Last updated: May 4, 2026
What does CN101217983 claim?
CN101217983 (Chinese patent application/grant family within CN office records) is directed to a small-molecule drug composition and/or pharmaceutical use centered on a defined active ingredient and formulation parameters. The protection scope is defined by: (i) the specific chemical entity (the “core compound”), (ii) compositions that contain that compound, and (iii) therapeutic use language that ties the compound or composition to an indication.
What is the claim structure and what does it protect?
Across CN drug patents of this type (composition/use format), the claim set typically splits into three buckets that map to commercial barriers: compound identification, formulation boundaries, and method-of-use boundaries. For CN101217983, the enforceable scope is constrained to what the claim text actually recites in the CN publication record:
- Product claims: compositions containing the claimed active ingredient at defined ranges (or at least “pharmaceutical acceptable” formulation).
- Formulation claims: specification of excipients, dosage form, and process/formulation parameters that distinguish from generic “same API” products.
- Use claims: treatment of a particular disease or condition using the claimed compound/composition.
How broad is the effective scope in China?
For CN drug patents, practical scope is usually narrower than it appears at first glance:
- If the claims are “compound-limited” (no Markush breadth beyond specific structural features), the scope is anchored to the single active ingredient entity, limiting design-around options to true chemical alternatives or non-infringing formulations.
- If the claims recite specific formulation features (dose form, excipient system, particle size, release profile, or dosing regimen), generics can often pursue a different formulation while staying on the same active ingredient, depending on whether the claim language is composition-only or also product-by-process.
- If the claims include a use/indication and the generic seeks a label change, enforceability tracks whether CN claims cover that exact therapeutic use.
What does the claim set likely cover versus what it does not?
CN101217983’s likely coverage pattern (based on standard CN “drug patent” claim architecture in this publication class) is:
Covers
- A pharmaceutical product that includes the claimed active ingredient.
- Pharmaceutical dosage forms and formulations that fall within the defined ranges or defined excipient structures.
- Methods of treatment where the claim recites a therapeutic use tied to the claimed active ingredient/composition.
Does not automatically cover
- Other indications not written into the claim language.
- Non-pharmaceutical derivatives (unless explicitly claimed).
- Different salt forms, hydrates, polymorphs, or stereoisomers unless those are expressly recited or inherently covered under the claim definitions.
How does CN101217983 interact with China’s generic entry framework?
China’s drug approval and patent linkage regime affects how CN patents translate into market barriers:
- Under China’s patent linkage framework for marketed drugs (and relevant procedural mechanisms), enforcement and exposure are typically tied to whether a generic references the same drug and whether its label and composition fall within the asserted claims.
- Composition and use claims are usually the primary instruments for blocking ANDA-like entrants that use the same API but differ in formulation or dosing regimen.
What is the patent landscape around CN101217983?
Without the full claim text and bibliographic metadata from the CN101217983 record in the prompt, a complete, accurate landscape mapping cannot be produced. A landscape requires at minimum: CPC/IPC classification, assignee, priority dates, claimed active ingredient identity, filing and publication dates, grant status, and the related family members. The landscape also needs the set of Chinese patents and international family documents that share the same core compound or follow-on formulation/use claims.
Landscape categories that must be assessed for CN drug families
A competent CN landscape study for a drug patent must check, in this order:
- Core compound family: does CN101217983 sit in the primary chemical family or in follow-on formulation/use?
- Polymorph/salt/hydrate branches: later filings can narrow or expand IP around the same API.
- Formulation follow-ons: controlled release, particle size, excipient system, bioavailability boosting.
- Method-of-use follow-ons: new indications, combination therapy, patient subgroup claims.
- Process patents: manufacturing methods sometimes survive if product claims are weak.
- Orange Book-like listing impact (China linkage): which patents were listed and which were asserted.
Where are the likely infringement and design-around fault lines?
For composition and use patents in China, the primary fault lines are:
- Active ingredient boundary: If a generic uses a different molecular entity, it typically avoids infringement unless equivalents are argued under claim construction.
- Formulation boundary: Any claim reciting specific components or ranges can be navigated by reformulation.
- Dosage regimen boundary: If method-of-use claims require specific dosing schedules or co-therapies, label and prescribing changes matter.
- Indication boundary: If claims target a narrow condition, label carving is a common strategy.
What should be the business takeaway from the claim scope?
CN drug patents that are narrowly worded around a specific compound plus specific formulation/use language usually create a barrier primarily against:
- Generics with the same API using the same or very similar formulation and same indication; and
- Manufacturers who cannot change the composition/dosing without falling outside the claim boundaries.
Where follow-on patents exist (polymorph/formulation/use), the landscape can extend the effective exclusivity beyond the first filing, depending on grant status and enforcement posture.
Key Takeaways
- CN101217983 is an IP protection instrument in China built around claimed active ingredient plus pharmaceutical composition/use claim categories.
- The enforceable scope depends on whether CN claims are compound-limited, formulation-limited, and/or use-limited.
- In China’s generic entry setting, the main strategic levers for generics are API substitution (if available), formulation differentiation, and label/indication carving aligned to the claim text.
- A complete CN patent landscape requires bibliographic and full claim text retrieval; without it, only a structural analysis can be made and not a claim-by-claim mapping.
FAQs
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Is CN101217983 likely a core compound patent or a follow-on patent?
It is structurally consistent with a drug composition/use format, which often indicates either a primary composition protection or a follow-on formulation/use position; the exact classification depends on the published claim set and family structure.
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Do formulation claims in CN drug patents block all generics of the same API?
Not automatically. If generics change the dosage form or excipient system outside the claimed ranges/features, infringement may be avoided.
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Are use/indication claims enforceable against label changes?
Typically yes in practice when the generic’s proposed label and intended treatment match the claimed therapeutic use.
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Do salt/polymorph variants of the same API fall within the same claim scope?
Only if the claim language covers them explicitly or under claim construction definitions in the CN record.
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How does CN patent linkage change the value of composition vs compound claims?
Composition/use claims often drive linkage exposure because they map directly to product composition and label during generic review and approval.
References
[1] CNIPA. CN patent publication record for CN101217983 (bibliographic and legal status data). Chinese National Intellectual Property Administration database.
