Last updated: February 19, 2026
This report analyzes China patent CN117398346, focusing on its scope, specific claims, and the broader patent landscape. The patent, filed on November 17, 2023, and published on January 30, 2024, pertains to a pharmaceutical composition and a preparation method. The claims cover a specific drug formulation designed for treating inflammatory and immune-related diseases. Analysis indicates potential market exclusivity for the named applicant within its claimed scope.
What is the Subject Matter of CN117398346?
Patent CN117398346 concerns a pharmaceutical composition. The core of the invention is a formulation intended for therapeutic use. This composition is described as being for the treatment of inflammatory and immune-related diseases. The patent also includes a method for preparing this composition.
The applicant for this patent is Chengdu Lixiang Pharmaceutical Co., Ltd. [1]. The patent publication number is CN117398346A. The international patent classification (IPC) codes associated with this patent are A61K 31/00 (Medicinal preparations containing organic active ingredients) and A61P 37/00 (Remedies for immunological complaints) [2]. These classifications indicate the primary technical fields and intended therapeutic applications of the patented invention.
What are the Specific Claims of CN117398346?
The patent CN117398346 contains several claims delineating the scope of protection. These claims define the precise boundaries of the intellectual property rights granted.
Claim 1: Composition of Matter
Claim 1 is the independent claim defining the pharmaceutical composition. It states:
"A pharmaceutical composition, characterized in that it comprises a therapeutically effective amount of a compound of Formula I or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier." [1]
- Formula I: The patent references "Formula I" without providing the explicit chemical structure within the abstract or immediately accessible summaries. However, the context of A61K 31/00 suggests Formula I represents a specific organic active pharmaceutical ingredient. Further investigation into the full patent document is required to identify the precise chemical entity of Formula I.
- Pharmaceutically Acceptable Salt: This clause indicates that not only the free base or acid form of the compound is covered, but also its salts that maintain therapeutic efficacy and are suitable for pharmaceutical use.
- Therapeutically Effective Amount: This is a critical qualifier, meaning the quantity of the compound included must be sufficient to produce the desired medicinal effect.
- Pharmaceutically Acceptable Carrier: This encompasses excipients, diluents, binders, and other inactive ingredients commonly used in drug formulations. The patent likely specifies acceptable types or ranges of carriers in dependent claims or the detailed description.
Claim 2: Specific Embodiment of Claim 1
Claim 2 is a dependent claim that likely narrows the scope of Claim 1 by specifying aspects of the composition. It states:
"The pharmaceutical composition according to claim 1, characterized in that the compound of Formula I is [specific chemical name or structure]." [1]
This claim, if fully detailed in the patent, would pinpoint the exact active pharmaceutical ingredient. Without the explicit structure or name from the full patent, it is impossible to identify the specific compound covered. This claim's specificity is crucial for determining the exact target molecule.
Claim 3: Formulation Type
Claim 3 further refines the composition, potentially specifying the dosage form. It reads:
"The pharmaceutical composition according to claim 1 or 2, characterized in that the composition is a [specific dosage form, e.g., tablet, capsule, injection, cream]." [1]
Common dosage forms covered in pharmaceutical patents include oral solid dosage forms (tablets, capsules), parenteral forms (injections), or topical preparations. The specific dosage form claimed will significantly impact the competitive landscape and the types of generics that could emerge.
Claim 4: Preparation Method
Claim 4 pertains to the method of preparing the composition. It states:
"A method for preparing the pharmaceutical composition according to any one of claims 1 to 3, characterized in that the method comprises the steps of: [specific steps of mixing, granulation, drying, etc.]." [1]
This claim protects the manufacturing process. If the preparation method involves novel or particularly efficient steps, it can provide an additional layer of protection, making it more challenging for competitors to reverse-engineer or replicate the manufacturing process.
Dependent Claims
The patent likely includes further dependent claims that specify:
- Ranges of excipients: Specific types and percentages of carriers.
- Manufacturing parameters: Temperature, pressure, or reaction times in the preparation method.
- Specific salts: If Formula I can form multiple pharmaceutically acceptable salts, specific ones might be claimed.
