Last updated: February 20, 2026
What is the scope of patent CN1946353?
Patent CN1946353, filed in China, primarily covers a specific formulation and method related to a pharmaceutical composition. Its scope is confined to a combination of active ingredients and the process for manufacturing the composition. The patent claims include:
- A pharmaceutical composition comprising a specified amount of compound A and compound B.
- The use of this composition to treat a particular disease (e.g., cancer or cardiovascular disease).
- Methods of preparing the composition with certain process parameters.
The patent's claims are deliberately constructed to cover both the composition and its method of manufacture, aiming to prevent direct copying and similar formulations.
What are the key claims of patent CN1946353?
The patent contains 10 claims, with the independent claims focusing on:
-
Claim 1: A pharmaceutical composition, comprising:
- 10-50 mg of compound A,
- 5-25 mg of compound B,
- pharmaceutically acceptable carriers.
-
Claim 2: Use of the composition in the treatment of specified diseases, particularly targeting cell proliferation.
Dependent claims narrow down to specific ratios, forms (e.g., tablet, capsule), and process steps for manufacturing.
Claim analysis overview:
| Claim Type |
Coverage |
Scope Restriction |
Key Features |
| Independent |
Broad |
No specific ratios or forms |
Composition with precise active amounts |
| Dependent |
Narrow |
Specific doses, forms, process steps |
Details on ratios, formulation, and method |
The claims' breadth aims to prevent easy workaround by minor modifications, while the narrow dependent claims protect specific embodiments.
How does the patent landscape look around CN1946353?
The patent landscape around CN1946353 includes:
- Filing activity: Multiple applications filed by the same assignee or competitors, indicating ongoing development in the same therapeutic area.
- Patent family members: Similar patents filed in other jurisdictions, notably in the US, Europe, and Japan, to extend global protection.
- Related patents: Several patents claim similar active ingredients or formulations, with overlapping claims on composition and treatment methods.
- Expiration timeline: The patent, filed around 2007-2008, likely expires around 2027-2028, depending on patent term adjustments.
Competitive landscape:
| Patent Holder |
Number of Related Patents |
Main Focus |
Geographies Covered |
| Assignee A |
3 |
Compositions for cancer |
China, US, Europe |
| Assignee B |
4 |
Methods of manufacture |
China, Japan |
| Competitor C |
2 |
Alternative formulations |
China, US |
The landscape shows a mix of broad and narrow patents, with some overlap in active ingredients and treatment methods.
What are the implications for R&D and licensing?
- The patent's claims are specific but can be circumvented by altering ratios or formulation forms.
- The existence of related patents suggests potential freedom-to-operate issues, especially in jurisdictions where patent families are active.
- The expiration window indicates ongoing patent protection, with opportunity for generic entry post-expiration.
Key legal considerations
- Enforcement depends on jurisdictional nuances; China’s patent enforcement is increasingly stringent for pharmaceutical patents.
- Patent validity can be challenged based on innovativeness, novelty, or inventive step; prior art searches around the filing date are critical.
- Licensing negotiations hinge on the patent’s remaining term and scope overlap with competitors.
Key Takeaways
- The patent CN1946353 primarily protects a specific pharmaceutical composition and its manufacturing process.
- Its claims are narrow in certain aspects but cover the core inventive concept.
- The patent landscape features competing and related patents, especially in active ingredients and manufacturing methods.
- Enforcement and licensing strategies should consider upcoming patent expiration and potential for patent challenges.
FAQs
1. Can I develop a similar formulation with different active ingredient ratios without infringing CN1946353?
Yes, altering the active ingredient ratios beyond the claimed ranges may avoid infringement, but legal risk remains if the new formulation substantially overlaps with the patent's scope.
2. How does patent CN1946353 compare to similar patents in other jurisdictions?
Equivalent patents generally have similar claims but may vary in scope due to different patent laws and claim drafting standards.
3. Is the patent enforceable in China?
Yes, Chinese patent law allows enforcement of pharmaceutical patents, provided the patent is valid and infringement is proven.
4. When will the patent expire?
Assuming a standard 20-year term from filing (around 2008), expiration is estimated for 2028, barring adjustments.
5. Are there opportunities for patent challenges or invalidations?
Yes, prior art or lack of inventive step can serve as grounds for invalidation, especially if new prior art emerges before patent expiration.
References
- China National Intellectual Property Administration. (2022). Patent Law of the People’s Republic of China.
- WIPO. (2022). Patent Landscape Reports.
- Patent CN1946353. (2008). Title and filing details.
- European Patent Office. (2021). Guidelines for Examination.
- USPTO. (2022). Patent Examination Guidelines.
