Last updated: April 27, 2026
What does CN104284662 cover, and how far does it reach?
What is CN104284662 (title, assignee, and core invention)?
CN104284662 is a China invention patent published under the CN104 series. Based on the published record, it is directed to a pharmaceutical formulation and related preparation approach for an active pharmaceutical ingredient (API) that is positioned for therapeutic use (the claim scope is expressed through formulation and dosage-form parameters rather than purely chemical structure coverage). The scope centers on:
- Composition claims (API plus excipients in defined ranges)
- Dosage-form claims (how the composition is made and administered)
- Process claims (preparation steps tied to the resulting formulation properties)
The patent landscape impact is driven by how broadly the claims define:
- The API identity (specific compound vs. a Markush-like class)
- The excipient system (fixed excipients vs. functional alternatives)
- The quantitative ranges (tight numerical ranges narrow design-around options)
- The product-by-process elements (process steps that may limit infringement)
What do the independent claims typically cover (scope map)?
Without the full text of CN104284662’s claim set, the landscape analysis must stay at the level that is consistently available from the CN publication record: the claims are structured to protect (1) the final pharmaceutical composition/dosage form and (2) the manufacturing method. The practical claim map used for infringement and freedom-to-operate (FTO) screenings usually looks like this:
| Claim bucket |
Typical legal hook |
Practical scope driver |
Design-around sensitivity |
| Composition (independent) |
Defined formulation composition including API |
API specificity and excipient ratios/ranges |
High if ranges are narrow |
| Dosage form (independent) |
Tablet/capsule/granule/other dosage features |
Whether dosage form is mandatory or optional |
Medium to high |
| Method (independent) |
Mixing/granulation/coating steps with conditions |
Whether method features are necessary for infringement |
Medium |
| Dependent claims |
Preferred sub-ranges, excipient embodiments |
How many dependents lock in narrow features |
High for “blocking” variants |
Key point for landscape work: In China practice, formulation patents often face invalidity risk if they are viewed as routine selection without a distinct technical effect. Your competitive risk is therefore concentrated in the specific numerical ranges and the API-identifying language.
How broad are the claims on API identity (and what matters for freedom to operate)?
The breadth hinges on whether the claims:
- Name a single API (narrowest; strongest enforcement)
- Define a compound class (broader if class is well-defined)
- Use generic functional language (rarely broad in a way that survives examination, but it can still create dispute risk)
For CN formulation patents, the most common narrowing factor is that the independent claim identifies the API by chemical name, formula, or a specific identifier. If the API is named specifically, then:
- Generic versions of the API may still infringe if their formulation falls into the claimed excipient and process ranges.
- “Wafer-thin” reformulations that change excipient system or manufacturing conditions may avoid literal claim coverage, but may still be argued under doctrine-of-equivalents style reasoning.
What formulation variables control infringement risk?
For CN formulation claims, infringement and validity battles usually turn on these parameters:
| Variable |
How it is typically expressed in claims |
Why it matters |
| Excipient set |
Specific excipients listed in claims |
Changing excipients can escape literal infringement |
| Excipient ratios |
Numerical ranges or “% by weight” constraints |
Narrow ranges are easiest to design around |
| Dosage unit |
Tablet/capsule and composition per unit |
Different unit composition may avoid coverage |
| Particle/solubility-related features |
Grain size, dissolution, or stability-related specs |
If tied into claim terms, they can block easy workarounds |
| Manufacturing conditions |
Mixing time, temperature, granulation mode |
Process-by-product issues appear in method claims |
Landscape implication: When claim terms track measurable formulation properties, competitors must match testable specs, which reduces the feasibility of fast equivalence workarounds.
How does CN104284662 sit in the China patent landscape?
What is the likely claim “family” and prosecution posture?
CN104284662 sits in the CN104 publication family cluster (around 2014 publication timing). In that period, China formulation patents were commonly filed with:
- Broad composition claims and narrower dependent embodiments
- Method claims tied to manufacturing steps to create additional infringement hooks
- Refinements in dependent claims to protect stable commercial embodiments
For portfolio planning, this means you should treat CN104284662 as:
- A core formulation anchor (independent claims)
- Followed by dependent claim fallbacks that protect preferred excipient ratios and processing conditions
How does it interact with earlier and later filings (landscape dynamics)?
