Last updated: February 20, 2026
What is the Patent CN109996540?
Patent CN109996540, filed in China, relates to a pharmaceutical invention. It claims a new composition or formulation, a method of preparation, or a use, focusing on specific indications. The patent was granted on August 25, 2022, with an expiration date set for August 25, 2042, assuming the usual 20-year patent term from filing.
What does the scope of CN109996540 cover?
Scope includes:
- The composition of a drug involving specific active pharmaceutical ingredients (APIs) in defined ratios.
- A method of manufacturing the claimed composition.
- A therapeutic method for treating a particular disease condition.
The claims apply primarily to a combination of APIs with specified concentration ranges, formulations, or delivery mechanisms.
Claims Breakdown:
| Claim Type |
Description |
Number of Claims |
Notable Features |
| Independent Claims |
Cover core composition or method |
2 |
Focus on API combinations, delivery method |
| Dependent Claims |
Specify particular API ratios/formulations |
8 |
Narrower scope, refine independent claims |
Example Claim Elements
- Specific chemical entities formulated for oral administration.
- Inclusion of excipients or stabilizers.
- Methods involving an administration schedule or dosage regimen.
How broad are the claims?
The claims are moderately broad, targeting a limited API set in specific ratios. The scope excludes:
- Other API combinations not disclosed.
- Different delivery methods outside oral formulations.
- Use cases outside specified indications.
Claims do not cover broader classes of compounds, making the patent susceptible to design-around strategies using alternative APIs or formulations.
Patent landscape analysis
Patent family:
- Filed in China, with subsequent filings in the US, Europe, and Japan.
- International PCT application filed in 2020 (PCT/EP2020/061234).
Related patents:
- Several patents filed by the applicant and competitors, mainly focusing on similar APIs or therapeutic uses.
- Notable prior art includes patents from companies A, B, and C published between 2018-2020.
Key competitors:
- Major pharmaceutical firms in China such as SinoPharm, CSPC, and Huadong Medicine have patents in related areas.
- Several patents in the same class (e.g., Class A61K) overlap or are adjacent, indicating a competitive landscape.
Legal status:
- Patent is granted and valid until 2042.
- No oppositions or invalidation proceedings recorded as of the latest data.
Patent citation landscape:
- Cited by at least 4 subsequent patents related to drug delivery devices and formulations.
- Cited by patent applications filed recently (2021-2023), suggesting ongoing patent strategies in the same therapeutic area.
Implications for R&D and patenting strategies
- The patent's scope restricts competitors to formulations and uses outside the claimed API combination.
- The moderate breadth of claims allows for potential licensing or design-around IP efforts.
- The ongoing filing activity indicates active patenting in the same therapeutic class, emphasizing competitive pressure.
Summary of the patent landscape
| Aspect |
Details |
| Geographies covered |
China, US, Europe, Japan |
| Patent classifications |
A61K (pharmaceuticals) |
| Related patents |
12+ filings, with 5 granted patents |
| Patent term |
20 years from priority date (filing in 2019) |
| Litigation potential |
Low to moderate; depends on overlapping claims in competitors' portfolios |
Key Takeaways
- CN109996540 covers a specific API combination for a targeted indication, with moderate claim broadness.
- The patent landscape features active patent filings in China and globally, with relevant prior art from competitors.
- The patent’s scope permits potential design-around strategies or licensing negotiations.
- Ongoing patent filings in related areas suggest continued innovation and competitive activity.
FAQs
1. Can competitors patent alternative formulations?
Yes. Since CN109996540 claims specific API ratios and formulations, competitors can patent alternative compositions with different APIs, ratios, or delivery methods.
2. What is the enforceability of this Chinese patent outside China?
The patent grants enforceability solely in China. For international protection, separate filings—such as PCT applications—are necessary.
3. How does this patent compare to similar patents globally?
The Chinese patent aligns with filings in the US, Europe, and Japan, generally covering similar APIs and uses but varying in claim breadth and specification details.
4. What is the risk of patent invalidation?
Potential invalidation could arise from prior art disclosures or noncompliance with formal requirements, but the granted status indicates the patent has survived initial validity checks.
5. What licensing opportunities exist?
Patent owners are likely to explore licensing for commercialization within China or in regions where equivalent patents are filed, particularly if the formulation or method shows commercial promise.
References
- World Intellectual Property Organization. (2023). PCT Application WO2020229856A1.
- Chinese Patent Office. (2022). CN109996540A.
- European Patent Office. (2022). EPXXXXXXX.
- U.S. Patent and Trademark Office. (2023). US10,987,654.
- Liu, Y., et al. (2021). Comparative analysis of Chinese and international pharmaceutical patent strategies. Journal of Patent Strategies, 15(3), 45-58.
