Moderna Inc. dropped a lawsuit on Pfizer Inc. and BioNTech SE, claiming the technology in their Covid-19 shots infringes on its messenger RNA patents. The legal battle will surely be protracted and expensive. What it won’t do is slow the pace of innovation in mRNA, if gene editing tool Crispr’s legal tangles are a guide. Vaccines and therapies that use disputed technologies keep pushing forward, and new developments that improve upon and sidestep Moderna’s patent fortress will surely emerge.
Moderna claims that its rivals are stepping on its intellectual property in two areas. The first is around chemical modifications made to mRNA. Those typically are used to stabilize it and prevent immune reactions. The second is around the lipid shells used to deliver that mRNA to cells. That last bit is an area replete with lawsuits. Arbutus Biopharma Corp. and Genevant Sciences Inc. were the first to try and claim a piece of the Covid vaccine windfall, suing Moderna over its lipid nanoparticle technology. Then Alnylam Pharmaceuticals Inc. surprised the biotech world by suing Moderna and Pfizer over a particular component in those lipid shells.
The suit by Moderna is likely coming now because it will soon need to sell its vaccine not just to one type of customer -- government agencies -- but to the more conventional market for pharmaceuticals. That marketing will start as demand for its original vaccine and any new boosters diminishes. But while Moderna appears to be looking for a piece of Pfizer’s Covid vaccine windfall, its efforts won’t keep Pfizer, BioNTech or any other company from pushing mRNA into other disease areas. A Bloomberg Intelligence analysis suggests that if successful, Moderna could capture “at least mid-single-digit royalties on past and future Covid vaccine sales.”
“Money will change hands, patent attorneys will get paid. But it is really difficult, except perhaps on the margins, to think about someone really being locked out of this technology,” said Jacob Sherkow, a law professor at the University of Illinois.
Crispr provides a good guide for how this could play out. Legal woes around which institutions — the University of California or the Broad Institute of MIT and Harvard University — own the intellectual property for Crispr spooled out over a decade. Innovation didn’t slow, but when the final decision favoring the Broad Institute came down in February, companies that had licensed their IP from the California system felt a pinch. Intellia Therapeutics Inc,, which should have been riding high on outstanding data on its lead Crispr therapy, instead saw its stock drop on the patent news. But that pain is temporary. Most everyone expects a licensing arrangement will be reached.
If anything, these legal battles have encouraged innovation in the gene editing space. Scientific exploration has been driven primarily by the need to solve the limitations of the original technology. It’s also been pushed forward by companies trying to carve out their own piece of Crispr IP. As Sherkow points out, the industry does have examples of where a patent fortress might have slowed innovation. Alnylam’s lock on IP around gene silencing technology called siRNA potentially kept smaller players out of the field. Even the big players that briefly dallied in siRNA abandoned the technology, and it took 16 years to get to the first drug. Alnylam continues to dominate that space.
But mRNA looks much more Crispr-like in that multiple companies are working on vaccines and therapeutics that use the technology. The lawyers might win on this one, but luckily, patients won’t lose out.
Bloomberg
