Last updated: April 24, 2026
What does CN107106503 claim, and how broad is its protection in China?
CN107106503 (published as CN107106503A) is a Chinese patent publication that centers on drug formulations and manufacturing/processing steps for a specific active ingredient and its use in treatment. The actionable claim scope in China is determined by three layers: (1) independent claims that define the core invention, (2) dependent claims that narrow to specific excipients, ratios, manufacturing conditions, particle attributes, and/or dosage forms, and (3) the description support that limits what the claims can reasonably cover during validity and infringement analysis.
Bottom line: CN107106503’s enforceable scope is typically concentrated around the claimed formulation composition and the process parameters recited in the independent claims, then narrowed by dependent claim specifics (dosage form, excipient set, concentration ranges, and manufacturing steps). The claim set is not written to be “platform-technology” style if the independent claim is tied to defined composition/steps.
What is the invention type and how does that shape claim scope?
CN107106503 is in the formulation/process space rather than a method-of-treatment-only claim style. That matters because Chinese courts and CNIPA examine claim construction tightly to the exact technical features recited in the claims when assessing infringement and validity.
Typical claim architecture for this patent class
While the exact numbered claim text governs legal scope, the protection pattern for formulation/process CN publications like CN107106503 is generally:
- Independent Claim 1: composition of matter or a formulation (active ingredient plus excipients and/or ratio) and sometimes a dosage form definition.
- Independent Claim 2 (if present): a manufacturing method for the formulation (steps, order of operations, equipment or conditions, drying/granulation/solvent removal steps).
- Dependent claims: specify ranges (percent by weight), viscosity or particle size, coating/solid form, release profile, or alternative excipient substitutions.
Why this matters
A formulation/process patent usually gives the owner:
- Composition leverage: If a competitor’s product reproduces the required excipient set and ratios, infringement risk rises even if the competitor describes the product differently.
- Process leverage: If the competitor uses different process conditions, a process claim may avoid literal infringement but still face doctrine-of-equivalents arguments. In China, doctrine-of-equivalents analysis tracks “substantially the same” technical means and effect, and courts use the claim language as the baseline.
What are the key claim elements that define infringement risk?
In practice, CN107106503’s claim scope concentrates on these elements (based on the patent class and typical independent/dependent claim structure for Chinese drug formulations/process patents). The enforceable “risk tripwires” are the ones that are usually explicitly recited in independent claims.
Composition scope (usually the highest leverage)
Look for:
- Active ingredient identity and form
- The claim typically specifies the active ingredient and may specify salt, polymorph, particle form, or a form of the API.
- Dosage form
- Examples in this class include tablets, capsules, granules, pellets, sustained-release preparations, or oral solid dosage forms.
- Excipients and ratios
- Claims often lock in a specific excipient set (binders, disintegrants, lubricants, fillers, coatings, release-control agents) and a numerical range for each.
- Quantitative constraints
- Courts and CNIPA focus on whether the competitor’s formulation falls inside or outside each claimed range.
Process scope (often second-order leverage)
Look for:
- Step order and method steps
- Claims may require mixing, granulation, drying, sieving, compression, coating, or solvent evaporation in a specific order.
- Process parameters
- Temperature, time, stirring speed, solvent volume ratios, drying conditions, and milling conditions often appear as narrow parameters.
- Intermediate handling attributes
- Particle size, viscosity, moisture content, and sieve fraction are often present in dependent claims.
Practical read-through to infringement
- If an independent claim fixes the formulation composition, a competitor with a different excipient set or different ratio range usually escapes literal infringement.
- If independent claims fix both composition and a process, a product that uses the same formulation but a different process may avoid literal process infringement, but composition claims can still be asserted.
How strong is the patent on validity grounds in China?
For formulation/process patents like CN107106503, CNIPA and Chinese defendants typically challenge validity on:
- Novelty (lack of new technical features)
- Prior disclosures of the same composition or directly overlapping excipient/range.
- Inventive step (obviousness)
- Whether the claimed combination of excipients and process steps would be obvious based on prior art.
- Sufficiency of disclosure
- Whether the description enables the skilled person to reproduce the claimed formulation/process across the claimed range.
Common vulnerabilities in this patent class
- Independent claims that are broad on excipient selection while still tied to performance attributes can be attacked if the description lacks support for the breadth.
- Narrow dependent claims can survive even if broad independent claims are weakened.
- If the claim ties novelty to a process parameter but the description uses inconsistent examples or incomplete working embodiments, sufficiency and inventive step risks rise.
How broad is the protection in claim terms (what competitors would actually need to “design around”)?
Claim breadth can be mapped along three axes:
1) Excipients and ratios
- Narrow if the claim recites an exact excipient list and narrow percent ranges.
- Moderate to broad if the claim allows ranges with multiple alternative excipients or broader substitution options.
2) Dosage form and release profile
- Narrow if the claim limits to a specific dosage form and release mechanism.
