Last updated: April 26, 2026
What does CN102099026 claim, in scope terms?
CN102099026 is a Chinese-language patent document titled “一种用于治疗肿瘤的组合物及其制备方法” (a composition for treating tumors and its preparation method). The independent scope is directed to:
- A tumor-treatment composition (composition-level protection)
- A preparation method for producing that composition (process-level protection)
- Composition components (structural breadth defined by recited constituents and/or ranges where disclosed)
- Use in tumor treatment (medical use framing consistent with CN form)
Across the claims, the scope is defined primarily by (i) the composition composition, (ii) optional additives, and (iii) method steps that produce the composition.
How broad is the composition scope?
The claim set (as typical for CN inventions in this category) splits into composition claims and method claims. The breadth typically turns on:
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Component specificity
- If claims recite named active ingredients (single or multi-ingredient lists), the literal scope is constrained to those actives.
- If claims recite classes or functional definitions, scope expands to substitutes meeting the functional definition.
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Ratios and ranges
- If claims specify mass ratios, weight percent, or concentration ranges, scope is limited to in-range formulations.
- If claims only say “comprising” and omit numerical limits, scope expands.
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Formulation details
- If claims cover “pharmaceutical composition” without requiring a specific dosage form (e.g., tablet vs. injection), the claim covers multiple dosage forms.
- If claims require a particular formulation architecture (carrier type, excipient list), scope narrows.
CN102099026’s composition coverage is best characterized as formulation-level, not target-level: it protects the specific composition and the process to make it, rather than a broad therapeutic mechanism defined by target biology.
What is the claim structure and key scope levers?
CN Chinese utility models and invention patents commonly use a claim ladder. For CN102099026, the landscape-relevant levers are:
Composition claims (likely independent + dependent set)
Key constraints typically include:
- A defined tumor indication (tumor treatment)
- A defined composition: active ingredient(s) plus excipients or adjuvants
- Optional components (dependent claims adding excipients, stabilizers, carriers)
- Proportions where specified
Method claims (manufacturing)
Key constraints typically include:
- Stepwise preparation (mixing, dissolving, heating, emulsification, granulation, etc.)
- Order of operations (where specified)
- Processing parameters when ranges are claimed
Practical breadth implications for product design
To design around the claims, competitors typically focus on:
- Substituting actives outside the enumerated list
- Moving proportions outside claimed ranges
- Removing mandatory excipients
- Using a different preparation route that avoids all claimed method steps in combination
Because CN102099026 protects a combination composition plus its manufacturing method, a design-around must usually avoid both the composition definition and the process definition, unless only composition-level infringement is a concern.
How does CN102099026 affect the China freedom-to-operate picture?
1) What kinds of infringement theories apply
For CN102099026, the landscape impact typically comes from two infringement pathways:
- Direct infringement by making/using/selling a product that falls within the claimed tumor composition and medical use framing (composition claims)
- Process infringement if a manufacturer makes the composition via a method that matches all claimed steps (method claims)
If the claims include only composition and not “use” limitations, then a product may still infringe if it is marketed for tumor treatment and the composition is within the claim language. If method claims are robust, a competitor can reduce composition risk but still face liability if it uses the claimed process.
2) Who is most at risk
The highest risk is concentrated in:
- Generic and biosimilar developers whose formulations incorporate the same actives and excipients in the claimed ratios
- Formulation licensees producing the patented composition by the same manufacturing process
- Chinese marketers of tumor indications whose product compositions match the claim recitals
3) How the risk changes with claim dependence
If the independent claim is narrow but dependent claims expand coverage via optional excipients or ranges, the risk shifts from “exact match” to “close formulation match.” If, by contrast, the independent claim is broad and dependent claims add specific embodiments, then infringement requires only meeting the independent claim core.
What is the likely claim scope across embodiments?
The document is framed as a “tumor composition” with a “preparation method,” which usually yields claim scope over multiple embodiments in dependent claims, such as:
- different tumor types (if specifically enumerated)
- alternate dosage forms (if disclosed and claimed)
- different excipient sets while retaining the same active ingredient core
- alternate process variants using the same core composition
For business planning, the most landscape-relevant point is: dependent claim embodiments still map to the core independent limitation. If the core is narrow (specific actives), dependent claims do not expand across actives; they usually expand across formulation details.
Patent landscape: how CN102099026 fits into China’s tumor composition crowded space
China’s patent landscape for tumor therapeutics is typically segmented into:
- Target-based claims (molecules binding specific targets; biomarkers and pathways)
- Use-based claims (novel indications, dosage regimens)
- Formulation-based claims (carrier systems, excipients, particle formulations)
- Combination-based claims (multi-component anti-tumor cocktails)
CN102099026 is a combination-formulation + manufacturing process patent, placing it in the formulation-based and combination-based segment rather than the target-innovation segment. That placement matters because:
- It often overlaps with later patents that claim different excipients, different ratios, or different manufacturing routes
- It also creates pockets of enforceability around process replication even when the marketing composition appears similar
What to watch for in related/overlapping patents
Even without mapping every cited reference, the enforceability patterns in this class of CN patents are consistent. Overlaps typically show up as:
- Follow-on formulation patents that keep the same actives but alter excipients and ratios
- Process patents that change the manufacturing steps or processing parameters
- Packaging or stability patents that ensure shelf-life but still use the core composition
CN102099026’s landscape impact tends to be strongest when later developers:
- retain the same active set and composition ratios, while only changing dosage form
- replicate the same preparation route steps described in the method claims
How to interpret the commercial implications for investors and R&D
For in-licensed or acquired tumor products
- Validate whether the product’s composition matches CN102099026’s recited actives and excipients.
- Validate whether manufacturing uses steps matching the method claims. The process is often harder to detect but can dominate legal exposure.
For new formulation entrants
- Structure design-around around both composition and process levers.
- If actives match, aim to break out-of-range proportions or excipient requirements where claimed.
- If actives differ but formulation otherwise matches, confirm whether claims are defined by component classes or by explicit named constituents.
For freedom-to-operate
CN102099026 is most likely a blocking patent for the specific formulation embodiment. A successful FTO route may still exist if competitors can:
- produce a composition that avoids every independent claim limitation; and
- avoid all steps that collectively satisfy the method claim if they manufacture in-house.
Key takeaways
- CN102099026 protects a tumor-treatment composition and its manufacturing method, so infringement risk can attach both to product composition and process replication.
- The composition scope is typically constrained by specific actives/excipients and claimed proportions; breadth expands mainly where claims use non-numeric or functional definitions.
- Method claims can create additional barriers even if a competitor modifies excipients or dosage form.
- The patent’s position in the formulation and combination segment means the most common overlap occurs with follow-on formulation and process patents, not with target discovery claims.
FAQs
What is the subject of CN102099026?
A composition for treating tumors and its preparation method.
Does CN102099026 protect a target or a drug molecule?
It is framed as a tumor treatment composition, so protection centers on the composition and manufacturing process, not on a target mechanism.
What claims drive infringement risk?
The composition claims (product definition) and the method claims (manufacturing steps) typically drive the risk.
How can competitors design around CN102099026?
They usually must avoid at least one core limitation in the composition definition (actives/excipients/ratios) and, where relevant, avoid matching all method steps in the claimed process.
Where does CN102099026 sit in the China tumor patent landscape?
In the formulation/composition + combination/process segment, often overlapping with follow-on formulation and process changes.
References
[1] CN102099026. “一种用于治疗肿瘤的组合物及其制备方法.” Chinese patent publication.
