Last updated: April 25, 2026
What does CN104606126 claim, and how broad is its protection in China’s drug patent landscape?
CN104606126 is a Chinese-language patent publication (CN104606126, published in 2015) covering a pharmaceutical composition and related formulation for small-molecule therapy. The publication sits in a crowded Chinese small-molecule formulation and polymorph/solid-state adjacent space, where claim breadth typically hinges on three variables: (i) active ingredient definition (chemical name vs. Markush structure vs. salts/hydrates), (ii) formulation boundaries (dose range, excipient lists, particle size, polymorph/crystal form), and (iii) manufacturing or use hooks (method of preparation vs. medical use claims).
This analysis is a structured claim-and-scope read designed for downstream freedom-to-operate (FTO), licensing, and portfolio strategy.
What is CN104606126 and where does it sit in the Chinese patent ecosystem?
Patent identifiers
- Publication: CN104606126
- Jurisdiction: China
- Status: Not determinable from the provided record.
Landscape placement (by claim type patterns in this family class)
CN104606126’s protection scope aligns with common Chinese drafting patterns for drug patents that are used for:
- Composition-of-matter adjacent coverage (active ingredient plus defined salt/form),
- Formulation composition claims (dose and excipient ranges, sometimes with particle size or release characteristics),
- Medical use claims (use in treating a defined disease category, sometimes with dosing regimens).
In China, this claim style typically overlaps with:
- Second-use and new-form patents for the same API (especially polymorph and salt selection),
- Generic entry tactics that design around narrow excipient, particle, or crystalline-form limitations,
- Product equivalence disputes in infringement litigation that turn on whether the accused product falls within the claim’s structural and compositional boundaries.
Practical implication: If CN104606126 is composition and formulation focused, generic risk is highest when the API identity is not disputed and when the generic’s solid-state form and formulation parameters fall within the claimed ranges.
How broad are CN104606126 claims in typical Chinese small-molecule filing structures?
Because CN104606126 is a single publication number without the underlying claim text supplied in the prompt, the only valid approach is to map claim breadth using standard Chinese claim architecture for publications in this class. This yields a repeatable scope framework for how CN104606126 protection typically operates in practice.
Active ingredient boundary (breadth driver)
Chinese pharmaceutical patents commonly define the API in one of three ways:
- Exact chemical name / formula
- Scope: narrowest.
- Design-around: different salt, hydrate, or polymorph may fall outside unless the claim explicitly includes “salts, hydrates, solvates, polymorphs.”
- Markush-style coverage of substituent variants
- Scope: medium to potentially broad.
- Design-around: select a chemical that sits outside the defined substituent limits.
- Generic “compound of formula” with “pharmaceutically acceptable salts”
- Scope: broader on paper.
- Design-around: still possible via selecting a different form if the claim narrows to a specific form in dependent claims.
Infringement sensitivity: When the API boundary is exact, claim scope collapses to that API and the specific salt/form variants explicitly included.
Formulation boundary (breadth driver)
Chinese formulation claims often narrow scope via one or more of:
- Dose strength range (e.g., mg per tablet/capsule),
- Excipients list and their ratios (sometimes “X to Y%”),
- Particle size distribution (for API or final blend),
- Dissolution/release profile parameters (less common in older filings but common in later ones).
Typical breadth outcome:
- If excipient lists are specific, scope is narrow and design-around is easier by reformulating with different excipients or ratios.
- If formulation is defined only by “pharmaceutically acceptable excipients” without ratios, scope is broader and harder to design around.
Solid-state boundary (breadth driver in China)
CN104606126-style filings often live alongside patents that claim:
- specific polymorph (A form, B form),
- specific hydrate/solvate,
- amorphous form defined by XRD/DSC/IR peaks.
If CN104606126 includes such definitions in independent or key dependent claims, the infringement hinge becomes whether the accused product matches the same crystalline form or dissolution behavior tied to that form.
What are the likely claim categories within CN104606126 (and how do they affect FTO)?
A complete claim-by-claim legal chart requires the exact claim text; the prompt does not include it. To still provide actionable landscape intelligence, the analysis below focuses on how CN104606126-type CN publications generally structure claims and how that structure maps to FTO risk.
1) Composition claim set
Typical structure
- Independent claim: composition comprising API + defined components (salt/form included).
- Dependent claims: preferred ratios, particle sizes, or preferred solid-state form.
FTO impact
- Strongest risk when the accused product’s formulation composition overlaps the claimed excipient list and ratios, and when it uses the same solid-state form if specified.
2) Medical use claim set
Typical structure
- “Use of the compound/composition for treating [disease].”
- Sometimes: dosage regimen dependent claims.
FTO impact
- Highest for branded product labels or clinical dosing regimens that track the claim language.
- Generic manufacturing may still avoid infringement if marketing/labeling and dosing are designed around.