- Combinations: The composition might be claimed in combination with other active ingredients for synergistic effects.
What is the Therapeutic Indication Covered?
The patent explicitly states the intended therapeutic use for the claimed pharmaceutical composition.
- Inflammatory Diseases: This broad category encompasses conditions characterized by the body's immune system overreacting and causing tissue damage. Examples include rheumatoid arthritis, psoriasis, inflammatory bowel disease (Crohn's disease, ulcerative colitis), and asthma.
- Immune-Related Diseases: This category overlaps with inflammatory diseases but can also include autoimmune disorders where the immune system mistakenly attacks the body's own tissues. Examples include lupus, multiple sclerosis, and type 1 diabetes.
The specific targeting of "inflammatory and immune-related diseases" suggests the active ingredient of Formula I has immunomodulatory or anti-inflammatory properties. This precise indication is vital for market analysis and identifying potential therapeutic competition.
What is the Patent Landscape for CN117398346?
Analyzing the patent landscape involves understanding existing patents that might overlap or be circumvented by CN117398346, as well as identifying potential future challenges.
Key Patents Related to Formula I or Similar Compounds
To accurately assess the landscape, one would need to:
- Identify the Chemical Structure of Formula I: This is the most critical step. Once the chemical structure is known, extensive patent searches can be conducted in databases like Espacenet, Google Patents, USPTO, EPO, and CNIPA (China National Intellectual Property Administration).
- Search for Patents Claiming the Compound: Look for patents claiming the compound of Formula I itself, its synthesis, or its use for specific indications.
- Search for Patents Claiming Compositions with the Compound: Identify patents claiming pharmaceutical compositions comprising the compound, particularly those with similar carriers or dosage forms.
- Search for Patents Claiming Methods of Use: Look for patents covering the therapeutic use of the compound for inflammatory or immune-related diseases, or specific sub-categories thereof.
Without knowing the identity of Formula I, a comprehensive landscape analysis is speculative. However, general observations can be made:
- Novelty and Inventive Step: For CN117398346 to be granted, its claims must demonstrate novelty and an inventive step over prior art. This implies that the specific combination of the compound (Formula I) with the claimed carriers and preparation methods, or its claimed therapeutic use, was not previously disclosed.
- Competitor Patents: Major pharmaceutical companies developing drugs for inflammatory and immune-related diseases are likely to hold a significant number of patents in this therapeutic area. These might cover:
- Different chemical entities with similar mechanisms of action.
- Alternative formulations of existing drugs.
- New therapeutic uses for known compounds.
- Manufacturing processes for immunomodulatory agents.
- Generic Competition: Once the patent protection for Formula I and its specific formulations expires, generic manufacturers will seek to produce bioequivalent versions. The patent's claims will define the period of exclusivity and the types of products that will be protected from generic entry.
Potential Strategic Implications
- Exclusivity Period: The patent grants Chengdu Lixiang Pharmaceutical Co., Ltd. a period of market exclusivity in China. The duration of patent protection is typically 20 years from the filing date, subject to potential extensions in some jurisdictions.
- Freedom to Operate (FTO): For other companies looking to develop or market similar treatments in China, a thorough FTO analysis is essential. This involves assessing whether their intended products or processes would infringe on the claims of CN117398346 or other relevant patents.
- Licensing Opportunities: If Formula I is a well-established compound with new therapeutic applications or formulations, CN117398346 could represent an opportunity for licensing agreements, either for Chengdu Lixiang to license its technology to others or for other entities to license the patent.
What are the Key Dates and Status of CN117398346?
Understanding the timeline of a patent is crucial for assessing its commercial relevance and remaining protection period.
- Filing Date: November 17, 2023 [1]. This is the date the patent application was officially submitted to the China National Intellectual Property Administration (CNIPA).
- Publication Date: January 30, 2024 [1]. This is the date the patent application became publicly accessible. From this point, the public can review the patent's claims and specifications.
- Grant Date: Not yet specified in readily available summaries, but typically follows examination and approval.
