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Patent landscape, scope, and claims: |
US Patent 9,045,519: Claim Scope, Cover Map, and U.S. Patent Landscape
US Drug Patent 9,045,519 claims pharmaceutical compositions that include a compound of formula I plus defined excipients in defined vehicle types (aqueous buffered solutions and powder), with explicit support for parenteral (including IV) and oral use. The patent’s practical enforcement scope is driven by three claim “axes”: (1) presence of the specific formula I compound, (2) the formulation context (buffered aqueous isotonic liquids vs powder solids), and (3) the excipient and carrier lists that cabin claim coverage.
What do the independent and dependent claims actually cover?
Claim 1 (independent): core composition in aqueous buffered solution
Claim 1 covers:
- Pharmaceutical composition
- comprising:
- the compound of formula I
- one or more pharmaceutical excipients
- in an aqueous buffered solution
This is a baseline composition claim limited by two elements that must both be present:
- The API is the compound of formula I.
- The formulation is in an aqueous buffered solution (not just any dosage form).
Coverage effect: Claim 1 is broad on excipient selection (it says “one or more pharmaceutical excipients” without requiring a specific subset) as long as the formulation is an aqueous buffered solution.
Claims 2–6: constrain formulation excipients and liquid carrier
These claims define explicit excipient subsets, which narrow the claim coverage to specific formulation choices.
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Claim 2: aqueous-buffered composition where the excipient is selected from:
- polyvinylpyrrolidinone (PVP)
- gelatin
- hydroxycellulose
- acacia
- polyethylene glycol (PEG)
- mannitol
- sodium chloride
- sodium citrate
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Claim 3–4: aqueous buffered solution is isotonic, and the isotonic buffer includes at least one of:
- isotonic saline solution
- 5% dextrose in water
- buffered sodium acetate solution
- buffered ammonium acetate solution
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Claim 5–6: aqueous buffered solution comprises a liquid carrier, where the liquid carrier includes:
- glycerol monostearate
- glycerol monostearate with a wax
- glycerol distearate
- glycerol distearate with a wax
Coverage effect: These claims provide narrower “slice” coverage. In practice, they create strong leverage against generic or follow-on products that match the formulation architecture (buffered isotonic aqueous media plus specific carriers).
Claims 7–9: parenteral and IV route emphasis
- Claim 7: suitable for parenteral administration
- Claim 8: suitable for intravenous administration
- Claim 9: suitable for continuous infusion or bolus
Coverage effect: Route suitability adds an additional infringement anchor for products marketed or labeled for these routes, even when the composition might otherwise look similar to non-IV products.
Claims 10–10: oral route
- Claim 10: suitable for oral administration
Coverage effect: This claim prevents the assignee from being boxed out if the compound/formulation is converted into oral dosage forms while retaining the claim’s formulation conditions.
Claims 11–13: powder formulation axis
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Claim 11: pharmaceutical composition comprising the compound of formula I plus excipients, where the composition is a powder
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Claim 12: powder includes a solid carrier selected from:
- starch
- lactose
- calcium sulfate dihydrate
- teffa alba
- magnesium stearate
- stearic acid
- talc
- pectin
- acacia
- agar
- gelatin
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Claim 13: solid carrier comprises glycerol monostearate / glycerol monostearate with wax / glycerol distearate / glycerol distearate with wax
Coverage effect: Claim 11 creates a separate formulation branch (solid powder) that can overlap with the liquid-carrier concepts through Claim 13’s specific lipid carrier types.
How broad is the scope, and where are the claim boundaries?
Breadth drivers
- “Compound of formula I” is the main technical switch. If the competitor’s API is inside formula I, composition coverage becomes relevant. If not, the claims likely do not attach.
- Claim 1 is broad on excipients because it does not limit to a single excipient list.
- Route suitability claims (7–9, 10) widen the enforcement perimeter to dosage forms meant for those routes.
Key boundaries (what the claims require)
- Aqueous buffered solution is required for Claims 1–10 (except the powder branch 11–13).
- Isotonic and specific isotonic buffers are only required in the dependent path (Claims 3–4).
- Liquid carrier composition is required in the dependent path (Claims 5–6).
- Powder is required for Claims 11–13.
- Solid carrier list is required for Claims 12 (and glycerol mono/distearate with wax is required for Claim 13).
Practical infringement mapping: formulation “templates” likely covered
Below are the formulation templates that most directly track the claim structure.
Template A: buffered isotonic aqueous solution with common excipients
- API: compound of formula I
- Vehicle: aqueous buffered solution that is isotonic
- Excipients: one or more from the Claim 2 list (PVP, gelatin, HPMC, acacia, PEG, mannitol, NaCl, sodium citrate)
- Isotonic buffer: isotonic saline or 5% dextrose or buffered sodium acetate or buffered ammonium acetate
Most relevant claims: 1 + 2 + 3 + 4
Template B: buffered aqueous solution using glycerol mono/distearate carriers
- API: compound of formula I
- Vehicle: aqueous buffered solution
- Liquid carrier: glycerol monostearate / glycerol distearate and wax variants
Most relevant claims: 1 + 5 + 6
Template C: IV continuous infusion or bolus
- Composition must still satisfy Claim 1 or the narrower dependent conditions
- Route suitability: intravenous
- Dosing mode: continuous infusion or bolus
Most relevant claims: 1 + 7 + 8 + 9 (and optionally 2–6)
Template D: powder dosage forms with specified solid carriers and glycerol mono/distearate
- API: compound of formula I
- Form: powder
- Solid carrier: one or more from Claim 12 list
- Includes lipid carrier: glycerol mono/distearate (with wax variants) as part of the solid carrier
Most relevant claims: 11 + 12 + 13
What does the landscape look like in the U.S., and how would competitors design around?
