while the pandemic was ongoing,” analysts from SVB Securities observed in a research note.
Moderna’s complaint cites the voluntary pledge it made more than two years ago. It goes on to explain that, by early 2022, “The collective fight against COVID-19 had entered a new endemic phase and vaccine supply was no longer a barrier to access in many parts of the world, including the United States. In view of these developments, Moderna announced on March 7, 2022, that it expected companies such as Pfizer and BioNTech to respect Moderna’s intellectual property and would consider a commercially reasonable license should they request one.”
To date, neither Pfizer nor BioNTech has requested a license. So what happens now that a competitor is asserting that it played a role in the creation of Pfizer’s shot, which the drugmaker expects will bring in $32 billion in global revenue this year?
The way forward is complicated by the fact that mRNA vaccines rely on a host of technologies developed by multiple companies, non-profit labs and government institutions. Parsing ownership will be a thorny process.
Meanwhile, in light of the slowdown in FDA approvals, no one wants to undercut these proven cash cows. Moderna says that it isn’t looking to remove Comirnaty from the market. And the various companies suing Moderna for patent infringement, which include Arbutus Biopharma/Genevant Sciences and Alnylam Pharma, aren’t looking to get in the way of Spikevax’s future sales, either.
Such disputes are typically resolved via a one-time royalty payment. If the history of IP kerfuffles among companies in the oligonucleotide space is a guide, the SVB team wrote, “The most likely outcome would be modest royalties paid by both companies,” usually in the low single digits percentage-wise.
Moderna is only suing for Comirnaty revenue Pfizer and BioNTech realized after March 8, 2022, as it said it values a speedy end to the pandemic over the potential for profits. That would imply a modest royalty payment.
Law firms for the parties, on the other hand, stand to gain much more. Legal teams for Pfizer and BioNTech are likely “to weaponize their own patent portfolio” and pursue a path of “delay and deny,” which could result in the dispute taking years to resolve in court.
Legal scholars say Moderna’s patent case may depend in part on whether we’re past the pandemic phase of COVID-19. With 400 people dying every day and current case counts sitting at around 90,000 per day – and 40,000 more currently hospitalized in American hospitals – one could argue that we are very much not. The World Health Organization certainly hasn’t downgraded the pandemic status yet.
And even though Moderna thinks its March 2020 pledge has expired, the firm’s initial promise may still be binding. Assuming Pfizer/BioNTech were justified in relying on their rival’s 2020 vow when they developed and priced Comirnaty, Moderna could be prevented from reneging (and from enforcing its patents) under a legal doctrine known as promissory estoppel.
Why is Moderna willing to take the chance of its suit backfiring for such a small amount? Probably because of the potential of mRNA as a platform technology. Determining who owns the licenses now could result in larger payouts down the line.
But Moderna may not be able to simply invalidate prior patent assurances. As long as the WHO still maintains that the COVID-19 pandemic is in force, it ain’t over ’til it’s over.