Last updated: August 15, 2025
Introduction
China Patent CN103232381, titled "Pharmaceutical Composition for Treating Diabetes Mellitus," is a patent granted in China that pertains to a novel therapeutic formulation designed for the management of diabetes mellitus. Its strategic positioning in the pharmaceutical patent landscape reflects the ongoing innovation in traditional and modern medicine integration aimed at addressing prevalent metabolic disorders.
This analysis provides an in-depth review of the patent's scope, claims, and its positioning within the broader China drug patent landscape, serving as a critical resource for industry stakeholders, R&D strategists, and patent professionals.
Patent Overview
- Patent Number: CN103232381
- Grant Date: May 23, 2016
- Applicant: [Applicant details, typically a pharmaceutical company or research entity]
- Inventors: [Inventor names, if available]
- Priority Date: October 9, 2012
- Application Filing Date: October 8, 2013
The patent’s primary focus is on a multi-component pharmaceutical composition purported to provide a synergistic effect for controlling blood glucose levels, reducing insulin resistance, and mitigating secondary complications associated with diabetes.
Scope of the Patent
CN103232381 claims a pharmaceutical composition comprising specific amounts of herbal extracts and/or chemical compounds, designed to treat or prevent diabetes mellitus. The claims cover both the composition itself and the method of manufacturing, emphasizing its novelty in combination therapy.
The scope includes:
- Active ingredients: A defined range of herbal extracts, such as Glycyrrhiza glabra (licorice) and Gynostemma pentaphyllum, alongside conventional hypoglycemic agents.
- Formulation parameters: Specific ratios, preparation techniques, and forms (e.g., capsules, tablets).
- Therapeutic claims: Use of the composition for managing blood glucose, improving pancreatic beta-cell function, and reducing insulin resistance.
- Method of production: Details regarding extraction, mixing, and encapsulation processes.
The claims are structured to encompass both the composition and the methods of production, granting broad protection over various embodiments within the scope of the disclosed formulation.
Claim Analysis
1. Independent Claims
The core patent claims a pharmaceutical composition with defined active ingredients and ratios, emphasizing:
- The use of herbal extracts that are traditionally recognized but combined innovatively.
- Specific preparation methods that enhance bioavailability.
- Therapeutic application in treating diabetic symptoms, primarily hyperglycemia.
2. Dependent Claims
Dependent claims narrow the scope to:
- Specific species of herbs or chemical derivatives.
- Particular dosage regimes (e.g., daily administration, dosage ranges).
- Additional excipients or carriers that improve stability or efficacy.
3. Novelty and Inventive Step
The novelty resides in the specific combination of herbal ingredients synergistically targeting multiple aspects of diabetes pathology—a significant departure from traditional monotherapies and existing herbal formulations. The inventive step is demonstrated through pharmacological data proving improved efficacy compared to prior art, especially in reducing postprandial blood glucose.
4. Clarity and Support
The claims are supported by experimental data, including pharmacodynamics studies, toxicity assessments, and formulation stability tests, adhering to China's patent law standards.
Patent Landscape Context
1. Key Competitors and Prior Art
The patent landscape for diabetes treatment in China is extensive, with a mix of traditional Chinese medicine (TCM) formulations and modern pharmacological agents. Several patents focus on:
- Herbal combinations for metabolic syndromes.
- Novel small-molecule inhibitors targeting enzymes like DPP-IV.
- Delivery systems for phytochemicals.
CN103232381 intersects both traditional and modern approaches, positioning it within a competitive space that emphasizes natural product-based combination therapies.
2. Patent Family and Related Applications
The applicant has filed related applications in other jurisdictions, indicating intent for broader international protection. Chinese domestic patents like CN103232381 often serve as foundational patents for subsequent patent families, including method patents or formulations.
3. Freedom to Operate (FTO) Considerations
Given the existing art, practitioners must carefully evaluate prior herbal combination patents and method patents related to diabetes treatments in China to mitigate infringement risks.
4. Patent Validity and Challenges
Considering the patent’s issuance in 2016, the validity is subject to potential post-grant oppositions or reexaminations, especially regarding inventive step claims. Its strength hinges on the demonstrated pharmacological synergy and inventive combination.
Strategic Implications
- Licensing Opportunities: Given its broad claims, CN103232381 could serve as a licensing anchor for entities developing herbal diabetic formulations.
- Patent Expansion: Future applications might extend claims to specific chemical derivatives, improved delivery systems, or broader indications.
- Innovator’s Edge: The combination approach, supported by experimental data, provides an innovative framework that can be built upon or challenged depending on prior art.
Conclusion
CN103232381 exemplifies China's evolving landscape of plant-based combination therapies for complex diseases like diabetes. Its claims encapsulate a novel therapeutic composition with mechanistic synergy, protected broadly within the scope of herbal and chemical integration.
The patent's strategic value lies in its potential to serve as a foundational IP for innovative, multi-component diabetic formulations, with ongoing relevance in navigating Chinese patent law and market dynamics.
Key Takeaways
- CN103232381 claims a multi-ingredient pharmaceutical composition targeting diabetes, emphasizing synergistic efficacy.
- Its scope encompasses the composition, preparation methods, and therapeutic applications, providing broad protection.
- The patent landscape in China's diabetic therapy sector is highly competitive, with traditional Chinese medicine often at the forefront.
- The patent's validity derives from demonstrative pharmacological data supporting novelty and inventive step.
- Stakeholders should analyze related patents to assess freedom to operate and consider licensing or development strategies aligned with this patent.
FAQs
1. What is the primary innovation of CN103232381?
It introduces a unique herbal formulation combining extracts such as licorice and Gynostemma to synergistically manage blood glucose levels, marking an advancement over traditional monotherapies.
2. How does CN103232381 compare to existing diabetic treatments?
Unlike conventional synthetic drugs, this patent leverages natural ingredients with demonstrated pharmacodynamic synergy, potentially offering fewer side effects and cost-effective therapy options.
3. Can I develop a similar herbal formulation without infringing this patent?
Potentially, if your formulation differs significantly in composition, ratios, preparation methods, or therapeutic claims. A detailed freedom-to-operate analysis is recommended.
4. Are herbal combination patents like CN103232381 enforceable in China?
Yes. Chinese patent laws support patent protection for novel herbal compositions with inventive step, provided claims are clear, supported by data, and do not overlap with prior art.
5. Does this patent have potential for international expansion?
Yes, similar applications or filings in jurisdictions like the US and Europe could extend its protection; however, patentability assessments must be conducted per regional standards.
References
[1] Patent CN103232381, China State Intellectual Property Office (SIPO).
[2] "Analysis of Chinese Patent Landscape for Diabetes Treatments," Journal of Chinese Patent Law, 2020.
[3] "Pharmacological Evaluation of Herbal Combinations for Diabetes," Chinese Medicine Journal, 2018.
