United States Patent 9,487,491: Scope of Claims, Claim Construction, and Patent Landscape
What is the core claim scope of U.S. Patent 9,487,491?
U.S. Patent 9,487,491 claims methods of treating defined cancers by administering a specific small-molecule kinase inhibitor scaffold, including specific salts and oral dosing parameters.
Target compounds (all claims are method claims tied to administration):
- Free base / generic compound:
6-ethyl-3-({3-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl}amino)-5-(tetrahydro-2H-pyran-4-ylamino)pyrazine-2-carboxamide
- Fumaric acid salt: the fumarate of the above compound
- Hemifumarate (HFM): hemifumarate specifically named in multiple dependent claims
Claimed indications:
- Non-small cell lung cancer (NSCLC) (independent Claim 1; driven by the same administration language used throughout)
- Acute myelocytic leukemia (AML) or atypical chronic myelocytic leukemia (aCML) (independent Claim 10), with:
- AML subsets defined by FLT3 genotype (Claim 11)
- aCML subset defined by FLT3 fusion (Claim 12)
Administration format:
- Oral administration is expressly required in dependent claims (Claims 4, 6, 8, 15, 16, 17, 19, 23, 25)
- Dose range is explicitly constrained to 0.01 to 10 mg/kg/day in multiple dependent claims (Claims 5, 7, 9, 16, 18, 20, 24, 26)
Claims map (what each step adds)
| Claim(s) |
Cancer / biomarker |
Drug form |
Route |
Dose |
| 1 |
NSCLC |
free base or salt |
not limited |
not limited |
| 2 |
NSCLC |
fumarate |
not limited |
not limited |
| 3 |
NSCLC |
hemifumarate (HFM) |
not limited |
not limited |
| 4 |
NSCLC |
free base or salt |
oral |
not limited |
| 5 |
NSCLC |
free base or salt |
oral (via Claim 4 dependency) |
0.01 to 10 mg/kg/day |
| 6 |
NSCLC |
fumarate |
oral |
not limited |
| 7 |
NSCLC |
fumarate |
oral |
0.01 to 10 mg/kg/day |
| 8 |
NSCLC |
HFM |
oral (via Claim 8 dependency) |
not limited |
| 9 |
NSCLC |
HFM |
oral |
0.01 to 10 mg/kg/day |
| 10 |
AML or aCML |
free base or salt |
not limited |
not limited |
| 11 |
AML subsets with FLT3 ITD / point mutation / mutant FLT3 polynucleotide-positive |
free base or salt |
not limited |
not limited |
| 12 |
aCML with FLT3 fusion polynucleotide-positive |
free base or salt |
not limited |
not limited |
| 13 |
AML/aCML |
fumarate |
not limited |
not limited |
| 14 |
AML/aCML |
HFM |
not limited |
not limited |
| 15 |
AML/aCML |
free base or salt |
oral |
not limited |
| 16 |
AML/aCML |
free base or salt |
oral |
0.01 to 10 mg/kg/day |
| 17 |
AML/aCML |
fumarate |
oral |
not limited |
| 18 |
AML/aCML |
fumarate |
oral |
0.01 to 10 mg/kg/day |
| 19 |
AML/aCML |
HFM |
oral |
not limited |
| 20 |
AML/aCML |
HFM |
oral |
0.01 to 10 mg/kg/day |
| 21 |
AML/aCML |
fumarate |
not limited |
not limited |
| 22 |
AML/aCML |
HFM |
not limited |
not limited |
| 23 |
AML/aCML |
fumarate |
oral |
not limited |
| 24 |
AML/aCML |
fumarate |
oral |
0.01 to 10 mg/kg/day |
| 25 |
AML/aCML |
HFM |
oral |
not limited |
| 26 |
AML/aCML |
HFM |
oral |
0.01 to 10 mg/kg/day |
How should these claims be construed in practice?
The patent is built around a method-of-use structure. The practical reach depends on what constitutes:
1) the “effective amount”,
2) whether an accused product uses the claimed compound or a salt, and
3) whether the accused regimen falls inside the oral route and mg/kg range (only for dependent claims that add those limitations).
1) “Effective amount” (independent-method broadness)
- Claims 1 and 10 are not restricted by route or mg/kg range.
- “Effective amount” is typically broad because it is defined by clinical effect rather than a fixed numeric regimen.
- For infringement, the key question is whether the regimen includes administration of the claimed compound (or a salt) to a patient with the claimed cancer.
Impact: In enforcement terms, Claims 1 and 10 are the “anchor” claims with the broadest structural reach.
2) Salt identity (fumarate vs hemifumarate vs “salt”)
- Claim 1 covers the compound “or a salt thereof.”
- Claim 2 narrows to fumaric acid salt.
- Claim 3 and the HFM line narrow to hemifumarate (HFM).
- For dependent claim coverage, the salt form matters.
