United States Patent 6,469,182: Scope, Claim Coverage, and US Landscape
What does US 6,469,182 claim cover?
US Patent 6,469,182 is directed to a method of inhibiting tumor growth in a patient by administering a specific compound (or a pharmaceutically acceptable salt). The independent claim statement provided is:
- Claim 1 (method claim): “A method of inhibiting growth of a tumor in a patient, said method comprising administering to said patient a compound of the formula: … or a pharmaceutically acceptable salt thereof.”
This claim structure is typical of oncology composition-to-method translations: the legal scope is driven primarily by (1) the exact identity of the “compound of the formula” and (2) the patient treatment purpose (“inhibiting growth of a tumor”).
Claim 1 scope components
| Scope element |
What it means legally for infringement/design-around |
| “Administering to said patient” |
Requires use in a treated patient (method of treatment). Direct administration is the operative act. |
| “Compound of the formula … or pharmaceutically acceptable salt” |
Coverage is limited to the formula-defined compound(s) and their salts. If an accused product does not meet the formula, it avoids the core claim. |
| “Inhibiting growth of a tumor in a patient” |
Provides the therapeutic intent/indication. It is not enough that the compound exists; the method claim is tethered to tumor-growth inhibition. |
What is missing from the claim text you provided, and how that affects claim interpretation
The claim excerpt includes the formula placeholder (“compound of the formula: …”), but the actual formula is not present. Under US patent claim construction, the numerical and structural limits of that formula determine what compounds fall within the literal scope.
Because the formula itself is not provided, the exact structural coverage cannot be enumerated from the excerpt alone. Without the formula, any attempt to list covered substituents, ring systems, stereochemistry, or salt types would be speculative.
How claim scope typically maps to infringement risk
Even with the formula omitted, the type of claim is clear: it is a method-of-treatment claim with a compound-defined limitation. That creates a practical infringement model:
- Literal infringement usually requires:
- the accused regimen includes administration of the formula-defined compound (or salt), and
- the regimen is directed to tumor growth inhibition in a patient.
- Design-around options generally focus on:
- using a compound that does not satisfy the formula limitation, or
- avoiding the compound/salt that matches the formula-defined structure.
How broad is the claim likely to be (given only the claim fragment)
From the provided claim language, the breadth comes from three levers:
-
No tumor type limitation in Claim 1 (as excerpted)
The claim does not specify tumor histology, organ, biomarker status, stage, or line of therapy. As written, it reads on “a tumor” in general.
-
No dosing, timing, or schedule in the excerpted Claim 1
The claim excerpt only requires administration; it does not recite mg/kg, cadence, cycles, duration, or combination partners (at least in the single claim text provided). That typically widens practical coverage.
-
Salt form is included
“Pharmaceutically acceptable salt thereof” expands coverage to salt variants that remain within the same active structure family.
What would determine whether the patent blocks competitors
The deciding factors for competitive freedom-to-operate for this patent are:
- The specific chemical identity defined by the missing formula.
- Whether a competitor’s active ingredient is the same (or a structurally within-formula equivalent as defined by literal claim construction).
- Whether the competitor’s labeling, prescribing, or documentation supports the “method of inhibiting growth of a tumor in a patient” use.
How this patent fits into the US oncology patent landscape
US oncology patents are usually partitioned across claim types:
- Chemical compound claims (composition of matter)
Block the molecule itself.
- Formulation claims (dosage forms, carriers, stability)
Block how the compound is delivered.
- Method-of-treatment claims (therapeutic use)
Block treating with the compound for a therapeutic purpose.
On the information provided, 6,469,182 is a method-of-treatment patent. That typically matters because:
- A competitor might avoid method claims by not performing the covered method, even if the compound is similar, depending on how the claim is drafted and how courts treat therapeutic intent and inducement.
- Conversely, if a competitor uses the compound for oncology broadly, method claims can still become a block even if dosage or regimen differs, as long as the therapeutic purpose is the same and the compound limitation is met.
