US Patent 10,039,780 (Cangrelor) : Scope of Claims and US Patent Landscape
US Drug Patent 10,039,780 claims a cangrelor-based treatment method focused on high-purity cangrelor and tight control of hydrolysis and oxidation degradants (with explicit impurity thresholds), in pharmaceutical formulations designed for parenteral (including IV) administration.
What does the patent claim cover at a high level?
The independent claim set is method-focused and ties three technical elements together:
- Use/administration: treating, or reducing the risk of, stent thrombosis or myocardial infarction.
- Active: high purity cangrelor (or a salt).
- Quality spec: the combined total of selected hydrolysis and oxidation degradants is capped, and the degradant set is defined by membership in an enumerated group.
- Route and formulation (dependent claims): formulation includes excipients (notably polyols, specifically mannitol and/or sorbitol) and is administered parenterally, with multiple dependent claims specifying IV dosing forms (bolus, continuous infusion, bolus plus infusion).
This is a “quality-controlled product-use” claim strategy: the clinical indication is coupled to a manufacturing/process-derived purity specification and excipient composition.
How broad is the core claim scope (independent claim 1 vs. dependent sets)?
Claim 1 scope
Claim 1 is the broadest framing in the user-provided set.
Claim 1 recites:
- A method for treating or reducing risk of stent thrombosis or myocardial infarction
- administering a pharmaceutical formulation comprising:
- high purity cangrelor or a salt
- one or more pharmaceutically acceptable excipients
- where:
- the combined total of selected hydrolysis and oxidation degradants is ≤ about 1.5% by weight of high purity cangrelor
- the selected degradants are one or more members selected from a defined group (membership is indicated in the claim text you provided but the full enumeration is not shown in your excerpt)
Effect on infringement / design-around: the claim is not limited to a single excipient pair and is not limited to IV-only administration (those appear in dependent claims). The main claim constraint is the degradant spec and the defined degradant identity set.
Claim 7 scope (narrower on excipients; strong “consisting of” lock-in)
Claim 7 recites a method similar to claim 1 but tightens formulation language:
- the formulation consists of:
- high purity cangrelor (or salt)
- mannitol and/or sorbitol as excipient(s)
“Consisting of” narrows the formulation boundary compared to “comprising,” because it restricts additional components beyond those listed (subject to patent claim construction norms for “consisting of”).
Effect: if a competitor uses polyols other than mannitol and/or sorbitol, or includes other excipients outside what is allowed under the “consisting of” interpretation, claim 7 is less likely to read.
What are the degradant/impurity thresholds that define infringement risk?
The claims are numerically tight. They define both:
- a combined degradant total (hydrolysis + oxidation degradants)
- an impurity-by-impurity set with separate caps
- a “maximum impurity level” pairing (impurities A and D)
Degradant total limits
Two tiers appear:
- ≤ about 1.5% by weight of high purity cangrelor (claim 1 and parallel claim 7 set)
- ≤ about 1.3% by weight (dependent claims: claim 2 and claim 8, and claim 12 for formulation claim 11)
Individual impurity thresholds (as provided)
For the impurity-labeled group, your text shows these caps:
- Impurity A < about 0.5% by weight
- Impurity B < about 0.2% by weight
- Impurity C < about 0.3% by weight
- Impurity D < about 0.2% by weight
- Impurity E < about 0.5% by weight (appears in the claim set tied to claim 7/11)
Also:
- Impurities A and D each < about 0.5% by weight (claim 4 and claim 10)
How these numbers change the “read range”
From a competitive strategy perspective, the claims create a grid:
- If a product stays under 1.5% combined total, it can still meet claim 1/7-level combined spec.
- If it stays under 1.3%, it meets the stricter dependent claim coverage.
- Separately, even if the combined total is low, any single impurity exceeding its cap can break coverage for the dependent claim set tied to those impurity-by-impurity thresholds.
What excipient requirements exist, and how do “polyol” claims constrain formulation?
Polyol generality (claim 5)
Claim 5:
This is broad: it can include multiple polyols, not limited to mannitol or sorbitol (depending on claim construction, and assuming “polyol” includes both).
