United States Patent 11,827,642: Scope, Claim Strength, and Landscape
What does US 11,827,642 claim?
US 11,827,642 is directed to a treatment method for indolent systemic mastocytosis (ISM) by administering a specific “compound” (not provided in the claim text you supplied) and pharmaceutically acceptable salts, with narrowing dependent claims tied to KIT Exon 17 mutations, including D816V.
Because only the partial claim set is shown (claim 1 through claim 5 and an incomplete claim 6), the analysis below limits itself to the claim elements that are actually present in the record excerpt you provided.
Claim set breakdown (as provided)
| Claim |
Core scope element |
Key limiting feature(s) |
Practical implication for freedom-to-operate (FTO) |
| 1 |
Method of treating indolent systemic mastocytosis |
Administering a “compound” (or pharmaceutically acceptable salt) |
Broadest method claim; potentially read on any ISM regimen that uses the claimed compound |
| 2 |
Pharmaceutical composition method |
Composition includes therapeutically effective amount + pharmaceutically acceptable carrier |
Captures formulations used to carry out claim 1 |
| 3 |
Mutation-defined ISM treatment |
Patient has KIT Exon 17 mutation |
Narrows claim 1 to genetically defined patient subgroup |
| 4 |
Mutation subtype |
Patient has D816 mutation in KIT Exon 17 |
Narrows further to D816 family |
| 5 |
Specific mutation |
D816 is D816V |
Narrowest subgroup among shown claims |
| 6 |
Treatment method using therapeutically effective amount |
Not provided in full |
No scope determination beyond the fragment “wherein the patient is administered …” |
How broad is the independent claim (Claim 1)?
Does Claim 1 cover all indolent systemic mastocytosis patients?
Yes, within the confines of the “compound” identity.
Claim 1 is a classic method-of-treatment claim with an open-ended patient definition:
- Disease: indolent systemic mastocytosis
- Clinical qualifier: “in a patient in need thereof”
- Therapeutic activity: “therapeutically effective amount”
- Agent: a compound which is: … (the structure or identity is not included in your excerpt)
- Existence of salts is explicit: “or a pharmaceutically acceptable salt thereof”
What is broad here
- The claim does not limit route of administration, dosing schedule, treatment duration, or specific clinical endpoints in the text you provided.
- It does not limit to any mutation status.
- It does not limit formulation type beyond the generic “administering.”
What is narrow here
- The “compound” identity is doing the heavy lifting. Without the compound specification, breadth cannot be measured by chemistry; but legally, the method claim is broad as to use and narrow as to agent.
Business impact
If your candidate product contains the same compound (or a pharmaceutically acceptable salt) recited in the claim, Claim 1 is a direct infringement risk for ISM treatment regimens in the US, regardless of mutation testing strategy.
Does Claim 2 create additional formulation coverage?
Is Claim 2 an independent manufacturing and product risk?
Claim 2 is still anchored to the method context (it says “patient is administered a pharmaceutical composition”), but it adds a formulation definition:
- Therapeutically effective amount of the compound or salt
-
- pharmaceutically acceptable carrier
This is typical of claims intended to cover:
- marketed or trial formulations,
- specific dosing forms used to deliver the claimed compound.
Coverage logic
- If the compound is the same as in Claim 1 and a carrier-based formulation is administered, Claim 2 targets that “composition as administered.”
Practical implication
Even if an accused regimen attempted to argue it “was not the same composition,” Claim 2’s definition is likely broad, because “pharmaceutically acceptable carrier” typically captures standard excipient categories. The exact carrier limitations, if any, are not shown in your excerpt.
How do the mutation-dependent claims change scope?
What does Claim 3 cover?
Claim 3 limits Claim 1 by patient genotype:
- KIT Exon 17 mutation present
Implications
- If your clinical label targets all ISM patients without genotype selection, Claim 1 is still the risk, not Claim 3.
- If a program targets only mutation-positive patients, Claim 3 can extend infringement risk even if a different agent were used for mutation-negative patients.
How much narrower is Claim 4?
Claim 4 limits further to:
- D816 mutation in KIT Exon 17
How narrow is Claim 5?
Claim 5 is specific:
Implications for design-around
To avoid Claim 3-5, a design-around would need to avoid using the claimed compound (or salt) in those mutation-defined patient groups. If the compound remains the same, avoiding mutation groups does not eliminate Claim 1 infringement risk unless you can truthfully and consistently treat only mutation-defined subpopulations while a broader claim is asserted only against those subgroups. In practice, Claim 1 is not limited by mutation status, so Claim 1 remains a more persistent risk.
What does the incomplete Claim 6 indicate about overall coverage?
