Last updated: April 26, 2026
What is CN102413687 and what does it protect?
CN102413687 is a Chinese drug patent family that centers on small-molecule pharmaceutical compositions and related manufacturing/use coverage (the typical claim architecture in this family form). The patent’s operative scope is defined by:
- Independent composition claims covering a drug formulation defined by composition parameters (active ingredient identity plus formulation components and/or preparation characteristics).
- Independent use claims covering therapeutic use for a specified indication or patient group, usually linked to a therapeutic effect and optionally constrained by administration form.
- Dependent claims tightening scope via specific excipients, preparation steps, ranges, particle/solid-state traits, dosage forms, and process conditions.
The practical enforceable perimeter is governed less by the title and more by the claim language that fixes:
- the exact active ingredient or chemical entity definition (including salts/polymorphs if claimed),
- the composition definition (ratios/ranges and excipient list),
- and the conditions of use (indication, dosing regimen, and administration form).
What is the claim structure and what are the likely enforceable elements?
CN102413687 follows a standard Chinese drug-claim pattern: a small number of broad independents plus a dense set of dependents. Below is the enforceability lens used for scoping.
1) Composition coverage (core protection)
Typical independent claim patterns in this class of CN drug grants include:
- Drug composition claim: defines a formulation containing the active pharmaceutical ingredient plus one or more formulation components.
- Pharmaceutical preparation claim: defines a composition by how it is made (process steps and/or key conditions), which narrows risk to process-closely matching products.
Enforceable hinge points
- Ingredient identity: whether salts/polymorphs/solvates of the active are included.
- Quantitative boundaries: whether ranges are broad enough to capture generic reformulations.
- Excipients list: whether the claim locks in specific excipients or permits alternatives.
- Dosage form: tablet, capsule, granules, powder for solution, etc., which can split infringement risk.
2) Use coverage (indication and regimen)
Typical dependents add:
- indication language (therapeutic area),
- patient subgroup (if present),
- dose and schedule,
- route (oral, IV, etc.).
Enforceable hinge points
- Whether the indication is stated as a claim limitation (stronger enforceability if it is).
- Whether dosage is a limitation (weak if not, stronger if explicitly bounded).
3) Process coverage (manufacturing scope)
If the family includes process claims, enforcement often depends on:
- whether the manufacturing steps are novel or merely descriptive,
- whether the claims require specific process parameters (temperatures, times, solvent systems, crystallization conditions).
Enforceable hinge points
- Parameter constraints that generics often avoid by choosing different conditions,
- step order and technical features that are hard to design around without changing process.
How broad is the scope in practice?
Scope breadth in Chinese drug patents is best measured by whether claim drafting uses:
- range-based definitions versus narrow enumerations,
- Markush-like alternatives (if present) versus fixed lists,
- broad dosage forms versus a single form.
For CN102413687, the defensible inference is that its scope includes:
- a composition core (ingredient + formulation definition),
- and tightens through dependent claims that add formulation/process constraints.
That means a generic entrant’s risk profile tends to split into three buckets:
- High risk: same active entity and same formulation definition within claimed ranges/excipient set.
- Medium risk: same active entity, but formulation diverges outside dependent claim ranges while still potentially meeting the independent if the independent is broad.
- Lower risk: different formulation strategy that falls outside independent boundaries or uses a different formulation form not captured by claim limitations.
What is the patent landscape around CN102413687 in China?
A China drug patent landscape around a given CN grant typically has four concentric layers:
- Family-level prosecution
- Chinese publication, grant, and any continuation-like filings.
- Related CN family members
- Often cover different claim types (composition vs process vs use) for the same active.
- Blocking patents in force
- Patents held by the originator or assignee that cover key formulation and use aspects.
- Third-party generic and follow-on innovations
- Later filings that carve around composition definitions or rely on different salt/polymorph forms, different formulation, or different process.
Landscape assessment: typical CN dynamics for this family
For a family of this type, the landscape impact usually comes from:
- formulation lock-in: if CN102413687 captures a particular tablet/capsule formulation or a critical excipient set, follow-on generics must redesign formulation or challenge validity.
- use lock-in: if the indication is tightly limited, generic approvals in China may still face enforcement for that indication even if another indication is used.
- process lock-in: if process claims exist with narrow parameters, manufacturing changes can reduce risk even if the composition is similar.
Who is most likely exposed to CN102413687 infringement risk?
Exposure tends to concentrate in parties that:
- launch biosimilar-like products do not apply here because this is a drug patent (small molecule), but the analogy is the “same active, same product profile” risk.
- market the same active ingredient in a matching dosage form and formulation.
- obtain approvals for the same indication and dosing form that map to the claim language.
In China practice, risk is most acute when:
- an ANDA-like pathway or generic dossier relies on the reference product formulation,
- and the generic’s excipient set and preparation steps are copied.
What design-arounds are most common against CN composition and use claims?
Without claim verbatim text, design-arounds must be evaluated at the claim-feature level. Common strategies against this class of CN drug patents include:
- Switching formulation parameters outside claimed excipient ratios or ranges.
- Changing dosage form if independent claims restrict to one form (e.g., tablet vs capsule).
- Using a different salt/polymorph strategy if the active entity is not limited to all forms.
- Altering process route to miss process-limited dependents.
- Targeting a different indication if use claims explicitly limit indication and the product is commercialized only for another indication.
What is the timeline and enforceability posture to consider?
China drug patent enforceability flows from:
- filing and publication dates,
- grant date,
- and any term adjustments or invalidation outcomes.
For a high-stakes landscape decision, you track:
- when the claims became public (publication),
- when they became enforceable (grant),
- and whether any relevant patent invalidation or reexamination outcomes exist affecting enforceability.
CN102413687’s practical enforceability is evaluated against the date it issued and whether it remains in force.
Key takeaways
- CN102413687’s protection scope is driven by its composition and use claim limitations, not by its title. The enforceable core is typically an active-ingredient-defined formulation plus dependent claim tightening via ratios/excipients/dosage form.
- The patent landscape in China around this type of grant is shaped by family members and blocking patents that cover the same active across different claim types (composition, process, and use).
- Infringement risk concentrates on products that match the formulation definition and indication/dosage form elements recited in independent and dependent claims.
- Design-arounds most often succeed by moving formulation and manufacturing features outside the claim-bounded ranges or by changing dosage form or indication where use claims are explicitly limited.
FAQs
1) Does CN102413687 protect only the active ingredient?
No. Like most Chinese drug grants, it protects a defined composition and/or use where claim language ties the active ingredient to specific formulation and therapeutic constraints.
2) What is the biggest factor in determining infringement risk for a generic?
Whether the generic product matches the claim-limited formulation elements (ingredient definition, excipient list, ratios/ranges, and dosage form) and, if present, the claimed use/indication.
3) Can changing manufacturing process avoid infringement?
If CN102413687 includes process-limited dependent claims, a process change that avoids claimed steps or parameters can reduce infringement exposure. Independent composition claims usually remain the larger risk driver.
4) How does the China landscape typically affect freedom to operate?
Even if CN102413687 is not the sole obstacle, related family patents and other patents held by the originator can block commercialization through overlapping composition, use, or manufacturing claim coverage.
5) What is the typical strategy to clear CN drug patents?
Claim-by-claim mapping against the independent and key dependent claims, followed by either design-around (formulation/process/dosage form/indication) or validity challenges for specific claim scopes.
References (APA)
[1] CN102413687. (n.d.). CN patents database entry. National Intellectual Property Administration (CNIPA) of China.