Impact: A competitor using a different counterion salt (e.g., hydrochloride, maleate) would try to avoid dependent claims specifically limited to “fumaric acid salt” or “hemifumarate (HFM).”
But independent claims still include “salt thereof,” depending on how “salt” is construed and whether the specific salt is within that universe.
3) Route limitation (oral)
- Oral administration is only added in dependent claims (e.g., Claims 4, 6, 8, 15, 17, 19, 23, 25).
- This means non-oral dosing formats (infusion, intrathecal, parenteral) are not excluded from coverage under Claims 1 and 10.
Impact: If a rival’s label or clinical regimen is non-oral, that reduces exposure to the dependent oral claims, but not necessarily the independent claims.
4) Dose limitation (0.01 to 10 mg/kg/day)
- Dose is only constrained in dependent claims (Claims 5, 7, 9, 16, 18, 20, 24, 26).
- Outside that numeric range can be a meaningful design-around if infringement is asserted based on dose-limited dependent claims.
Impact: The mg/kg range is an execution parameter; it is relevant to regimen design and to label-adjacent medical practice.
What does the biomarker language add to the leukemia claims?
The leukemia portion adds a genotype-based patient group.
AML biomarker limitation (Claim 11)
- Mutant FLT3 polynucleotide-positive AML, including:
- FLT3 internal tandem duplication (ITD) positive
- AML with FLT3 point mutation
aCML biomarker limitation (Claim 12)
- FLT3 fusion polynucleotide-positive aCML
Impact:
- These provisions narrow Claim 10’s broader AML/aCML treatment frame into specific molecular subsets for the dependent coverage.
- Even if a competitor treats AML broadly, the biomarker-defined dependent claims can be harder to trigger unless the treated population matches those FLT3 criteria.
Where is the likely competitive threat inside the claim stack?
A claim set like this creates three practical “risk zones”:
1) Compound/salt presence risk (core):
If the same compound or a fumarate/hemifumarate is used, the risk is structurally high for both NSCLC and FLT3-driven leukemias.
2) Indication risk (anchor):
- NSCLC treatment with the compound hits Claim 1 regardless of route and dosing.
- AML/aCML treatment hits Claim 10 similarly.
3) Regimen risk (dependent):
- Oral regimens trigger dependent oral claims.
- 0.01 to 10 mg/kg/day dosing triggers additional dependent claims.
What is the patent landscape around U.S. 9,487,491?
No landscape can be produced from the information supplied. A patent landscape requires at minimum:
- application/publication numbers for this patent and family members,
- the assignee,
- related continuations/divisionals,
- cited references/forward citations,
- terminal disclaimers and expiration/adjustment,
- and competitor products and their asserted infringement theories.
The request does not provide any of these dataset elements, and producing a landscape without them would not be actionable.
Net scope summary for business decisions
Core protected activity (highest value claim positions)
- Treat NSCLC by administering the specific compound (or salt) (Claim 1)
- Treat AML or aCML by administering the specific compound (or salt) (Claim 10)
Key expansion levers (dependent claim coverage)
- Use of fumarate (Claim 2) and hemifumarate (Claim 3) for NSCLC
- Use of fumarate (Claim 13) and hemifumarate (Claim 14) for AML/aCML
- Oral dosing (multiple dependent claims)
- Dose range 0.01 to 10 mg/kg/day (multiple dependent claims)
Key Takeaways
- U.S. Patent 9,487,491 is a method-of-treatment patent focused on administration of a single specific compound (and its salts) to treat NSCLC and FLT3-driven AML/aCML subsets.
- The broadest exposure sits in Claims 1 (NSCLC) and 10 (AML/aCML) because they do not limit route or mg/kg/day.
- The most exploitable design-arounds are likely tied to salt form, oral route, and dose range, which are only added in dependent claims.
- The leukemia portion uses FLT3 genotype/fusion definitions in dependent claims, narrowing the molecular population that triggers those particular claim variants.
FAQs
1) Does the patent limit treatment to a specific dosing schedule beyond “effective amount”?
No for the independent claims (Claims 1 and 10). Dose range limits appear only in dependent claims (0.01 to 10 mg/kg/day).
2) Is oral administration required for infringement?
Not for the independent claims. Oral is limited in multiple dependent claims.
3) Does the patent require a specific salt?
Independent claims cover the compound “or a salt thereof.” Dependent claims separately require the fumaric acid salt or specifically hemifumarate (HFM).
4) What leukemia subgroup is explicitly claimed?
AML subsets defined by FLT3 mutations/ITD (Claim 11) and aCML defined by FLT3 fusion (Claim 12).
5) Which claims are most important for a compound-similar competitor?
Claims 1 and 10 because they attach to administering the compound (or its salts) for NSCLC and AML/aCML without route or mg/kg limits.
References
[1] U.S. Patent 9,487,491 (claims provided in prompt).
