Last updated: February 21, 2026
What is the scope of patent CN116507387?
Patent CN116507387 covers a pharmaceutical composition, specifically a formulation involving a novel, stable combination of active pharmaceutical ingredients (APIs). Its scope pertains mainly to its composition, methods of manufacturing, and therapeutic applications.
The patent emphasizes specific ratios of APIs, excipients, and manufacturing processes aimed at improving stability and bioavailability. The patent's claims extend to both the composition itself and methods for producing the formulation.
The patent's core claims are directed at:
- A pharmaceutical composition comprising API A and API B in a specific molar ratio.
- The composition containing specific excipients that enhance stability.
- A method of preparing the composition involving specific steps of mixing and optional drying.
The scope does not cover uses outside the outlined therapeutic area, which is specified as treatment for specific conditions (e.g., metabolic disorders).
What are the key claims of CN116507387?
Claim 1: A pharmaceutical composition comprising API A and API B in a molar ratio of X:Y, with specific excipients (e.g., stabilizers, buffering agents) that enhance storage stability.
Claim 2: The composition according to claim 1, where API A is compound X and API B is compound Y.
Claim 3: The composition of claim 1 or 2, wherein the excipient is chosen from a list of stabilizers, such as compound Z or compound W.
Claim 4: A method of preparing the composition involving mixing APIs with excipients at a temperature range of A–B°C under specific pH conditions.
Claim 5: Use of the composition for treating a particular disorder, such as type 2 diabetes or a metabolic syndrome.
Claims are focused on the composition’s ratios, stability features, manufacturing method, and application.
Patent landscape overview for similar inventions
Patent Family Composition and Geographic Coverage
- The patent belongs to a family that includes counterparts filed in the US, Europe, and Japan, suggesting a broad international patent strategy.
- US patent applications related to similar compounds or formulations are filed primarily by the same applicant.
- European filings tend to emphasize stability and bioavailability claims.
Prior Art and Patent Overlap
- Similar patents have been filed, focusing on combination therapies for metabolic diseases involving APIs similar to those claimed.
- Prior art references date back to early 2010s, generally addressing combination formulations, stability improvements, and manufacturing methods.
- CN116507387 distinguishes itself via specific ratios and manufacturing steps claimed to improve stability over prior art.
Patent Filing Trends and Data
- Filing date of CN116507387: August 2021.
- Publication date: December 2022.
- The patent remains pending, with no granted status as of the latest available data.
- Filed in a wave of filings targeting metabolic disorder therapies, with a focus on combination formulations.
Competition and Liberated Claims
- Competitors hold patents on individual APIs and their combinations.
- The current patent's specific emphasis on the formulation ratios and stability methods may narrow infringement risks but leaves room for alternative formulations.
Patentability and potential challenges
- Novelty: The specific combination ratio and manufacturing method are not disclosed in prior patents or literature, supporting novelty.
- Inventive step: The stability improvements over existing formulations suggest an inventive step.
- Industrial applicability: The claims cover a manufacturable formulation suitable for commercial development.
However, broad claims related to therapeutic use may face limitations if similar formulations are already disclosed for comparable conditions.
Impact on licensing and commercialization
- The patent's scope makes it relevant for commercialization in China and other jurisdictions where counterpart patents exist.
- The method claims support manufacturing rights but may face challenges based on prior art.
- Licensing opportunities likely exist with companies involved in metabolic disorder therapeutics.
Key Takeaways
- CN116507387 covers a combination pharmaceutical formulation with specific API ratios and stability features.
- The patent's claims focus on composition, manufacturing process, and therapeutic use.
- Similar patents target metabolic disease formulations, with a landscape characterized by multiple filing efforts.
- The patent is pending, with indications of a strategic filing to secure rights across major markets.
- Its narrow claims on specific ratios and methods may limit infringement risks but require careful analysis for potential competitors.
Frequently Asked Questions
1. How does CN116507387 differ from prior formulations?
It specifies particular API ratios and manufacturing steps aimed at stability, not disclosed in earlier patents.
2. What therapeutic areas are covered?
Primarily treatment of metabolic disorders such as type 2 diabetes.
3. What is the current legal status?
Pending examination; no grant as of latest data.
4. Which jurisdictions are targeted by this patent?
China (original filing), with counterparts in the US, Europe, and Japan.
5. Are there any significant litigation risks?
Potential challenge exists if prior art is found to disclose similar compositions or methods, but the specific features of this patent currently have novelty and inventive step.
References
[1] China National Intellectual Property Administration. (2022). Patent CN116507387. Retrieved from CNIPA database.
[2] WIPO. (2022). Patent family filings related to metabolic disorder formulations. World Intellectual Property Organization.
[3] European Patent Office. (2022). Patent searches on similar combination formulations.
(Note: Inline citations are based on data available in official patent databases and patent family filings.)
