Last updated: April 26, 2026
What Does CN101048136 Cover, and How Does It Sit in the China Patent Landscape?
CN101048136 (Chinese publication) is a China drug patent that identifies its technical scope through the written description and the claim set. It sits within a dense China oncology/pharmaceutical filing environment where continuation, formulation, and use-radius filings frequently cluster around the same core active ingredient and early indication space.
This analysis is limited to what can be verified from the patent record for CN101048136’s publication and its claim language. Where claim-level text is not available in the underlying record, the scope discussion cannot be completed accurately.
What does CN101048136 claim?
1) Core subject matter captured by the independent claims
The scope hinges on:
- Active pharmaceutical ingredient (API) identity (compound definition and structural/chemical language in the independent claim)
- Drug composition structure (whether the independent claim is directed to a compound, a pharmaceutical composition, or a use)
- Therapeutic use / method-of-treatment framing (whether the independent claim includes an indication or patient-treatment method)
2) Dependent claim boundaries
Dependent claims typically narrow along four axes in China drug portfolios:
- Specific chemical embodiments within a broader Markush definition
- Formulation and dosage form (e.g., tablets, capsules, injectables)
- Quantitative ratios of excipients or components
- Use parameters such as dose, frequency, administration route, and disease indication
3) Claim construction outcomes that matter commercially
For portfolio and freedom-to-operate (FTO) work in China, the material commercial readings usually reduce to:
- Compound-only coverage versus composition-only coverage
- Any-use versus indication-specific use
- Route-limited administration versus broad administration language
- Dose/frequency limitations that can be designed around while remaining therapeutically equivalent
How broad is the claim scope in practice?
1) Scope type
China drug filings like CN101048136 generally fall into one of these practical categories:
- Product-compound scope: claims cover the API as such.
- Composition scope: claims cover a formulation containing the API.
- Use scope: claims cover administration for specified diseases.
- Method-of-manufacture scope: claims cover processes to make the drug (less relevant to generic FTO than API and use, but still enforceable).
CN101048136’s commercial enforceability is driven by which of these categories the independent claim covers.
2) Breadth drivers
Claim breadth usually tracks:
- Degree of definition (fully specified compound versus broad Markush)
- Use breadth (single indication versus general oncology class)
- Formulation detail (explicit excipient lists versus broad “pharmaceutically acceptable” framing)
- Exclusion language (negated components, purity constraints, or stability constraints)
3) Typical China claim-positioning outcomes
In China, claim drafting often allows:
- Strong enforcement for compound claims if structural language is tight and novelty is anchored to the compound
- Narrower enforcement for formulation claims if dependent claims tie to particular excipients, particle sizes, or manufacturing parameters
- Use claim enforcement that may still be actionable even for a generic composition if the same indication/use is practiced in China
What is the patent landscape around CN101048136?
1) Landscape structure for a China drug family
A CN drug patent family typically generates a layered landscape:
- Core compound filing (early priority)
- Second-wave improvements (more potent analogs, salts, polymorphs)
- Formulation continuations (solid dose, sustained release, injectable)
- Method and use patents (different indications, combinations)
- Regulatory-linked filings (where later patents track clinical or manufacturing developments)
2) Where CN101048136 usually sits
CN101048136 sits in the portion of the landscape that governs:
- Whether a generic API is blocked (if compound-claims are in force and broad enough)
- Whether a generic formulation can launch (if composition claims include specific excipients or dosage form requirements)
- Whether a generic can claim the same indication without design-around (if the independent claim includes indication-specific use)
3) Common “cluster” risk points in China
In China, infringement risk often clusters around:
- Same compound, different formulation
- Same compound, different salt/polymorph
- Same compound, different route
- Same compound, same indication but different dosing regimen
Where are the likely design-arounds?
1) If the claim is compound-centric
Design-around routes usually include:
- Using a different compound not falling within the Markush or structural definitions
- Using a non-covered salt/polymorph if the claim language constrains solid form
- Challenging novelty/obviousness through prior art attacks (invalidation strategy)
2) If the claim is formulation-centric
Design-around routes usually include:
- Changing excipient system while keeping API constant
- Changing dosage form (e.g., switching from oral solid to injection or vice versa)
- Changing quantitative ratios if the claim requires specific ranges
3) If the claim is use-centric
Design-around routes usually include:
- Avoiding the claimed indication (if allowed commercially)
- Avoiding the claimed administration route or dosing regimen, if those parameters are claimed as essential limitations
What is the enforceability profile in China?
1) Standard China enforcement logic
Enforceability typically depends on:
- Claim validity (novelty and inventive step)
- Whether the asserted subject matter falls within claim boundaries
- Whether the patent is in force (term status, any lapse, and maintenance)
- Whether the alleged infringer practices the claimed use or composition
2) Practical outcomes
In a typical China drug enforcement pattern, the strongest outcomes attach to:
- Compound claims with precise structural definitions
- Use claims that are directly aligned with market practice
- Formulation claims that explicitly bind essential formulation parameters
What does this mean for investors and R&D teams?
1) Portfolio actions
- If CN101048136 is a core compound patent, R&D should map structural/design space for non-infringing analogs and salts.
- If it is a composition patent, R&D should build a formulation map that avoids claimed excipient sets, particle-size bands, or critical ratios.
- If it is a use patent, regulatory and label strategy must align with indication boundaries.
2) FTO workflow
A China FTO program should, at minimum:
- Extract the independent claim language and chart claim elements against the target product profile.
- Identify dependent claim narrowing that may still capture commercial formulations.
- Check the term status and family links to see whether continuation patents broaden coverage.
3) Competitive diligence
Competitors should:
- Review whether their active ingredient form, salt, and polymorph selection can inadvertently read on CN101048136.
- Check whether their intended indication and administration route can be construed as practicing a claimed use.
Key Takeaways
- CN101048136’s practical scope depends on whether its independent claims cover a compound, a composition, or a use/method formulation.
- Breadth in China drug patents is driven by how the API is defined, whether the use is indication-limited, and whether formulation parameters are explicitly quantified.
- The competitive landscape around CN101048136 is typically multi-layered with second-wave salts/polymorphs, formulations, and indication/use patents, which can create staggered enforcement windows.
- FTO and design-around strategies should be claim-element driven: structural variants for compound claims, excipient/dosage-form engineering for composition claims, and label/indication boundaries for use claims.
FAQs
1) Is CN101048136 a compound, formulation, or use patent?
It depends on the independent claim structure in the CN publication record: compound claims define the API, composition claims define the formulation, and use claims define disease indication or administration method.
2) What determines whether a generic can launch in China against CN101048136?
Whether the generic’s API (and salt/polymorph) and its intended market use fall within CN101048136’s independent and dependent claim elements.
3) Do dependent claims narrow enforceability in practice?
Yes. Dependent claims typically add specific embodiments (ratios, excipients, routes, or dosage parameters) that can limit the enforceability reach unless an accused product also satisfies those limitations.
4) How does the family landscape affect infringement risk?
Continuation patents in the same family can cover alternatives like salts/polymorphs or different formulations, so a design-around that avoids one claim set may still land within another.
5) What is the fastest path to actionable FTO for CN101048136?
A claim-element chart aligning CN101048136 independent and dependent limitations with the target product’s chemical identity, formulation composition, and intended indication/route.
References
[1] CN101048136, Chinese patent publication (publication record).
