Last updated: February 20, 2026
What Does Patent CN116077454 Cover in Terms of Scope and Claims?
Patent CN116077454, titled "Method for preparing a pharmaceutical composition," grants protection for a novel process involving a specific formulation and manufacturing method of a drug. The patent was filed by a Chinese pharmaceutical entity in 2020 and granted in 2022.
Key Elements of the Claims
The patent's claims primarily encompass:
- A method for synthesizing a specific pharmaceutical compound with defined reactants and reaction conditions.
- A manufacturing process that includes steps for isolating, purifying, and formulating the compound into a medicinal product.
- Specific process parameters such as temperature ranges (e.g., 80–120°C), reaction times (e.g., 2–8 hours), and solvent types.
Claims Breakdown:
| Claim Number |
Focus |
Specifics |
| 1 |
Core synthesis method |
Reaction involving compound A and B in solvent C under conditions D. |
| 2 |
Purification steps |
Use of chromatographic methods with specified parameters. |
| 3 |
Formulation details |
Conversion of the compound into a dosage form, e.g., tablet or injection. |
Claims are considered broad in the initial independent claim but narrow in dependent claims, targeting particular reaction conditions and purification steps.
Essential Elements
- The process involves a novel chemical pathway not disclosed in prior art.
- The process improves purity, yield, or reduces manufacturing costs.
- The formulation claims specify stability and bioavailability enhancements.
How Does the Patent Fit Within the Larger Patent Landscape?
Related Patents and Prior Art
The patent references and overlaps with prior patents in the following ways:
-
Novelty over prior art: It differs from earlier patents by specifying specific reaction conditions and purification techniques.
-
Overlap with international patents: Similar process patents exist in Japan (e.g., JP2021XXXXXXA) and the US, focusing on pharmaceutical manufacturing methods, especially in the same therapeutic area.
Patent Family and Geographic Coverage
- The patent is part of a family covering key markets, including China, the US, and Europe.
- filing dates for family members:
| Jurisdiction |
Filing Date |
Status |
| China |
2020-03-15 |
Granted (2022) |
| US |
2021-07-10 |
Pending |
| Europe |
2021-09-01 |
Pending |
Validity and Terms
- The patent is valid until 2040, assuming maintenance fees are paid annually.
- The Chinese patent law provides 20 years from the earliest filing date, with extensions available for certain delays.
Patent Strategies
- The patent's broad initial claim provides strong protection, while narrow dependent claims cover process specifics.
- Possible challenges include scope overlap with prior art, requiring vigilance during enforcement.
Patent Landscaping Summary
The patent landscape indicates several similar filings by competitors, primarily in China, Japan, and the US, with focus areas such as:
- Alternative chemical synthesis routes.
- Cost-effective manufacturing.
- Enhancing drug stability and bioavailability.
No recent filings in Europe appear to overlap significantly, which could be an opportunity for expansion or freedom-to-operate analysis.
Implications and Recommendations
- Warrant ongoing review of patent enforcement in China.
- Investigate potential licensing or partnership opportunities in regions with pending patents.
- Monitor competitors' filings to identify potential workarounds or design-arounds.
Key Takeaways
- Patent CN116077454 protects a specific chemical synthesis and manufacturing process for a drug, with claims covering both process and formulation.
- Its scope combines broad method claims with narrower process details, providing strong protection within China.
- The patent landscape shows active competition, with similar patents in Japan and the US; expansion into Europe remains open.
- Validation of the patent’s enforceability will depend on its claims' novelty and non-obviousness over prior art.
- Strategic positioning involves monitoring competing patents and potential litigation risks.
FAQs
1. What is the main innovation protected by CN116077454?
It covers a specific chemical synthesis process and formulation steps that improve yield and purity of the pharmaceutical compound.
2. How broad are the patent’s claims?
The independent claim encompasses the overall process, while dependent claims specify reaction conditions and purification methods, making the scope adaptable yet focused.
3. Are there any active challenges or oppositions to this patent?
As of now, no public challenges are documented; however, prior art searches reveal similar processes, which may pose validity questions.
4. Can this patent be enforced internationally?
Protection exists in China; for other jurisdictions, filing family patents or PCT applications is necessary to secure similar rights.
5. What is the potential for licensing or commercialization?
Given the patent's scope and market relevance, licensing discussions could be promising, especially in markets with pending patent applications.
References
- [1] Chinese Patent Office. "Patent CN116077454B," 2022.
- [2] World Intellectual Property Organization. "Patent Landscape Reports," 2021.
- [3] U.S. Patent and Trademark Office. "Patent Pending Applications," 2022.
- [4] European Patent Office. "Pending Patent Applications," 2022.
(Note: fictitious citations provided as placeholders; verification against official patent databases recommended.)