What the claim implies about breadth of use
The language “inhibiting growth of a tumor in a patient” is broad by default. In practice, the scope often remains broad even when later dependent claims narrow:
- If dependent claims specify tumor types, stages, biomarkers, or combination partners, those narrower claims can help establish the “core” compound limitation applies broadly.
- If no dependent claims narrow, Claim 1 alone can reach wide clinical use.
What to look for in dependent claims and specification (and why it matters)
You provided only Claim 1’s excerpt. The patent’s actual legal reach usually depends on:
- Dependent claims: whether they narrow by tumor type, route (oral vs IV), schedule, or combinatorial regimen.
- Specification: whether it defines the formula precisely and discloses salt forms, embodiments, and therapeutic examples that align to “inhibiting tumor growth.”
Without the dependent claims and the formula text, a reliable full scope map cannot be constructed from the excerpt alone.
What is the competitive and litigation-relevant risk profile?
Given only the method claim structure, risk concentrates in:
- Any oncology program using the same formula-defined active
- Any regimen that a prescriber would reasonably frame as inhibiting tumor growth
- Any salt form that is “pharmaceutically acceptable” and derived from the formula-defined compound
If an accused regimen uses a different structural entity, the formula limitation becomes the primary fence.
US patent landscape: how 6,469,182 would typically be positioned
Within an oncology chemical series, the typical US landscape around a method patent includes:
- earlier composition patents on the same chemical scaffold,
- later combination patents (with another cytotoxic, kinase inhibitor, checkpoint inhibitor, or targeted agent),
- and formulation patents for delivery improvements (solubilizers, nanoparticles, sustained-release carriers).
A method-only patent can still be commercially significant if:
- composition coverage has expired or is weaker, while
- a specific therapeutic use remains protected by claims that are not easily avoided.
Practical freedom-to-operate lens for this specific claim type
Because Claim 1 is a compound-of-formula-based method-of-treatment claim, FTO decisions generally reduce to two questions:
- Is the active administered by the regimen literally within the claimed formula?
- Does the regimen constitute a method of inhibiting tumor growth in a patient?
If both are yes, the patent is a likely barrier.
Key takeaways on scope
- Claim 1 is a method-of-treatment claim anchored to administration of a formula-defined compound or its pharmaceutically acceptable salt.
- The excerpted Claim 1 reads broad on “a tumor” and is not limited by tumor type, stage, or schedule in the provided text.
- Competitive impact hinges on the missing formula and on how competitors’ oncology use is documented as tumor-growth inhibition.
Key Takeaways
- US 6,469,182 Claim 1 covers a method of inhibiting tumor growth by administering a formula-defined compound or its pharmaceutically acceptable salts.
- The claim’s breadth is structurally driven: coverage depends on the exact chemical formula limitation and includes at least salt variants.
- The provided excerpt does not include the formula, so the exact set of covered chemical structures cannot be enumerated from the text you supplied.
- Litigation and FTO risk concentrate on whether an accused regimen administers the same formula-defined active for tumor-growth inhibition in patients.
FAQs
1) Is US 6,469,182 a composition or a method patent?
It is framed as a method of inhibiting tumor growth via administration of a specified compound (Claim 1 excerpt).
2) Does Claim 1 limit the tumor type?
The excerpted Claim 1 uses “a tumor,” without specifying a histology, so it is not tumor-type-limited as presented.
3) Does the claim cover salts?
Yes, it includes “pharmaceutically acceptable salt thereof.”
4) Does the claim require a specific dosing regimen?
The provided Claim 1 language requires administration but does not include dosing/schedule terms in the excerpt.
5) What determines whether a competitor infringes?
The operative requirements are whether the competitor administers a compound that matches the formula-defined limitation and the treatment method is aimed at inhibiting tumor growth.
References
[1] United States Patent 6,469,182 (Claim 1 text as provided by user).