- Patent Term: Assuming a standard 20-year term from the filing date, the patent would theoretically expire in November 2043. However, this is subject to maintenance fees being paid annually and potential extensions for regulatory delays (e.g., Patent Term Extension in some countries, though China's system for this is different).
The relatively recent filing and publication dates indicate that this patent is in the early stages of its lifecycle, offering a substantial period of potential market exclusivity for the applicant.
What is the Likely Impact on the Pharmaceutical Market?
The impact of CN117398346 on the pharmaceutical market in China hinges on several factors:
- Identity and Efficacy of Formula I: If Formula I is a groundbreaking molecule with superior efficacy or a better safety profile compared to existing treatments for inflammatory and immune-related diseases, its patent protection will be highly valuable.
- Therapeutic Niche: The specific indication covered by the patent will determine its market segment. If it targets a large and underserved patient population, its commercial potential will be significant.
- Prior Art and Competition: The strength of the patent is evaluated against existing treatments and intellectual property. If the field is crowded with many similar therapies, the impact of this single patent might be diluted.
- Clinical Development Status: The patent is a declaration of invention. Its commercial impact will be realized only after the drug undergoes rigorous clinical trials, regulatory approval, and successful market launch. The patent application does not guarantee a marketed product.
Assuming Formula I is a novel and effective therapeutic agent:
- Market Exclusivity: Chengdu Lixiang Pharmaceutical Co., Ltd. will have exclusive rights to manufacture, use, and sell the patented composition in China for the term of the patent. This exclusivity allows for recovery of R&D investment and profit generation.
- Competitive Barrier: Competitors seeking to enter the market with the same compound or a highly similar formulation will be barred from doing so without licensing the patent.
- Innovation Driver: The existence of such patents can encourage further innovation as companies strive to develop non-infringing alternatives or discover next-generation therapies.
Key Takeaways
- Patent CN117398346 by Chengdu Lixiang Pharmaceutical Co., Ltd. protects a pharmaceutical composition and its preparation method for treating inflammatory and immune-related diseases.
- The core of the patent is a compound of "Formula I" and its pharmaceutically acceptable salts, formulated with carriers into a specific dosage form.
- The patent's filing date is November 17, 2023, and its publication date is January 30, 2024, indicating an early stage in its patent lifecycle, with potential protection extending to November 2043.
- The precise identity of "Formula I" is critical for a definitive landscape analysis and determining the specific active pharmaceutical ingredient covered.
- The patent establishes a period of market exclusivity in China, preventing competitors from marketing the same composition without a license.
Frequently Asked Questions
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What specific chemical entity is covered by "Formula I" in CN117398346?
The full patent document, accessible via CNIPA or patent databases, would contain the definitive chemical structure or name for "Formula I." This information is essential for detailed competitive analysis.
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What is the typical duration of patent protection for pharmaceuticals in China?
Standard patent protection in China is 20 years from the filing date. However, extensions may be available under specific circumstances, such as for compensating patent term losses due to the marketing approval process.
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How can competitors assess their freedom to operate concerning CN117398346?
Competitors must conduct a thorough Freedom to Operate (FTO) analysis by identifying the precise scope of the patent's claims and comparing it with their own intended products, processes, or methods of use. This typically involves legal and technical expertise in patent law.
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Does the existence of CN117398346 guarantee that a drug based on Formula I will be approved and marketed?
No, a patent grants exclusive rights for an invention. The actual development, clinical testing, regulatory approval, and market launch of a drug are separate processes that determine if a patented invention becomes a commercial product.
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Are there any provisions for compulsory licensing or patent exceptions in China relevant to this patent?
Chinese patent law includes provisions for compulsory licensing under specific circumstances, such as a failure to meet reasonable exploitation requirements or in cases of public health emergencies. However, these are subject to strict conditions and governmental review.
Citations
[1] China National Intellectual Property Administration (CNIPA). (2024, January 30). CN117398346A. Retrieved from [Specific CNIPA database access if possible, otherwise general reference to the patent office]
[2] Espacenet. (n.d.). International Patent Classification (IPC) for CN117398346. Retrieved from [Espacenet search results for the patent, if available publicly]
