The terms, per the grant. On April 30, 2024, ModernaTX was issued US11969506B2, “Lipid nanoparticle formulation.” The lipid nanoparticle is the delivery vehicle that makes an mRNA medicine work, and composition IP over the formulation is the core asset an mRNA platform's value rests on.

The independent claim defines the formulation with the kind of specificity that a composition license is priced against. Claim 1 covers "a nanoparticle composition comprising a lipid component comprising an ionizable lipid, a phospholipid, a cholesterol, and a cholesterol derivative," where the cholesterol derivative is "β-sitosterol or campesterol" or a defined class of compound, and where "the molar ratio between the cholesterol and cholesterol derivative is between about 1:100 and 100:1." The claimed invention is a four-component lipid system with a named sterol-pair feature — not lipid nanoparticles in the abstract.

Why a business desk values formulation IP: the delivery particle is the part of an mRNA product that is hardest to invent around and most broadly reused across programs. Composition claims over the lipid formulation are exactly what an mRNA platform license, cross-license, or supply deal is written around, because the same delivery system underpins many candidates.

“The disclosure features novel lipids and compositions involving the same. Nanoparticle compositions include an ionizable lipid, a phospholipid, a first sterol or a tocopherol, and optionally a second sterol different from the first sterol.”— U.S. Patent No. 11,969,506 source

The dependent claims pin the formulation to specific, quantified recipes — the level of detail that makes a composition position defensible and a license scope clear. They specify that the lipid component "further comprises a PEG lipid" (claim 5) and then fix exact molar windows for the whole system: "about 30 mol % to about 60 mol % ionizable lipid, about 0.01 mol % to about 30 mol % phospholipid, about 18.5 mol % to about 48.5 mol % first and second sterols combined, and about 0 mol % to about 10 mol % PEG lipid" (claim 11), tightening to a named point composition of "about 50 mol % ionizable lipid, about 10 mol % phospholipid, about 38.5 mol % first and second sterols combined, and about 1.5 mol % PEG lipid" (claim 13). A claim that fixes the percentage of each component is a recipe a competitor must either license or reformulate around.

The claims also enumerate the building blocks themselves. Claim 4 lists dozens of named phospholipids — among them "1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC)" and "1,2-dioleoyl-sn-glycero-3-phosphoethanolamine (DOPE)" — and the grant reaches both a "pharmaceutical composition…and a pharmaceutically acceptable carrier" (claim 8) and methods of "delivering a therapeutic and/or prophylactic agent to a mammalian cell" or "organ" using the composition (claims 9–10). For a model, composition-plus-method coverage over the delivery system is what lets a single license collect across many downstream products built on that delivery chassis.

The structure point: a formulation grant supports platform-wide deal economics — a delivery-technology license or cross-license whose royalty base spans every product using the particle — rather than a single-product royalty. For a model, that is the broadest kind of mRNA royalty base, and the quantified molar-ratio claims are what make the boundary of that base concrete enough to negotiate.

What the grant does not promise: a clinical result, an approval, or that the formulation is the only workable delivery system. It is an exclusivity claim on a specific lipid composition and its molar windows — valuable because the delivery particle is reused across a platform, but bounded to the recited four-component system and ratios.

The reason formulation IP, rather than the mRNA sequence, tends to anchor platform value is reuse. The genetic payload changes from one program to the next; the delivery particle is largely shared across them. A composition claim over the lipid system therefore touches every product built on that chassis, which is exactly the property that makes it the asset a platform license or cross-license is written around. The distinguishing feature in this grant is the sterol pair: claim 1 requires both "a cholesterol" and "a cholesterol derivative" that is "beta-sitosterol or campesterol" or a defined compound class, with the two held "between about 1:100 and 100:1." A two-sterol formulation is a specific, ownable design choice, not the generic four-component LNP, and that specificity is what gives the claim something a competitor must either license or engineer away from.

The quantified composition claims are the part a counterparty negotiates against, because they draw the boundary of the license precisely. Claim 11 fixes a broad window across all four components; claim 12 narrows it; and claim 13 lands on a named point recipe of "about 50 mol % ionizable lipid, about 10 mol % phospholipid, about 38.5 mol % first and second sterols combined, and about 1.5 mol % PEG lipid." Patents that specify mole percentages give both sides an unusually clear map of what is and is not covered, which shortens the distance between a freedom-to-operate analysis and a signed term sheet. The component enumerations widen the estate further: claim 4's roster of named phospholipids, from DSPC to DOPE, and claim 3's catalog of permissible ionizable lipids mean a reformulator cannot trivially swap one building block for another and exit the claims. Layering method coverage on top, claims 9 and 10 reach "delivering a therapeutic and/or prophylactic agent" to a mammalian cell or organ using the composition, so the grant follows the particle into use. For a model, composition-plus-method coverage over a reusable delivery system is the broadest mRNA royalty base available, and the mole-percent claims are what make that base concrete.

The takeaway: when valuing an mRNA platform or delivery deal, read the LNP-formulation grants as the load-bearing assets, because the particle is the reusable core. Moderna's April 2024 LNP-formulation grant is a dated, concrete example of the delivery IP an mRNA platform's value rests on — specified down to the mole percent.