We carefully looked at each component of the Moderna mRNA-1273 vaccine in our last post. Now we are going to look at what Moderna patents (and a couple others) might cover at least some of the components of their vaccine. Please note that this post is not a legal opinion, but rather just an inquisitive look at patents that may or may not be related to the mRNA-1273 vaccine.
According to Moderna’s website, there are seven representative patents that protect its mRNA-1273 vaccine. These patents are:
US 10,703,789
US 10,702,600
US 10,577,403
US 10,442,756
US 10,266,485
US 10,064,959
US 9,868,692
From our previous post, the Moderna COVID-19 vaccine is a white/off-white lipid nanoparticle (LNP) suspension having the following components.
Active Ingredient:
mRNA-1273 (a nucleic acid)(mRNA encoding a polypeptide)
Lipid Formulation Components:
SM-102 (a proprietary ionizable lipid)(likely a cationic lipid)
PEG 2000 DMG (a PEG lipid)
Cholesterol
DSPC (a phospholipid)(also a neutral lipid)
Buffering/Solubilizing Components:
Not relevant to this discussion
For a patent to protect (cover) the Moderna vaccine, it must claim at least one component of the five vaccine components listed above and it cannot require a component not in the vaccine. Simple enough. Let us see how relevant the second Moderna patents are.
1. US 10,703,789: recites a pharmaceutical composition comprising:
a plurality of LNP, comprising
a cationic lipid,
a neutral lipid,
a cholesterol,
a PEG lipid, and,
an mRNA encoding a polypeptide
While this patent does not specifically discuss coronavirus, SARS-CoV-2, or COVID-19, it is quite possible that the pharmaceutical composition claims cover the mRNA-1273 vaccine. It appears that all four lipid components are present. And the mRNA has specific requirements (not shown above) that could relate to mRNA-1273.
2. US 10,702,600: recites a composition comprising:
a messenger ribonucleic acid (mRNA) comprising an open reading frame encoding a beta-coronavirus S protein or S protein subunit formulated in a lipid nanoparticle.
Turns out, SARS-CoV-2 virus is a beta-coronavirus. So, even though this patent discusses SARS-CoV-1, not SARS-CoV-2, it still might cover the mRNA-1273 vaccine.
3. US 10,577,403, recites a pharmaceutical composition comprising:
a plurality of LNP, comprising
a cationic lipid,
a neutral lipid,
a cholesterol,
a PEG lipid, and,
an mRNA encoding a plasma membrane protein
Patents 1 & 3 are in the same patent family. The only difference in claim 1 of patent #3 is that the mRNA encodes a plasma membrane protein instead of just a polypeptide (which one presumes would encompass a plasma membrane protein). The patent does not define whether the S protein (spike protein) is considered a plasma protein. Since Moderna refers to this patent, it is possible they contend that the S protein is a plasma membrane protein.
4. US 10,442,756, claims novel lipids.
While this patent does not specifically discuss coronavirus, SARS-CoV-2, COVID-19, it is quite possible that the claimed lipids, which are described as cationic and/or ionizable, at least generically cover the SM-102 lipid of the mRNA-1273 vaccine.
5. US 10,266,485, claims novel lipids.
This patent is like #4, except that the lipid claims are narrower.
6. US 10,064,959, claims synthetic mRNA made by a specific process.
While this patent does not specifically discuss coronavirus, SARS-CoV-2, or COVID-19, it is quite possible that the claimed methodology is that used to synthesize mRNA-1273. We do not know how mRNA-1273 is made as this is Moderna’s proprietary technology. We can assume that Moderna listed this patent because its methodology is being used.
7. US 9,868,692, claims one ionizable lipid and a LNP containing it.
While this patent does not specifically discuss coronavirus, SARS-CoV-2, or COVID-19, the fact that it only claims one lipid and Moderna refers to it as a relevant patent, we must assume that this lipid is SM-102. We cannot confirm as Moderna has kept the structure of SM-102 confidential.
To conclude, Moderna’s seven patents cover a process of making mRNA, mRNA-LNP compositions, and generic/specific lipids. I also note that their patent estate is quite robust. They have invested substantial time and money into their IP.
In the 26 August 2020 VanceIP News, we discussed a potential fly in the ointment for Moderna’s vaccine. The fly was patents owned by Arbutus Biopharma, specifically US 8,058,069 (US ‘069) and US 9,364,435 (US ‘435). Moderna had tried to invalidate these patents and failed completely with US ‘069 and partially with US ‘435 (claims 7-8, 10-11, 13, and 16-20 found not invalid). We now know the contents of the mRNA-1273 vaccine (mostly at least). As you will see below, it is understandable why Moderna took the offense against US ‘069 and US ‘435.
US ‘069 claims, in part, a nucleic acid-lipid particle comprising:
(a) a nucleic acid;
(b) a cationic lipid;
(c) a non-cationic lipid comprising a mixture of a phospholipid and cholesterol; and
(d) a conjugated lipid that inhibits aggregation of particles.
We know that mRNA-1273 is a nucleic acid, SM-102 is a cationic lipid (or at least we assume), DSPC is a phospholipid, cholesterol is present in the mRNA-1273 vaccine, and the conjugated lipid can be a PEG-lipid conjugate (which probably reads on PEG 2000 DMG). The claims in US ‘069 do appear close enough for Moderna to prefer to invalidate the patent, if possible.
Some of the surviving claims US ‘435 recite nucleic acid-lipid particles like that of US ‘069. What might be more interesting to Moderna is the following method of treating claim (paraphrased) that survived Moderna’s challenge.
A method for the in vivo delivery of a nucleic acid, by administering a claimed nucleic acid-lipid particle
Injection of mRNA-1273 could be considered in vivo delivery of a nucleic acid. Like with US ‘069, US ‘435 seems close enough to warrant Moderna seeking invalidation.
Hope you all enjoyed our two-part series on the Moderna vaccine. It is both a tremendous technological achievement and an interesting study in how one protects a life science invention. Feel free to send any comments or questions you may have.