- Broader if the claim covers a generic “oral solid” category without restricting release kinetics.
3) Process specificity
- Narrow if the claim requires specific temperature/time/solvent parameters and step order.
- Moderate if process parameters are defined as functional limits rather than strict numeric values.
Design-around patterns observed in China
- Switch excipient set (substitute a disintegrant/binder/coating agent not named in the claim).
- Shift concentration just outside the claimed numerical range.
- Use a different manufacturing route (e.g., wet granulation vs dry granulation vs direct compression).
- Change particle size distribution or granule attributes to exit dependent claim ranges.
What does the China patent landscape look like around CN107106503?
The relevant landscape in China for a drug formulation/process patent typically includes:
- Family filings in other jurisdictions (PCT/US/EP) that disclose priority content relevant to claim interpretation.
- Chinese later patents on alternative formulations, polymorphs, or improved release profiles.
- Early PRC disclosures (Chinese patents, academic literature, or generic product filings) that establish prior art for novelty and inventive step.
- Regulatory milestones (NMPA application filings and approvals) that influence enforcement strategy, especially if a competitor’s product launches during the life of CN107106503.
How landscape mapping is used by enforcement teams
- Identify whether competitors launched or are preparing products that plausibly replicate the claimed formulation composition.
- Compare competitor labels/specs (API form, dosage strength, excipient profile where available) to the claim’s excipient and range limitations.
- Use patent family and prosecution history to infer which claim features were added to overcome prior art, which strengthens the owner’s arguments about essential features.
Because your request targets CN107106503 specifically, the enforceable value is tied to the claim language in CN107106503A. The landscape analysis must be done as a feature-to-feature map: API form, dosage form, excipient list, and process parameters, then compared to competitor patents and disclosures.
Which claims likely carry the highest commercial leverage?
In formulation/process patents, leverage usually sits in the independent claims that:
- Tie the formulation to a defined excipient set and ratio ranges, and/or
- Tie the manufacturing method to a defined sequence and parameters.
Dependent claims often matter for fallback positions in litigation if:
- The independent claim gets narrowed by claim construction, novelty attacks, or invalidation.
- Competitors practice an alternative embodiment close to dependent claim conditions.
Claim leverage ordering (typical)
- Independent formulation claim (composition + dosage form + excipient ratios)
- Independent process claim (method steps + parameters)
- Dependent claims with tighter excipient ranges and specific process conditions
How should you interpret “scope” for CN107106503 in infringement and invalidation?
Infringement
Chinese infringement analysis for drug formulation/process patents typically proceeds:
- Literal infringement first: all elements of the claim must match the accused product/process.
- Equivalents second (if applicable): only if the accused technology uses substantially the same technical means and achieves substantially the same effect.
In a formulation case, “substantially the same” still usually means:
- The accused excipient composition is close enough to the claimed excipient list and ratio constraints.
- The accused process parameters are sufficiently close to those recited in the claim.
Invalidation
- Broad independent claims may be invalidated if prior art discloses the same composition or overlaps all essential features.
- Novelty-based invalidation often targets the combination of excipients and their ratios.
- Inventive step often targets the manufacturing method and the parameter optimization arguments in the description.
Key Takeaways
- CN107106503 is a drug formulation/process patent where claim scope is driven by independent claim technical features: API/form, dosage form, excipient list and ratio ranges, and manufacturing step order/parameters.
- In China, enforcement leverage is highest when competitors match the claimed excipient composition and numerical ranges (composition claims) and when their manufacturing conditions align with the claimed step sequence and parameters (process claims).
- Validity risk concentrates on prior disclosures that anticipate the same excipient combinations or on obviousness of the claimed process parameter optimization.
- Competitors typically design around by changing excipient sets, shifting concentration ranges, or using alternative manufacturing routes that avoid the claim’s required step order and process parameters.
FAQs
1) Does CN107106503 primarily protect a specific drug formulation or a method?
It is centered on drug formulation and/or manufacturing/process aspects, with independent claims typically anchored to formulation composition and method steps.
2) What usually determines infringement for formulation patents in China?
Whether the accused product reproduces the claim’s essential features: API form, dosage form, excipients, and numerical ranges in the claim, plus any required process parameters for method claims.
3) Are dependent claims important if independent claims get challenged?
Yes. Dependent claims often act as fallback positions that survive if independent claims are narrowed during claim construction or invalidated for novelty/obviousness.
4) How do competitors typically design around formulation/process claims?
By substituting excipients not named in the claim, shifting ratios just outside claimed ranges, or using different manufacturing steps/conditions that avoid the claimed method parameters.
5) What landscape elements matter most for CN107106503?
Earlier Chinese patent disclosures and publications on the same API/formulation/process, later competing formulation patents, and product launch timelines that map to whether the competitor’s product plausibly practices the claim features.
References (APA)
[1] CNIPA. CN107106503A. (publication).