A full U.S. landscape assessment requires the following patent-identifying inputs: the patent’s assignee, title, application family, priority dates, and the identity of “compound of formula I” (chemical definition). Your prompt provides only the claim text and not the API structure or patent bibliographic fields. Under those constraints, a complete and accurate U.S. freedom-to-operate and landscape (continuations, related patents in the same family, overlapping formulation patents, and NCE/combination patents with later filing dates) cannot be generated without risking fabrication.
Given that constraint, the only actionable landscape conclusions that can be made from the claim language itself are design-around levers.
Design-around levers grounded in the claim text
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Avoid “aqueous buffered solution” architecture
Moving to a non-buffered aqueous system might attempt to escape Claims 1–10 (but powder claims 11–13 remain a separate path). If the product remains buffered, the shield is limited.
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Avoid isotonic buffers only if attempting to exit dependent claims 3–4
You can still land in Claim 1 and 2 coverage if excipients match; isotonicity only tightens Claims 3–4.
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Avoid the defined liquid carriers
If glycerol monostearate or glycerol distearate (with wax variants) are present as liquid carriers, Claims 5–6 are implicated. Removing these and substituting different lipid emulsifiers could target dependent coverage.
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Avoid IV route suitability claims
Claims 7–9 depend on parenteral and intravenous suitability. Labeling and intended use matter. If a competitor never intends IV administration, it can target those dependent claims. Claim 10 (oral) is still a separate vector.
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For powder products: avoid the specified solid carrier list and glycerol mono/distearate presence
Claims 11–13 are triggered by a powder dosage form and by the defined solid carriers. A competitor can attempt to use different solid carriers and exclude glycerol monostearate/glycerol distearate lipid carriers in the powder scaffold.
Claim coverage map by dosage form and route
| Dosage form |
Route context in claims |
Vehicle condition |
Carrier condition |
Most relevant claims |
| Aqueous buffered liquid |
Parenteral, IV, continuous infusion or bolus |
Aqueous buffered solution |
Optional excipient selection; optional isotonicity; optional glycerol mono/distearate liquid carrier |
1, 2, 3–4, 5–6, 7–9 |
| Aqueous buffered liquid |
Oral administration suitability |
Aqueous buffered solution |
Same as Claim 1 (plus any dependent limitations) |
1, 10 (and optionally 2–6) |
| Powder |
Not explicitly route-limited in provided claims |
Powder form |
Solid carrier from list; optional glycerol mono/distearate with wax as solid carrier |
11–13 |
What is the “strongest” claim set for enforcement?
Based strictly on claim mechanics:
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Best enforcement leverage is where a product matches:
- compound of formula I
- in aqueous buffered solution
- optionally isotonic (Claims 3–4)
- optionally with glycerol mono/distearate liquid carriers (Claims 5–6)
- and is intended for IV infusion/bolus (Claims 7–9) or oral use (Claim 10)
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For competitors, the most direct risk is “template A + template C” for IV products and “template D” for powder products.
Key Takeaways
- US 9,045,519 covers compositions containing the compound of formula I in two formulation branches: aqueous buffered liquids (Claims 1–10) and powders (Claims 11–13).
- The claim scope is anchored by vehicle type (aqueous buffered solution vs powder) and narrowed by explicit excipient/carrier lists, especially PVP/gelatin/HPMC/acacia/PEG/mannitol/NaCl/sodium citrate, isotonicity + specific buffers, and glycerol monostearate/glycerol distearate with wax as liquid/solid carriers.
- Route-specific dependent claims support enforcement for parenteral, IV, and IV continuous infusion or bolus, plus oral suitability.
- The strongest “at-risk” design zone for competitors is use of buffered isotonic aqueous formulations with glycerol mono/distearate carriers, or powder formulations using the listed solid carriers including glycerol mono/distearate with wax.
FAQs
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Is Claim 1 limited to specific excipients?
No. Claim 1 requires “one or more pharmaceutical excipients” without restricting the excipient list; the restriction appears in dependent Claim 2.
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Does isotonicity matter for infringement?
Isotonicity is required only for the dependent path in Claims 3–4. A formulation can still fall under Claim 1 without being isotonic.
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What excipients are explicitly named in the claim set?
Claim 2 lists: PVP, gelatin, hydroxycellulose, acacia, PEG, mannitol, sodium chloride, and sodium citrate.
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Does the patent cover both liquid and powder dosage forms?
Yes. Claims 1–10 cover aqueous buffered solutions. Claims 11–13 cover powder formulations.
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What carrier types are singled out for the liquid and powder forms?
The claims single out glycerol monostearate and glycerol distearate, including with waxes, as liquid carriers (Claims 5–6) and as part of the solid carrier in powder compositions (Claim 13).
References
- United States Patent 9,045,519 (claims excerpt provided in prompt).
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