Specific mannitol/sorbitol (claims 6 and 7 set)
- Claim 6: excipients are mannitol and sorbitol (likely both present).
- Claim 7 and dependent claim set: formulation consists of high purity cangrelor plus mannitol and/or sorbitol.
The “consisting of” plus specific polyol list is the strongest excipient boundary in your text.
How does the patent treat route of administration and dosing form?
Multiple dependent claims specify parenteral route and IV modality:
- Claim 15: parenteral mode
- Claim 16: IV administration
- Claim 17: IV as:
- bolus
- continuous infusion
- bolus followed by continuous infusion
The claim text also extends to reconstitution into a sterile formulation, then IV dosing:
- Claims 18-20: reconstituted sterile formulation, parenteral/IV/IV bolus vs infusion variants
- Claims 21-23: similar structure for the claim 11 formulation set
Business impact
These dependent claims can matter for enforcement if competitors market:
- an alternate route (e.g., subcutaneous) for a cangrelor-like product, or
- an IV-only product with a degradant profile outside the defined spec.
If the clinical labeling and the actual method used by prescribers align with the IV administration form described, the dependent claims become more actionable.
Is there a quantitative composition range for cangrelor in the formulation?
Yes. Claim 14 adds a composition ratio:
- formulation comprises approximately 16–21% high purity cangrelor by weight
- and 84–79% excipients by weight
That is a material narrowing: it targets concentration windows. A competitor with substantially different concentrations may avoid these dependent claims even if they meet the degradant thresholds.
What does the claim architecture look like (and what does it imply)?
From your excerpt, the claim family is arranged as:
- Broad independent method claim (claim 1) with:
- degradant cap at ≤1.5%
- broad excipient category (“one or more pharmaceutically acceptable excipients”)
- A narrower independent method set (claim 7) with:
- “consisting of” formulation constraint to mannitol and/or sorbitol
- same degradant cap concept
- Multiple dependent claims:
- tighter combined degradant cap (≤1.3%)
- individual impurity caps (A-D; plus E in the claim 7 set)
- specific excipient constraints (polyols; mannitol/sorbitol)
- composition range (16-21% cangrelor)
- parenteral/IV administration plus bolus/infusion variants
- reconstitution into sterile formulation prior to IV dosing
This is a layered strategy: claim 1 captures a broad class of “high purity + degradant spec + method of use,” while claim 7 and its dependents sharpen excipient and sterile IV practice.
How to map claim scope to a practical patent landscape view in the US
Without the remainder of your patent identifiers (publication, family members, priority, prosecution history) or an external database pull, the landscape below is limited to a structure-driven map based on what US patent 10,039,780 is doing: it is a secondary quality specification layer on top of known cangrelor indications.
Landscape nodes implied by the claim set
- Ingredient strategy: “high purity cangrelor” vs ordinary cangrelor
- CMC specification strategy: oxidation/hydrolysis degradants and explicit impurity targets
- Formulation strategy: polyol excipients, especially mannitol/sorbitol
- Admin route strategy: parenteral, IV, and infusion regimens
- Composition window strategy: 16–21% by weight cangrelor
Likely enforcement posture
- The patent is strongest against products that:
- are positioned as cangrelor for the same clinical indication (stent thrombosis / MI risk reduction)
- use an IV parenteral presentation consistent with dependents
- meet degradant/impurity specifications within the claimed bands
- use mannitol/sorbitol in the “consisting of” sense
Likely design-around posture
- Increase the combined hydrolysis/oxidation degradants above the caps (if clinically acceptable and tolerable from a regulatory standpoint)
- Modify excipient system beyond mannitol/sorbitol (to escape “consisting of” formulations)
- Use different concentration outside 16–21% (to avoid claim 14)
- Use routes not covered by dependents (if feasible)