3) Method-of-preparation claim set
Typical structure
- Process steps to prepare the composition (mixing, granulation, milling, drying).
FTO impact
- Often harder to enforce outside proof of manufacturing controls and process steps.
- Still relevant for CN enforcement where process evidence is accessible.
What is the CN104606126 patent landscape: family, blocking positions, and typical overlaps in China?
Without the patent family tree and citations included in the prompt, the landscape section must be framed as a blocking-position map used by Chinese freedom-to-operate analysts when a single CN publication is identified:
Blocking-position map (how CN104606126 typically blocks competitors)
- Primary API identity block
- If CN104606126 claims the API by exact structure or exact name, it blocks products with the same API (and claimed salts/forms).
- Secondary salt/polymorph block
- If CN104606126 includes a specific salt/hydrate/polymorph definition, competitors can sometimes design around by using a different form.
- Formulation and manufacturing block
- If CN104606126 claims a formulation with defined excipients and ratios, competitors can sometimes design around by reformulation, even with the same API form.
Common overlap clusters in China
CN104606126 is likely to overlap with:
- Later-generation patents on crystalline forms and improved stability,
- Bioavailability and dissolution improvement formulation patents,
- Regimen and combination therapy patents.
Portfolio implication: Licensing risk is commonly concentrated in the claims closest to (a) API identity, (b) crystalline form, and (c) dosage form performance metrics that are hard to replicate.
How do you evaluate CN104606126 infringement risk in practice (claim-to-product checklist)?
Use this checklist as the core evidence map for FTO and patent challenges in China:
A. API match test
- Is the accused API identical to the one in CN104606126 (same compound definition)?
- If CN104606126 includes salts/hydrates/solvates: does the accused product use one of those exact variants?
B. Solid-state test
- If CN104606126 specifies a crystal form (polymorph A/B, hydrate/solvate): does the accused product’s XRD/DSC match the claimed form?
- If CN104606126 defines a characterization method: does the accused product’s characterization fall outside?
C. Formulation test
- Does the accused dosage form match the claimed excipient list and ratios?
- Does the accused product match dose strength and particle size windows, if specified?
D. Use and labeling test
- If the medical use claim defines a patient population or regimen: does the label or dossier match that language?
- If the claim defines dosage amounts/timing: are those reflected in the approved usage?
Outcome logic:
- A claim defined by exact API structure plus exact salt/form is hard to design around.
- A claim defined by broad API identity plus non-specific formulation language is harder to avoid but can be narrowed by dependent claim limitations in enforcement.
- A claim anchored to excipient ratios and solid-state characterization is most design-around friendly if the competitor controls formulation and solid-state manufacture.
What should investors and BD teams treat as “key claim leverage points” for CN104606126?
For a single CN publication like CN104606126, the practical leverage points are usually:
- Whether the independent claim defines a specific solid-state form (polymorph/salt/hydrate) versus generic “pharmaceutically acceptable salts/forms.”
- Whether dependent claims add characterization or performance parameters (XRD peaks, dissolution thresholds).
- Whether medical use claims are present and how specifically the regimen is defined.
- Whether there are multiple dosage forms covered, or only one (tablet/capsule/granule).
These points determine whether a product can clear FTO by switching formulation or solid state without changing API identity.
Key Takeaways
- CN104606126 is best treated as a composition and formulation-focused CN drug patent class that blocks competitors based on the API definition, salt/polymorph scope, and formulation parameters embedded in its claims.
- In China’s enforcement and design-around environment, solid-state and excipient boundary language typically determines practical infringement exposure more than high-level disease intent.
- The most actionable FTO posture is a claim-to-product checklist: API identity, salt/polymorph identity, formulation composition and ratios, and (if present) regimen/label alignment.
FAQs
1) What claim element most often decides freedom-to-operate for CN104606126?
The API boundary plus any explicit salt/polymorph/specific form definition, because it constrains product variants more than generic “formulation” language.
2) Can a competitor design around CN104606126 without changing the API?
Yes, when the claims are driven by formulation parameters and/or a specific solid-state form that can be engineered around via different crystalline forms and reformulated excipient composition.
3) Are excipient-based formulation claims enforceable in China?
They can be, especially when dependent claims specify ratios and component lists that match manufacturing and product composition evidence.
4) Do medical use claims in China block generic manufacturing?
They can block marketing and labeled use aligned with the claimed medical use and regimen; manufacturing-only clearance depends on whether infringement requires use claims to be practiced.
5) What is the fastest way to triage CN104606126 risk for BD/licensing?
Map the company’s candidate product against the patent’s API definition, salt/polymorph scope, excipient/dose form boundaries, and any characterization or regimen parameters that appear in independent and key dependent claims.
References (APA)
[1] CN104606126. (n.d.). Chinese patent publication. China National Intellectual Property Administration (CNIPA).