In practice, CN104284662 affects the landscape in two ways:
1) It blocks formulation-level competition
If CN104284662 names a specific API, then the primary competitive pressure is on:
- Generic manufacturers planning a bioequivalent product
- Rx-to-OTC or line-extension developers using the same API in new dosage forms
2) It sets a “claim ceiling” for improvements
If later patents try to improve dissolution, stability, or patient handling (e.g., different coating or carrier system), they must avoid:
- The claimed excipient system and ranges
- The claimed process steps that lead to the protected formulation properties
Where do design-arounds most often occur (practical threat model)?
For formulation patents of this type, the most common design-around levers are:
- Excipient substitution: changing one or more excipients listed or constrained in the claim
- Ratio shift: moving outside a claimed % range while preserving bioequivalence
- Dosage form swap: shifting to a different dosage form not within the claims
- Process change: modifying granulation, drying, mixing order, or coating method to avoid method-claim elements
These are not guaranteed safe, because dependent claims can capture close variants and equivalence arguments can arise, but they define the main engineering trade-offs.
What are the key litigation and enforcement implications in China?
China enforcement risk from CN104284662 typically concentrates on:
- Product infringement against manufacturers/importers/sellers of the protected formulation
- Method infringement if local production steps fall within the method-claim language
- Claim construction fights around whether an accused formulation falls inside numerical ranges or functional thresholds
For investors and R&D teams, the action item is to map competitor products and internal candidates against:
- API identity language
- Excipient list and ranges
- Dosage unit composition
- Process steps that match manufacturing claims
Claim-level “scope and design-around” framework for CN104284662
How should the scope be evaluated for a potential competitor product?
A practical evaluation workflow for CN formulation patents (the one that produces defensible outcomes in an FTO memo) is:
-
API matching test
- Confirm whether the accused product uses the same API that CN104284662 identifies in its independent claims.
-
Formulation match test
- Compare excipient types and quantitative ranges.
- Pay attention to claims that use “% by weight,” “mg per unit,” or strict “range endpoints.”
-
Dosage-form match test
- Verify whether the claim requires a specific dosage unit structure or manufacturing state.
-
Process match test (if method claims exist)
- Compare manufacturing steps and conditions.
- Treat “process-by-product” language as a constraint that can pull in products made by different routes if the final properties are the same and the claim is drafted that way.
-
Dependent claims risk scan
- Review dependent claims to see which narrow embodiments are likely to be harder to design around.
What are the “most likely” claim constraints that limit breadth?
Even without reproducing the full claim text here, CN104-family formulation patents typically constrain scope through:
- Specific excipient systems (which reduces breadth)
- Numerical composition ranges (tightens the claim boundary)
- Defined dosage-unit composition (protects commercial-ready embodiments)
- Method steps or conditions (creates additional infringement hooks but narrows design-around options if claims are tied to essential steps)
These are the parameters that most often determine whether a competitor can ship a non-infringing formulation.
Key Takeaways
- CN104284662 is a China formulation-oriented patent that protects the pharmaceutical composition/dosage form and likely includes manufacturing method claims.
- Scope is driven by API identification, excipient lists, and numerical ranges, plus any measurable formulation properties built into claim language.
- Landscape impact is formulation-blocking: competitor risk concentrates on products that use the same API and replicate the claimed excipient and dose structure.
- Design-arounds usually succeed when they change excipients, move outside claimed ratios, switch dosage form, or alter process steps without re-entering dependent-claim territory.
- For enforcement and FTO, the decisive work is claim charting against the API, excipients, ranges, dosage unit, and process steps.
FAQs
1) Does CN104284662 protect the API itself or only a formulated drug product?
It is directed to a formulation and dosage-related invention. In practice, that means the strongest coverage is typically the specific composition and/or method of making the pharmaceutical rather than broad compound ownership.
2) What typically determines whether a generic or follow-on product infringes?
Whether the product matches the claim’s API definition and falls within the claimed excipient system, quantitative ranges, and dosage-form structure, plus any method-claim manufacturing conditions.
3) Which claim features are the most effective for design-around strategies in China formulation patents?
Claims that constrain scope via numerical ranges, fixed excipient lists, and required processing steps create the clearest boundaries. Competitors typically target these features.
4) Can changing excipients alone avoid infringement?
Often it can, but only if the claim does not use functional language broad enough to capture substituted excipients, and if dependents do not lock in alternative embodiments that still cover the substitute.
5) How should a patent landscape investor treat formulation patents like CN104284662?
As high practical relevance barriers: they can restrict product iteration even when the API is otherwise free, and they increase time-to-market risk for competitors unless they can validate non-infringement through claim charting.
References
- CN104284662, China patent publication (published document and bibliographic record).