- Ensure impurity-by-impurity exceedances break the dependent claims (careful: doing so may still leave claim 1 read if claim 1 does not include the impurity-by-impurity limitations)
Claim-by-claim scope digest (as provided)
| Claim |
Core subject |
Main narrowing elements |
| 1 |
Method for treating/reducing risk of stent thrombosis or MI |
High purity cangrelor (or salt) + excipients; selected hydrolysis/oxidation degradants ≤ ~1.5% by weight |
| 2 |
Dependent |
combined degradants ≤ ~1.3% |
| 3 |
Dependent impurity caps |
Impurity A <0.5%; B <0.2%; C <0.3%; D <0.2%; total impurity <0.5% |
| 4 |
Dependent impurity cap |
max impurity level of A and D each <0.5% |
| 5 |
Dependent excipient |
excipient is a polyol |
| 6 |
Dependent excipient |
excipients are mannitol and sorbitol |
| 7 |
Independent method variant |
formulation “consisting of” high purity cangrelor + mannitol and/or sorbitol; combined degradants ≤ ~1.5% |
| 8 |
Dependent |
combined degradants ≤ ~1.3% |
| 9 |
Dependent impurity caps |
A <0.5%; B <0.2%; C <0.3%; D <0.2%; E <0.5% |
| 10 |
Dependent impurity cap |
A and D each <0.5% |
| 11 |
Dependent formulation (as written) |
“consisting of” set and same degradant concepts; appears to define a formulation claim basis |
| 12 |
Dependent |
combined degradants ≤ ~1.3% |
| 13 |
Dependent impurity caps |
A <0.5%; B <0.2%; C <0.3%; D <0.2%; E <0.5% |
| 14 |
Dependent formulation |
cangrelor 16–21% by weight; excipients 84–79% |
| 15 |
Dependent route |
parenteral mode |
| 16 |
Dependent route |
IV administration |
| 17 |
Dependent IV regimen |
bolus; continuous infusion; or bolus + infusion |
| 18 |
Dependent sterile practice |
reconstituted sterile formulation + parenteral |
| 19 |
Dependent sterile + route |
reconstituted sterile + IV |
| 20 |
Dependent sterile + regimen |
reconstituted sterile + IV bolus/infusion variants |
| 21 |
Dependent sterile practice |
reconstituted sterile + parenteral (claim 11 set) |
| 22 |
Dependent sterile + route |
reconstituted sterile + IV (claim 11 set) |
| 23 |
Dependent sterile + regimen |
reconstituted sterile + IV bolus/infusion variants (claim 11 set) |
Key takeaways
- US 10,039,780 is a method-of-use claim for stent thrombosis/MI risk reduction using high purity cangrelor tied to tight control of oxidation/hydrolysis degradants.
- The core enforceable lever is the combined selected hydrolysis + oxidation degradants cap at ≤ ~1.5% (with dependent tightening to ≤ ~1.3%).
- Dependent claims add a composition-control layer via impurity-by-impurity thresholds (A-E with specific numeric caps) that can eliminate coverage even if the combined degradant total is compliant.
- The excipient strategy is layered: broad polyol (claim 5) and narrow mannitol/sorbitol with “consisting of” constraint (claim 7), which can materially affect design-around.
- Route and administration dependents concentrate on parenteral IV use and bolus/infusion modalities, including reconstituted sterile formulations.
FAQs
1) What is the single most important numeric limitation in US 10,039,780?
The combined total of selected hydrolysis and oxidation degradants is capped at about 1.5% by weight of high purity cangrelor (with a dependent cap at about 1.3%).
2) Does the patent require specific excipients in the broadest claim?
Claim 1 allows one or more pharmaceutically acceptable excipients. Specific excipients like polyols (claim 5) and mannitol/sorbitol (claim 6 and claim 7 set) appear in dependent claims and/or “consisting of” formulations.
3) Which claims are most formulation-specific beyond the degradant spec?
Claim 14 adds a concentration window: 16–21% cangrelor and 84–79% excipients by weight.
4) How does “consisting of” change the excipient coverage?
For the claim 7 set, “consisting of” limits the formulation to high purity cangrelor and mannitol and/or sorbitol as listed excipients, constraining additional components.
5) What dosing modalities are explicitly called out?
The patent text explicitly covers IV administration in bolus form, continuous infusion form, or bolus followed by continuous infusion (claims 17, 20, and 23).
References
- US Patent 10,039,780.
