What is Alnylam’s Covid patent lawsuit against Moderna and Pfizer all about?
Zachary Silbersher
Moderna faces a new patent lawsuit related to its Covid vaccine. On March 17, Alnylam Pharmaceuticals commenced two separate patent lawsuits—one against Moderna and another against Pfizer. Both suits claim that the Covid manufacturers’ vaccines are infringing a patent owned by Alnylam. So what are Alnylam’s lawsuits all about?
Both lawsuits assert the same single patent, U.S. Patent No. 11,246,933. The patent purports to cover a cationic lipid. mRNA therapies, which includes both Moderna’s and Pfizer’s vaccines, rely upon nucleic acid-lipid particles (LNP) to deliver the nucleic acid payload to the body.
Moderna’s LNP delivery system includes four-lipid systems (also available here) ingredients, one of which is a cationic lipid. The other ingredients include a non-cationic phospholipid, cholesterol and a conjugated lipid. Each individual lipid performs one or more functions to improve delivery of the nucleic acid payload. Cationic lipids are positively charged, and therefore, interact with the negative charge on the nucleic acid to essentially create a protective bubble around the RNA. They also interact with negative charges on cell membranes to promote transfection efficiency, i.e., delivery into the cell. Phospholipids along with cholesterol help stabilize the lipid complex, and conjugated lipids help increase the time the drug remains active within the body.
Accoding to Alnylam’s complaint, cationic lipids do not exist naturally in nature, and they must therefore be synthesized. Early uses of cationic lipids for LNP delivery systems yielded concerns regarding toxicity issues. Alnylam therefore claims to have overcome some of these issues by inventing proprietary cationic lipids that are biodegradable, and can therefore be metabolized and eliminated from the body in a manner that reduces toxicity concerns.
The patent that Alnylam is asserting against both Moderna and Pfizer includes one of these purportedly proprietary cationic lipids. Specifically, the ‘933 patent is directed to cationic lipids that are biodegradable for LNP delivery of mRNA drugs.
Alnylam’s patent is a very new one—the patent issued on February 15, 2022. However, the patent is a continuation of several earlier parent applications claiming priority as early as December 2011. Nevertheless, the recent issuance of the ‘933 patent may partially explain why we are seeing this lawsuit now, rather than sometime earlier.
Moderna has separately claimed to have its own patent covering the cationic lipid that it uses in its vaccine. As I discussed in an separate post, Moderna’s cationic lipid is known as SM-102, and the patent is U.S. Patent No. 9,868,692. Moderna’s ‘692 patent has a priority date of September 2016. Interestingly, Moderna’s patent does not appear to cite to any of Alnylam’s cationic patents within the patent family including the ‘933 patent. Likewise, Alnylam’s ‘933 patent does not appear to cite to Moderna’s cationic lipid patent. Despite all of this, based on technicalities in patent law, there is a universe where Moderna has a patent covering its own proprietary cationic lipid, but nevertheless also infringes upon Alnylam’s patent.
(Moderna owns other patents covering different embodiments of other cationic lipids. Given that Alnylam appears to sell its own drugs, which also use some of its patented technology, what would be very interesting, although at this point it is only speculation, is if Moderna counterclaimed against Alnylam for infringement of one its patents.)
According to Alnylam’s complaint, Pfizer also uses a four-lipid LNP delivery system for its mRNA vaccine. In particular, Pfizer’s LNP system uses a biodegradable cationic lipid known as ALC-0315.
In its lawsuit against Moderan and Pfizer, Alnylam is only seeking monetary relief—i.e., past damages and a future royalty. Importantly, Alnylam is not pursuing an injunction against either Moderna’s or Pfizer’s vaccines, and cannot therefore, by virtue of this lawsuit, remove either vaccine from the market.
Rather, Alnylam’s goal from these suits is to extract a royalty on each vaccine sold by Moderna and Pfizer. Alnylam is not required to make a royalty demand at this time, and thus, it is not clear yet what that royalty demand might be. Nevertheless, a general rule of thumb regarding patent damages is that, the more critical a patented feature is to the infringing product, the higher the royalty rate. For retail products, that is often assessed in terms of consumer demand—if a patented feature is expressly marketed, and consumer surveys show that the feature is what drives demand, that can be evidence to substantiate a higher royalty.
Vaccines are not marketed in the same way as consumer electronics. Yet, there appears to be recognition within the industry that developing a workable LNP delivery system has been one of the major obstacles to successfully developing mRNA therapies. Indeed, Alnylam quotes a former Moderna scientist who purportedly claimed that LNP Technology is the “unsung hero of the whole thing.” (See Alnylam’s complaint against Moderna, ¶ 41, quoting Ryan Cross, “Without these lipid shells, there would be no mRNA vaccines for COVID-19,” Chemical & Engineering News).
Alnylam’s lawsuit claims that, in 2014, Alnylam and Moderna discussed the possibility of Moderna licensing Alnylam’s patented LNP technology. In particular, the parties appear to have entered an NDA, and Alnylam claims to have disclosed confidential information regarding its LNP technology. Alnylam also claims that at the time of these discussions, Moderna had not yet developed its own proprietary cationic lipid technology. Unlike its suit against Moderna, Alnylam’s suit against Pfizer does not allege any prior licensing discussions between the companies regarding the prospect of Pfizer licensing Alnylam’s patents.
This difference could theoretically become very important with respect to the damages that Alnylam could claim. If Alnylam’s allegations against Moderna are true, that could bolster a claim that Moderna is not only infringing Alnylam’s patent, but copied the patent willfully. That, in turn, could potentially subject Moderna to upwards of treble damages or a potentially higher royalty rate as compared to what might be recoverable against Pfizer.
That said, interestingly, Alnylam does not make any willfulness allegations against either Pfizer or Moderna that we would typically see when a plaintiff is preserving a claim for willful damages. Accordingly, Alnylam may have deliberately chosen to make its claim for relief in these suits rather conservative—not asking for an injunction, and not including affirmative willfulness allegations. Perhaps that is intended to stave off any negative allegations that Alnylam is greedily attempting to grab more than it is entitled to. We may be near the end of the pandemic, but sensitivities around suing the vaccine makers remains somewhat untested.
A final interesting wrinkle to this suit is that one of Alnylam’s principle products is a ONPATTRO®. Arbutus, which is embroiled within its own high-profile lawsuit against Moderna, has separately licensed certain LNP patents to Alnylam in connection with ONPATTRO®.
Accordingly, the company suing Moderna for infringing an LNP patent has separately licensed LNP patents from the other company suing Moderna for LNP patents. If the players within this space are not that numerous, it begs the question why Moderna has not shored up a low royalty license with each of them to avoid the hassle and expense of drawn-out patent litigation. Perhaps the simplest answer is the correct one—Moderna really doesn’t believe it is infringing any of these patents, and it is intent on proving it. That remains to be seen.