The excerpt stops at:
- “wherein the patient is administered a therapeutically effective amount of the compound which is:”
Claim 6 likely adds a further defining condition, such as:
- a specific chemical identity, salt form, stereochemistry, or formulation/dose regimen,
- a specific treatment schedule,
- or an additional biomarker or clinical condition.
Because the defining language after “which is:” is not provided, no legally operative narrowing can be determined for Claim 6 from your supplied text.
Claim scope as it would be construed in infringement practice (US)
Key infringement theory for method claims
To infringe Claim 1 or dependent claims, the party that performs the method must:
- Treat an “indolent systemic mastocytosis” patient,
- Administer the therapeutically effective amount of the recited compound (or salt),
- Perform each limitation in combination (for dependent claims, the additional mutation limitation must also be met).
Who is the likely infringing actor?
For US method-of-treatment patents, infringement is typically pursued against:
- prescribing physicians,
- healthcare providers who administer the drug,
- and sometimes entities that direct or control the treatment.
Manufacturers generally face risk through induced/contributory theories for downstream use, depending on jurisdictional strategy and how the patent holder frames knowledge and encouragement.
Landscape: where 11,827,642 fits in an ISM / KIT-D816V patent stack
What the claim language suggests about the patent’s role
Even without the compound identity text, the claim structure implies the patent is a use patent that anchors:
- a therapeutic application (ISM),
- an agent class tied to a chemical definition embedded after “wherein the method comprises administering…a compound which is: …” (not shown),
- and a targeted biomarker context via KIT Exon 17 D816V.
This is consistent with common drug-patent architecture:
- early composition-of-matter claims on the compound and salts,
- followed by method-of-use claims for clinically defined populations and genotypes.
Likely adjacency in the US portfolio (how this claim “stacks”)
Based on the claim elements you provided, US 11,827,642 is best viewed as occupying the following risk lanes for an ISM asset:
- Agent-specific method lane
Any ISM treatment using the same compound or its salts can land in Claim 1.
- Formulation lane
Standard carrier-based formulations administered to patients create coverage under Claim 2.
- Genotype-lane
Programs focused on KIT Exon 17 mutations, especially D816V, can face layered claims under Claims 3-5.
What typical portfolio holders do with this structure
Patent holders often pursue:
- separate claims for broader “disease state” use (Claim 1-type),
- separate claims for formulation (Claim 2-type),
- and separate claims for genotype selection to strengthen enforceability against narrower clinical adoption (Claim 3-5-type).
Freedom-to-operate implications for product developers
If your product is the same compound (or salt) and you intend ISM treatment
Risk rises immediately:
- Claim 1 covers the method in ISM without mutation restriction.
- Claim 2 covers composition administration broadly.
- Mutation-defined claims add further fallbacks.
If your product is different but targets KIT D816V in ISM
- Claims 3-5 require the specific “compound” identity from the missing portion of Claim 1.
- If the compound differs, Claims 3-5 may not read at all because the agent limitation remains unresolved.
If you plan to restrict use to non-ISM indications
Then Claim 1 is not implicated by that specific claim element, assuming marketing and prescribing do not include ISM treatment “in a patient in need thereof.”
Key Takeaways
- US 11,827,642 is an indolent systemic mastocytosis method-of-treatment patent that hinges on a single recited compound (or pharmaceutically acceptable salt).
- Claim 1 is the broadest use claim: ISM + therapeutically effective administration of the recited compound, with no mutation limitation.
- Claim 2 adds formulation coverage via a therapeutically effective amount + pharmaceutically acceptable carrier composition administered to the patient.
- Claims 3-5 narrow by genetics: KIT Exon 17 mutation, D816 mutation, and D816V.
- The excerpted Claim 6 is incomplete, so it cannot be used to further narrow scope in this analysis.
FAQs
-
Does US 11,827,642 require KIT mutation status for infringement of Claim 1?
No. Claim 1 (as provided) covers ISM treatment without specifying KIT genotype.
-
Is a salt form covered if the claim mentions “pharmaceutically acceptable salt”?
Yes. Claim 1 and Claim 2 expressly include pharmaceutically acceptable salts of the recited compound.
-
Does Claim 2 protect the drug formulation, or only the method?
Claim 2 is a method-of-administration claim that specifies the composition administered: drug (or salt) plus pharmaceutically acceptable carrier.
-
Are Claims 3-5 separate inventions or additional limitations?
They are dependent claims adding patient genotype limitations (KIT Exon 17 mutation; D816; D816V) on top of Claim 1’s method and compound limitations.
-
Can a company avoid infringement by targeting only KIT D816V-positive patients?
Not from a Claim 1 standpoint. Claim 1 is not limited to mutation status (it covers ISM generally), so avoiding mutation-negative patients does not eliminate risk if the recited compound is used.
References
- United States Patent US 11,827,642 (claim text excerpt provided in prompt).
